Helixgate https://validator.w3.org/feed/docs/rss2.html Home 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 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 Brain Glucose Levels Act as a Metabolic Switch for Myelin Formation Acelyrin founder Shao-Lee Lin emerges at Cue, as it becomes latest to license from China AstraZeneca’s breast cancer drug fails to earn backing of FDA advisory committee 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 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 DNA-guided CRISPR–Cas12a effectors for programmable RNA recognition and cleavage Remembering J. Craig Venter: a relentless scientist who changed biotech — and was all too easily misunderstood STAT+: Katherine Szarama named acting director of FDA’s vaccines and biologics center STAT+: In her own words: Surgeon general nominee Nicole Saphier expresses enthusiasm and caution for MAHA Corcept ties ALS drug to improved 2-year survival as Phase 3 start date nears STAT+: Hair-raising trial results, and Servier’s M&A wishlist Genomics Pioneer and Life Sciences Entrepreneur J. Craig Venter Dies at 79 Seaport, Hemab price IPOs, while Avalyn soars in Nasdaq debut Merck drops early-stage TROP ADC, keeps deal doors open as Keytruda clock ticks FDA’s oncology advisors vote against ‘new paradigm’ in AstraZeneca trial Advanced Neural Probes Reveal Predictable Patterns in Epileptic Brain Activity Court dismisses part of Lilly lawsuit against Empower, some claims can proceed STAT+: As artificial intelligence show off diagnostic chops, scientists reckon with the way forward Lilly’s weight loss pill reaches brand new patients, even without full-court marketing press Merck still sees ‘compelling’ outlook for Terns leukemia drug UniQure, in ‘symbolic’ win, to seek UK approval of Huntington’s gene therapy Pathogenic Bacterium Rewires Gut Environment to Colonize and Cause Disease Avalyn’s upsized IPO; Alector ends another study in GSK partnership FDA pauses schizophrenia trial after patient death  XTL Bio to acquire psychedelic biotech; WuXi AppTec’s Q1 revenue rise STAT+: Cigna will exit ACA individual markets next year, adding to tumult for patients UniQure eyes UK approval for embattled Huntington’s gene therapy after FDA quarrel What we heard at a health tech conference in Boston BMS positions Cobenfy as safer alternative ahead of pivotal Alzheimer’s psychosis readout AstraZeneca’s camizestrant ambitions stumble as FDA panel rejects novel oral SERD proposal STAT+: Pharmalittle: We’re reading about a Supreme Court hearing on ‘skinny labels,’ AstraZeneca U.K. expansion, and more CVS’ healthcare delivery chief eyes potential in clinical AI Lilly clocks 56% revenue increase in Q1 but declining prices stunt growth Bioprocessing Applications Laboratory Opened in Korea by Ecolab Life Sciences Smog from wildfires increasingly harmful, data show Patient death prompts FDA pause on Newron’s Phase 3 schizophrenia study Lack of specifics on obesity pill sales hover over Lilly’s first quarter Novartis unveils North Carolina factory as final new build in $23B US expansion