Talazoparib Tosylate

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2025 and reaffirmed its 2025 financial guidance(1). EXECUTIVE COMMENTARY Dr. Albert Bourla, Chairman and CEO of Pfizer: “We continued to execute with focus and discipline against our strategic priorities, including strengthening our R&D organization and driving improved productivity. With the underlying strength of our business, we believe we can be agile in navigating an uncertain and volatile external environment.” David Denton, CFO and EVP of Pfizer: “Our overall solid first-quarter performance demonstrates our continued focus on commercial execution amid U.S. Medicare Part D headwinds. Our focus on operational efficiency and financial discipline is driving strong results to our bottom line. We are currently trending towards the upper end of our 2025 Adjusted diluted EPS guidance range.” OVERALL RESULTS Additional Anticipated Net Cost Savings of Approximately $1.2 Billion (4) Primarily in SI&A by End of 2027 Expanded Program to Include Anticipated R&D Re-Organization Cost Savings of Approximately $500 Million by End of 2026, with Savings to be Reinvested in the Pipeline Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(5). Results for the first quarter of 2025 and 2024(6) are summarized below. ($ in millions, except per share amounts) First-Quarter 2025 2024 % Change Revenues $ 13,715 $ 14,879 (8 %) Reported(2) Net Income 2,967 3,115 (5 %) Reported(2) Diluted EPS 0.52 0.55 (5 %) Adjusted(3) Income 5,237 4,674 12 % Adjusted(3) Diluted EPS 0.92 0.82 12 % REVENUES ($ in millions) First-Quarter 2025 2024 % Change Total Oper. Global Biopharmaceuticals Business (Biopharma) $ 13,441 $ 14,604 (8 %) (6 %) Pfizer CentreOne (PC1) 257 258 — 2 % Pfizer Ignite 17 17 (3 %) (3 %) TOTAL REVENUES $ 13,715 $ 14,879 (8 %) (6 %) 2025 FINANCIAL GUIDANCE(1) Pfizer’s 2025 financial guidance(1) is presented below. Revenues $61.0 to $64.0 billion Adjusted(3) SI&A Expenses $13.3 to $14.3 billion Adjusted(3) R&D Expenses $10.7 to $11.7 billion Effective Tax Rate on Adjusted(3) Income Approximately 15.0% Adjusted(3) Diluted EPS $2.80 to $3.00 CAPITAL ALLOCATION During the first three months of 2025, Pfizer deployed its capital in a variety of ways, which primarily included: $2.2 billion invested in internal research and development projects, and Approximately $90 million invested in business development transactions. No share repurchases have been completed to date in 2025. As of April 29, 2025, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. Pfizer has actively de-levered and as of March 30, 2025 is below our previously stated gross leverage(7) target. The company expects to continue to de-lever in a prudent manner in order to maintain a balanced capital allocation strategy. This includes maintaining the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases. Diluted weighted-average shares outstanding of 5,710 million and 5,697 million were used to calculate Reported(2) and Adjusted(3) diluted EPS for first-quarter 2025 and 2024, respectively. QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2025 vs. First-Quarter 2024) First-quarter 2025 revenues totaled $13.7 billion, a decrease of $1.2 billion, or 8%, compared to the prior-year quarter, reflecting an operational decrease of $908 million, or 6%, as well as an unfavorable impact of foreign exchange of $256 million, or 2%. The operational decrease was primarily driven by a decline in Paxlovid revenues, partially offset by growth from the Vyndaqel family, Comirnaty(8), and several other products across categories despite the unfavorable impact of higher manufacturer discounts resulting from the Inflation Reduction Act (IRA) Medicare Part D Redesign. First-quarter 2025 operational revenue reflected higher revenues primarily for: more than offset primarily by lower revenues for: GAAP Reported(2) Statement of Operations Highlights SELECTED REPORTED(2) COSTS AND EXPENSES ($ in millions) First-Quarter 2025 2024 % Change Total Oper. Cost of Sales(2) $ 2,845 $ 3,379 (16 %) (9 %) Percent of Revenues 20.7 % 22.7 % N/A N/A SI&A Expenses(2) 3,031 3,495 (13 %) (12 %) R&D Expenses(2) 2,203 2,493 (12 %) (11 %) Acquired IPR&D Expenses(2) 9 — * * Other (Income)/Deductions—net(2) 953 680 40 % 54 % Effective Tax Rate on Reported(2) Income (6.8 %) 8.6 % * Indicates calculation not meaningful or results are greater than 100%. First-quarter 2025 Cost of Sales(2) as a percentage of revenues decreased by 2.0 percentage points compared to the prior-year quarter, driven primarily by a favorable revision of our estimate of accrued royalties and the favorable impact of foreign exchange, partially offset by the unfavorable impact of changes in sales mix as well as the non-recurrence of the Paxlovid favorable final adjustment(9) recorded in the first quarter of 2024 to the estimated non-cash revenue reversal recorded in the fourth quarter of 2023. First-quarter 2025 SI&A Expenses(2) decreased 12% operationally compared with the prior-year quarter, primarily reflecting ongoing productivity improvements that drove a decrease in marketing and promotional spend for various products and lower spending in corporate enabling functions, as well as lower spending on COVID-19 products. First-quarter 2025 R&D Expenses(2) decreased 11% operationally compared with the prior-year quarter, driven primarily by a net decrease in spending due to pipeline focus and optimization, as well as lower compensation-related expenses. The unfavorable period-over-period change in Other (income)/deductions—net(2) of $273 million for the first quarter of 2025, compared with the prior-year quarter, was driven primarily by (i) net losses on equity securities in the first quarter of 2025 versus net gains on equity securities in the first quarter of 2024, (ii) the non-recurrence of a gain on the partial sale of our investment in Haleon plc in the first quarter of 2024 and (iii) higher intangible asset impairment charges; partially offset by (iv) lower net interest expense. Pfizer’s effective tax rate on Reported(2) income for the first quarter of 2025 is negative, primarily due to favorable global income tax resolutions in multiple tax jurisdictions spanning multiple tax years, as well as a favorable change in the jurisdictional mix of earnings. Adjusted(3) Statement of Operations Highlights SELECTED ADJUSTED(3) COSTS AND EXPENSES ($ in millions) First-Quarter 2025 2024 % Change Total Oper. Adjusted(3) Cost of Sales $ 2,593 $ 3,036 (15 %) (8 %) Percent of Revenues 18.9 % 20.4 % N/A N/A Adjusted(3) SI&A Expenses 3,010 3,454 (13 %) (12 %) Adjusted(3) R&D Expenses 2,173 2,477 (12 %) (12 %) Adjusted(3) Other (Income)/Deductions—net 246 296 (17 %) 14 % Effective Tax Rate on Adjusted(3) Income 7.8 % 16.6 % See the reconciliations of certain Reported(2) to non-GAAP Adjusted(3) financial measures and associated footnotes in the financial tables section of this press release located at the hyperlink below. RECENT NOTABLE DEVELOPMENTS (Since February 4, 2025) Product Developments Product/Project Milestone Recent Development Link Abrysvo (Respiratory Syncytial Virus Vaccine) Regulatory April 2025. Announced the European Commission (EC) amended the marketing authorization for Abrysvo to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age. The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. Full Release ACIP Vote April 2025. Announced the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of RSV vaccines approved for adults 50-59 years of age at increased risk of RSV-associated LRTD, which includes Abrysvo. The updated ACIP recommendation, which lowers the recommended age for RSV vaccination from 60 to 50 for high-risk adults, is pending final approval by the director of the CDC and the Department of Health and Human Services. Full Release Adcetris (brentuximab vedotin) Regulatory February 2025. Announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Adcetris in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma, after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy. Full Release Padcev (enfortumab vedotin-ejfv) Phase 3 Results February 2025. Pfizer and Astellas Pharma Inc. presented additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of Padcev plus Keytruda(10) (pembrolizumab, a PD-1 inhibitor) in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months), with no new safety signals identified. Full Release Talzenna (talazoparib) Phase 3 Results February 2025. Announced positive OS results from the Phase 3 TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI), demonstrating a statistically significant and clinically meaningful improvement in OS compared to placebo plus Xtandi in patients with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The safety profile of Talzenna plus Xtandi was generally consistent with the known safety profile of each medicine. Full Release Pipeline Developments A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration. Product/Project Milestone Recent Development Link danuglipron Discontinued April 2025. Announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management. This decision followed a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators. The company remains committed to evaluating and advancing promising programs for cardiovascular and metabolic diseases, including obesity. Full Release sasanlimab Phase 3 Results April 2025. Presented results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The findings showed a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression, with the sasanlimab combination regimen as compared with SOC treatment alone. The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors. Pfizer has shared these data with global health authorities to support potential regulatory filings. Full Release vepdegestrant Phase 3 Results March 2025. Arvinas, Inc. and Pfizer announced topline results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, demonstrating a statistically significant and clinically meaningful improvement in PFS compared to fulvestrant. The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population. Full Release Corporate