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  • Michel Detheux appointed CEO of Muna Therapeutics, GSK Alzheimer’s partner, as Genentech loses scientist Alex Hoffman
    Michel Detheux has taken over as chief executive of Danish neuro‑biotech Muna Therapeutics, succeeding Rita Balice‑Gordon in the role. Muna Therapeutics continues its collaboration with GlaxoSmith…
    Endpoints · 1mo agoNeutral↗ source
  • FDA issues warning letter to Sanofi's Genzyme Irish manufacturing site over quality and data integrity concerns
    The U.S. Food and Drug Administration sent a warning letter late last month to the Ireland‑based manufacturing facility operated by Genzyme, which is now owned by Sanofi. The agency highlighted se…
    Endpoints · 1mo agoRegulatoryNegative↗ source
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  • Ipsen to acquire Swiss biotech Memo Therapeutics in up to €800 million deal for BK virus drug
    Ipsen announced it will purchase Memo Therapeutics, a Swiss biotech, in a transaction valued at up to about €800 million. The agreement provides Memo investors with €200 million upfront and potent…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Abivax shares jump 40% after Phase 3 data show no excess cancer risk for ulcerative colitis drug
    Abivax reported new safety data from its Phase 3 trial of obefazimod in ulcerative colitis. The data indicated malignancy rates among trial participants were comparable to background rates observed…
    BioPharma Dive · 1mo agoPositive↗ source
  • Biotech funding surge: 40 companies secure $100M+ rounds in H1 2026
    Endpoints News reported that 40 private biotech firms announced funding rounds of at least $100 million each in the first half of 2026. This count surpasses the number recorded for the same period…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA approves Orca Bio's T cell therapy Tregzi to lower transplant complications in blood cancer patients
    The U.S. Food and Drug Administration has granted approval to Orca Bio's T cell therapy aimed at improving outcomes for patients undergoing blood cancer transplants. The therapy, named Tregzi, is…
    Endpoints · 1mo agoApprovalPositive↗ source
  • BridgeBio secures up to $1 billion in preferred equity as United Therapeutics invests $140 million to acquire Thymmune
    BridgeBio Pharma announced that Sixth Street Partners and HealthCare Royalty will provide up to $1 billion in preferred equity to support its upcoming product launches. The financing is structured…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • BridgeBio secures $1 billion in equity financing ahead of three upcoming drug launches
    BridgeBio Pharma announced it has raised about $1 billion through a preferred equity transaction. The new capital will strengthen its balance sheet as the company prepares three potential drug lau…
    Endpoints · 1mo agoDealNeutral↗ source
  • Angitia halts Phase 3 trial of AGA111 for degenerative disc disease
    Angitia Biopharmaceuticals announced that it has ended the Phase 3 study of its investigational therapy AGA111 in patients with degenerative disc disease who had undergone lumbar interbody fusion.…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Merck ends Phase 2 trial of Alzheimer’s drug MK-1167 from partner Neuphoria
    Merck announced it has terminated a mid-stage Phase 2 study of an experimental Alzheimer’s therapy. The drug, called MK-1167, is an oral candidate that was being developed in collaboration with bi…
    Endpoints · 1mo agoNegative↗ source
  • WuXi AppTec seeks court order to remove itself from U.S. Pentagon's Chinese military-linked company list
    WuXi AppTec has filed a petition for a preliminary injunction to halt its inclusion on the Pentagon's list of firms with alleged ties to the Chinese military. The company says the designation is d…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Ipsen to acquire Memo Therapeutics and its kidney infection candidate
    French drugmaker Ipsen announced a new acquisition, agreeing to buy Memo Therapeutics along with its experimental kidney infection drug. This marks Ipsen's second transaction announced within a wee…
    Endpoints · 1mo agoDealPositive↗ source
  • Upcoming FDA decisions in Q3 2026 could signal agency flexibility
    The piece highlights five FDA actions slated for the third quarter of 2026 that industry participants are tracking. Observers say the outcomes may reveal how flexible the agency will be under its…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • 92Bio revives experimental T cell engager previously handed to Amgen
    92Bio, a small California biotech, announced it is bringing back an experimental T‑cell engager it originally created before transferring the program to Amgen. The company said the candidate will…
    Endpoints · 1mo agoNeutral↗ source
  • Ipsen to buy Kartos Therapeutics for $450M, gaining Phase 3 myelofibrosis drug navtemadlin
    French pharmaceutical company Ipsen announced it will acquire California-based Kartos Therapeutics, paying $450 million upfront. The acquisition gives Ipsen control of navtemadlin, an MDM2 inhibito…
    BioPharma Dive · 1mo agoDealNeutral↗ 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 · 1mo agoRegulatoryNegative↗ source
  • Anthropic debuts Claude Science, an AI product for bioscience
    Anthropic upended software programming with the runaway success of the coding agent Claude Code. For its next act, the AI lab is turning its attention to biopharma. On Tuesday, Anthropic announced…
    Endpoints · 1mo ago↗ source
  • Eli Lilly, Fujifilm among seven selected for FDA’s PreCheck pilot
    The FDA has chosen the first seven companies to participate in its PreCheck pilot program, a group that includes large drugmakers Eli Lilly and Regeneron as well as manufacturers Cellares and Fujif…
    Endpoints · 1mo ago↗ source
  • AbbVie and Genmab's latest win brings Epkinly closer to label expansion
    AbbVie and Genmab’s bispecific antibody Epkinly succeeded in combination with a widely used cancer drug, bringing it one step closer to a potential label expansion in diffuse large B cell lymphoma.…
    Endpoints · 1mo ago↗ source
  • Abivax aims to set cancer concerns with ulcerative colitis drug to rest
    Late on Monday, Abivax released new trial data on its ulcerative colitis candidate, showing that cancer cases in a Phase 3 trial were within the expected range for these patients. The company says…
    Endpoints · 1mo ago↗ source
  • Viridian may have edge over Amgen in eye drug showdown, analysts argue
    The FDA, through a new approval, gave Viridian's drug a label that some on Wall Street believe makes it well-positioned to compete against Tepezza in the thyroid eye disease market.
    BioPharma Dive · 1mo ago↗ source
  • Health AI caution crosses into confidence
    How people in health tech feel about AI in healthcare has changed drastically from just a year ago. Each year, health tech venture firm Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan…
    Endpoints · 1mo ago↗ source
  • These biotechs just landed big fundraising hauls. Here’s what they pitched to investors.
    Biotechs aimed at eye diseases, autoimmune conditions and longevity medicine have pulled in some of the largest capital raises so far this year.
    BioPharma Dive · 1mo ago↗ source
  • FDA's acting director of cell and gene therapies to leave position
    Vijay Kumar is leaving his role as acting director of CBER's Office of Therapeutic Products and will soon consider options both inside and outside the FDA, he told Endpoints News on Tuesday. Kumar…
    Endpoints · 1mo ago↗ source
  • Sarepta's FDA decision date; Flare gets Anna Protopapas as CEO
    Plus news about Deerfield, InflaRx, Praxis, Nuvectis, Pyxis Oncology, Vistagen, Arcutis Biotherapeutics and Nxera. 🔎 FDA to decide on future of Sarepta exon-skipping drugs by end of February: The…
    Endpoints · 1mo ago↗ source