Helixgate https://validator.w3.org/feed/docs/rss2.html Home No FDA permission, no problem: New flavored vape policy worries experts GSK cuts deal with Sino to broaden reach of hepatitis B drug Daiichi eyes almost $15B in oncology sales by 2030 in ADC franchise push New home for Novo’s Parkinson’s cell therapy; GSK turns to China for hep B drug RegVelo AI Model Predicts Cell Fate, Tackles Developmental Disorders and Cancer STAT+: Astellas treatment offers new hope to a devastated rare disease community Braveheart Bio’s Hengrui-licensed cardiac drug scores second clinical win Daiichi takes $850M charge, axes facility investment as ADC demand forecast falls Biotech layoffs are easing, but is the worst over? Diabetes Drug Metformin’s Blood Glucose-Lowering Effects Tied to Action on Gut Cells The connection between periods and mental health European regulators greenlight Fractyl Health’s clinical test of GLP-1 gene therapy CSL sinks to nine-year low on revenue warning, $5B write-down Precision in motion: Decoding the critical operations behind the logistics of next-generation cell and gene therapies Opinion: AI doctors should be licensed. Here’s a framework to do that Advances in RSV Vaccine Research and Development Published FDA rejections point to manufacturing, data gaps as key stumbling blocks Merck, Amgen double down on bad cholesterol to vanquish number 1 killer StockWatch: enGene Shares Crater on Declines in Complete Response Rates to Bladder Cancer Therapy Scientists successfully transfer longevity gene and extend lifespan Makary’s reported FDA removal could be ‘broad positive’ for biopharma Quantum firm hailed by Amgen tech leader as an ‘extraordinary platform’ plans IPO Experts wonder ‘Where is the CDC?’ as hantavirus outbreak unfolds Partner’s Bizengri cleared by FDA for ultra-rare cancer days after winning priority voucher Opinion: Dr. Glaucomflecken wants the corporatization of medicine to be national news Biotech’s new company model; The super poop behind a startup launch; and more New Hepta blood test could predict GLP-1 response Spain readies for evacuations as a hantavirus-hit cruise ship heads for the Canary Islands STAT+: Roche to buy PathAI for $750 million STAT+: Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drug Trump signs off on plan to oust embattled FDA Commissioner Marty Makary: report FDA Commissioner Makary to be fired, WSJ reports Daiichi Sankyo posts ‘extraordinary loss’ of nearly $1B How Digital Orchestration Is Redefining Regulatory Infrastructure for Cell and Gene Therapy Remembering J. Craig Venter, PhD Opinion: I’m fighting misinformation online. False hantavirus claims follow a now-familiar playbook Former FDA leaders, pharma speak out on mifepristone Trump plans to fire FDA chief Marty Makary: report FDA delays Leqembi decision; Artiva raises $300M; Pharvaris prices offering ASGCT CEO David Barrett Previews the Upcoming Conference in Boston ParcelBio Unveils Programmable mRNA Platform Backed by $13M Financing FDA to reevaluate spurned cell therapy; Under-the-skin Leqembi review extended Rewriting the Oncology Playbook STAT+: Pharmalittle: We’re reading about an FDA gender rule change, its program for one-day inspections, and more ASGCT Honors Mohamed Abou‑el‑Enein as Outstanding New Investigator ‘Pharma, not really’: Top young AI talent shuns careers at big drugmakers Biogen, Eisai hit with 3-month delay for starting SubQ Alzheimer’s therapy Lilly invests $4.5B in Indiana manufacturing, opens doors of 1st genetic medicine site Gilead sets blockbuster bar for Yeztugo’s first full year on the market