Developments Topic Recent Development Link Cost Realignment Program(4) Announced at Q1-2025 Earnings. Pfizer announced approximately $1.2 billion of additional anticipated savings associated with its ongoing cost realignment program(4), expected to be achieved by the end of 2027, designed to further reduce costs primarily in SI&A driven in large part by enhanced digital enablement, including automation and AI, and simplification of business processes. We expect one-time costs to achieve the additional savings to be incurred through 2027 and to total approximately $1.6 billion, primarily representing cash expenditures for severance, digital enablement and implementation. We remain on track to deliver net cost savings of approximately $4.5 billion by the end of 2025, and, with the additional targeted savings, we now expect total net cost savings of approximately $5.7 billion from this program through 2027. N/A Announced at Q1-2025 Earnings. In connection with our efforts to simplify the structure and sharpen the focus of our R&D organization, in the first quarter of 2025 we expanded this program after having identified additional opportunities to drive improvements in productivity and operational efficiencies through enhanced digital enablement, including automation and AI, and simplification of business processes. Savings associated with the simplification of our R&D organization are anticipated to be realized by the end of 2026 and are expected to total approximately $500 million and be reinvested in R&D programs. We expect one-time costs to implement these initiatives to be incurred through 2026 and to total approximately $600 million, primarily representing cash expenditures for severance, digital enablement and implementation. N/A Haleon Stock Sale March 2025. Pfizer sold 618 million ordinary shares of its investment in Haleon to institutional investors and separately Haleon purchased 44 million ordinary shares from Pfizer for a combined total net proceeds of approximately $3.3 billion. This follows the previously announced sale of 700 million Haleon shares in January 2025 which resulted in approximately $3.0 billion in net cash proceeds. Pfizer has fully exited its position in Haleon. N/A R&D Leadership March 2025. James List, M.D., Ph.D., joined Pfizer as Chief Internal Medicine Officer, overseeing the company’s Internal Medicine portfolio, from early discovery to late development, inclusive of Medical Affairs and Business Development strategies. He is responsible for advancing Pfizer’s emerging pipeline of cardiovascular, metabolic, and obesity medicines. Dr. List reports to Chris Boshoff, M.D., Ph.D., Chief Scientific Officer and President, Pfizer Research & Development. Full Release February 2025. Announced Jeffrey Legos, Ph.D., MBA, will join Pfizer as Chief Oncology Officer and will be responsible for leading the company’s Oncology R&D, overseeing all functions from pre-clinical to late-stage clinical development activities. Dr. Legos will report to Chris Boshoff, and will succeed Roger Dansey, M.D., Interim Chief Oncology Officer, who will transition to retirement as previously communicated. Full Release February 2025. Announced Patrizia Cavazzoni, M.D., rejoined Pfizer as Chief Medical Officer, Executive Vice President. In this role, Dr. Cavazzoni leads Pfizer’s regulatory, pharmacovigilance, safety, epidemiology, and medical information and evidence generation, among other medical functions, and reports to Chris Boshoff. Full Release PFIZER TO HOST CONFERENCE CALL Please find Pfizer’s press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink: https://investors.pfizer.com/Q1-2025-PFE-Earnings-Release (Note: If clicking on the above link does not open a new webpage, you may need to cut and paste the above URL into your browser's address bar.) Pfizer will host a live conference call and webcast today at 10:00 AM EDT. To access the live conference call and view the first-quarter 2025 earnings presentation, accompanying prepared remarks from management, and infographic, visit our website at pfizer.com/investors. You can also listen to the conference call by dialing either 800-456-4352 in the U.S. and Canada or 785-424-1086 outside of the U.S. and Canada. The passcode is “67619”. The transcript and webcast replay of the call will be made available on our website at pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days. For additional details, see the financial schedules and product revenue table within the press release located at the hyperlink above, and the attached disclosure notice. (1) Pfizer does not provide guidance for U.S. generally accepted accounting principles (GAAP) Reported financial measures (other than revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of unusual gains and losses, certain acquisition-related expenses, gains and losses from equity securities, actuarial gains and losses from pension and postretirement plan remeasurements, potential future asset impairments and pending litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period. Financial guidance for full-year 2025 reflects the following: Does not assume the completion of any business development transactions not completed as of March 30, 2025. An anticipated unfavorable revenue impact of approximately $0.6 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost patent or regulatory protection or that are anticipated to lose patent or regulatory protection. Exchange rates assumed are a blend of actual rates in effect through first-quarter 2025 and mid-April 2025 rates for the remainder of the year. Guidance for Adjusted (3) diluted EPS assumes diluted weighted-average shares outstanding of approximately 5.74 billion shares, and assumes no share repurchases in 2025. Does not currently include any potential impact related to future tariffs and trade policy changes, which we are unable to predict at this time. (2) Revenues is defined as revenues in accordance with U.S. GAAP. Reported net income and its components are defined as net income attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP. (3) Adjusted income and Adjusted diluted EPS are defined as U.S. GAAP net income attributable to Pfizer Inc. common shareholders and U.S. GAAP diluted EPS attributable to Pfizer Inc. common shareholders before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the first quarter of 2025 and 2024 in the press release at the hyperlink above. Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS(2). See the Non-GAAP Financial Measure: Adjusted Income section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s 2024 Annual Report on Form 10-K and the accompanying Non-GAAP Financial Measure: Adjusted Income section of the press release located at the hyperlink above for a definition of each component of Adjusted income as well as other relevant information. (4) Approximately $4.5 billion of overall net cost savings from Pfizer’s ongoing cost realignment program are expected to be achieved by the end of 2025. An additional approximately $1.2 billion of anticipated net cost savings is expected to be fully achieved by the end of 2027. The net cost savings are calculated versus the midpoint of Pfizer’s 2023 SI&A and R&D expense guidance provided on August 1, 2023. (5) References to operational variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although foreign exchange rate changes are part of Pfizer’s business, they are not within Pfizer’s control and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer’s results. (6) Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer’s first quarter for U.S. subsidiaries reflects the three months ended on March 30, 2025 and March 31, 2024, while Pfizer’s first quarter for subsidiaries operating outside the U.S. reflects the three months ended on February 23, 2025 and February 25, 2024. (7) Gross leverage (Adjusted Debt to Non-GAAP Adjusted EBITDA ratio) is determined by comparing our total debt (including short-term borrowings, long-term debt, repatriation tax, and lease liabilities (short- and long-term)) as of March 30, 2025 to Non-GAAP Adjusted EBITDA. Non-GAAP Adjusted EBITDA is determined by making the following adjustments to GAAP Income from continuing operations before provision/(benefit) for taxes on income: (i) adding net interest expense, depreciation & amortization, acquisition-related charges, restructuring charges and asset impairment charges; and (ii) adjusting by actuarial valuation and other pension and postretirement plan gains/(losses), gains/(losses) on equity securities, and certain other certain significant items. (8) As used in this document, “Comirnaty” refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine; Comirnaty (COVID-19 Vaccine, mRNA) original monovalent formula; the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5); the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula); Comirnaty (COVID-19 Vaccine, mRNA) 2023-2024 Formula; Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula); Comirnaty (COVID-19 Vaccine, mRNA) 2024-2025 Formula; Comirnaty Original/Omicron BA.1; Comirnaty Original/Omicron BA.4/BA.5; Comirnaty Omicron XBB.1.5; Comirnaty JN.1 and Comirnaty KP.2. “Comirnaty” includes product revenues and alliance revenues related to sales of the above-mentioned vaccines. (9) First-quarter 2024 Paxlovid revenue included a $771 million favorable final adjustment to the estimated non-cash revenue reversal of $3.5 billion recorded in fourth-quarter 2023, reflecting 5.1 million EUA-labeled treatment courses returned by the U.S. government through February 29, 2024 versus the estimated 6.5 million treatment courses that were expected to be returned as of December 31, 2023. (10) Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of April 29, 2025. