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1,397 stories matching this filter · ← front page

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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 · 23d 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 · 23d agoPositive↗ source
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Former FDA oncology chief calls for agency restructuring after recent staff cuts
Richard Pazdur, who led the FDA’s Oncology Center of Excellence for more than twenty years, said the agency now faces a "golden opportunity" to restructure its operations. He made the comments aft…
Endpoints · 23d agoRegulatoryNeutral↗ 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 · 23d 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 · 23d 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 · 24d agoNeutral↗ 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 · 24d 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 · 24d agoDealPositive↗ source
  • Gilead and Merck to unveil detailed Phase 3 results of once‑weekly oral HIV regimen at AIDS 2026; Dimension Capital launches $800M fund
    Gilead Sciences and Merck announced that they will present detailed results from their Phase 3 trials of a once‑weekly oral HIV treatment regimen at the upcoming AIDS 2026 conference. The data wil…
    Endpoints · 24d agoNeutral↗ 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 · 24d 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 · 24d agoNegative readoutNegative↗ source
  • FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical study
    The U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in…
    Endpoints · 24d agoRegulatoryNegative↗ 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 · 24d agoRegulatoryPositive↗ source
  • FDA to appoint permanent heads of CBER and CDER alongside new commissioner
    The FDA is preparing to announce a series of senior leadership changes concurrent with the appointment of a new commissioner. Among the planned announcements are permanent appointments for the hea…
    Endpoints · 24d agoRegulatoryNeutral↗ source
  • Agios halts development of next‑generation sickle‑cell drug tebapivat after disappointing mid‑stage trial
    Agios Therapeutics announced it will discontinue development of tebapivat, a next‑generation therapy for sickle cell disease, after the drug failed to demonstrate sufficient efficacy in a Phase 2 t…
    Endpoints · 24d agoNegative readoutNegative↗ 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 · 24d 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 · 24d agoRegulatoryPositive↗ source
  • Broad Institute partners with Boston Children’s Hospital and Jackson Lab to launch Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard announced a partnership with Boston Children’s Hospital and the Jackson Laboratory to create a Center for Therapeutic Genetics focused on rare diseases. The…
    Endpoints · 24d agoPositive↗ 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 · 24d 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 · 24d 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 · 24d 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 · 25d 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 · 25d agoRegulatoryNeutral↗ source
  • Novo Nordisk files lawsuit against Eli Lilly over allegedly deceptive GLP-1 dose ads
    Novo Nordisk has initiated legal action against Eli Lilly in a U.S. court, alleging that Lilly's recent advertisements misrepresent the dosing of GLP-1 obesity treatments. The company says the ads…
    Endpoints · 24d agoNegative↗ 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 · 24d agoDealPositive↗ source