News
Obsidian, Galera to advance cell therapy following reverse merger
4+ hour, 26+ min ago (10+ words) Bio Pharma Dive...
Biogen builds case for Spinraza successor with fresh data
1+ mon, 4+ day ago (389+ words) More early-stage data show the drug, called salanersen, appeared to have positive effects on neurodegeneration and motor function in patients previously treated with Novartis" Zolgensma. Biogen picked up salanersen from its longtime partner Ionis Pharmaceuticals in 2022, looking to it as…...
Pep Gen muscular dystrophy drug gets "surprise" hold from FDA
1+ mon, 1+ week ago (309+ words) The issue triggering the hold" the program's second since 2023" involves mouse data the company claims to have submitted to the FDA in 2024, according to one analyst. The timing of the FDA's action is confusing because the agency has had the…...
With Vivtex deal, Novo gains a chance at better oral obesity drugs
1+ mon, 2+ week ago (19+ words) Bio Pharma Dive Don't miss tomorrow's biopharma industry news...
The formula for biotech success in 2026: Confidence, resilience and funding
2+ mon, 2+ week ago (784+ words) Survey of 260+ biotech leaders assesses the biotech climate, trends, opportunities and risks. Don't miss tomorrow's biopharma industry news The formula for biotech success in 2026: Confidence, resilience and funding For biotech companies the past two years have been challenging. Biotech investments…...
AI is slashing jobs across industries. Will pharma be next?
1+ mon, 3+ week ago (814+ words) Despite a wave of AI-fueled layoffs, the pharma and biotech industries could be spared from massive job losses for now. Super Bowl ads have long been a cultural bellwether, and at this year's big game, AI was a top trend…...
FDA leaders say one pivotal trial, not two, should be "default" for drug approvals
1+ mon, 3+ week ago (484+ words) In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards. The new position is the latest from an agency that has pledged…...
FDA accepts BMS protein degrader for review; Disc rare disease drug rejected
1+ mon, 3+ week ago (963+ words) Cytokinetics" heart disease drug secured European approval. Elsewhere, Teva and Sanofi reported longer-term data from an experimental therapy targeting ulcerative colitis and Crohn"s disease. Don't miss tomorrow's biopharma industry news FDA accepts BMS protein degrader for review; Disc rare…...
FDA rejects Regenxbio treatment in another blow to gene therapy
2+ mon, 5+ day ago (570+ words) The decision comes two weeks after the agency halted testing due to safety concerns and represents the latest regulatory setback for a gene therapy maker. The Food and Drug Administration rejected a gene therapy Regenxbio has been developing for a…...
Small and mighty: single-domain antibodies pack a biological punch
2+ mon, 6+ day ago (406+ words) What are VHH antibodies? In addition to indicators of growing clinical confidence and investment in next generation biologics, the global VHH nanobody market is growing, with CAGR estimates around 15%. This growth is driven by their promise for use in applications…...