Helixgate https://validator.w3.org/feed/docs/rss2.html Sanofi strikes Cheplapharm deal to divest 20 older medicines as CEO pushes for innovation FDA approves first radioligand equivalent, Curium’s copycat of Novartis’ Lutathera As ‘cultural weight’ of a psychedelic approval looms, FDA hearing focuses on access and safety FDA Approves Pixclara (floretyrosine F 18) FET-PET Imaging Agent for Glioma FDA Approves Reduced Monitoring Time for First Two Doses of Imdelltra Biofrontera Announces FDA Approval of Ameluz Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma FDA Approves Bexlutry (lutetium Lu 177 dotatate) for Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors WCLC: Lung cancer news from BioNTech, Akeso, and Roche FDA to decide on Takeda’s psoriasis blockbuster hope in Q1 GSK wagers $750m on Chimagen multiple myeloma therapy Electra sets terms for IPO, hoping to raise up to $347m STAT+: Vera kidney drug Trutakna shows strong final results in Phase 3 trial STAT+: Obesity drugmakers are testing in kids as young as 6 Axoltis misses the mark in phase 2 ALS study, but will persevere with the synthetic peptide FDA launches pilot program to speed up sluggish phase 1 trials Connect’s Dupixent rival flunks phase 2 asthma trial, but biotech sees reasons for hope Lilly pledges up to $237M per program in CNS genetic med collab with Canadian biotech Sionna lays off 46% of workforce in strategic shift after cystic fibrosis trial fail GSK doubles down on Chimagen with $750M multiple myeloma wager J&J’s Contineum-partnered depression drug flunks another phase 2 test As ‘cultural weight’ of a psychedelic approval looms, FDA hearing focuses on access and safety FDA reduces monitoring time for Amgen’s Imdelltra infusions Cheplapharm to take over 20 medicines and three sites from Sanofi Scholar Rock SMA drug approved by FDA Cellectis quits CAR-T and pivots to ‘in vivo’ gene editing AstraZeneca’s newly approved pill fails frontline breast cancer study Summit, Akeso look to shed PD-1/VEGF drug doubts with latest study results FDA launches pilot program to speed up early US drug research WCLC ‘26: A new ‘ADC era,’ China questions and AstraZeneca’s spotlight FDA clears first generic radioligand drug; Sionna turns to layoffs Ensuring safety and accountability in China’s biomedical translation system GSK Presents Positive Registrational Data to Potentially Expand Jideytro (zidesamtinib) to First-Line ROS1-Positive Non-Small Cell Lung Cancer UCB Receives U.S. FDA Breakthrough Therapy Designation for Cimzia (certolizumab pegol) in Pregnant Women with Antiphospholipid Syndrome (APS) PDUFA reauthorization offers a chance at clinical trial reforms. Will the US take it? FDA could approve psychedelics before redosing is resolved Suppressor tRNAs take two translational steps forward Psychedelics at FDA, Mike Davis’ CDER and translating tRNAs — a BioCentury podcast   STAT+: Pharmalittle: We’re reading about another AstraZeneca trial failure, a Novo name change, and more Scholar Rock secures first FDA approval for muscle-targeting rare disease drug Blood centers can help biopharma scale cell and gene therapies Cyclic peptides open new drug frontiers, if manufacturing can keep up AstraZeneca’s newly approved cancer pill fails late-stage study, blocking path to bigger market Definium moves toward FDA submission for LSD drug in anxiety after ‘another clear win’ Summit, BioNTech, more headline WCLC with next-gen lung cancer drugs Novo Nordisk rebrands as Novo as new CEO charts turnaround Scholar Rock gets first drug approval as FDA okays Isembyld Resistance grows to Recordati’s private equity takeover AZ’s Etcamah falls short in first-line breast cancer trial FDA Approves Omcazio (cabozantinib) Capsule Formulation for Administration Without Regard to Food Home