Helixgate https://validator.w3.org/feed/docs/rss2.html Regulatory lessons from FDA review of approved AAV gene therapies Decision quality in biopharma portfolio renewal Sarepta’s new CEO confident in clinical execution as DMD competitors close in Forge’s Piteri-Molina on AI, Ohio and what’s next for gene therapy manufacturing Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked November Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked November Agios axes 100-plus R&D roles while awaiting FDA decision Moderna enjoys stable vaccine sales thanks to global COVID uptake Agios axes 100-plus R&D roles while awaiting FDA decision Moderna enjoys stable vaccine sales thanks to global COVID uptake Moderna enjoys stable vaccine sales thanks to global COVID uptake Alethio raises $90M to target rare blood cancers T-Therapeutics reloads with a $133M megaround for bispecifics This week in charts: 3 drug launches Wall Street is watching Lilly, Hims reach GLP-1 deal; Alnylam sales chief to step down Novartis reveals cancer cases possibly linked to gene therapy Zolgensma FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma Office of Health Advancement (OHA) Guidance Documents FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck squamous cell carcinoma Voyager, C4 cut workforces Drugs@FDA Data Files Nisa Leung’s Aulis Capital closes $200M debut fund: Venture Report Alethio: A mutation-agnostic approach to essential thrombocythemia With $600M fund, Formation Bio puts a financing twist on hub-and-spoke model Citizen science program helps find exotic ticks Dren Bio raises $350m for dibotatug clinical development Glenmark opens Allentown distribution hub in US Pelthos and Castle Creek plan merger to target skin diseases Inovio’s Voceryq receives FDA accelerated approval for RRP Bavarian Nordic secures four-year UK vaccine supply deal Lonza to acquire five US manufacturing sites from Merck KGaA FDA to review uniQure’s BLA for Huntington’s gene therapy GEBRO and Spektus sign collaboration for ActraFlex STAT+: Pharmalittle: We’re reading about India’s new manufacturing rules, clinical trials in China, and more Revealing the Chemistry Around Us Through Mass Spectrometry What Biotech Licensing Really Buys Beyond Conventional CRISPR Oral Sleep Apnea Therapy Poised to Expand Treatment Options Beyond the Payload Orphan Therapeutics Accelerator In-Licenses Its First Gene Therapy, Eyes Pipeline Expansion Tissue Engineering Takes Shape Where DNA Copying Fails Can Decide How Cancer Cells Respond to PARP Inhibitors Boehringer Ingelheim Inks Up-to-$7.4B+ Cancer Drug Collaboration with Sino Biopharmaceutical Bird Flu Vaccine Developed Using AI Outperforms Current Stockpiled Vaccines in Preclinical Tests STAT+: In China, a flood of controversial clinical trials slows to a trickle STAT+: Revolution Medicines’ pancreatic cancer drug has stunning commercial debut STAT+: A possible comeback for a failed sickle cell gene therapy STAT+: Novartis cites cases of previously unknown tumors possibly tied to its SMA gene therapy Tetraploid Astrocytes Emerge as Potential Players in Drug-Resistant Temporal Lobe Epilepsy Home