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments. This earnings release and the related attachments contain forward-looking statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; reorganizations; business plans, strategy, goals and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, discontinuations, clinical trial results and other developing data, revenue contribution and projections, potential pricing and reimbursement, potential market dynamics, including demand, market size and utilization rates and growth, performance, timing of exclusivity and potential benefits; strategic reviews; leverage and capital allocation objectives; an enterprise-wide cost realignment program (including anticipated costs, savings and potential benefits); a Manufacturing Optimization Program to reduce our cost of goods sold (including anticipated costs, savings and potential benefits); dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, including our December 2023 acquisition of Seagen, and our ability to successfully capitalize on growth opportunities and prospects; manufacturing and product supply; our ongoing efforts to respond to COVID-19; our expectations regarding the impact of COVID-19 on our business, operations and financial results; and the expected seasonality of demand for certain of our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions and we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Pfizer’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: Risks Related to Our Business, Industry and Operations, and Business Development: the outcome of research and development (R&D) activities, including the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; risks associated with preliminary, early stage or interim data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from our pipeline programs will be published in scientific journal publications, and if so, when and with what modifications and interpretations; and uncertainties regarding the future development of our product candidates, including whether or when our product candidates will advance to future studies or phases of development or whether or when regulatory applications may be filed for any of our product candidates; our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval for new products and indications from regulators on a timely basis or at all; regulatory decisions impacting labeling, approval or authorization, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; uncertainties regarding the ability to obtain or maintain, and the scope of, recommendations by technical or advisory committees, and the timing of, and ability to obtain, pricing approvals and product launches, all of which could impact the availability or commercial potential of our products and product candidates; claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the conduct or outcome of post-approval clinical trials, pharmacovigilance or Risk Evaluation and Mitigation Strategies, which could impact marketing approval, product labeling, and/or availability or commercial potential; the success and impact of external business development activities, including the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which has in the past and could in the future result in increased leverage and/or a downgrade of our credit ratings and could limit our ability to obtain future financing; challenges integrating the businesses and operations; disruption to business or operations relationships; risks related to growing revenues for certain acquired or partnered products; significant transaction costs; and unknown liabilities; competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product candidates; the ability to successfully market both new and existing products, including biosimilars; difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on; and legal or regulatory actions; the impact of public health outbreaks, epidemics or pandemics (such as COVID-19) on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials; risks and uncertainties related to Comirnaty and Paxlovid or any potential future COVID-19 vaccines, treatments or combinations, including, among others, the risk that as the market for COVID-19 products remains endemic and seasonal, demand for our COVID-19 products has and may continue to be reduced or not meet expectations, which has in the past and may continue to lead to reduced revenues, excess inventory or other unanticipated charges; risks related to our ability to develop and commercialize variant adapted vaccines, combinations and/or treatments; uncertainties related to recommendations and coverage for, and the public’s adherence to, vaccines, boosters, treatments or combinations; and potential third-party royalties or other claims related to Comirnaty and Paxlovid; trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products; interest rate and foreign currency exchange rate fluctuations, including the impact of global trade tensions, as well as currency devaluations and monetary policy actions in countries experiencing high inflation or deflation rates; any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues; the impact of the increased presence of counterfeit medicines, vaccines or other products in the pharmaceutical supply chain; any significant issues related to the outsourcing of certain operational and staff functions to third parties; any significant issues related to our JVs and other third-party business arrangements, including modifications or disputes related to supply agreements or other contracts with customers including governments or other payors; uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions, such as inflation or interest rate fluctuations, and recent and possible future changes in global financial markets; the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation, sanctions, tariffs and/or other restrictive government actions, changes in intellectual property legal protections and remedies, unstable governments and legal systems and inter-governmental disputes; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy regarding tariffs; the risk and impact of tariffs on our business, which is subject to a number of factors including, but not limited to, restrictions on trade, the effective date and duration of such tariffs, countries included in the scope of tariffs, changes to amounts of tariffs, and potential retaliatory tariffs or other retaliatory actions imposed by other countries; the impact of disruptions related to climate change and natural disasters; any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, political or civil unrest or military action, including the ongoing conflicts between Russia and Ukraine and in the Middle East and the resulting economic or other consequences; the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, such as our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines, and our voluntary withdrawal of all lots of Oxbryta in all markets where it is approved and any regulatory or other impact on Oxbryta and other sickle cell disease assets; trade buying patterns; the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments; the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives and growth strategies, and cost-reduction and productivity initiatives, including any potential future phases, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs, organizational disruption, adverse effects on employee morale, retention issues or other unintended consequences; the ability to successfully achieve our climate-related goals and progress our environmental sustainability and other priorities; Risks Related to Government Regulation and Legal Proceedings: the impact of any U.S. healthcare reform or legislation, including executive orders or other change in laws, regulations or policy, or any significant spending reduction or cost control efforts affecting Medicare, Medicaid, the 340B Drug Pricing Program or other publicly funded or subsidized health programs, including the Inflation Reduction Act of 2022 (IRA) and the IRA Medicare Part D Redesign, or changes in the tax treatment of employer-sponsored health insurance that may be implemented; U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, reimbursement or access to or recommendations for our medicines and vaccines, taxes or other restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive biopharmaceutical markets; risks and uncertainties related to potential changes to vaccine or other healthcare policy in the U.S.; legislation or regulatory action in markets outside of the U.S., such as China or Europe, including, without limitation, laws related to pharmaceutical product pricing, intellectual property, medical regulation, environmental protections, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain products to control costs in those markets; legal defense costs, insurance expenses, settlement costs and contingencies, including without limitation, those related to legal proceedings and actual or alleged environmental contamination; the risk and impact of an adverse decision or settlement and risk related to the adequacy of reserves related to legal proceedings; the risk and impact of tax related litigation and investigations; governmental laws, regulations and policies affecting our operations, including, without limitation, the IRA, as well as changes in such laws, regulations or policies or their interpretation, including, among others, changes in tariffs, tax laws and regulations internationally and in the U.S., the adoption of global minimum taxation requirements outside the U.S. generally effective in most jurisdictions since January 1, 2024, government cost-cutting measures and related impacts on, among other matters, government staffing, resources and ability to timely review and process regulatory or other submissions, and potential changes to existing tax laws, tariffs, or changes to other laws, regulations or policies in the U.S., including by the U.S. Presidential administration and Congress, as well as in other countries; Risks Related to Intellectual Property, Technology and Cybersecurity: the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all; risks to our products, patents and other intellectual property, such as: (i) claims of invalidity that could result in loss of patent coverage; (ii) claims of patent infringement, including asserted and/or unasserted intellectual property claims; (iii) claims we may assert against intellectual property rights held by third parties; (iv) challenges faced by our collaboration or licensing partners to the validity of their patent rights; or (v) any pressure from, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products, including Comirnaty and Paxlovid; any significant breakdown or interruption of our information technology systems and infrastructure (including cloud services); any business disruption, theft of confidential or proprietary information, security threats on facilities or infrastructure, extortion or integrity compromise resulting from a cyber-attack, which may include those using adversarial artificial intelligence techniques, or other malfeasance by, but not limited to, nation states, employees, business partners or others; and risks and challenges related to the use of software and services that include artificial intelligence-based functionality and other emerging technologies. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether. The information contained on our website or any third-party website is not incorporated by reference into this earnings release. All trademarks mentioned are the property of their owners. Certain of the products and product candidates discussed in this earnings release are being co-researched, co-developed and/or co-promoted in collaboration with other companies for which Pfizer’s rights vary by market or are the subject of agreements pursuant to which Pfizer has commercialization rights in certain markets.

