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  • Celldex halts skin disease program after barzolvolimab fails phase 2 trial
    Celldex Therapeutics announced it is discontinuing development of its anti‑KIT antibody barzolvolimab for chronic skin disorders after the drug failed to meet its primary endpoint in a phase 2 stud…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Summit and Akeso sharpen case for ivonescimab with new Western data
    Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistic…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
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  • Why moving from Big Pharma to a midsize specialty firm can boost impact and leadership
    Thomas Kolaras, formerly with large pharmaceutical companies, now works at SERB Pharmaceuticals and reflects on the benefits and constraints of big‑pharma environments. He highlights the rigorous p…
    BioSpace · 1mo agoPositive↗ source
  • Webinar Highlights Emerging Recovery in Biopharma Hiring and Talent Strategies for Commercial Growth
    The BioSpace webinar "From Clinical to Commercial: Talent Strategies for Biopharma Growth" examined recent hiring activity across the biopharma sector and offered guidance for companies preparing t…
    BioSpace · 29d agoPositive↗ source
  • Cambridge biopharma job postings surge 120% as six firms ramp up hiring
    Job listings for biopharma positions in Cambridge, Massachusetts, have jumped 120% year over year on the BioSpace platform. The upward trend began in February, saw a brief dip in May, and accelerat…
    BioSpace · 1mo agoPositive↗ source
  • Novartis drops mid-stage radioligand therapy 177Lu-NeoB after weak early data
    Novartis has discontinued its mid-stage radioligand therapy 177Lu-NeoB, which was being tested for breast cancer and other solid tumors. The company said early clinical data did not show enough ef…
    BioSpace · 1mo agoNeutral↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 1mo agoNeutral↗ source
  • FDA revokes Orange B color additive and proposes to drop Citrus Red No. 2 from food approvals
    The U.S. Food and Drug Administration issued a final order that revokes the authorized use of Orange B as a food color additive. The agency also proposed revoking Citrus Red No. 2, a pigment autho…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Dyne Therapeutics receives early 2027 FDA decision date for Duchenne therapy, analysts anticipate smooth review
    Dyne Therapeutics' investigational Duchenne muscular dystrophy therapy, zeleciment rostudirsen, has had its BLA accepted by the FDA with a target action date of Jan 21, 2027. Analysts at Oppenheim…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Samsung Biologics proposes $1.8B acquisition of PolyPeptide to enter fast-growing obesity peptide market
    Samsung Biologics, a South Korean contract development and manufacturing organization, announced an offer to acquire Swiss CDMO PolyPeptide for CHF 1.46 billion (about $1.8 billion). PolyPeptide s…
    BioSpace · 1mo agoDealPositive↗ source
  • Novartis says it will keep seeking sub-$2 billion bolt-on deals worldwide, staying geography-agnostic
    Novartis CEO Vas Narasimhan told investors on the second‑quarter earnings call that the company will continue to pursue bolt‑on acquisitions below $2 billion and has no plans to overhaul its busine…
    BioSpace · 1mo agoDealNeutral↗ source
  • Agios halts sickle cell drug program after disappointing phase 2 results
    Agios announced it is stopping development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a phase 2 trial failed to meet expectations. The study enrolle…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Biotech firms rally to defend FDA's mifepristone approval in Louisiana lawsuit
    Biotech companies, executives and investors filed an amicus brief supporting the FDA in the Louisiana case that seeks to limit access to the abortion pill mifepristone. The brief is signed by 61 e…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Agios drops next-gen sickle cell drug after Phase 2 data show no advantage over Novo’s candidate
    Agios Pharmaceuticals said it is halting development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a mid‑stage trial failed to demonstrate a benefit ove…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • FDA’s 505(b)(2) pathway offers faster, cheaper drug development and commercial gains
    The FDA’s 505(b)(2) regulatory route lets drug sponsors build on existing safety and efficacy data while proposing meaningful changes to a known product. By leveraging prior findings, companies can…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Axiom Biosciences targets Hong Kong IPO to raise up to $200 million for regenerative therapy pipeline
    Axiom Biosciences, a San Diego‑based biotech, announced plans to list on the Hong Kong Stock Exchange rather than the traditional U.S. exchanges. The company aims to use the offering to secure new…
    BioSpace · 1mo agoDealPositive↗ source
  • Jupiter Neurosciences signs $100M deal for U.S. rights to PharmAla's MDMA therapy ALA-002
    Jupiter Neurosciences announced a licensing agreement with Canadian biotech PharmAla Biotech to obtain U.S. rights to an MDMA‑based drug, ALA‑002, aimed at treating neuropsychiatric conditions. Th…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Novartis halts phase-2 radioligand therapy Lu-NeoB after disappointing data, but reaffirms commitment to RLT
    Novartis announced it is halting development of Lu-NeoB, a gastrin-releasing peptide receptor-targeting radioligand therapy, after phase-2 data failed to demonstrate sufficient efficacy. The candi…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Lupin spins out two phase-1 cancer candidates into US startup Kaveri, taking majority stake and providing seed funding
    Lupin, an Indian generics manufacturer, has created a U.S.-based spinout called Kaveri Therapeutics by transferring two clinical-phase cancer drug candidates. The assets are a PRMT5 inhibitor (LNP…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelines
    The U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Ashlins Pharma licenses interferon alpha-2b from Lee's, eyes $50M raise to pursue FDA approval for rare disease
    Ashlins Pharmaceuticals has signed a licensing agreement with Hong Kong‑based Lee’s Pharmaceutical to obtain the ex‑China rights to a Chinese formulation of interferon alpha‑2b. The deal, announced…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • ‘We’ve been looking for a novel approach’: Why Novartis CEO ended ADC holdout for $1.5B Myricx deal
    For years, as Big Pharma poured billions into ADCs, Novartis CEO Vas Narasimhan notably stayed on the sidelines. Asked by Fierce during Novartis’ Q2 earnings call, Narasimhan explained why he is en…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Roche appoints Dan Malarek as President and CEO of Diagnostics North America, creates new CCO role
    Roche announced that Dan Malarek, who has led Foundation Medicine since 2023, will become President and CEO of Roche Diagnostics North America. Malarek, a 19‑year veteran of Roche, will succeed Br…
    Fierce Biotech · 1mo agoPositive↗ source
  • EU releases AI Act transparency guidelines, impacting healthcare AI developers
    The European Commission published new guidelines on Monday to help providers and deployers of AI systems meet the transparency obligations set out in the EU AI Act. The guidance includes examples…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, affecting health-tech developers
    The European Commission has published new guidelines to help providers and users of artificial intelligence systems meet the transparency obligations set out in the EU AI Act. The document explain…
    raps · 1mo agoRegulatoryNeutral↗ source