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  • Novartis scraps TREM2 ALS candidate after Phase 2 failure
    Novartis announced it is halting development of its TREM2-targeting drug VHB937, also known as lifonebart, after the Phase 2 trial in amyotrophic lateral sclerosis (ALS) did not meet its primary en…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Sling Therapeutics raises $123M to fund Phase 3 trial of former Astellas cancer drug for thyroid eye disease
    Investors have committed $123 million to Sling Therapeutics, a small Michigan biotech focused on eye‑disease treatments. The funding will support a Phase 3 clinical trial of a drug originally deve…
    Endpoints · 1mo agoDealPositive↗ source
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  • Skyhawk Therapeutics reports symptom improvement for Huntington's disease in Phase 1/2 extension study
    Skyhawk Therapeutics announced that its RNA-splicing candidate SKY-0515 showed a measurable improvement in symptoms for patients with Huntington's disease during an extension of its Phase 1/2 trial…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Biotech firms race to hire AI-savvy scientists as talent gap widens
    AI is becoming integral to biotech research and development, prompting companies to seek staff who can blend biology with machine learning and data engineering. Recruiters say the hardest-to-find…
    BioSpace · 1mo agoNeutral↗ source
  • Biotech firms increase product launches as capital markets improve
    A growing number of biotech companies are bringing new medicines to market, a trend analysts link to improving capital markets. While the majority of approved drugs still come from large pharmaceu…
    BioSpace · 1mo agoPositive↗ source
  • Yale and Harvard faculty question benefits of FDA's 'America First' user fee provisions
    Yale and Harvard medical school faculty have voiced concerns about the latest FDA user fee agreement, which includes a set of "America First" provisions. The provisions are designed to prioritize…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Novartis stops ALS TREM2 stabilizer after Phase 2 miss, marking fourth trial setback in a month
    Novartis has halted development of its TREM2 stabilizer VHB937, also known as lifonebart, for amyotrophic lateral sclerosis after the drug failed to meet either the primary or secondary endpoints i…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Biopharma workers increasingly postpone retirement, poll shows 52% plan to stay longer
    Biopharma professionals are rethinking retirement, with a BioSpace LinkedIn poll indicating that 52% expect to retire later than originally planned. Overall, 63% of respondents said they have chang…
    BioSpace · 1mo agoNeutral↗ source
  • GSK to acquire Chimagen’s trispecific T-cell engager program in deal up to $750 million
    GSK announced it will acquire a preclinical trispecific T cell engager program from Chinese biotech Chimagen Biosciences in a transaction that could total up to $750 million. The agreement provide…
    BioSpace · 1mo agoDealPositive↗ source
  • Vera Therapeutics reports two-year data showing Trutakna stabilizes kidney function in IgA nephropathy, paving way for full FDA approval
    Vera Therapeutics announced that its recently approved drug Trutakna has produced encouraging two-year results in patients with IgA nephropathy, a chronic autoimmune kidney disease. The data indic…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • RegCell secures multi-million dollar Series A to advance Nobel-winning regulatory T-cell therapy
    RegCell, a biotech founded by Nobel laureate Shimon Sakaguchi, announced a new financing round to move its regulatory T-cell (Treg) program toward clinical testing. The company’s CEO Michael McCul…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA launches Operation TrialBlazer to accelerate early-stage drug trials and bring research back to the U.S.
    The FDA announced it is now accepting applications for Operation TrialBlazer, an expedited IND pilot program. The program pairs drug sponsors with qualified U.S. research institutions to cut the r…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • FDA launches expedited IND pilot program, integrating public feedback into qualification criteria
    The FDA announced that its long-awaited expedited investigational new drug (IND) pilot program has started accepting applications as of Tuesday. Agency leaders Karim Mikhail and Michael Davis, new…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Axoltis reports Phase 2 failure of experimental ALS drug but notes small signal
    Axoltis Pharma, a French biotech, announced that its Phase 2 trial of an experimental ALS therapy did not meet its primary endpoints. The company said the data were noisy but observed a modest tre…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Stakeholders call on FDA to set safety and treatment standards for emerging psychedelic therapies
    At a recent public hearing, experts and other stakeholders emphasized the need for clear safety and access guidelines as psychedelic medicines move closer to market. The FDA is intensifying effort…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Cullinan-Taiho eye FDA filing for zipalertinib after trial shows strong PFS benefit despite three deaths
    Cullinan Therapeutics and its partner Taiho Oncology said they will seek FDA approval for zipalertinib, an oral therapy for a subset of non‑small cell lung cancer, based on data from a late‑stage s…
    BioSpace · 1mo agoPositive readoutNeutral↗ source
  • J&J and Contineum's oral M1 inhibitor fails second mid-stage depression trial
    Contineum Therapeutics and Johnson & Johnson reported that their oral M1 receptor inhibitor, known as PIPE-307 or JNJ-5120, did not meet its primary endpoints in a Phase II study for major depressi…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Blood centers poised to boost cell and gene therapy supply chains
    Blood centers have the donors, resources and community footprint that drug sponsors need to address supply chain bottlenecks for cell and gene therapies. Cell and gene therapies such as CAR‑T and…
    BioSpace · 1mo agoPositive↗ source
  • FDA approves first radioligand generic, pitting Curium against Novartis' Lutathera
    The U.S. Food and Drug Administration has granted approval to Curium’s radioligand product, the first generic in this therapeutic class. The approved drug is a direct equivalent of Novartis’ Lutat…
    Endpoints · 1mo agoApprovalNeutral↗ source
  • Centric Compounding initiates nationwide recall of three injectable drugs due to API contamination
    Centric Compounding, a Houston-based pharmacy, announced a nationwide recall of three injectable products after detecting contamination in an active pharmaceutical ingredient. The recall includes…
    Endpoints · 1mo agoCRLNegative↗ source
  • GSK to close German vaccine plant and cut 650 jobs as flu vaccine demand falls
    GSK announced it will wind down its vaccine manufacturing site in Germany, ending operations at the facility. The decision follows a rigorous review and reflects a decline in demand for egg‑based…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • GSK to cut 650 jobs as it shuts German vaccine plant and consolidates production in Canada
    GSK announced it will close its vaccine manufacturing facility in Dresden, Germany, resulting in about 650 layoffs. The decision follows a review and aligns with a $2.5 billion cost‑saving program…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • GSK signs new agreement with China's Chimagen for trispecific T-cell engager targeting blood cancers
    GSK, the UK‑based pharmaceutical company, has entered into a fresh licensing agreement with Chinese biotech Chimagen Biosciences. The partnership focuses on a trispecific T‑cell engager designed fo…
    Endpoints · 1mo agoDealPositive↗ source
  • Experts urge FDA to require credentials for psychedelic therapy providers
    At a recent public hearing, mental health experts called on the FDA to adopt safety measures as it pushes to speed up psychedelic therapy development. The experts specifically recommended that pro…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Sionna Therapeutics to lay off 46% of staff after cystic fibrosis trial setback
    Sionna Therapeutics announced it will cut 46% of its workforce following an unexpected failure in its cystic fibrosis trial. The company, which employed about 59 people, said roughly 27 employees…
    Endpoints · 1mo agoLayoffsNegative↗ source