Check back to this tracker for regulatory updates on marketed drugs, including expansions into new geographies and indications. Welcome to Fierce Pharma's regulatory tracker for the first half of 2025. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Be sure to come back regularly for the latest updates.UPDATED: Friday, March 14 at 9:25 a.m. ETChina's National Medical Products Administration (NMPA) has approved Innovent's Sycume as a treatment for thyroid eye disease (TED).The drug, also known as teprotumumab N01, becomes the first anti-insulin-like growth factor 1 receptor (IGF-1R) antibody to score approval in the country.In a press release, Innovent said the drug's approval "has ended a 70-year drought of no new treatment option for TED in China."In the U.S., teprotumumab is marketed by Amgen as Tepezza. In Europe, officials have expanded the label for Bristol Myers Squibb's cell therapy Breyanzi.Specifically, the European Commission approved the drug for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.The approval is based on results from the global phase 2 study called TRANSCEND FL, which enrolled patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL. In the third-line-plus treatment setting, 97.1% of patients responded to the drug, and 94.2% of patients achieved a complete response.Before this approval, Breyanzi had scored EU nods to treat certain patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma and primary mediastinal large B-cell lymphoma.UPDATED: Thursday, March 13 at 8:30 a.m. ETKelun-Biotech's TROP 2 ADC sacituzumab tirumotecan (sac-TMT) has scored its second approval in China.The country's National Medical Products Administration (NMPA) approved the drug to treat certain adults with EGFR-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The nod covers the drug's use in patients who have progressed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy, Kelun said in a press release.With the approval, sac-TMT becomes the first TROP2 ADC approved to treat lung cancer anywhere in the world, according to the company.In a pivotal study, the drug "demonstrated a statistically significant and clinically meaningful improvement" in objective response rate, progression-free survival and overall survival compared with docetaxel, Kelun said. The study tested the drugs in patients with locally advanced or metastatic EGFR-mutant NSCLC who failed after prior treatment with an EGFR-TKI and platinum-based chemo.The approval is sac-TMT's second in the country after the NMPA approved it to treat certain patients with  triple negative breast cancer last year.In 2022, Merck & Co. licensed ex-China rights to the drug.UPDATED: Friday, March 7 at 9:35 a.m. ETThe European Commission (EC) has signed off on Bristol Myers Squibb’s immunotherapy combination of Opdivo and Yervoy to treat first-line patients with advanced or unresectable hepatocellular carcinoma (HCC).The nod was based on Opdivo and Yervoy showing an overall survival edge in the CheckMate-9DW trial over an investigator's choice of oral treatments.The Opdivo-Yervoy combo also faces an FDA decision date of April 21 to treat unresectable HCC. In 2020, the FDA granted accelerated approval to Opdivo-Yervoy to treat second-line advanced HCC.Opdivo and Yervoy were originally approved to treat melanoma, in 2014 and 2011 respectively. In combination, they have been blessed by the FDA in four other cancer types: renal cell carcinoma (2018), colorectal cancer (2018), mesothelioma (2020) and lung cancer (2020).Approximately 90% of liver cancer diagnoses are of the HCC type, BMS said. Liver cancer is the world’s third leading cause of cancer deaths.The FDA has expanded its approval for ALK’s immunotherapy Odactra for house dust mite (HDM) allergies to children ages 5 through 11. The under-the-tongue tablet was originally approved for adults in 2017 and then for adolescents ages 12 to 17 in 2023.UPDATED: Thursday, March 6 at 9:45 a.m. ETARS Pharmaceuticals needle-free epinephrine option, neffy nasal spray, can now be used to treat type 1 allergic reactions including anaphylaxis in children.To win the pediatric nod from the FDA, ARS ran studies proving that pharmacokinetic and pharmacodynamic responses from neffy in both children and adults were consistent with that of standard epinephrine injection products. The label expansion comes after the drug’s August approval as the first major innovation in epinephrine delivery in more than 35 years. Needle-free delivery is especially significant in the pediatric population as many children and caregivers fear needle-based auto-injectors, standing to delay lifesaving treatment.Human factor studies also show that children as young as 10 can use the nasal spray effectively and that untrained individuals, such as babysitters or teachers, can also correctly administer the drug. In the U.S., nearly 4 out of every 10 epinephrine prescriptions are for children under the age of 18 and some one in 13 children have severe food allergies, with more than 40% having experienced severe reactions, according to ARS. UPDATED: Wednesday, March 5 at 10:10 a.m. ETRoche's supplemental biologics application for Gazyva to treat lupus nephritis has been accepted for review by the FDA, the company said in a Wednesday press release.The filing leverages results from the phase 3 REGENCY study, which showed that 46.4% of patients with lupus nephritis who received Gazyva plus standard care achieved a complete renal response after 76 weeks. For patients who received standard care alone, the number was 33.1%, according to study results published last month.First approved in 2013, Gazyva is already cleared to treat chronic lymphocytic leukemia and follicular lymphoma in certain situations.The FDA is expected to make a decision on the lupus nephritis filing by October, according to Roche.UPDATED: Monday, March 3 at 4:30 p.m. ETDespite a reconsideration after a prior rejection, Australian drug regulators ultimately passed on Eisai's BioArtic-partnered Alzheimer’s disease treatment Leqembi. The Therapeutic Goods Administration (TGA) of Australia first decided against approval for patients with early Alzheimer’s disease in October. Eisai then requested reconsideration of the decision in December, proposing the same narrow indication given to the drug by the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA). Those approvals stipulate that Leqembi can only be used in patients with one or no copies of the ApoE4 gene due to safety concerns linking two copies of the gene to increased risks of brain swelling and bleeding, a side effect known as Amyloid Related Imaging Abnormalities (ARIAs).However, the TGA did not agree with the safety profile of Leqembi in ApoE4 heterozygotes, or those with one copy of the ApoE4 gene. Instead, the regulator offered an alternative narrow indication covering only ApoE4 noncarriers. Eisai floated other indications instead, including one that would keep the ApoE4 noncarrier and heterozygote patient populations but require heterozygotes to receive treatment in specialist centers with expert physician supervision. Still, the TGA rejected those options.BioArtic, Eisai’s long-time research partner that originally developed the antibody that became Leqembi, said it’s “very disappointed” by TGA’s decision, CEO Gunilla Osswald said in a statement. Eisai said it remains committed to ensuring eligible Australians can access the treatment and is “exploring options” to achieve this including a potential review by Australia’s Administrative Review Tribunal. UPDATED: Friday, Feb. 28 at 10:30 a.m. ETThe CDC said it's investigating five hospitalizations related to heart and nervous system events following vaccination with Valneva's Ixchiq among people 65 years and older. Ixchiq became the first FDA-approved chikungunya vaccine in November 2023. The CDC currently recommends the live-attenuated shot to be used for adults traveling to a country or territory where there is a chikungunya outbreak. Based on information from the CDC, at least four of the five individuals had also received other vaccines, and most of them had significant underlying medical conditions, a Valneva spokesperson said in a statement to Fierce Pharma."Valneva has not identified any safety signal concerns through post-marketing safety monitoring, including periodic safety reports and routine signal detection activities, and Ixchiq’s safety profile remains consistent with clinical trial data, unchanged and positive," the spokesperson said.The CDC said findings from its investigation will be discussed with experts at an Advisory Committee on Immunization Practices (ACIP) meeting. This year's first