Cytokinetics Shares New Aficamten Data at ESC Heart Failure 2025 Congress
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data arising from two analyses from SEQUOIA-HCM, (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), and results from a real-world analysis related to…
Makary’s ‘Conditional Approval’ Plan for Rare Diseases Raises More Questions Than It Answers
FDA Under Makary Eyes New Pathway for Rare Disease Drugs Amid Debate Over Feasibility and Safety While the U.S. Food and Drug Administration (FDA) under new Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. may seem a far…
FDA, NIH Push for Non-Animal Testing Methods as Experts Cite Research Limitations
FDA and NIH Push Toward Replacing Animal Testing with AI and Human Organoids In a groundbreaking move, the FDA—under Commissioner Marty Makary—announced plans in April to significantly reduce animal testing requirements for monoclonal antibodies and other therapies. The agency aims…
Cutting FDA Rules Won’t Bring Big Savings for Industry
Why Deregulation Won’t Deliver for the Pharmaceutical Industry The current U.S. presidential administration under Donald Trump has begun eliminating federal regulatory staff and announced plans to dramatically scale back regulations. While administration figures like senior advisor Elon Musk and U.S.…
75th Regeneron ISEF Awards Over $9M to Teen Scientists Worldwide
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science proudly announced the winners of the 75th Regeneron International Science and Engineering Fair (Regeneron ISEF), the world’s largest pre-college STEM competition. The event brought together nearly 1,700 young innovators from 48…
Lars Fruergaard Jørgensen to Step Down as CEO of Novo Nordisk A/S
Novo Nordisk has announced significant leadership changes, including the upcoming departure of CEO Lars Fruergaard Jørgensen. As part of a mutual agreement with the Novo Nordisk Board of Directors, Jørgensen will step down from his role, though he will continue…
Chaos Erupts in ODAC Meeting Preparations After FDA Reductions
As the FDA gears up for a jam-packed Oncologic Drugs Advisory Committee (ODAC) meeting next week, internal sources are raising concerns about the agency’s preparedness. According to an FDA insider who spoke with BioSpace on condition of anonymity, staffing challenges…
Regeneron Wins Antitrust Case Against Amgen, Safeguarding Biotech Innovation and Patient Access to Life-Saving PCSK9 Therapies
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced a significant legal victory after a jury in the U.S. District Court for the District of Delaware ruled that Amgen Inc. violated multiple antitrust and tort laws. The jury found that Amgen unlawfully leveraged…
Promising Novartis Data at ASCO and EHA Reflects Strong Pipeline and Innovative Portfolio
Novartis is set to unveil data from 60 company- and investigator-sponsored abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Congress. These presentations spotlight advances that could reshape clinical practice across…
Merck’s Phase 3 KEYNOTE-B96 Trial Meets PFS Goal in Platinum-Resistant Ovarian Cancer
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today reported that its Phase 3 KEYNOTE-B96 trial (ENGOT-ov65) has met its primary endpoint, showing a statistically significant improvement in progression-free survival (PFS) for patients with platinum-resistant recurrent…
Shockwave Medical Showcases Cardiovascular Innovations at EuroPCR 2025
Shockwave Medical, Inc., now part of Johnson & Johnson MedTech and a global leader in circulatory restoration, announced today that it will showcase data from 23 company-sponsored studies—including three late-breaking presentations—at EuroPCR 2025, taking place from May 20–23 in Paris.…
Celebrating the Launch of the Grinnell Empowerment Command Center
Central Iowa Shelter & Services (CISS), in partnership with Iowa Total Care, will hold a ribbon cutting ceremony to unveil the new Empowerment Command Center and Affordable Housing Project on Wednesday, May 21 at 11:00 a.m. The event will take…