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  • UK regulator suspends Tavneos sales as MHRA follows EMA decision; UniQure files for Huntington's gene therapy approval
    The UK Medicines and Healthcare products Regulatory Agency has ordered a halt to the sale of the drug Tavneos, citing concerns that align with a recent decision by the European Medicines Agency. T…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • Teva's experimental antibody cuts intestinal damage in celiac patients after gluten challenge
    Teva reported that a single injection of an experimental antibody markedly lowered intestinal damage in participants with celiac disease who continued to consume gluten daily. The study was a glut…
    Endpoints · 10d agoPositive readoutPositive
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  • Typewriter secures $56M to advance jumping-gene platform and in vivo CAR-T therapies
    Typewriter, a biotech startup, announced it has closed a $56 million financing round. The capital will be used to develop its jumping-gene platform, which seeks to deliver full genes without viral…
    Endpoints · 10d agoDealPositive↗ source
  • FDA alerts AVID Medical users to correct convenience kits containing recalled sodium chloride ampules
    The Center for Devices and Radiological Health has posted an Early Alert warning that certain AVID Medical convenience kits may contain sodium chloride ampules recalled by Huons Co. AVID Medical h…
    fda medwatch · 10d agoRegulatoryNeutral↗ source
  • Medline issues correction for convenience kits with potentially non-sterile BD ChloraPrep applicators
    Medline has sent a correction notice after the FDA identified that some BD ChloraPrep applicators included in its convenience kits may not be sterile. The agency says the devices could cause tempo…
    fda medwatch · 10d agoCRLNeutral↗ source
  • Novartis halts CD19 CAR-T trial after three deaths, Bristol Myers also pauses similar program
    Novartis announced a pause to its CD19-directed CAR-T cell therapy trials after three patients experienced fatal immune reactions. The company said the deaths were linked to a severe cytokine relea…
    Endpoints · 11d agoCRLNegative↗ source
  • GSK to begin Phase 3 trial of mRNA seasonal flu vaccine after strong Phase 2 results
    GSK announced it will start a Phase 3 study of its mRNA vaccine targeting seasonal influenza. The move follows Phase 2 data that showed the candidate produced higher immune responses than traditio…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • Novartis' Rhapsido shows safety edge and relapse reduction in Phase 3 multiple sclerosis trials
    Novartis reported results from two identical Phase 3 studies of its BTK inhibitor Rhapsido in patients with multiple sclerosis. The trials showed the oral pill lowered the annualized relapse rate…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • ARPA-H grants up to $125M to accelerate on-demand custom RNA therapy manufacturing
    ARPA-H announced a new funding initiative aimed at speeding the creation of personalized RNA medicines. The agency will provide up to $125 million in total awards. Five research groups were select…
    Endpoints · 10d agoDealPositive↗ source
  • Eli Lilly's 2026 acquisitions boost over 50 biotech venture investors
    Eli Lilly announced its thirteenth acquisition of 2026, continuing a busy year of dealmaking for the drugmaker. The transactions have involved at least fifty different venture capital firms, sendi…
    Endpoints · 11d agoDealPositive↗ source
  • Roche partners with Simcere Zaiming on trispecific T cell engager, $75M upfront
    Roche announced a collaboration with Chinese biopharma Simcere Zaiming to develop a trispecific T cell engager aimed at cancer therapy. The agreement includes an upfront payment of $75 million to…
    Endpoints · 11d agoDealPositive↗ source
  • ARCH Venture Partners aims to raise $3 billion for its 14th biotech fund
    ARCH Venture Partners, a leading biotech venture capital firm, announced its intention to raise about $3 billion for a new fund. The proposed fund would be the firm's 14th and would rank among the…
    Endpoints · 11d agoDealNeutral↗ source
  • Alumis' TYK2 lupus drug fails mid-stage trial, CEO says clear path forward
