Eli Lilly & Co.

iStock, Victor Golmer Wednesday’s update to the regulator’s drug shortage database is good news for Novo Nordisk, which has struggled to keep up with demand for the blockbuster GLP-1 drugs. All doses of Novo Nordisk ’s semaglutide—sold as Ozempic for type 2 diabetes and as Wegovy for obesity—are now available, according to a Wednesday update to the FDA’s drug shortages database. Still, the regulator’s webpage continues to list semaglutide’s status as “currently in shortage.” It is unclear if compounders will need to stop producing and marketing their remixed versions of semaglutide due to Wednesday’s supply update—or if the FDA will enforce action against these pharmacies. Earlier this month, the FDA announced that it was rethinking the shortage status of Eli Lilly’s tirzepatide brands Mounjaro and Zepbound—which the regulator had taken off its shortage list just days earlier—after a complaint from the Outsourcing Facilities Association (OFA). In its lawsuit, the trade group called the FDA “reckless” in declaring the end of the tirzepatide shortage, noting that the decision could “deprive patients of a vital treatment for type 2 and obesity.” Currently, the FDA still officially considers the tirzepatide shortage to be “ resolved ,” according to its website. It remains to be seen whether the OFA will similar complaint for semaglutide. Wednesday’s supply update comes after nearly a year of aggressive manufacturing investments from Novo. In November 2023, the pharma announced a $6 billion boost to its production capacity in Denmark, dedicated for a multi-product facility focused on active pharmaceutical ingredients. Novo in March 2024 also injected $556 million into its Chinese operation, following it up in June 2024 with a $4.1 billion commitment to its manufacturing footprint in North Carolina. Novo Holdings, the controlling shareholder of Novo Nordisk, announced in February 2024 its $16.5 billion acquisition of CDMO giant Catalent. In a related $11 billion deal, Novo Holdings plans to sell three of Catalent’s sites to Novo Nordisk to help expand production of its GLP-1 drugs. However, the Novo Holdings-Catalent buyout is facing opposition. Earlier this month, Sen. Elizabeth Warren (D-Mass.) urged Federal Trade Commission Chair Lina Khan to “carefully scrutinize” the Catalent deal which, if allowed to push through, will give Novo “unprecedented visibility into and control over its competitor’s production capacity, costs, and business practices.” Lilly CEO David Ricks said in a Q2 earnings call in August that the company remains concerned about the Novo-Catalent deal. “We’ve aired those concerns publicly and privately since the proposed transaction was announced, and we’re waiting to see what happens,” Ricks told analysts. Last week, Roche CEO Thomas Schinecker urged regulatory authorities to block Novo Holdings’ buyout of Catalent, arguing that the deal would have wide-ranging negative effects on the industry. “Limiting the competition in this space is not a good idea,” Schinecker said in a media call. However, he insisted that Roche would not be affected by the deal but it “could be a problem for other smaller players,” according to Reuters . Unions, consumer groups and public interest organizations have also raised concerns about the acquisition, noting in a letter to Khan that the merger “would be harmful to competition across various therapeutic areas.”

