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  • AbbVie and Genmab's Epkinly shows positive combo results, moving toward label expansion in DLBCL
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a successful outcome when tested together with a commonly used cancer therapy. The data indicate that the combination was…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Sarepta receives FDA decision deadline for exon-skipping therapies, appoints Anna Protopapas as Flare CEO
    The U.S. Food and Drug Administration has set a deadline for a decision on Sarepta Therapeutics' exon‑skipping drug program, with the agency expected to rule by the end of February. The timing is…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
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  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Unicycive Therapeutics receives second FDA complete response letter for kidney drug amid manufacturing problems
    Unicycive Therapeutics' chronic kidney disease drug, a phosphate binder called oxylanthanum carbonate (OLC), has been rejected by the U.S. Food and Drug Administration for a second time. The FDA c…
    Endpoints · 4mo agoCRLNegative↗ source
  • Beeline Medicines secures $126M from Bain Capital, CPPIB and Bristol Myers to expand immunology pipeline
    Beeline Medicines, a spinout from Bristol Myers Squibb, announced it has received an additional $126 million in financing. The new capital comes from existing investors Bain Capital and the Canada…
    Endpoints · 4mo agoDealPositive↗ source
  • FDA reviewers recommend against adding seven peptides to bulk drug list for compounding
    FDA reviewers have advised that seven widely used peptides should not be added to the FDA's bulk drug substance list for compounding. Their recommendation comes before an upcoming advisory committe…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Abivax reports ulcerative colitis trial cancer rates align with expectations
    Abivax released new data from its Phase 3 trial of an ulcerative colitis candidate. The data show that the number of cancer cases observed was within the range normally expected for ulcerative col…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Biotech firms raise record funds in 2026, with $2.1 bn round for Isomorphic Labs
    After a few slow years, the biotech financing landscape is showing signs of recovery, though investors remain cautious about where they place capital. A recent PharmaVoice reader poll found that 2…
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • Anthropic launches Claude Science, AI platform aimed at bioscience and drug discovery
    Anthropic, known for its Claude Code AI coding assistant, announced a new product called Claude Science aimed at the life‑science sector. The platform is designed to help biopharma researchers wit…
    Endpoints · 4mo agoPositive↗ source
  • Health tech executives grow confident in AI, survey shows sharp shift in attitudes
    A yearly survey conducted by Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan Mangini reveals that confidence in using artificial intelligence within healthcare has risen sharply over t…
    Endpoints · 4mo agoPositive↗ source
  • Virtual mental-health firms accelerate AI chatbot development using therapy session data
    People are turning to artificial intelligence for daily tasks, companionship and emotional support, prompting virtual mental‑health providers to explore AI solutions. Companies that were previousl…
    Endpoints · 4mo agoNeutral↗ source
  • FDA acting director of cell and gene therapies Vijay Kumar to depart his post
    Vijay Kumar, who has been serving as the acting director of the Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products, announced he will leave his position. In an inte…
    Endpoints · 4mo agoNeutral↗ source
  • Nominations Open for 2026 Endpoints 11 Biotech Awards
    Nominations for the 2026 Endpoints 11 awards are now being accepted, with submissions due by July 15. The awards target private biotech startups that have differentiated science, strong leadership…
    Endpoints · 4mo agoNeutral↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 4mo agoNeutral↗ source
  • NEJM retracts pivotal data for Amgen's Tavneos, adding new hurdle for the autoimmune drug
    The New England Journal of Medicine has withdrawn the pivotal data that supported Amgen’s autoimmune therapy Tavneos. The retraction was requested by two academic authors who raised concerns about…
    Endpoints · 4mo agoNegative↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 4mo agoRegulatoryPositive↗ source
  • Zymeworks CEO says $1 billion Theravance acquisition offers strong value despite recent setbacks
    Zymeworks chief executive Kenneth Galbraith explained why the company believes its near-$1 billion purchase of Theravance makes strategic sense. He noted that Theravance has faced operational diff…
    Endpoints · 4mo agoDealPositive↗ source
  • Evommune's lead drug fails in chronic hives trial, shares tumble over 30%
    Evommune reported its first major trial readout since going public last year, focusing on its lead candidate for chronic spontaneous urticaria, a condition where patients experience recurring hives…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Talawar Therapeutics merges with JATT II Acquisition to list on Nasdaq as AstraZeneca reports Phase 3 success in pediatric bone disease
    Talawar Therapeutics announced a combination with blank‑check company JATT II Acquisition Corp, a deal that will place Talawar on the Nasdaq exchange. The SPAC transaction gives Talawar public‑mar…
    Endpoints · 4mo agoDealPositive↗ source
  • Chinese partnerships are becoming the pharma industry's new tax inversion strategy
    The article notes that a decade after the wave of U.S. tax inversions, the pharmaceutical sector is now seeing a similar pattern with deals involving Chinese entities. Analysts argue that these tra…
    Endpoints · 4mo agoDealNeutral↗ source
  • Ipsen to acquire blood-cancer specialist Kartos Therapeutics for $450 million upfront
    Ipsen announced it will purchase Kartos Therapeutics, a company focused on blood cancers. The transaction includes a $450 million cash payment at closing, with the possibility of up to $1.75 billi…
    Endpoints · 4mo agoDealPositive↗ source
  • BioCryst to shut internal drug discovery and close Alabama research site
    BioCryst Pharmaceuticals announced it is winding down its internal drug discovery efforts. The company said it will seek future programs through external collaborations rather than in‑house resear…
    Endpoints · 4mo agoNegative↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • J&J EVP John Reed Discusses R&D Model, Oncology Deals and Pipeline Growth Potential
    John Reed, executive vice president of Innovative Medicine at Johnson & Johnson, brings more than a decade of experience overseeing drug pipelines at three of the world’s largest pharmaceutical com…
    Endpoints · 4mo agoNeutral↗ source
  • Over 200 biopharma investors urge EU governments to strengthen Europe's life-science sector
    More than 200 biopharma investors and companies have signed an open letter addressed to EU member states, calling for action to improve Europe's life‑science sector. The signatories argue that Eur…
    Endpoints · 4mo agoRegulatoryNeutral↗ source