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  • FDA pushes back decision on Capricor’s Duchenne cell therapy, GSK clears hepatitis B drug in Japan
    The U.S. Food and Drug Administration has extended its review of Capricor Therapeutics' experimental Duchenne muscular dystrophy cell therapy, deramiocel. The agency moved its decision deadline fro…
    BioPharma Dive · 18d agoRegulatoryNeutral↗ source
  • Roche to acquire Hanmi's lean-mass preserving obesity shot in $2.3 bn deal
    Roche announced a partnership with South Korean company Hanmi Pharm to obtain rights to a novel obesity drug outside South Korea. Under the agreement, Roche will pay $190 million upfront and could…
    BioPharma Dive · 18d agoDealPositive↗ source
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  • FDA places hold on REGENXBIO's Hunter syndrome gene therapy after spinal nodules found, company pauses resubmission
    The FDA placed a clinical hold on RGX-121, REGENXBIO's gene therapy for Hunter syndrome, after MRI scans showed small nodules or cystic masses in the spines of five trial participants. The finding…
    BioSpace · 18d agoRegulatoryNegative↗ source
  • FDA grants three-month extension for Capricor’s Duchenne therapy deramiocel, sets new action date Nov 22
    The U.S. Food and Drug Administration has given Capricor Therapeutics a three‑month extension to review additional data for its Duchenne muscular dystrophy cell therapy, deramiocel. The agency has…
    BioSpace · 18d agoRegulatoryNeutral↗ source
  • Pharma marketers urged to adopt share-of-answer strategy as AI use surges among physicians
    Pharma marketers are planning for 2027 as artificial intelligence reshapes how clinicians seek clinical answers. The rise of AI tools means that traditional metrics like share of voice and broad om…
    BioPharma Dive · 18d agoNeutral↗ source
  • FDA’s new leadership aims to restore reliability, but each application remains judged on its data
    The FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…
    BioSpace · 19d agoRegulatoryNeutral↗ source
  • Cellares to cut 100 jobs after losing contract with unnamed large pharma customer
    Cellares, a cell therapy manufacturing startup based in South San Francisco, announced it will lay off about 100 employees. The cuts follow the termination of a contract by an unnamed large pharma…
    BioPharma Dive · 18d agoLayoffsNegative↗ source
  • Health Secretary Kennedy criticizes CDC vaccine classification scheme and shared decision-making category
    Robert F. Kennedy Jr., serving as Health Secretary, has raised concerns about how the CDC categorizes vaccine recommendations. The CDC uses three categories: routine recommendations for universal…
    BioSpace · 18d agoRegulatoryNegative↗ source
  • Boehringer Ingelheim pauses Phase 1 study of oral candidate BI 3031185 after safety event
    Boehringer Ingelheim has placed a Phase 1 study of its oral candidate BI 3031185 on hold after a safety event was identified. The trial, run in Japan with healthy volunteers, was assessing tolerab…
    BioSpace · 18d agoCRLNegative↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 18d agoNeutral↗ source
  • Lilly leads GLP-1 weight-loss market while Novo Nordisk’s Wegovy exceeds expectations but falls short of forecasts
    Eli Lilly and Novo Nordisk are intensifying their battle for dominance in the multibillion‑dollar GLP‑1 weight‑loss market, with each company promoting its own set of injectable therapies and pipel…
    BioPharma Dive · 21d agoEarningsNeutral↗ source
  • US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deaths
    Three recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…
    BioSpace · 21d agoRegulatoryNegative↗ source
  • Werewolf Therapeutics merges with Ambros in $150M deal to advance non‑opioid painkiller for rare limb injury syndrome
    Werewolf Therapeutics and Ambros Therapeutics announced a merger valued at $150 million, creating a new company that will retain the Ambros name. The deal includes a private placement to fund the…
    BioSpace · 21d agoDealPositive↗ source
  • Novo Nordisk launches Phase 3 trial of lower maintenance doses of oral Wegovy for obesity
    Novo Nordisk has begun a Phase 3, placebo-controlled study called OASIS 5 to evaluate two lower oral doses of its GLP-1 weight-loss drug Wegovy (semaglutide) in people who are obese or overweight.…
    BioSpace · 21d agoCRLNeutral↗ source
  • Capricor shareholders face board overhaul push as investors demand meeting and capital-preservation plan amid DMD cell therapy delay
    Kaos Capital, describing itself as a significant shareholder of Capricor Therapeutics, sent a letter to fellow investors calling for an immediate meeting, a change of the board, and a capital-prese…
    BioSpace · 21d agoNegative↗ source
  • Activist Kaos Capital pushes governance overhaul at Capricor ahead of FDA Duchenne decision
    Activist investor Kaos Capital has sent a letter to Capricor Therapeutics shareholders demanding a “governance reset.” The firm asks for a meeting to nominate two independent directors, create an M…
    BioPharma Dive · 21d agoNegative↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 22d agoPositive readoutPositive↗ source
  • Merck and Moderna’s melanoma vaccine shows positive Phase 3 results, boosting investor confidence
    Merck and Moderna announced that their personalized melanoma vaccine met the primary endpoint of recurrence‑free survival in a Phase 3 trial when given together with Keytruda. The study showed pati…
    BioSpace · 22d agoPositive readoutPositive↗ source
  • Roche commits $750 million to double Oregon plant capacity as obesity drug push grows
    Roche's Genentech announced a $750 million investment to enlarge its device fill-finish facility in Hillsboro, Oregon. The expansion will double the plant's size and add end-to-end capabilities fo…
    BioSpace · 22d agoDealPositive↗ source
  • Scribe Therapeutics’ early-stage IPO surges 43% as epigenetic cholesterol drug enters clinic
    Scribe Therapeutics filed for an IPO while its lead epigenetic therapy moves into early clinical testing, a rare combination in a market that prefers later-stage, de-risked offerings. The company…
    BioSpace · 22d agoPositive↗ source
  • Regeneron secures FDA approval for Pasatru, second U.S. treatment for rare bone disease FOP
    Regeneron received FDA approval for its antibody garetosmab, marketed as Pasatru, for treatment of fibrodysplasia ossificans progressiva (FOP) in adults. The approval makes Pasatru the second ther…
    BioSpace · 22d agoApprovalPositive↗ source
  • Layoffs hit over 1,300 workers across seven biopharma M&A deals in 2026
    Workforce reductions this year have affected at least seven biopharma companies that recently completed mergers or acquisitions, eliminating a minimum of 1,359 jobs, according to BioSpace data. Th…
    BioSpace · 23d agoLayoffsNegative↗ source
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 22d agoApprovalPositive↗ source
  • Ultragenyx secures first gene therapy approval for GSDIa as Sanfilippo asset decision pending
    Ultragenyx received accelerated FDA approval for its gene therapy DTX401, marketed as Genglycos, to treat glycogen storage disease type Ia (GSDIa). The approval comes as the company awaits a secon…
    BioSpace · 22d agoApprovalPositive↗ source
  • Biotech firms EMD Serono and Exelixis cut remote R&D staff as they enforce office return policies
    Biopharma workers at two biotech companies are losing jobs as employers shift away from remote work. The changes affect research and development staff who were previously allowed to work from home.…
    BioSpace · 23d agoLayoffsNegative↗ source