The collaborative effort drives awareness about biomarker testing to the metastatic breast cancer community WASHINGTON, Oct. 30, 2024 /PRNewswire/ -- LUNGevity Foundation, a nationally recognized nonprofit dedicated to transforming how people are diagnosed and live with lung cancer through research, education, and support, is proud to announce a partnership with Living Beyond Breast Cancer (LBBC), a nationally recognized nonprofit dedicated to providing trusted information for people at every stage of their breast cancer journey, to spread awareness about biomarker testing for people diagnosed with metastatic breast cancer through the No One Missed: Breast Cancer campaign. The successful No One Missed: Lung Cancer campaign launched in 2021 and has reached millions of people with the importance of biomarker testing – specific drivers in a person's cancer that cause the cancer to grow and spread in different ways – at diagnosis and progression. With the support of campaign founding partner AstraZeneca and additional sponsors, the No One Missed: Breast Cancer campaign launched in June and is rapidly reaching a new audience. As with lung cancer, biomarker testing is a powerful tool that plays a critical role in understanding and guiding treatment decisions for those living with metastatic breast cancer (MBC). However, not all patients with MBC receive biomarker testing at the time of diagnosis and when there is cancer progression. There is no cure for MBC despite clinical advancements, with one-third of women diagnosed in the US living at least 5 years after diagnosis. However, knowing the presence of biomarkers can help those living with MBC and their healthcare teams make better treatment decisions. "As the understanding of metastatic breast cancer grows and more treatment options become available, biomarker testing has become a game changer to help patients and their doctors make more informed decisions," said Jean Sachs, MSS, MLSP, Chief Executive Officer, Living Beyond Breast Cancer. "For someone living with metastatic breast cancer, their cancer may evolve and their biomarkers may change. This signifies an important need for conversations between patients and healthcare teams about biomarker testing at diagnosis and every time a cancer progresses." "LUNGevity is proud to partner with Living Beyond Breast Cancer to expand the reach of the No One Missed campaign," said Andrea Ferris, president and CEO, LUNGevity Foundation. "We hope this resource will help improve patient and doctor conversations about biomarker testing." "In the US, 1 in 8 women will be diagnosed with breast cancer in their lifetime," said Mohit Manrao, Senior Vice President, US Oncology Business Unit, AstraZeneca. "We're proud to partner with organizations like LUNGevity Foundation and Living Beyond Breast Cancer to change these numbers and ensure patients have access to critical resources and information to better understand the unique qualities of their cancer, and ultimately ensure they receive the right treatment at the right time." About the No One Missed Campaign No One Missed is a community-led campaign driven by LUNGevity Foundation and supported by patient advocacy, pharmaceutical, and biotechnology organizations. The campaign's mission is to build public awareness of biomarker testing as a critical part of a cancer diagnosis and prognosis and empower patients to discuss biomarker testing with their healthcare team. No One Missed: Lung Cancer is supported by founding partner AstraZeneca, supporting member Daiichi-Sankyo, members Merck and Regeneron, and supporters Boehringer Ingelheim, Foundation Medicine, Genentech, Pfizer, Taiho Oncology, Takeda Oncology, and Thermo Fisher Scientific. Supporting partners include AONN, ALK Positive, AEACap, EGFR Resisters, Exon20Group, IASLC, KRAS Kickers, MET Crusaders, NTRKers, ONS, RETpositive, The ROS1ders, and US Oncology Research. No One Missed: Breast Cancer is supported by premier sponsor AstraZeneca; member sponsors Daiichi-Sankyo, Lilly, Merck, and Genentech; supporter sponsor Novartis; and friend sponsors Foundation Medicine and Relay Therapeutics. Additionally, No One Missed: Breast Cancer is supported by partners Breastcancer.org, Cancer Support Community, FORCE, Metastatic Breast Cancer Alliance, SHARE, Susan G. Komen, The Chrysalis Initiative, TOUCH: The Black Breast Cancer Alliance, and Young Survival Coalition. About Living Beyond Breast Cancer Living Beyond Breast Cancer is a national nonprofit organization that seeks to create a world that understands there is more than one way to have breast cancer. To fulfill its mission of providing trusted information and a community of support to those impacted by the disease, Living Beyond Breast Cancer offers in-person experiences and on-demand emotional, practical, and evidence-based content that is meaningful to those newly diagnosed, in-treatment, post-treatment and living with metastatic disease. Visit for more information. About LUNGevity Foundation LUNGevity, the nation's leading lung cancer organization, is transforming what it means to be diagnosed and live with lung cancer. LUNGevity