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  • Haisco licenses inflammatory disease candidate to US startup Sentivera; ViiV's HIV drug cleared for newborns
    Haisco Pharmaceutical announced that it has granted a license to US biotech Sentivera for the ex‑China rights to an unnamed inflammatory‑disease candidate. The agreement gives Sentivera the ability…
    Endpoints · 17d agoDealNeutral↗ source
  • Aurora Therapeutics halts lead CRISPR program and cuts staff
    Aurora Therapeutics, founded as the first company dedicated to developing custom CRISPR-based gene-editing medicines, announced a major restructuring. The firm said it is laying off several employ…
    Endpoints · 17d agoLayoffsNegative↗ source
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  • Akeso and Summit report ivonescimab meets primary endpoint in China Phase 3 biliary tract cancer trial
    Akeso Therapeutics and partner Summit Therapeutics announced that their bispecific antibody ivonescimab achieved the primary efficacy endpoint in a Phase 3 study conducted exclusively in China. Th…
    Endpoints · 17d agoPositive readoutPositive↗ source
  • Faro AI secures $37M Series B to accelerate clinical trials with artificial intelligence
    Faro AI, a San Diego‑based startup, announced a $37 million Series B financing round aimed at expanding its artificial‑intelligence platform. The new funding will be directed toward developing too…
    Endpoints · 17d agoDealPositive↗ source
  • Baxter recalls two lots of 0.9% Sodium Chloride Injection over possible fiberglass particles
    Baxter International announced a voluntary recall of two batches of its 0.9% Sodium Chloride Injection after detecting potential fiberglass particles in the solution. The company said the particul…
    fda medwatch · 18d agoCRLNegative↗ source
  • Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System after sheath tip separation reports
    Boston Scientific announced a recall of its ENROUTE Transcarotid Neuroprotection System and the ENROUTE Transcarotid Neuroprotection System Plus. The FDA classified the recall as the most serious…
    fda medwatch · 18d agoCRLNegative↗ source
  • Spyre Therapeutics deprioritizes anti-TL1A rheumatoid arthritis candidate after modest Phase 2 results
    Spyre Therapeutics said on Tuesday it will shift resources away from its anti-TL1A antibody that was being developed for rheumatoid arthritis. The decision follows the Phase 2 study, which showed…
    Endpoints · 17d agoNegative readoutNegative↗ source
  • Cellares defends its cell therapy platform after Bristol Myers ends partnership
    Cellares, a cell therapy manufacturing startup, responded to criticism from Bristol Myers Squibb after the drugmaker terminated their agreement. Bristol Myers withdrew, saying Cellares' commercial…
    Endpoints · 17d agoNegative↗ source
  • Industry groups call for clearer FDA guidance on QRIs in expedited IND pilot
    Pharmaceutical trade groups have voiced concerns about the FDA's proposed expedited IND pilot, which aims to speed entry of drug candidates into first‑in‑human studies. The groups say the FDA need…
    raps · 18d agoRegulatoryNeutral↗ source
  • FDA expands Jazz's Ziihera use to frontline gastric cancer
    FDA granted approval for Jazz Pharmaceuticals' bispecific antibody Ziihera as a frontline treatment for certain gastric cancer patients. This is the first time Ziihera will be marketed to newly di…
    Endpoints · 18d agoApprovalPositive↗ source
  • J&J’s Imaavy gains first-in-class label for warm autoimmune hemolytic anemia
    J&J announced that its monoclonal antibody Imaavy has received a label expansion in the United States. The expanded indication makes Imaavy the first therapy approved specifically for warm autoimm…
    Endpoints · 18d agoApprovalPositive↗ source
  • Sword Health proposes acquisition of mental-health startup Headspace, linking two digital health unicorns
    Sword Health announced a proposal to acquire Headspace, a mental-health startup, according to a filing with Massachusetts state officials. The deal would combine two digital-health companies that…
    Endpoints · 18d agoDealNeutral↗ source
  • Haisco Pharmaceutical partners with ARCH Venture Partners and Population Health in new China-focused deal