    Alumis announced that its TYK2 inhibitor did not meet primary endpoints in a mid-stage study in patients with lupus. The trial, which was the company's lead program, was designed to evaluate effic…
    Endpoints · 11d agoNegative readoutNegative↗ source
  • K Health plans IPO by 2029 after recent funding round
    K Health, a virtual‑care company that uses AI, announced its intention to go public by 2029. CEO Allon Bloch made the comment after a recent fundraising round, signalling the firm is preparing for…
    Endpoints · 11d agoPositive↗ source
  • Trump announces voluntary pricing agreements with nine new drug makers
    President Donald Trump hosted a drug pricing event on Monday, joined by executives from several pharmaceutical companies and senior health officials. At the meeting he announced voluntary pricing…
    Endpoints · 10d agoRegulatoryNeutral↗ source
  • Arsenal Biosciences trims most of its workforce as it shifts focus to in vivo CAR T therapy
    Arsenal Biosciences announced another round of staff reductions, letting go of the majority of its employees. This follows a previous reduction about a year ago that cut roughly half of its workfo…
    Endpoints · 10d agoLayoffsNegative↗ source
  • Medline recalls neonatal and infant heated wire breathing circuits over connector failures
    Medline has issued a recall for specific neonatal and infant heated wire breathing circuits after identifying failures in the electrical connector. The FDA has classified the issue as potentially…
    fda medwatch · 11d agoCRLNegative↗ source
  • Google Gemini adds Zocdoc booking, while Solv partners with Amazon
    In August, Google revealed that users of its Gemini AI platform can schedule medical appointments directly through Zocdoc, integrating AI assistance with healthcare scheduling. The move expands Ge…
    Endpoints · 10d agoDealPositive↗ source
  • Eli Lilly to acquire Merida Biosciences for up to $2.875 billion, bolstering its immunology pipeline
    Eli Lilly announced a deal to purchase Merida Biosciences, a biotech focused on immunology, for a total consideration that could reach $2.875 billion. The acquisition adds Merida's assets in fast-…
    Endpoints · 12d agoDealPositive↗ source
  • Sanofi-backed Electra Therapeutics files for Nasdaq IPO to fund Phase 2/3 immunology program
    Electra Therapeutics announced it has filed with securities regulators to begin trading on the Nasdaq shortly after the Labor Day holiday. The Sanofi-backed biotech aims to raise capital through t…
    Endpoints · 12d agoDealPositive↗ source
  • Trump announces nine voluntary drug pricing agreements with mid-size biotech firms
    On August 31, 2026, the White House announced that President Donald Trump has secured nine new voluntary drug-pricing agreements with mid-size biotechnology companies. The companies entered the de…
    Endpoints · 11d agoDealNeutral↗ source
  • Industry insiders invited to take Q3 BioPharma Sentiment Survey
    Signal's Endpoints team is launching the third quarterly BioPharma Sentiment Index (BPSI) survey, a three minute questionnaire that captures industry views. The survey asks participants to share p…
    Endpoints · 12d agoNeutral↗ source
  • Ana Salazar Modela Tu Cuerpo recalls Lipofit Extreme Fat Burner 2.0 after FDA finds undeclared fluoxetine and DNP
    Ana Salazar Modela Tu Cuerpo Inc. announced a voluntary nationwide recall of its Lipofit Extreme Fat Burner 2.0 on August 27, 2026, targeting the lot with expiration in September 2027. FDA laborat…
    fda medwatch · 12d agoCRLNegative↗ source
  • AstraZeneca’s oral relaxin drug shows partial success in mid-stage heart-failure trial
    AstraZeneca reported that its oral relaxin agonist improved cardiac function in a subset of patients enrolled in a mid-stage heart‑failure study. The trial demonstrated measurable benefits for some…
    Endpoints · 13d agoPositive readoutPositive↗ source
  • Arrowhead's RNAi drug Redemplo shows safety advantage over Ionis in late-stage triglyceride trials
    At the European Society of Cardiology meeting in Munich, Arrowhead Pharmaceuticals presented new data on its RNA interference candidate Redemplo. Redemplo was evaluated in two late-stage studies i…
    Endpoints · 13d agoPositive readoutPositive↗ source