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  • FDA’s drug review center adds over 100 staff in a quarter, first net gain since late 2024
    The FDA’s Center for Drug Evaluation and Research (CDER) reported hiring more than 100 new employees in the most recent quarter. This net increase is the first time the drug center has added more…
    Endpoints · 1mo agoNeutral↗ source
  • Cellular Intelligence hires neurologist to assess Novo Nordisk's Parkinson's stem cell program
    Cellular Intelligence, an AI‑driven biotech, announced it is evaluating Novo Nordisk's Parkinson's stem cell therapy after Novo shut down its cell therapy unit. The company engaged neurologist and…
    Endpoints · 1mo agoDealNeutral↗ source
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  • AstraZeneca shares tumble after heart drug trial fails
    AstraZeneca's stock fell in early trading on Thursday after the company disclosed that its experimental heart disease therapy, developed with Ionis Pharmaceuticals, did not meet primary endpoints i…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Eli Lilly leads biotech M&A in H1, leveraging obesity drug success and trillion-dollar scale
    Eli Lilly, already the largest pharmaceutical company, has emerged as a leading buyer of biotech assets in the first half of 2026. Its trillion-dollar market size and recent successes in obesity t…
    Endpoints · 1mo agoDealPositive↗ source
  • ARPA-H earmarks $160 million for custom gene-editing therapies, sparking debate on adequacy
    ARPA-H announced a $160 million investment to support development of bespoke gene‑editing treatments. This follows a recent case where an infant was rescued from a lethal disease using a personaliz…
    Endpoints · 1mo agoNeutral↗ source
  • HHS proposes new rule to compensate Covid-19 vaccine injury claims
    The U.S. Department of Health and Human Services has issued a proposed rule that would create a compensation mechanism for people who say they were injured by Covid-19 vaccines. The new system is…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Roche halts development of Huntington’s disease drug tominersen after ten years of trials
    Roche announced it is stopping work on tominersen, its experimental therapy for Huntington’s disease. The decision follows a Phase 2 study in which the drug performed no better than placebo. The c…
    Endpoints · 1mo agoNegative↗ source
  • UK regulator advises stopping reimbursement for Amgen's lung cancer drug Lumakras for new patients
    The National Institute for Health and Care Excellence (NICE) in the United Kingdom released draft guidance recommending that government reimbursement for Amgen’s lung cancer therapy Lumakras be dis…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA reprimands Lundbeck Seattle Biopharmaceuticals for inflated claims on Vyepti migraine webpages
    The U.S. Food and Drug Administration issued an untitled letter to Lundbeck Seattle Biopharmaceuticals criticizing two promotional webpages about its migraine treatment Vyepti. The agency said the…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA pauses public release of Complete Response Letters to limit litigation risk
    The FDA announced it has temporarily halted the routine public posting of Complete Response Letters (CRLs), which are letters sent to drug sponsors when the agency does not approve a marketing appl…
    Endpoints · 1mo agoCRLNeutral↗ source
  • Ipsen's Dysport shows positive Phase 3 results in migraine, Tarsus acquires iRenix for $75M
    Ipsen reported that its injectable neurotoxin Dysport met the primary endpoint in a Phase 3 trial aimed at reducing monthly migraine days. The trial demonstrated a statistically significant reduct…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • GSK terminates $700 million Alector partnership after recent trial setbacks
    GSK has decided to end its collaboration with Alector, a biotech focused on neurodegenerative diseases. The agreement originally included a $700 million upfront payment. The move follows two high-…
    Endpoints · 1mo agoDealNegative↗ source
  • Mid-year roundup highlights top health-tech trends in 2026
    The editorial team notes that the first half of 2026 has been unusually active for health technology. Five major developments have been identified as the most significant so far. One clear theme i…
    Endpoints · 1mo agoNeutral↗ source
  • Catalent to sell its Nottingham oral solid dose facility to CDMO Codis
    Catalent announced it will divest its United Kingdom manufacturing site, selling the oral solid dose factory located in Nottingham. The buyer is Codis, a contract development and manufacturing org…
    Endpoints · 1mo agoDealNeutral↗ source
  • Prime Medicine clears legal hurdle with Beam Therapeutics, moves AATD gene therapy toward clinic
    Prime Medicine announced it will advance its AATD gene editing candidate into clinical trials after arbitrators ruled in its favor in a dispute with Beam Therapeutics. The dispute centered on a 20…
    Endpoints · 1mo agoPositive↗ source
  • Novartis announces reduction of 322 jobs at New Jersey facility
    Novartis filed a WARN notice indicating it will eliminate 322 positions at its East Hanover, New Jersey site. The reduction is part of a broader restructuring effort aimed at streamlining operation…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • HHS pushes FDA to formalize public release of rejection letters to drug makers
    HHS announced it is preparing a new FDA regulation that would codify the agency's practice of publishing complete response letters (CRLs) that inform pharmaceutical companies of a drug's rejection.…
    Endpoints · 1mo agoCRLNeutral↗ source
  • Biohaven targets muscle-sparing obesity market to compete with Lilly's GLP-1 drugs
    Biohaven is positioning itself to address obesity by developing treatments that preserve lean muscle, a differentiator from existing GLP-1 therapies. The company sees an opportunity to act as a "s…
    Endpoints · 1mo agoNeutral↗ source
  • Sanofi proposes to cease negative statements about CSL's flu vaccine amid EU probe
    Sanofi has offered to stop making disparaging comments about CSL's flu vaccine following an investigation launched by the European Commission. The offer comes two weeks after the Commission began p…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Sino Biopharm hooks AstraZeneca, GSK for separate respiratory partnerships
    Sino Biopharmaceutical announced drug development and sales pacts with two UK pharma companies on Wednesday. One will see the Hong Kong biotech license an investigational PDE3/4 inhibitor to AstraZ…
    Endpoints · 1mo ago↗ source
  • Satellos gives early look at Duchenne pill in adults ahead of key data in children
    Satellos Bioscience is building its case for a Duchenne muscular dystrophy pill with data in adult patients ahead of a potentially pivotal readout in children later this year. The Canadian biotech’…
    Endpoints · 1mo ago↗ source
  • Vertex's Crinetics deal points to big ambitions for cystic fibrosis leader
    Vertex Pharmaceuticals' $10 billion acquisition of an endocrinology startup represents the company’s clearest and boldest step toward the upper echelon of the biopharma industry. Long a biotech suc…
    Endpoints · 1mo ago↗ source
  • Tampa General kicks off legal fight over Lilly's 340B restrictions
    Tampa General Hospital sued Eli Lilly for halting its 340B discounts, kicking off a broader fight over whether pharmaceutical companies can condition drug discounts on new claims data requirements.…
    Endpoints · 1mo ago↗ source
  • Vera's IgAN approval kicks off competition with Otsuka
    Vera Therapeutics’ fusion protein atacicept got an accelerated approval on Tuesday for a chronic autoimmune disease that damages the kidneys. The drug will be marketed as Trutakna for immunoglobuli…
    Endpoints · 1mo ago↗ source
  • Compass Pathways touts durability data for psilocybin drug in depression ahead of year-end filing
    Compass Pathways said Tuesday that patients in the second of its two pivotal psilocybin trials maintained their response to treatment for at least six months, keeping the company on track to comple…
    Endpoints · 1mo ago↗ source