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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.

TOP STORIES
The move is part of a strategic restructuring aimed at getting azenosertib to the market for patients with gynecological malignancies.
The approval continues the trend of GLP-1s expanding into indications outside of diabetes and weight loss.
The discontinuation comes after the investigational drug, volenrelaxin, failed a related heart failure study in an overlapping patient population.
IRA
The U.S. Centers for Medicare and Medicaid Services has named Novo Nordisk’s Wegovy, Ozempic and Rybelsus as part of the second round of the IRA drug price negotiation program, even as the pharma challenges the program.
Donald Trump continues to make waves in biopharma; Sage rejects Biogen’s unsolicited takeover offer; the obesity space sees more action with new company launches, IPOs and fresh data; and experts get ready for an important era in the Duchenne muscular dystrophy space.
FDA
Ahead of Robert F. Kennedy Jr.’s confirmation hearings, experts—and RFK’s own family—expressed concerns about his vaccine-related views, though the same experts are largely unfazed by the level of power he and Marty Makary could ultimately wield over the FDA.
It’s been a rocky few months for BioAge Labs, which shuttered a Phase II trial of its lead candidate azelaprag Tuesday after the molecule caused liver-based side effects.
The results, which come on the heels of the FDA’s approval of J&J’s esketamine nasal spray Spravato as a monotherapy for treatment-resistant depression, could serve to further bolster a space hit hard by the rejection of Lykos’ MDMA-based PTSD therapy in August 2024.
Atara Biotherapeutics’ layoffs could leave the biotech with around 80 employees. The cuts follow news that the FDA rejected Ebvallo, a T cell therapy approved in Europe for a transplant-related blood cancer, and placed a clinical hold on the company’s active drug applications.
Landing a job remains challenging for life sciences professionals, according to a new BioSpace report. While 59% of surveyed organizations are actively recruiting, nearly half of unemployed survey respondents had been out of work for at least six months, and 20% of surveyed employers expect to lay off employees this year.
The company, co-founded by Nobel Laureate Craig Mello, aims to push molecules for Huntington’s and a form of epilepsy into Phase I trials, with additional preclinical assets targeting Parkinson’s and Alzheimer’s.
Versant Ventures continues to invest in the increasingly competitive obesity space, this time launching Helicore with $65 million and a GIP-targeting asset intended to induce higher-quality weight loss.
UPCOMING EVENTS
PRESS RELEASES
Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market access
Highlights TempraMed signs non-binding LOI for exclusive distribution in Kuwait with Elegir Trading Kuwait represents a high-value market with significant demand for insulin, GLP-1 therapies, biologics, and other temperature-sensitive medications LOI includes minimum annual purchase commitments in Year 1 Expands TempraMed’s footprint across the Middle East and supports broader regional commercialization strategy Potential future expansion includes VIVI Med™, VIVI Epi™, and VIVI Cap Smart™ products
— Veteran Physician-Scientist Brings Over 25 Years of Pulmonary and Cardiopulmonary Clinical Development Leadership Spanning Pfizer, Gilead, and Aerovate Therapeutics —
MARKET RESEARCH REPORTS