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  • Biotech leaders urge faster IND process as FDA launches TrialBlazer pilot
    The U.S. Department of Health and Human Services has introduced Operation TrialBlazer, a pilot program aimed at simplifying the investigational new drug (IND) application and approval process. The…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 1mo agoCRLNegative↗ source
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  • TGA seeks industry input on adopting 11 international scientific guidelines in Australia
    The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework. The agency has opene…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Medline orders correction of convenience kits containing lidocaine and bupivacaine in dextrose injection
    Medline has issued a correction for certain convenience kits that include lidocaine hydrochloride and bupivacaine hydrochloride mixed with dextrose injection. The FDA has classified this recall as…
    fda medwatch · 1mo agoCRLNegative↗ source
  • American Regent recalls two lots of Adequan canine injection and two lots of Adequan i.m. for horses due to glass fibers
    American Regent Animal Health announced a nationwide recall of specific lots of its Adequan products for dogs and horses. The recall includes two lots of the 100 mg/mL 5 mL multi‑dose canine injec…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Novo Nordisk’s IL-6 drug ziltivekimab misses Phase 3 cardiovascular endpoint, shares drop 9%
    Novo Nordisk announced that its IL-6 inhibitor ziltivekimab did not meet the primary goal in a late-stage Phase 3 trial aimed at lowering major cardiovascular events. The ZEUS study enrolled patie…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Alnylam cuts TTR franchise guidance, market cap loses $10.8B as shares tumble 28%
    Alnylam announced a reduction in its full-year revenue outlook for its transthyretin (TTR) franchise, trimming the midpoint by $200 million. The company now projects TTR therapy sales of $4.2 bill…
    BioSpace · 1mo agoEarningsNegative↗ source
  • ResMed issues correction for Astral ventilators due to electrical component failure risk
    ResMed has released a correction for certain Astral ventilators after identifying a faulty electrical component that could interrupt therapy and cause serious injury or death. The FDA classifies t…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Capricor CEO hints at possible lawsuit after FDA panel rejects Duchenne cardiomyopathy therapy
    An FDA Cellular, Tissue, and Gene Therapies advisory committee voted 9-3 against recommending Capricor Therapeutics' cell therapy deramiocel for Duchenne muscular dystrophy cardiomyopathy. The pane…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Eli Lilly and Resilience commit $750 million to expand U.S. KwikPen device capacity for diabetes and obesity treatments
    Eli Lilly and contract development and manufacturing organization Resilience have announced a $750 million investment to boost U.S. production of the KwikPen device that delivers Lilly’s injectable…
    BioSpace · 1mo agoDealPositive↗ source
  • Resilience and Eli Lilly commit $750 million to expand Cincinnati GLP-1 injectable production
    Resilience and Eli Lilly announced a joint $750 million investment to expand drug manufacturing capacity in Cincinnati. The expansion will add at least 400 jobs and increase Resilience's workforce…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Moderna sticks to 10% revenue growth goal despite Phase 3 norovirus vaccine miss
    Moderna said it will continue to aim for up to 10% revenue growth this year, even though its experimental norovirus vaccine did not achieve statistical significance in a Phase 3 interim analysis.…
    BioSpace · 1mo agoNegative readoutNeutral↗ source
  • Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk
    The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
    fda medwatch · 1mo agoCRLNegative↗ source
  • AbbVie shares slip 4% as Q2 immunology earnings beat falls short of lofty expectations
    AbbVie’s stock fell about 4% on Friday after the company reported second‑quarter results that modestly exceeded analyst forecasts, disappointing investors who had set very high expectations. The f…
    BioSpace · 1mo agoEarningsNegative↗ source
  • Sanofi CEO pledges to rebuild trust and expand partnership with Regeneron
    Sanofi's new chief executive, Belén Garijo, told analysts that restoring the relationship with longtime partner Regeneron is a top priority. She said the company wants to be more transparent and to…
    BioPharma Dive · 1mo agoNeutral↗ source
  • UniQure prepares for FDA advisory committee on Huntington’s gene therapy amid rare-disease regulatory jitters
    UniQure said it is ready to present its Huntington's disease gene therapy, AMT-130, to an FDA advisory committee, as discussed in its Q2 earnings call. The company expects the FDA may schedule the…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Trump administration proposes 340B rebate pilot for 2027, hospitals push back
    The Health Resources and Services Administration announced a new pilot that would shift some 340B drug discounts to rebate payments starting in 2027. The proposal follows a previous attempt earlie…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • FDA announces reorganization and CTAGTAC votes on Duchenne muscular dystrophy and melanoma therapies
    The FDA disclosed a major internal reorganization aimed at streamlining its operations and improving efficiency across its divisions. The agency’s Cellular, Tissue, and Gene Therapies Advisory Com…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on container closure and device components for biosimilar combination products
    The FDA issued draft guidance aimed at helping sponsors develop container closure systems and device constituents for biosimilar and interchangeable biosimilar combination products. The guidance f…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 1mo agoEarningsNegative↗ source
  • Johnson & Johnson secures option to acquire in-vivo CAR-T developer Sail Biomedicines for up to $2.6 billion
    Johnson & Johnson announced a strategic partnership with Sail Biomedicines, a Flagship Pioneering‑backed startup, that includes an upfront cash payment and an equity investment. The initial paymen…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • BMS beats Q2 forecasts and lifts 2026 outlook despite delays in Cobenfy and milvexian data
    BMS reported second‑quarter revenue of $12.97 billion, topping analysts' estimate of $11.73 billion, and earnings per share of $2.04, well above the $1.60 consensus. The strong results prompted the…
    BioSpace · 1mo agoEarningsNeutral↗ source