Helixgate https://validator.w3.org/feed/docs/rss2.html Home Vertex drops mRNA cystic fibrosis program over ‘tolerability’ issues Gene Syntax Determines DNA Supercoiling and Modulates Gene Expression Blood Stem Cells Evade Immune Attack in Aplastic Anemia Through Gene Mutations Protein Biomarkers in Practice: Strategies to Reduce Drug Development Risk TRACS Enables Strain-Level Tracking of Microbial Transmission STAT+: French regulator fines Novo and Lilly over weight loss ad campaigns Optical Pooled CRISPR Screen Reveals Regulators of NF-κB Dynamics in Human Cells Opinion: Mifepristone court ruling makes drug development riskier for everyone FDA search for new CBER head focused on small group of final candidates Celcuity strengthens case for ASCO-spotlighted breast cancer drug Passage cuts 75% of workforce after FDA trial design request Supreme Court restores access to abortion pill mifepristone through telehealth, mail, and pharmacies Celcuity breast cancer win; Odyssey plans $205M IPO; Latus Bio extends Series A STAT+: Pump the brakes on AI, buddy; and deposition deadlock Big Tech Targets Drug Discovery with Wave of Life Science Platforms Federal court blocks mailing of mifepristone Gene therapy’s evidence problem—lessons from recent FDA decisions Windward Bio gets $165M to take China-derived drug into Phase 3 asthma trial Passage launches strategic review and 75% layoffs after gene therapy path blocked by FDA First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial NICE recommends Rystiggo for rare autoimmune disease  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 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 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 UCB bets $2 billion on Candid’s T cell engager ambitions Digital twins of ex vivo human lungs enable accurate and personalized evaluation of therapeutic efficacy 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 Samsung Biologics workers begin five-day strike over wage disputes  Acelyrin founder Shao-Lee Lin emerges at Cue, as it becomes latest to license from China 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