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2,087 stories matching this filter · ← front page

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  • Roche turns to Dualitas to find new bispecific approaches for immunology
    Roche is turning up the heat on its hunt for next-generation bispecific antibodies in a deal that will involve screening 300,000 new combinations for inflammatory and immunology conditions. The Swi…
    Endpoints · 1mo ago↗ source
  • Psychedelic therapeutics near first FDA approval as Compass Pathways and Definium report promising results
    BioSpace notes that the psychedelic drug sector is regaining momentum after a setback in 2024 when Lykos’ MDMA therapy failed to win FDA clearance. The focus has shifted to new candidates, with Com…
    BioSpace · 1mo agoRegulatoryPositive↗ source
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FDA holds psychedelic forum as Definium reports third successful Phase 3 trial of oral LSD for anxiety
The FDA convened a public forum on Monday to discuss the near‑term outlook for psychedelic drug development, highlighting interest from companies such as Compass Pathways and Definium Therapeutics.…
BioSpace · 1mo agoPositive readoutPositive↗ source
  • Five major drugmakers cooperate with House investigation of Chinese military hospital trials
    Rep. John Moolenaar, a Republican from Michigan, announced that five large pharmaceutical companies are working with a congressional probe into clinical trials conducted at Chinese military hospita…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Gilead signs HIV PrEP partnership with PAHO in Latin America
    Gilead Sciences announced a new agreement with the Pan American Health Organization to expand access to HIV pre‑exposure prophylaxis across Latin American markets. The partnership aims to leverage…
    Endpoints · 1mo agoDealPositive↗ source
  • Stanford researchers create mice with human neurons to advance disease studies
    Researchers at Stanford University have engineered mice whose cerebral cortex is largely filled with human neurons, replacing missing cells in the animal brain. The chimeric mice are presented as…
    Endpoints · 1mo agoPositive↗ source
  • FDA issues warning letter to Bausch & Lomb over aseptic processing concerns
    FDA sent a warning letter to Bausch & Lomb after inspectors reviewed the company’s response to earlier observations at its Florida plant. The agency said the response did not demonstrate a commitme…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Novo and Anthropic partner to test Claude Science AI platform in drug discovery R&D
    Novo, the Danish pharmaceutical company, announced a partnership with AI firm Anthropic. The collaboration will focus on evaluating Anthropic’s Claude Science AI model within Novo’s research and d…
    Endpoints · 1mo agoDealPositive↗ source
  • Sling Therapeutics raises $123M Series C to advance oral thyroid eye disease drug
    Sling Therapeutics raised $123 million in a Series C financing round to move its oral drug candidate for thyroid eye disease forward. The capital will fund development of linsitinib, the only late…
    BioSpace · 1mo agoDealPositive↗ source
  • 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
  • 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
  • FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30
    The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials. The pilot pairs drug developer…
    fda press · 1mo agoRegulatoryNeutral↗ source