    Haisco Pharmaceutical, a China-based drugmaker, has continued its active summer dealmaking by striking a new partnership. The partnership brings together ARCH Venture Partners, a venture capital f…
    Endpoints · 18d agoDealPositive↗ source
  • OmicsBank secures $2.25M to expand overseas patient data platform for biopharma
    OmicsBank announced it has closed a $2.25 million financing round aimed at scaling its platform that aggregates patient health data from overseas sources for use by biopharma companies. The compan…
    Endpoints · 18d agoDealPositive↗ source
  • FDA expands labels for J&J’s Imaavy and Jazz’s Ziihera; Teva under Turkish antitrust probe
    The U.S. Food and Drug Administration has broadened the approved uses for Johnson & Johnson’s oncology drug Imaavy and Jazz Pharmaceuticals’ Ziihera, adding new indications to each label. These la…
    raps · 19d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on potency testing for immunotherapy products
    The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…
    raps · 19d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to drugmakers in China, India and the US over GMP violations
    The U.S. Food and Drug Administration has issued warning letters to a number of manufacturers in China, India and the United States. The letters cite multiple violations of good manufacturing prac…
    raps · 19d agoRegulatoryNegative↗ source
  • Amgen and academic centers discuss FDA pilot to accelerate first-in-human trials
    The U.S. Food and Drug Administration is working with industry and research institutions on a pilot program aimed at speeding first-in-human studies. The effort is intended to counter the rapid tim…
    Endpoints · 18d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to drug manufacturers in India, China and US over GMP violations
    The FDA has sent formal warning letters to several companies located in India, China and the United States. The letters cite multiple breaches of current good manufacturing practice standards in t…
    raps · 19d agoRegulatoryNegative↗ source
  • Bristol Myers Squibb ends partnership with Cellares, prompting the cell therapy maker to restructure
    Bristol Myers Squibb announced that it is terminating its collaboration with Cellares after completing a comprehensive evaluation of the partnership. The decision was driven by BMS’s assessment th…
    Endpoints · 18d agoDealNegative↗ source
  • TwinStrand wins patent lawsuit as GSK’s hepatitis B therapy receives Japanese approval
    TwinStrand Biosciences, a DNA sequencing spin‑out from the University of Washington, announced it has prevailed in a patent infringement lawsuit against a California‑based competitor. The court’s…
    Endpoints · 19d agoApprovalPositive↗ source
  • FDA alerts users to destroy AVID Medical IV start kits containing recalled BD ChloraPrep applicators due to fungal contamination risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert warning that certain AVID Medical convenience kits may pose a high‑risk fungal contamination problem because they contain…
    fda medwatch · 20d agoRegulatoryNegative↗ source
  • DC judge dismisses Merck's challenge to Medicare drug price negotiations
    A Washington D.C. federal judge rejected Merck's lawsuit contesting Medicare drug price negotiations under the Inflation Reduction Act. Judge Colleen Kollar-Kotelly of the U.S. District Court for t…
    Endpoints · 19d agoRegulatoryNegative↗ source
  • Regenxbio faces second FDA clinical hold, delaying Hunter syndrome gene therapy filing
    Regenxbio announced that its gene therapy for Hunter syndrome has received a second clinical hold from the FDA this year. The company said it no longer expects to submit an NDA or seek approval in…
    Endpoints · 19d agoRegulatoryNegative↗ source
  • Roche commits $190 million upfront to license Hanmi's early-stage muscle-building obesity drug, total deal up to $2.3 billion
    Roche announced it will pay $190 million upfront to license an early-stage obesity drug from South Korean company Hanmi Pharm. The compound is described as a non-incretin, muscle-building therapy a…
    Endpoints · 19d agoDealPositive↗ source