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  • FDA issues partial hold on Biohaven’s experimental epilepsy drug opakalim, pausing recruitment in late-stage trial
    Biohaven announced that the FDA has placed a partial hold on its experimental epilepsy therapy, opakalim, after the company recently transferred rights to the drug in a licensing agreement. The ag…
    BioPharma Dive · 3d agoRegulatoryNegative↗ source
  • Shionogi's mid-stage stroke drug redasemtide fails, while Bayer's Hyrnuo receives expanded NSCLC label
    Shionogi reported that its experimental stroke therapy redasemtide did not achieve the primary endpoint in a mid-stage clinical trial, marking a setback for the company’s neurology pipeline. The f…
    Endpoints · 3d agoNegative readoutNeutral↗ source
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Infectious Disease459
  • ARPA-H launches ADVOCATE program to fund AI agents for health tech companies
    ARPA-H, the federal agency that funds breakthrough health technologies, announced the start of a new initiative called ADVOCATE. The program will award millions of dollars in grants to health-tech…
    Endpoints · 3d agoPositive↗ source
  • FDA imposes partial clinical hold on Biohaven's experimental epilepsy drug BHV-7000
    FDA announced a partial clinical hold on Biohaven's ion channel program, affecting the epilepsy trial of the experimental drug BHV-7000. The hold was issued after the agency requested additional p…
    Endpoints · 3d agoRegulatoryNegative↗ source
  • Reverse mergers surge as biotech firms seek public listings via shell companies
    Reverse mergers, once dismissed, are now a common route for biotech startups to gain a public listing by merging with shell companies. Data from JB Strategy Partners shows roughly two dozen such d…
    BioPharma Dive · 3d agoDealNegative↗ source
  • BridgeBio Oncology shares tumble 24% as it narrows KRAS program focus
    BridgeBio Oncology Therapeutics saw its stock drop sharply after announcing a strategic shift. The company said it will scale back its broader pipeline to concentrate resources on its lead KRAS in…
    Endpoints · 4d agoNegative↗ source
  • FDA places partial hold on Biohaven epilepsy drug BHV-7000 amid $350 million licensing deal
    The U.S. Food and Drug Administration issued a partial clinical hold on enrollment for Biohaven’s epilepsy candidate BHV-7000 after rodent studies raised questions about drug metabolites. The hold…
    Fierce Biotech · 4d agoRegulatoryNegative↗ source
  • Takeda R&D chief Andy Plump to retire after string of recent FDA approvals
    Takeda's long-serving research and development president Andy Plump will step down in June. He joined the Japanese drugmaker in 2015 from Sanofi and has led the R&D organization since then. His ex…
    Fierce Biotech · 4d agoPositive↗ source
  • Pharma investment in UK rises as government increases drug pricing and engagement
    The UK trade group says pharmaceutical investment is picking up after a lull last year. The uptick follows recent government steps to raise reimbursement rates for medicines and to foster closer c…
    Endpoints · 4d agoRegulatoryPositive↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027, will stay on board through 2027
    Takeda announced that Andy Plump, who has led the company's research and development since 2015, will retire in June 2027. Plump will remain president of R&D until a successor is appointed and wil…
    BioPharma Dive · 3d agoNeutral↗ source
  • Lonza announces new spray-drying plant in Bend, Oregon as Samsung Bio secures $262 million contract
    Lonza announced plans to construct a new commercial spray-drying facility in Bend, Oregon, expanding its manufacturing footprint in the United States. The plant will increase Lonza’s capacity to p…
    Endpoints · 3d agoPositive↗ source
  • Scientists boycott American Diabetes Association after conference expulsions
    Following the removal of five scientists from its annual conference in June, members of the American Diabetes Association (ADA) have initiated a boycott of the organization. The protest stems from…
    Fierce Biotech · 3d agoNegative↗ source
  • Biotech industry rebounds as Endpoints 11 awards return in Boston