seeks to make an immediate impact on quality of life and survivorship for everyone touched by the disease—while promoting health equity by addressing disparities throughout the care continuum. Through research, we use an innovative and holistic approach to finding lung cancer earlier when it is most treatable; advance research into new treatments so people may live longer and better; and ensure a diverse, vital pipeline of investigators for the future of the lung cancer field. Through advocacy, we foster groundbreaking collaborations to ensure all people have access to screening, biomarker testing, and treatment breakthroughs. Through community, we educate, support, and connect people affected by lung cancer so that they can get the best healthcare and live longer and better lives. Comprehensive resources include a medically vetted and patient-centric website, Patient Gateways for specific types of lung cancer, a toll-free HELPLine for personalized support, international survivor conferences, and tools to find a clinical trial. All these programs are designed to help us achieve our vision—a world where no one dies of lung cancer. LUNGevity Foundation is proud to be a four-star Charity Navigator organization. Please visit to learn more. SOURCE LUNGevity Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization. Recently, Viva Biotech's portfolio companies have new updates. Keep reading for more details. Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes October 15, 2024, Germantown, MD. Seraxis Inc., a clinical stage regenerative medicine company invested by Viva BioInnovator (VBI), has received FDA's allowance of an Investigational New Drug (IND) application for a Phase I/II clinical study of its novel islet replacement therapy SR-02. SR-02 is the first reprogrammed stem cell-derived pancreatic product candidate allowed by FDA for testing in humans as a potential functional cure for insulin-requiring diabetes. Arthrosi Therapeutics and ApicHope Pharmaceutical Co-developed Gout Treatment AR882 Achieves Promising Phase II Clinical Results in China and Granted Fast Track Designation by the FDA According to ApicHope Pharmaceutical, Arthrosi Therapeutics, Inc. ("Arthrosi"), a portfolio company incubated by Viva Biotech, has achieved outstanding results in a Phase II clinical trial for the investigational gout treatment AR882. Developed in collaboration with ApicHope Pharmaceutical, this Class I novel drug showed promising outcomes for treating primary gout with hyperuricemia and has now entered Phase II clinical trials in China. The Phase II clinical trial primarily aimed to explore the optimal dosing of AR882 capsules for treating primary gout with hyperuricemia and to preliminarily assess the drug's efficacy and safety. The primary endpoint was the percentage of patients with serum uric acid levels below 360 μmol/L after eight weeks of treatment. By week six, AR882 demonstrated significant efficacy, with the 75mg dose of AR882 showing superiority over Febuxostat (P<0.001). AR882 exhibited an excellent safety profile, with no severe adverse events reported. Mild to moderate side effects observed included diarrhea, headache, and upper respiratory infections. Importantly, AR882 did not interfere with the management of patients' comorbidities, which remained stable throughout the trial. On August 19, Arthrosi Therapeutics announced that it received FDA Fast Track Designation for AR882 in Tophaceous Gout. Antag Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lead Molecule, AT-7687 Copenhagen, Denmark – October 9, 2024 – Antag Therapeutics, a leading biopharmaceutical company focused on targeting the Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor to pioneer novel treatments for obesity and invested and incubated by Viva BioInnovator (VBI), announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead molecule, AT-7687. This milestone enables Antag Therapeutics to initiate its Phase I clinical trial, which will evaluate the safety, tolerability, and pharmacokinetics of AT-7687 in both healthy lean and healthy obese subjects. The study will also explore AT-7687 as a monotherapy and in combination with semaglutide, a GLP-1 receptor agonist, in healthy obese individuals. Cybrexa Therapeutics Announces First Patient Dosed with First-in-Class Peptide-Drug Conjugate CBX-12 in Phase 2 Trial in Ovarian Cancer NEW HAVEN, Conn. – October 7, 2024 – Cybrexa Therapeutics, invested and incubated by Viva BioInnovator (VBI), a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide-drug conjugate (PDC) therapeutics, announced that the first patient has been dosed in a Phase 2 clinical trial evaluating CBX-12 in patients with platinum-resistant or refractory ovarian cancer. CBX-12 is a first-in-class PDC that uses Cybrexa's proprietary alphalex™ technology to enhance the delivery of exatecan, a potent, established topoisomerase 1 (TOP1) inhibitor, directly to tumor cells while sparing healthy tissue. This trial initiation follows promising Phase 1 results, which demonstrated CBX-12's broad activity across ovarian, breast, non-small cell lung cancer (NSCLC), thymic, gallbladder, and