ACIP meeting, which was supposed to take place this week, was postponed with no new time provided by the CDC.The U.K. has approved Moderna's respiratory syncytial virus (RSV) vaccine mRESVIA to protect patients ages 60 and over against lower respiratory tract disease caused by the virus.In a study conducted in about 37,000 older adults, people who received mRESVIA had a 79% reduction in their risk of getting lower respiratory tract disease caused by RSV, compared with those who received placebo, around four months after vaccination.The shot will be manufactured at the Moderna Innovation and Technology Centre in Oxfordshire, which will be fully operational later this year, CEO Stéphane Bancel said in a statement.As is the case in the U.S., Moderna's mRNA shot will compete with GSK's Arexvy and Pfizer's Abrysvo in the U.K. as well.UPDATED: Thursday, Feb. 27 at 8:32 a.m. ETAfter being turned away by the FDA nearly one year ago, Regeneron this week said that the U.S. agency has accepted for review its biologics license application for bispecific antibody odronextamab.The FDA is expected to act on the application by July 30, Regeneron said in a Wednesday press release.In March of 2024, the agency rejected an accelerated approval filing for the drug based on the timeline of Regeneron's ongoing confirmatory trials. That decision spurred some confusion at Regeneron—and beyond—about a new requirement from the agency that confirmatory trials be "well underway" by the time it awards accelerated approvals.Early this year, the FDA sought to clear up the issue with new guidance on its expectations around accelerated approvals and confirmatory trial timelines.Nevertheless, Regeneron's review for the drug to treat patients with relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy now appears back on track. In its latest press release, Regeneron said the resubmission "follows the achievement of an FDA-mandated enrollment target for the Phase 3 confirmatory trial." As the company notes, the enrollment target was the "sole approvability issue identified by the FDA" in its last submission.In Europe, regulators last year approved the drug for patients with R/R FL and R/R diffuse large B-cell lymphoma after two or more lines of systemic therapy. The medicine carries the brand name Ordspono in the region.In a phase 2 study, 80% of patients with FL who were treated with odronextamab responded to the therapy, with 74% achieving a complete response.UPDATED: Tuesday, Feb. 25 at 9:30 a.m. ETMerck's Keytruda, already boasting some 40 FDA approvals, has picked up a priority review in a proposed new use.The company's filing for the drug as part of a perioperative regimen for patients with resectable locally advanced head and neck squamous cell carcinoma has been accepted for a speedy review, Merck said on Tuesday.The filing seeks approval for Keytruda as a neoadjuvant treatment prior to surgery, followed by its administration as an adjuvant treatment in combination with standard of care radiotherapy—with or without cisplatin—after surgery. Afterward, the company's filing proposes Keytruda being used as a single agent.Merck's application leverages results from the KEYNOTE-689 trial, which showed that the perioperative regimen significantly reduced the risk of disease recurrence, worsening or death in certain patients with resected HNSCC compared with traditional postsurgical radiotherapy alone.The FDA is expected to act on the application by June 23.In Japan, Sanofi's Sarclisa has picked up an approval to treat newly diagnosed patients with multiple myeloma.Japan's Ministry of Health, Labour and Welfare (MHLW) approved the drug as part of a combination with bortezomib, lenalidomide, and dexamethasone (VRd) in the patient group based on results from the phase 3 IMROZ trial. The study showed that Sarclisa's addition to VRd significantly improved progression-free survival compared with VRd alone in patients with newly diagnosed, transplant-ineligible multiple myeloma.Sarclisa launched in 2020 in Japan and is approved as a part of four different regimens in the country, Sanofi noted in a press release.UPDATED: Monday, Feb. 24 at 10:52 a.m. ETGilead's application for twice-yearly lenacapavir has been accepted by the European Medicines Agency for accelerated review as an HIV pre-exposure prophylaxis (PrEP) option. Simultaneously, the drug will be assessed under EU-Medicines for all, which can be used to facilitate expedited review processes in countries outside the EU, including in low- and lower-middle-income countries. The FDA has put lenacapavir's PrEP application under priority review last week with a target decision date set for June 19, 2025.Several companies have launched their biosimilar products referencing Johnson & Johnson's star inflammatory disease drug Stelara in the U.S., following Amgen's January launch of Wezlana as the first biosimilar referencing the star IL-12/23 inhibitor. Teva and Alvotech just rolled out Selarsdi covering all indications and presentations of the original Stelara. Teva can start to claim interchangeability after an exclusivity period for Wezlana ends on April 30. Sandoz announced the launch of its Samsung Bioepis-partnered Pyzchiva, which the Swiss company views as a key driver in its global growth strategy. Sandoz touts Pyzchiva's extended stability, including the ability to be re-refrigerate, as an advantage over the original Stelara.In addition, Biocon Biologics has also entered the U.S. Stelara biosimilar market with Yesintek. It marks the Biocon subsidiary's "first product launch in the United States since becoming a fully integrated global biosimilars organization," CEO Shreehas Tambe said in a release. The FDA has granted priority review to Bristol Myers Squibb's application for Opdivo and Yervoy in first-line unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The goal date is June 23, 2025.The filing was based on data from the phase 3 CheckMate-8HW trial. The combo lowered the risk of disease progression or death by 38% versus Opdivo alone in MSI-H/dMMR mCRC, according to an update of the study presented in January.The FDA has updated the label of Indivior's Sublocade for severe opioid use disorder. The new label allows healthcare providers to start treatment with Sublocade after a single dose of transmucosal buprenorphine and a one-hour observation period. This rapid initiation "may lessen some of the practical obstacles to treatment induction," according to Indivior.In addition, the FDA has approved additional injection sites for Sublocade, an extended-release formulation of buprenorphine. The drug can now be administered in the abdomen, thigh, buttock or back of the upper arm.UPDATED: Friday, Feb. 21 at 9:30 a.m. ETGilead's seladelpar has secured a conditional marketing nod in Europe to treat adults with primary biliary cholangitis (PBC).The approval covers seladelpar's use in combination with ursodeoxycholic acid (UDCA) for those who have an inadequate response to UDCA alone, or as a monotherapy for people who can't tolerate UDCA.In the U.S., seladelpar picked up FDA approval last year and is branded as Livdelzi.A chronic autoimmune disease, PCB affects roughly 22 out of 100,000 people in Europe. The disease is more common in women and causes liver damage that can progress to liver failure if untreated. Symptoms include chronic itch and fatigue, and there is no cure for the disease.The approval is largely based on results from the phase 3 Response study, which showed that roughly three times as many patients on seladelpar achieved a composite biochemical response than those on placebo. The conditional approval will be contingent on positive results from future confirmatory studies.In Japan, authorities have approved CSL's subcutaneous Andembry for the prevention of acute attacks of hereditary angioedema (HAE).The drug offers patients the first pre-filled pen presentation for monthly subcutaneous administration for long-term prophylaxis of HAE, CSL said in a press release.The Japanese nod adds to the drug's other approvals in Europe, Australia and the U.K.UPDATED: Thursday, Feb. 20 at 10:00 a.m. ETBristol Myers Squibb's Breyanzi has won reimbursement backing from England's National Institute for Health and Care Excellence (NICE) in second-line large B-cell lymphoma, becoming the first CAR-T therapy to be recommended by the agency for this cancer type. The endorsement comes after NICE had originally rejected Breyanzi in October 2024 during its draft assessment. The drug cost watchdog changed its mind after BMS "offered an improved commercial arrangement" to the NHS based on its 297,000 pound sterling (about $375,000) list price per person, according to a press release.About 600 people in England could benefit from the therapy per year, according to NICE, which called the one-time CAR-T treatment "a significant advance in lymphoma care." In another reversal, NICE has also changed a previous rejection and signed off on UCB's Fintepla as an add-on treatment for seizures associated with Lennox-Gastaut syndrome (LGS) in people ages 2 years and above. The drug already has coverage under NHS for treating seizures from Dravet syndrome.LGS is a rare but severely debilitating form of epilepsy that begins in early childhood. By NICE's estimate, about 1,400 patients live with the disease in its jurisdiction.NICE changed its mind after UCB offered "an improved discount" to the drug's list price, the agency noted. Using a cost comparison approach, UCB convinced NICE's drug reviewers that Fintepla provides similar or greater health benefits compared to cannabidiol plus clobazam—which is already covered for LGS in the NHS—at a similar or lower cost.  