Step back from the multitude of details that go into every big pharma pipeline, and you’ll see the influence that blockbusters have on the entire field. These days, making your mark in R&D at the level the top 15 spenders play requires not just one, two or three experimental drugs that can earn a billion dollars a year. It’s typically about a slate that includes candidates that can bring in $3 billion to $5 billion a year, preferably more. The numbers keep getting bigger. When Merck execs look a

TUESDAY, April 1, 2025 -- The heart-related death rate among pregnant women and new mothers more than doubled between 1999 and 2022, researchers have found. Just under 9.1 mothers for every million people died from heart-related diseases in 2022, up from 3.6 per million in 1999, according to results presented Sunday at the American College of Cardiology’s annual meeting in Chicago. Black women and women living in Southern states are at the highest risk, researchers found. “We’re heading in the

Eli Lilly’s RNA candidate has reduced levels of a protein linked with cardiovascular disease risk in a mid-stage trial in patients with high cholesterol. Solbinsiran, a small interfering RNA, administered at a 400 mg dose achieved a 14.3% placebo-adjusted reduction in levels of apolipoprotein B (ApoB) at 180 days. The data were presented Monday at the American College of Cardiology meeting in Chicago and published in the Lancet . The reduction is statistically significant, Lilly reported, meetin

— Data demonstrated multiple clinical benefits beyond linear growth —  NDA supported by data from three randomized, double-blind, placebo-controlled clinical trials in children with achondroplasia, with up to three years of open-label extension data —  MAA in EU on track for submission during Q3 2025 COPENHAGEN, Denmark I March 31, 2025 I Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has submitted its New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for TransC

COPENHAGEN, Denmark I March 31, 2025 I Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS ® (Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak. The approval follows a standard review with the FDA of a supplementa

EchoSolv AS will be fully integrated into ScImage's medical workflow platform, facilitating streamlined deployment within MedAxiom's hospital and cardiology networks. ScImage is a nationally recognised Cloud and integrated workflow management platform, with over 1,200 users, specialising in the collation of medical images and secure, real-time access to patient information for a broad client base across the US. MedAxiom is an American College of Cardiology company and the cardiovascular communit

Professional society will continue to work with stakeholders to develop a more effective and efficient legislative regulatory framework that ensures high-quality patient care while fostering rapid innovation and the promise of new diagnostic technologies ROCKVILLE, Md., March 31, 2025 /PRNewswire/ -- The Association for Molecular Pathology, the premier global molecular diagnostic professional society, and pathologist Michael Laposata, M.D., Ph.D., today announced a favorable ruling in their laws

SHANGHAI, March 31, 2025 /PRNewswire/ -- On April 1, 2025, Beijing Time, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics") announced that Merck has exercised the global commercialization option for pimicotinib (ABSK021), with an option exercise fee of USD85.0 million, under the licensing agreement signed in December 2023. The development represents further deepening of the collaboration, underscoring the unwavering commitment and confidence that both parties possess for the ongoing advance

SALT LAKE CITY, March 31, 2025 /PRNewswire/ -- ARUP Laboratories applauded today's federal court ruling in favor of the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), vacating in its entirety the FDA's final rule to regulate laboratory-developed tests (LDTs) as medical devices. As a result of the decision, the rule and its compliance deadlines, the first of which would have occurred on May 6, 2025, are no longer in effect. Continue Reading "ARU

SHANGHAI, March 31, 2025 /PRNewswire/ -- WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, today announced that its Active Pharmaceutical Ingredient (API) manufacturing sites at Changzhou and Taixing in Jiangsu province of China, successfully passed U.S. Food and Drug Administration (FDA) inspections back-to-back in March — both without a single observation and with no Form 483 iss