FDA Reinstates Generic Drug Policy Group After April Firings
FDA; generic drugs; policy office; Division of Policy Development; reinstatement; layoffs; drug prices; administrative leave
Insmed’s ‘Unprecedented’ Phase 2 PAH Results Propel Stock and Next-Phase Plans
Insmed; PAH; TPIP; Phase 2b; clinical trial; treprostinil palmitil inhalation powder; stock surge; pulmonary arterial hypertension; Phase 3 trial; biotech
Recursion and Genentech Announce Significant Staff Layoffs in 2025
Recursion Pharmaceuticals; Genentech; biotech layoffs; workforce reduction; pipeline cutbacks; biotech funding; pharmaceutical industry; 2025 layoffs
Inside ASCO 2025: Big Data Drops and a Towering Campaign – Key News Highlights
ASCO 2025; cancer research; big data; campaigns; clinical oncology; artificial intelligence; HER2; lung cancer; breast cancer; therapeutic vaccines
Vertex Lays Off 125 Staffers, Shrinks Rhode Island Campus After Diabetes Therapy Setback
Vertex Pharmaceuticals; layoffs; Rhode Island; diabetes therapy; VX-264; cell-device combo; clinical trial failure; facility consolidation
New Rules and Regulatory Trends in Biopharma Manufacturing in 2025
biopharma manufacturing; 2025 regulations; FDA; digital quality systems; green manufacturing; import rules; Trump administration tariffs; country-of-origin labeling; forced labor compliance; serialization
Insmed’s TPIP PAH Therapy Advances to Phase III Following Positive Phase 2b Results
Insmed; TPIP; treprostinil palmitil inhalation powder; pulmonary arterial hypertension; PAH; Phase 2b trial; Phase III trial; clinical trial results; FDA engagement
FDA Places Clinical Hold on Five Gilead HIV Studies Due to Safety Concerns
FDA; Gilead Sciences; HIV; clinical hold; GS-1720; GS-4182; clinical trials; safety signal; CD4+ T-cell; lymphocyte count; Biktarvy; lenacapavir
Antares Therapeutics Launches with $177M to Tackle ‘Undruggable’ Targets After Scorpion Spinout
Antares Therapeutics; Scorpion Therapeutics; biotech spinoff; $177M Series A; undruggable targets; oncology; precision medicine; Eli Lilly acquisition; preclinical pipeline
National Resilience Restructures Manufacturing Footprint, Closes 6 of 10 Plants
National Resilience; manufacturing; CDMO; restructuring; overcapacity; biotech