The drug is covered only if the frequency of drop seizures is checked every six months, at which point the frequency is reduced by at least 30% compared with before starting treatment. UPDATED: Tuesday, Feb. 18 at 11:04 a.m. ETMerck’s Welireg snagged its first two approvals in Europe, with the nods covering certain patients with von Hippel-Lidau (VHL) disease and advanced clear renal cell carcinoma (RCC).The European Commission specifically approved the medicine as a treatment for those with VHL disease who have associated, localized RCC, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors. The drug is approved in cases when localized procedures are unsuitable, making Welireg the first available treatment for VHL-associated tumors in Europe. The med also won a nod for adult patients with advanced clear cell RCC that has progressed following two or more lines of therapy, including a PD-1/L1 and at least two VEGF-targeted therapies.The European nods, which are conditional authorizations, follow similar approvals in the U.S. Merck will make the drug commercially available individual European countries after the complication of national reimbursement procedures, among other launch timing factors, the company said.Gilead’s twice-yearly pre-exposure prophylaxis (PrEP) candidate lenacapavir is on the FDA’s review table with a decision date of June 19.The drug, which is currently approved as Sunlenca for multi-drug resistant HIV, would be the first twice-yearly PrEP option on the market. The company’s FDA bid is the first step of its detailed global launch and access strategy.Gilead’s lenacapivir application is backed by two phase 3 trials, one of which showed an impressive 100% risk reduction. The company describes the med as a “foundation” for potential future HIV therapies, it said in a release.Sanofi and Regeneron’s immunology powerhouse Dupixent is aiming to secure a new use in chronic skin disease bullous pemphigoid (BP) with an FDA decision expected by June 20.If approved, the med would be the only targeted BP treatment available in the U.S. The disease is hallmarked by intense itch and blisters and impacts a population of around 27,000 adults, typically elderly adults, whose condition is not controlled by systemic corticosteroids.  The companies’ FDA bid has been granted priority review and is based on a study of 106 adults with moderate-to-severe BP. In the trial, five times more patients who received Dupixent achieved sustained disease remission compared to those on placebo, according to Sanofi. UPDATED: Friday, Feb. 14 at 9:20 a.m. ETCSL's hereditary angioedema (HAE) therapy Andembry has secured approval from the European Commission.The drug is the first once-monthly treatment targeting factor XIIa to prevent HAE attacks in patients 12 and older. In a phase 3 trial, the drug significantly reduced investigator-confirmed HAE attacks per month versus placebo, according to results published in The Lancet in April 2023.Last month, regulators in Australia and the U.K. signed off on the medicine."Andembry, CSL's first approved recombinant monoclonal antibody discovered and developed entirely by CSL, underscores our more than 40-year legacy in HAE research and treatment optimization and our decades-long journey to bring this innovation to patients," Bill Mezzanotte, M.D., CSL's head of R&D, said in a press release.Now, CSL plans to engage in access and reimbursement negotiations with national authorities across Europe as the company progresses with the rollout.Also in Europe, officials signed off on CSL and Arcturus Therapeutics' self-amplifying mRNA COVID-19 vaccine, Kostaive, for use in individuals ages 18 and older.The approval is based on results from an integrated phase 1/2/3 study and late-stage booster trials, the partners said in a press release. Late last year, the European Medicines Agency recommended the vaccine for approval.Besides Europe, the vaccine is approved in Japan.Galderma's efforts to expand the market for Nemluvio are bearing more fruit.In Europe, officials approved the subcutaneous drug for the treatment of moderate-to-severe atopic dermatitis in patients ages 12 and older. In addition, the drug scored an endorsement to treat prurigo nodularis in adults.In the late-stage Arcadia and Olympia clinical trial programs, the drug "significantly improved itch, skin lesions and sleep disturbance, in patients with moderate-to-severe atopic dermatitis and adults with prurigo nodularis, respectively," Galderma said in a Friday press release.The drug is also approved in the U.S. and is under review in Canada, Brazil, South Korea and other countries.China has approved its 22nd PD-1/L1 product. The approval went to SinoCellTech's finotonlimab for its use alongside chemo in first-line head and neck cancer. In a China phase 3 trial, the combo reduced the risk of death by 27% versus chemo alone, extending the median overall survival by 3.6 months to 14.1 months, according to results published in Nature Medicine.The go-ahead marks the first for a PD-1/L1 inhibitor that covers all head and neck cancer patients in China. In the country, Merck & Co.'s Keytruda is allowed as a monotherapy only in PD-L1-positive disease, SinoCellTech noted in a securities filing (Chinese). UPDATED: Wednesday, Feb. 12 at 10:20 a.m. ETAcoramidis, the transthyretin amyloid cardiomyopathy (ATTR-CM) drug developed by BridgeBio and licensed by Bayer in Europe, has been approved by the European Commission. Bayer plans to make the transthyretin stabilizer available in Europe under the brand name Beyonttra in the first half of this year.The approval is based on results from the phase 3 ATTRibute-CM study trial showing that Beyonttra significantly reduced the composite endpoint of all-cause mortality and cardiovascular-related hospitalizations compared with placebo. During the open-label extension phase of the study, Beyonttra demonstrated a relative risk reduction in deaths of 34% after 42 months.Beyonttra's launch is one of Bayer's “must-win battles” as the German company navigates the loss of exclusivity of its top-selling drug, blood thinner Xarelto, Stefan Oelrich, head of Bayer’s pharma division, said at the J.P. Morgan Healthcare Conference in January.Travere Therapeutics said it has aligned with the FDA on its plan to submit Filspari for traditional approval in focal segmental glomerulosclerosis (FSGS), a rare kidney disease. The move comes after a Filspari phase 3 trial in that indication failed on its primary endpoint of eGFR slope, a measurement of kidney disease progression. It also comes as findings from a collaborative global project called ARASOL linked a decrease in proteinuria over 24 months to a reduction in the risk of kidney failure in FSGS. Filspari has shown a benefit in lowering proteinuria. Travere plans to file this application around the end of March using existing data from the phase 3 DUPLEX and phase 2 DUET studies. The company will request a priority review, which Leerink Partners analysts believe is likely to be granted as there are no approved therapies for FSGS. Given that the understanding around proteinuria as a potential full approval endpoint is new, Leerink analysts said it would not be surprising if the FDA wanted to discuss the results during an advisory committee meeting.An approval in FSGS would be "transformational" for Filspari and Travere, Leerink said in a Tuesday note, because it could give the drug $1.1 billion in peak sales across the U.S. and EU based on a "relatively conservative peak penetration" of less than 20%. For Filspari sales, the FSGS indication could eventually surpass IgA nephropathy, for which Filspari is currently approved and is starting to face more competition, according to Leerink Partners.UPDATED: Monday, Feb. 10 at 9:45 a.m. ETBristol Myers Squibb’s cancer combo Opdivo plus Yervoy has scored an approval recommendation in the E.U., thanks to an endorsement from the EMA’s Committee for Medicinal Products for Human Use (CHMP) as a first-line treatment in adults with unresectable or advanced hepatocellular carcinoma.With the thumbs up from CHMP, the Opvido-Yervoy combo now moves forward to the European Commission (EC) for a final approval decision.The CHMP based its green light on results from the combo’s phase 3 CheckMate -9DW trial, in which patients on Opdivo and Yervoy charted a median overall survival of 23.7 months, compared to 20.6 months in patients who received an alternative regimen of Lenvima (lenvatinib) or sorafenib.BMS’ cancer combo is up for a similar approval in the U.S., with the FDA scheduled to make its decision on a potential first-line unresectable HCC nod by April 21.The drugmaker also won a CHMP endorsement for its CAR-T therapy Breyanzi to treat adults with relapsed or refractory follicular lymphoma (FL) who’ve previously tried two or more systemic therapies.BMS used data from its phase 2 TRANSCEND FL study to support the recommendation. In the trial, Breyanzi charted an overall response rate of 97.1% and a complete response rate of 94.2%, which was sufficient to meet the study’s primary and secondary endpoints, BMS said in a release.Breyanzi already carries multiple oncology approvals in Europe, including in relapsed or refractory diffuse large B-cell lymphoma and high grade B-cell lymphoma.Late last month, the FDA gave a thumbs up to German drugmaker medac’s alkylating agent Grafapex, also known as treosulfan, alongside the antimetabolite medicine fludarabine, as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adults and kids ages one and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).Alkylating agents cause breakage of DNA strand to help thwart the ability of cancer cells to multiply.Medac’s approval was backed up by a study looking primarily at overall survival in 570 adults ages 18 to 70 years old with AML or MDS who were randomized to receive either Grafapex or busulfan with fludarabine as a preparative regimen for allogeneic transplant. UPDATED: Wednesday, Feb. 5 at 9:05 a.m. ETNovartis' Kisqali has secured a label expansion from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA).The new approval covers Kisqali's use in combination with an aromatase inhibitor (AI) in patients with HR+/HER2- early breast cancer at high risk of recurrence. Previously, the drug was approved by the MHRA to treat advanced breast cancer, according to a Feb. 4 press release from Novartis.The latest approval is based on results from the phase 3 NATALEE trial, which showed that the addition of Kisqali to treatment with an AI cut the risk of invasive disease, recurrence, or death compared to AI treatment alone in patients with HR+/HER2- early breast cancer.Last fall, the drug picked up an FDA nod in patients with HR+/HER2- early breast cancer based on the NATALEE study results.Vaccine specialist Valneva has picked up an approval from the MHRA, as well.The agency approved the company's chikungunya vaccine, Ixchiq, for use in people 18 years of age and older. Late-stage trial data show the vaccine "induces a rapid and strong immune response," according to a press release from the company.Valneva manufactures the shot at its facility in Livingston, Scotland.Previously, the vaccine secured approvals in the United States, Canada and Europe. UPDATED: Friday, Jan. 31 at 9:35 a.m. ETVertex's groundbreaking launch of Casgevy keeps racking up more milestones around the globe.Friday, the company said it has reached a reimbursement agreement with NHS England that'll allow eligible patients with sickle cell disease access to the CRISPR/Cas9 gene-edited therapy. Along with the NHS England agreement, the National Institute for Health and Care Excellence (NICE) has signed off on the drug's use, Vertex said in a press release.The reimbursement deal follows a similar agreement, unveiled last summer, for the drug in patients with transfusion-dependent beta thalassemia.