Helixgate https://validator.w3.org/feed/docs/rss2.html Home Gene therapy’s evidence problem—lessons from recent FDA decisions Windward Bio gets $165M to take China-derived drug into Phase 3 asthma trial First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial Summit shares descend as PD-1/VEGF asset misses early survival mark FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed data STAT+: Biotech raises $42 million to run Huntington’s disease trial UCB to acquire Candid in $2.2B bet on bispecifics for autoimmune diseases What is your AI drug repurposing strategy missing? Opinion: Are blue zones real? Answering that question is harder than ever FDA Action Alert: Argenx, AstraZeneca/Daiichi Sankyo, Biogen/Eisai and Cingulate StockWatch: Patient Death, Rival’s Patent Challenge Sink Erasca Shares Federal appeals court blocks mailing of abortion pill mifepristone Bristol Myers’ pivotal year; Should AI be swinging bigger?; and more UCB bets $2 billion on Candid’s T cell engager ambitions Arvinas’ ‘Protac’ breast cancer drug cleared by FDA DNA-Containing Extracellular Vesicles Boost Antitumor Responses in Mice Moderna in talks with FDA over Phase 4 Covid vaccine data FDA approves Pfizer and Arvinas’ breast cancer drug despite underwhelming data Figurate SCADA System Launched to Overcome Digital Bottlenecks During Biopharma Manufacturing Q&A: Seaport CEO and CSO on learning from Karuna and the future of CNS research STAT+: Up and down the ladder: The latest comings and goings Summit’s ‘self-inflicted’ stumble; Esperion’s take-private deal Brain Glucose Levels Act as a Metabolic Switch for Myelin Formation Federal court blocks mailing of mifepristone Samsung Biologics workers begin five-day strike over wage disputes  Novartis unveils North Carolina API plant as final piece of $23B US expansion Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlook Moderna beats revenue expectations with $389M, but litigation dogs earnings STAT+: Axsome wins FDA nod for Alzheimer’s agitation The missing link in treating cancer PFAS is still in some infant formula Summit slips on ivonescimab’s apparent interim miss in sign of investor frustration Amgen positions MariTide as potential ‘best monthly’ obesity drug Axsome wins first non-antipsychotic FDA approval for Alzheimer’s agitation AstraZeneca’s breast cancer drug fails to earn backing of FDA advisory committee Corcept ties ALS drug to improved 2-year survival as Phase 3 start date nears Seaport, Hemab price IPOs, while Avalyn soars in Nasdaq debut Remembering J. Craig Venter: a relentless scientist who changed biotech — and was all too easily misunderstood Approaches to Reducing Toxicity and Side Effects in Cell and Gene Therapy FDA taps Szarama as acting CBER director as Prasad’s tumultuous tenure ends STAT+: Her daughter Mila got a bespoke medicine. Now she’s starting a new biotech to make more Don’t toss cannabis leaves: Scientists found rare compounds with medical potential ‘M&A used to be the only way to go’: Why Seaport’s CEO opted for route to upsized $255M IPO Two biotechs raise a combined $556M in latest spurt of IPOs STAT+: OxyContin maker Purdue Pharma set to dissolve after judge approves its criminal sentence TxPert: using multiple knowledge graphs for prediction of transcriptomic perturbation effects DNA-guided CRISPR–Cas12a effectors for programmable RNA recognition and cleavage STAT+: Katherine Szarama named acting director of FDA’s vaccines and biologics center Acelyrin founder Shao-Lee Lin emerges at Cue, as it becomes latest to license from China