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1,712 stories matching this filter · ← front page

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  • FDA places second clinical hold on Regenxbio’s Hunter syndrome gene therapy after spinal masses detected
    The FDA issued another clinical hold on Regenxbio’s RGX-121 gene therapy for Hunter syndrome after investigators found spinal masses in five trial participants. The masses, observed on MRI scans,…
    BioPharma Dive · 50m agoRegulatoryNegative↗ source
  • Roche's Genentech signs up to $2.3B deal with Hanmi for weight-loss drug that preserves lean mass
    Roche, through its Genentech subsidiary, has entered a licensing agreement with South Korea's Hanmi Pharm that could be worth up to $2.3 billion, including a $190 million upfront payment. The deal…
    BioSpace · 3h 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 · 3h agoRegulatoryNegative↗ source
  • Roche commits $190 million upfront to license Hanmi's early-stage muscle-building obesity drug, total deal up to $2.3 billion
    Roche announced it will pay $190 million upfront to license an early-stage obesity drug from South Korean company Hanmi Pharm. The compound is described as a non-incretin, muscle-building therapy a…
    Endpoints · 5h agoDealPositive↗ source
  • Option-to-acquire structures stay uncommon amid biotech's busy M&A season
    Biotech companies are experiencing one of the busiest deal-making years on record, with a flood of announced mergers and acquisitions. Two recent transactions have highlighted the option-to-acquir…
    Endpoints · 6h agoDealNeutral↗ 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 · 7h 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 · 12h agoRegulatoryNeutral↗ source
  • Cardio firms including AstraZeneca and Novartis to showcase heart drug data at ESC 2026
    At the European Society of Cardiology's annual meeting in 2026, several pharmaceutical companies will present cardiovascular data. The lineup includes AstraZeneca, Ionis, Cytokinetics, Novartis an…
    Endpoints · 1h agoNeutral↗ 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 · 4h 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 · 4h 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 · 4h agoNeutral↗ source
  • FDA extends review of Capricor cell therapy; Pain drug startup to go public
    The agency is now reviewing an updated application for deramiocel with a “refined” indication. Elsewhere, a startup co-founded by Vivek Ramaswamy is taking a speedy path to the public markets.
    BioPharma Dive · 1h ago↗ source
  • Capricor’s Duchenne therapy has new life after FDA grants 3-month extension
    The FDA has granted a three-month extension for Capricor Therapeutics’ Duchenne muscular dystrophy hopeful deramiocel in order to review additional data and consider a refined indication. The new t…
    BioSpace · 1h ago↗ source
  • Cellares, a cell therapy manufacturing specialist, to lay off 100 employees
    The restructuring comes after an unnamed "large pharmaceutical customer" terminated a contract with the company, Cellares CEO Fabian Gerlinghaus posted on LinkedIn.
    BioPharma Dive · 1h ago↗ source
  • Regenxbio hit with another clinical hold for Hunter syndrome gene therapy
    Regenxbio said it no longer expects to file for FDA approval of its Hunter syndrome gene therapy in the near future after the program was slapped with its second clinical hold this year. The compan…
    Endpoints · 1h ago↗ source
  • FDA delays Capricor's deramiocel PDUFA date to review new data
    The FDA is pushing back its decision on Capricor Therapeutics’ problematic Duchenne muscular dystrophy therapy to review additional data for a more niche indication. The company on Monday said the…
    Endpoints · 1h ago↗ source
  • TwinStrand wins patent case; GSK’s hepatitis B drug approved in Japan
    TwinStrand Biosciences wins patent case: The DNA sequencing company, which spun out of the University of Washington, announced on Monday that it won a patent infringement lawsuit against a Californ…
    Endpoints · 1h ago↗ source
  • Roche commits to lean-mass preservation with Hanmi obesity deal
    For $190 million up front and as much as $2.3 billion overall, the Swiss drugmaker is building its portfolio with a shot that aims to spur weight loss but spare muscle tissue.
    BioPharma Dive · 2h ago↗ source
  • Qiagen appoints new chief executive after 9-month search
    Molecular diagnostics specialist Qiagen has a new CEO as Jonathan M. Pratt takes the reins.
    Fierce Biotech · 6h ago↗ source
  • TME holds onto $1B dream for brain cancer drug as search for partners nears conclusion
    TME Pharma’s hunt for a partner for its brain cancer drug is closer to bearing fruit as the German biotech clings onto its hope of generating $1 billion in peak sales from the asset.
    Fierce Biotech · 6h ago↗ source
  • Spruce’s successful FDA talks plant seeds for Q4 filing of ultra-rare disease drug
    Spruce Biosciences has taken another step toward filing for FDA approval of its ultra-rare disease drug candidate, ticking off some of the manufacturing tasks needed to submit the long-awaited appl…
    Fierce Biotech · 6h ago↗ source
  • Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings
    The FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.
    Fierce Biotech · 8h ago↗ source
  • Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test
    Roche and Eli Lilly have won FDA clearance for their latest Alzheimer’s disease diagnostic.
    Fierce Biotech · 9h ago↗ source
  • Roche pens $2.5B pact for Hanmi’s clinical-stage obesity drug targeting less-explored mechanism
    Roche has taken its obesity strategy into uncharted territory via a $190 million upfront payment for a clinical-stage urocortin-2 analog from South Korea’s Hanmi Pharm.
    Fierce Biotech · 12h ago↗ source
  • Merck and Moderna report positive topline results for personalized cancer vaccine
    A third death was reported in China’s expedited clinical trials, raising safety concerns for fast‑track studies in the region. Merck and Moderna announced positive topline data from their personal…
    Endpoints · 2d agoPositive readoutPositive↗ source