“We are pleased to have reached this new agreement that ensures both eligible SCD and TDT patients can now be treated with Casgevy, recognizing the value a one-time treatment can provide to patients, their families and the healthcare system," Vertex International senior vice president Ludovic Fenaux said in a statement.In its approval bid for Fabhalta in C3 glomerulopathy, Novartis will no longer face an FDA advisory committee meeting, CEO Vas Narasimhan said on Friday.The advisory committee meeting had been scheduled for next month but will no longer take place.Speaking with members of the media on Friday, Narasimhan said the "FDA no longer deemed it necessary to hold an advisory committee meeting.""We think it's based on, you know, the overall data package we've been able to generate, and the additional follow on data that we've provided the agency," the CEO continued. So we look forward to now bringing forward that medicine as a third indication approval for Fabhalta."Amid Europe's ongoing regulatory review of Eisai and Biogen's Alzheimer's disease medicine Leqembi, the European Commission (EC) has flagged new safety information for review.In November, Europe's Committee for Medicinal Products for Human Use (CHMP) recommended market approval of the drug. Since then, EC has asked the committee to "consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion," the partners said in a Friday press release. The companies didn't reveal the nature of the new safety information flagged by the EC. CHMP will dig into the new info during a meeting next month, according to the release."We believe that the EC’s requests can be addressed with existing information and will be evaluated by the CHMP because of the clear and sufficient information available," the partners said in the release. "We will continue to work closely with the authorities toward approval in the EU."UPDATED: Monday, Jan. 27 at 10:43 a.m. ETMerck’s Welireg is up for a potential FDA label expansion by May 26. The agency granted a priority review to the company's bid to expand the drug's label into advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL), which would add to currently approved indications in advanced renal cell carcinoma and von Hippel-Lindau disease.Welireg generated $139 million in sales during 2024’s third quarter and is the only approved HIF-2α inhibitor in the U.S.Merck’s application in PPGL is based on objective response rate and duration of response rate data from the phase 2 LITESPARK-015 trial, which enrolled 322 patients and will be presented at an upcoming medical meeting, according to the company. Up to 2,000 new cases of the tumors are diagnosed yearly in the U.S.Merck is evaluating Welireg across other rare oncologic diseases both on its own and in combination with other therapies. The FDA is evaluating Alvotech and Teva’s proposed biosimilar to Johnson & Johnson’s Simponi and Simponi Aria.Alvotech, which is responsible for development and manufacturing under its longstanding collaboration with Teva, announced positive top line results from its confirmatory trial of the Simponi copycat back in April. The partners expect the FDA to complete its review process in the fourth quarter of 2025. Simponi was first approved in 2009 and treats a variety of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, among others. Simponi is an injected drug, while Simponi Aria is the infused version. The franchise picked up $2.19 billion for J&J in 2023 sales.Alvotech and Teva's product is the first biosimilar to the blockbuster arthritis med to be accepted for review.UPDATED: Thursday, Jan. 23 at 10:00 a.m. ETBiogen said its applications for a high-dose version of the spinal muscular atrophy med Spinraza have been accepted for review by the FDA and the European Medicines Agency. The new regimen comprises a more rapid loading regimen of two 50 mg doses given two weeks apart and a maintenance regimen given at 28 mg every four months. Currently, the drug's FDA-approved loading regimen features three doses given 14 days apart, plus a fourth dose 30 days after the third. The drug is currently approved in 12 mg doses.The high-dose applications are based on results from the phase 2/3 Devote trial, which favored the high-dose version versus an external sham control and the currently available dose on the measure of patients' reduction in plasma neurofilament light chain (NfL), a marker for neurodegeneration.The higher dose regimen also reduced the risk of death or permanent ventilation by 68% relative to sham and 30% compared with the 12 mg regimen.The high-dose Spinraza is Biogen's answer to competitors such as Novartis' gene therapy Zolgensma.Amneal has won FDA approvals for generics referencing AbbVie's Alzheimer's combo drug Namzaric and Novartis' cancer therapy Afinitor Disperz. Amneal has launched the Namzaric generic with 180-day market exclusivity.Separately, Amneal said it has won tentative approval from the FDA for a generic to Bausch Health's star irritable bowel syndrome med Xifaxan. Bausch Health has previously reached settlement agreements with Teva, Sun Pharma and Sandoz, pushing their generic entry dates into 2028 or upon an earlier launch of a rival generic product. Xifaxan is one of 15 drugs up for the second cycle of Medicare price negotiations under the Inflation Reduction Act. UPDATED: Tuesday, Jan. 21 at 8:57 a.m. ETThe European Commission has approved Johnson & Johnson's combination of Lazcluze and Rybrevant for the first-line treatment of certain adults with advanced non-small cell lung cancer (NSCLC), the company said in a press release.Specifically, the combo is approved in Europe for patients with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.In approving the use, EU regulators reviewed results from the phase 3 MARIPOSA study. The trial showed that the combination reduced the risk of disease progression or death by 30% compared with AstraZeneca's Tagrisso in patients with newly diagnosed, EGFR-mutant non-small cell lung cancer. The results yielded a U.S. approval for the J&J combination last summer. Earlier this month, J&J touted an overall survival win from the study. At the time, a company executive heralded the regimen as "a new standard of care for patients with EGFR non-small cell lung cancer."Also in Europe, officials have endorsed GSK's Jemperli to treat all adult patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors. MMRp and MSS cases represent approximately 75% of patients diagnosed with endometrial cancer, GSK said in a press release.The approval covers Jemperli's use in combination with chemotherapy.Late last year, Europe's Committee for Medicinal Products for Human Use (CHMP) recommended the label expansion.In England, the National Institute for Health and Care Excellence (NICE) recommended AstraZeneca's Tagrisso for treating people with EGFR mutation-positive non-small-cell lung cancer (NSCLC) after surgery.The recommendation means that hundreds of patients will benefit from routine access to the drug, which is taken daily alongside chemotherapy, according to a notice from the Roy Castle Lung Cancer Foundation.Previously, EGFR mutation-positive NSCLC patients relied on chemotherapy to prevent cancer recurrence after surgery, according to the foundation.“I am pleased we have been able to recommend that this targeted treatment for a specific gene mutation of lung cancer will be routinely available on the NHS," NICE's director of medicines evaluation, Helen Knight, said in a statement.UPDATED: Thursday, Jan. 16 at 10:25 a.m. ETEli Lilly's Omvoh has picked up its second major FDA nod. After the IL-23 inhibitor's approval in 2023 to treat ulcerative colitis, the agency has now signed off on Omvoh to treat Crohn's disease. Specifically, the FDA approved Omvoh to treat moderately to severely active Crohn's disease in adults.In a phase 3 study, 53% of patients treated with Omvoh achieved clinical remission after a year of treatment. That number compared with 36% for those on placebo.In addition, 46% of patients treated with Omvoh had visible healing of the intestinal lining after a year. In the placebo group, the number was 23%.The trial enrolled patients with moderately to severely active Crohn's disease who had experienced an inadequate response, loss of response or who could not tolerate corticosteroids, immunomodulators and/or biologics.With the FDA nod, Lilly's drug will go up against some heavy hitters in the Crohn's space, including Johnson & Johnson's Stelara and AbbVie's duo of Skyrizi and Rinvoq.UPDATED: Wednesday, Jan. 15 at 8:12 a.m. ETSanofi's Sarclisa has gained approval from China's National Medical Products Administration (NMPA) to treat adults with multiple myeloma who've received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.The approval covers Sarclisa's use in combination with pomalidomide and