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  • 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
  • GSK ends $2.2 billion brain drug partnership with Alector after trial failures
    GSK and California‑based biotech Alector have ended their collaboration after both experimental brain drugs failed to meet development milestones. The partnership, announced in July 2021, gave GSK…
    BioPharma Dive · 1mo agoDealNegative↗ source
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  • 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
  • HHS launches Operation Trialblazer to accelerate U.S. drug research amid growing competition from China
    The Department of Health and Human Services introduced a new initiative called Operation Trialblazer aimed at speeding early-stage drug research in the United States. The plan calls for coordinate…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ 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
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ 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
  • AstraZeneca and GSK strike new China partnerships with Sino Biopharm
    Sino Biopharm announced two separate agreements with the United Kingdom's largest drugmakers, AstraZeneca and GSK, to deepen their presence in the Chinese market. AstraZeneca will license rights t…
    BioPharma Dive · 1mo agoDealPositive↗ 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
  • Arbitration panel rules Prime Medicine did not breach Beam deal over AATD therapy
    An arbitration panel has ruled that Prime Medicine did not violate its 2019 collaboration agreement with Beam Therapeutics by advancing a treatment for alpha‑1 antitrypsin deficiency (AATD). The de…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Sino Biopharm signs separate respiratory partnership deals with AstraZeneca and GSK
    Sino Biopharm announced it has entered into two distinct agreements with UK-based pharmaceutical companies focused on respiratory medicines. One agreement involves licensing its investigational PD…
    Endpoints · 1mo agoDealPositive↗ 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
  • 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
  • Oberland pours up to $400M into MeiraGTx eye gene therapies
    The funding deal is a vote of confidence in the sales potential of multiple prospects in late-stage development — one of which MeiraGTx recently reacquired from J&J.
    BioPharma Dive · 1mo ago↗ source
  • Kailera says obesity pill succeeds in late-stage trial in China
    The drug spurred about 10% weight loss over 10 months, though that finding came alongside high rates of gastrointestinal side effects that “alarmed” one analyst.
    BioPharma Dive · 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
  • Hengrui, Kailera's GLP-1 pill posts encouraging efficacy but high side effect rates in late-stage China trials
    The GLP-1 pill being developed by Hengrui Pharma and Kailera Therapeutics posted decent results in two late-stage China-based trials — one in obesity and the other in diabetes. But the safety profi…
    Endpoints · 1mo ago↗ source