    The article notes that the Endpoints 11 awards will be unveiled in Boston on the night of September 24, marking the event’s return after a period of industry slowdown. It reflects on how the biote…
    Endpoints · 3d agoNeutral↗ source
  • Takeda R&D chief Andy Plump to leave after 12 years
    Takeda announced that its President of Research and Development, Andy Plump, M.D., Ph.D., will depart the company in June after serving in the role for twelve years. He will remain in charge of R&D…
    Fierce Biotech · 3d agoNeutral↗ source
  • Oura files S-1, outlining its plans to expand into healthcare as it prepares for IPO
    Oura, known for its sleep-tracking ring, has submitted a registration statement on Form S-1 as it moves toward an initial public offering. In the filing, the company describes a broader healthcare…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • Medical Action Industries issues correction for epidural kits containing recalled Huons Co. lidocaine ampules
    Medical Action Industries has released a correction notice for several of its epidural kit products after discovering that they contain lidocaine ampules from Huons Co. that were previously recalle…
    fda medwatch · 4d agoCRLNeutral↗ source
  • Evommune gives up hope for MRGPRX2 antagonist to treat itch after latest phase 2 fail
    Evommune’s MRGPRX2 antagonist has flunked another phase 2 trial, wiping out the biotech’s last hopes of developing the therapy for any itch-related conditions.
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • Solstice Oncology secures $225M Series A to advance CTLA-4 antibody porustobart in colon cancer
    Solstice Oncology, a biotech startup focused on immunotherapy, announced it has raised $225 million in a Series A financing round. The funding will support development of its lead candidate, a CTL…
    BioPharma Dive · 5d agoDealPositive↗ source
  • Luma Group closes $410 million, 15-year life-science venture fund
    Luma Group announced that its first life‑science venture capital fund has reached final close, raising $410 million for a 15‑year investment period. The New York‑based firm said the capital will be…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Encoded Therapeutics secures $275M Series F to push Dravet gene therapy and expand manufacturing
    Encoded Therapeutics, a biotech focused on neuro‑genetic disorders, announced a $275 million Series F financing round. The capital was co‑led by Google Ventures and an undisclosed healthcare fund,…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Tyra Biosciences reports phase 2 bladder cancer data, complete response rates miss analyst targets, shares slide
    Tyra Biosciences disclosed early phase 2 results for its FGFR3‑selective inhibitor dabogratinib in patients with low‑grade, intermediate‑risk non‑muscle‑invasive bladder cancer. The trial evaluate…
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • Abbott receives FDA clearance for TactiFlex Duo catheter, offering flexible AFib ablation options
    Abbott announced that the U.S. Food and Drug Administration has cleared its new TactiFlex Duo catheter for use in atrial fibrillation ablation. The catheter can deliver pulsed field ablation, radi…
    Fierce Biotech · 5d agoRegulatoryPositive↗ source
  • Beeline's oral lupus drug afimetoran meets primary endpoint in Phase 2, paving way for Phase 3
    Beeline Medicines announced that its oral small-molecule inhibitor afimetoran achieved the primary endpoint in a 48-week Phase 2 trial in patients with systemic lupus erythematosus (SLE). The tria…
    Fierce Biotech · 5d agoPositive readoutPositive↗ source
  • Tyra Biosciences’ bladder cancer pill misses expected response rate in Phase 2 trial
    Shares of Tyra Biosciences dropped about 20% after data from its Phase 2 study of a bladder cancer pill fell short of market expectations. The experimental drug, dabogratinib, is taken daily and t…
    BioPharma Dive · 4d agoNegative readoutNegative↗ source
  • Encoded Therapeutics raises $275 million in Series F round for Dravet syndrome program
    Encoded Therapeutics announced closing a Series F financing round that brought in $275 million. The round was led by GV with participation from an undisclosed healthcare investor. The new capital…
    Endpoints · 4d agoDealPositive↗ source