dexamethasone (Pd).Regulators in China endorsed the drug based on results from the phase 3 ICARIA-MM study, as well as bridging data from a China-based study, Sanofi said in a press release. In ICARIA-MM, the addition of Sarclisa to Pd resulted in a 40% reduction in patients' risk of disease progression or death. "We look forward to continuing to build strong partnerships with the medical community, local companies, and authorities in China as we work to bring more innovative treatments to patients," Sanofi's head of oncology, Olivier Nataf, said in a statement.As Biogen and Eisai work to grow Leqembi in Alzheimer's disease, the FDA has accepted a biologics license application for the drug's subcutaneous maintenance dosing option. With a potential approval, Leqembi would become the first anti-amyloid therapy to offer at-home maintenance dosing.The FDA is set to make a decision on the filing by August 31, according to a Biogen press release.UPDATED: Thursday, Jan. 9 at 11:15 a.m. ETEngland’s National Institute for Health and Care Excellence (NICE) recommended AstraZeneca’s Lynparza for use in the region’s National Health Service, clearing the way for around 1,200 eligible patients to reap the benefits of the treatment.The recommendation covers Lynparza’s use in patients with HER2-negative, locally advanced or metastatic breast cancer who have BRCA1 or BRCA2 mutations and have had chemotherapy. NICE based its decision in part on results from the company’s OlympiAD phase 3 study, which proved that the drug could cut the risk of disease worsening or death by 42%.NICE had originally begun its assessment of the treatment in that indication in 2018, but ended it citing a lack of evidence submitted by the company. This time around, NICE assessed the med using a faster cost comparison process that compared Lynparza to Pfizer’s Talzenna in benefits and cost. Stallergenes Greer’s peanut allergy treatment Palforzia scored a label expansion in Europe, extending the drug’s use to toddlers aged 1 through 3 years old.Palforzia is now cleared for use in those aged 1 to 17 years old and is the only approved oral immunotherapy in the U.S. and Europe for toddlers with a confirmed peanut allergy diagnosis. The drug is meant to gradually increase the body’s ability to tolerate small amounts of peanuts through carefully controlled initial dose escalation and up-dosing.The European Commission based its nod on the company’s POSEIDON phase 3 study, which was a double-blind, placebo-controlled food challenge after six months of treatment. Agios Pharmaceuticals’ Pyrukynd is up for an FDA decision in non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia on Sept. 7.The company filed its bid for approval last month after finding success in two phase 3 trials assessing the drug in the non-transfusion-dependent and transfusion-dependent populations. Thalassemia is a rare, inherited blood disorder with limited treatment options. The disease is hallmarked by the abnormal production of hemoglobin, which causes chronic anemia and can lead to other complications.Pyruknd won its first approval in 2022 for pyruvate kinase (PK) deficiency, marking the first drug approved to treat the disease. Merck’s Gardasil HPV vaccine won approval from the National Medical Products Administration of China for males aged 9 to 26 years old, making the first option of its kind available for the country's male population.The vaccine was previously approved for use in females who are 9 to 45 years of age and has helped protect over 50 million women in China from certain HPV-related cancers and diseases since its first approval, Merck’s president of Human Health International, Joseph Romanelli, said in a release.Gardasil has recently seen slumping sales in China, where it's being marketed by Merck’s regional commercial partner Zhifei Biological Products. Rob David previously called the expansion to the male population a “significant opportunity.” UPDATED: Tuesday, Jan. 7 at 3:57 p.m. ETThe FDA tacked on additional warning information to the prescribing information for Agios’ pyruvate kinase (PK) deficiency drug Pyrukynd, flagging instances of liver deficiency in certain situations.The label update follows liver injury observations in patients who received Pyrukynd at a dose higher than is recommended for PK deficiency, according to an SEC filing from the company.The drug was approved by the FDA in 2022 as the first medicine to treat hemolytic anemia in adults with PK deficiency. Besides this use, the company is exploring expansions into beta thalassemia and sickle cell disease.The updated "Warnings and Precautions" section urges prescribers to run liver tests on patients before initiating treatment and monthly for the first six months of treatment. Patients should stop treatment if hepatic injury is suspected.Bayer is vying for a third indication for its Nubeqa (darolutamide) in China, this time for its use in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer.The company filed an application for the label expansion with China’s National Medical Products Administration, leveraging data from its phase 3 ARANOTE trial. In the study, Nubeqa and ADT significantly reduced the risk of radiological progression or death by 46% compared with placebo plus ADT.The nod would add to the drug’s two existing approvals in China, which cover other prostate cancer patient populations. It is estimated that the prevalence of prostate cancer in China will exceed 161,000 cases annually by 2026, according to Bayer. Dizal’s non-small cell lung cancer (NSCLC) candidate sunvozertinib will get a speedy FDA review after the agency granted priority review to the company’s new drug application.The company is specifically going after an approval to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Sunvozertinib won its world-first approval in China in 2023. UPDATED: Monday, Jan. 6 at 10:25 a.m. ETAmgen's DLL3-targeted bispecific antibody Imdylltra, known as Imdelltra in the U.S., has won a conditional marketing authorization from the U.K.'s Medicines and Healthcare products Regulatory Agency as a third-line therapy for small cell lung cancer.The conditional nod is based on results from the phase 2 DeLLphi-301 trial, which showed that the T-cell engager triggered a tumor response rate of 41%, with the median response lasting 9.7 months. It follows an FDA approval in May 2024.China has approved Astellas' first-in-class Claudin 18.2 drug Vyloy, following similar moves by drug regulators in Japan and the U.S.The drug's Chinese indication is in first-line, CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. The CLDN18.2 biomarker is expressed by about 35% of Chinese stomach cancer patients, according to Astellas.The approval was backed by two global phase 3 trials, dubbed Glow and Spotlight, which evaluated Vyloy in combination with the chemotherapy regimens CAPOX and mFOLFOX6, respectively. Both trials linked the drug's chemo combo to longer life expectancy and progression-free survival time compared with chemo alone.UPDATED: Friday, Jan. 3 at 2:45 p.m. ETGSK’s IL-5 inhibitor Nucala scored a nod in China to treat people with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP), a condition that impacts nearly 30 million people in China.The drug was approved by China’s National Medical Products Administration for use as an add-on therapy along with intranasal corticosteroids for patients with CRSwNP who don’t achieve adequate disease control with systemic corticosteroids or surgery. The indication is Nucala’s third in China and comes after prior approvals in eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.An FDA advisory committee panel is scheduled to discuss the merits of Novartis’ oral factor B inhibitor Fabhalta in the rare kidney disease C3 glomerulopathy (C3G).The Cardiovascular and Renal Drugs Advisory Committee will meet on February 24, according to an FDA document (PDF). The drug was approved by the agency in 2023 as a treatment for paroxysmal nocturnal hemoglobinuria, winning the title of the first oral monotherapy approved for the rare blood disorder. Fabhalta received a second nod for immunoglobulin A nephropathy (IgAN) in August.In studies, Fabhalta proved that it could reduce proteinuria for C3G patients, a marker for delaying progression to kidney failure. So far, there are no approved treatments for the ultra-rare disease, which causes about 50% of patients to progress to kidney failure within ten years of diagnosis. UPDATED: Thursday, Jan. 2 at 1:45 p.m. ETShortly before the new year, Merck & Co. scored an approval for its potential blockbuster Winrevair in the U.K. The pulmonary arterial hypertension (PAH) drug, which also goes by the name sotatercept, was originally picked up via Merck’s $11.5 billion acquisition of Acceleron back in 2021.The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Winrevair in combination with other PAH therapies to improve exercise capacity in adult patients who live with moderate or marked limitations of physical activity.Patients with PAH suffer from high blood pressure in the blood vessels that supply the lungs, which can ultimately damage the right side of the heart. Winrevair, for its part, targets the causes of PAH responsible for the narrowing of the arteries in the lungs, in turn making it easier for the heart to pump blood to the pair of organs, according to the U.K. government’s release.The MHRA based its approval on a study of 323 PAH patients that saw Winrevair best placebo at improving exercise ability. The main measure of effectiveness in the trial was the difference in distance patients could walk in six minutes before and after treatment.At the trial’s 24-week treatment mark, patients on Winrevair plus other PAH medicines improved their walking distance by around 34 meters, versus one meter in patients who received placebo.Merck’s U.K. nod for Winrevair follows green lights from the U.S. FDA last March and the European Commission in August.At the time of the drug’s U.S. approval last year, J.P. Morgan’s Chris Schott estimated Winrevair could eventually reel in peak sales between $3 billion and $4 billion.