colorectal cancers, along with a manageable safety profile. Basking Biosciences Doses First Patients in Phase 2 Clinical Trial of Reversible Thrombolytic BB-031 for Acute Ischemic Stroke Columbus, Ohio – Sept. 10, 2024 – Basking Biosciences (Basking), invested and incubated by Viva BioInnovator (VBI), a clinical-stage biopharmaceutical company developing a novel acute thrombolytic therapy, announced that the first patients have been dosed in RAISE, a Phase 2 clinical trial evaluating BB-031 in patients presenting with acute ischemic stroke (AIS). HAYA Therapeutics Announces Collaboration with Lilly to Discover Novel Regulatory Genome Targets for Obesity and Related Metabolic Conditions Using Proprietary RNA Platform LAUSANNE, Switzerland & SAN DIEGO, HAYA Therapeutics, SA, invested and incubated by Viva BioInnovator (VBI), a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics for chronic diseases, announced a multi-year agreement with Eli Lilly and Company to apply HAYA's advanced RNA-guided regulatory genome platform to support preclinical drug discovery efforts in obesity and related metabolic conditions. The partners will identify multiple regulatory genome derived RNA-based drug targets to address these chronic conditions. Under the terms of the collaboration, HAYA will receive an upfront payment, including an equity investment, and is eligible to receive up to an aggregate $1 billion in pre-clinical, clinical and commercial milestone payments, as well as royalties on product sales. About Seraxis Seraxis is bringing transformative therapies to the millions of people worldwide struggling with the management of insulin-requiring diabetes and the associated life-threatening complications. Seraxis' lead program, SR-02, is a novel islet replacement therapy for patients of insulin-requiring diabetes with concurrent immunosuppression therapy. This therapy is the foundation of Seraxis follow-on therapies for patients without immune suppression. Frazier Life Sciences, Polaris Partners, Eli Lilly and Company, the T1D Fund and others are investors in Seraxis. Visit . About Arthrosi Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing AR882, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout. In the U.S., an estimated 13 million individuals are diagnosed with gout and approximately 2 million of those patients have visible tophi. In Phase II studies, AR882 demonstrated encouraging efficacy and safety compared to standard of care (SOC), while Phase IIb results showed impressive success in the complete elimination of tophi. Arthrosi is currently advancing AR882 into Phase III clinical trials. About Antag Therapeutics Antag Therapeutics is a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies for obesity and cardiometabolic diseases through GIP receptor antagonism. As a pioneer in exploring the potential of GIP receptor antagonists, the company is dedicated to advancing science and improving patient outcomes by delivering groundbreaking solutions that address unmet medical needs. For more information, please visit . About Cybrexa Therapeutics Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent, tumor-targeting peptide-drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa is on a mission to create therapeutics that revolutionize the standard of care in oncology, and its robust pipeline aims to combat breast, ovarian, non-small cell lung cancer, and a range of other tumors. Its assets are built on Cybrexa's alphalex™ technology platform, which enables intracellular delivery of highly potent anti-cancer treatments. Cybrexa is based in New Haven, Connecticut and was founded in 2017. For more information, please visit or follow us on LinkedIn and X. About Basking Biosciences Basking Biosciences, a clinical-stage biopharmaceutical company, was founded to solve the biggest need in acute thrombosis – for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries, and whose activity can be quickly reversed in the event of a bleeding complication. Leveraging RNA aptamer technology, our lead drug candidate, BB-031, targets von Willebrand Factor (vWF), an important structural component of blood clots and driver of the clotting process, and is designed to be safer, more effective, and able to significantly expand the population receiving acute revascularization therapy. About HAYA Therapeutics HAYA Therapeutics is a precision medicines company developing programmable therapeutics targeting regulatory RNAs derived from the dark genome, a cell information processing unit, to reprogram pathological cell states for a broad range of diseases, including cardiovascular and metabolic diseases and cancer. The company is using its innovative platform to gain novel insights into the biology of disease cell states and the long non-coding RNAs (lncRNAs) that regulate them. HAYA's lead therapeutic candidate is HTX-001, in development for the treatment of heart failure. HAYA is also developing a pipeline of lncRNA-targeting precision therapies for the cell-specific treatment of diseases in other tissues. SOURCE Viva Biotech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED