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  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry groups have asked the U.S. Food and Drug Administration to broaden its draft guidance on the use of scientifically valid prior knowledge in developing gene therapies that involve genome ed…
    raps · 9d agoRegulatoryNeutral↗ source
  • Pfizer grants Medicus co-development rights to CD228-targeted ADC PF-08046031
    Pfizer announced it is transferring co-development rights for its CD228-targeted antibody-drug conjugate, PF-08046031, to Medicus Pharma. The ADC, originally discovered by Seagen, will now be adva…
    Endpoints · 9d agoDealNeutral↗ source
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  • Novartis licenses Alteogen’s hyaluronidase enzyme ALT-B4 in new drug delivery partnership
    Novartis announced a licensing agreement with South Korean biotech Alteogen to use its hyaluronidase enzyme ALT-B4 for drug delivery applications. The enzyme will be produced using Alteogen’s prop…
    Endpoints · 9d agoDealNeutral↗ source
  • UK government proposes legal amendments to modernize medicines and medical device regulations
    The UK government has introduced a set of legal amendments aimed at updating the framework that governs medicines and medical devices. The changes are intended to streamline approval processes, in…
    raps · 9d agoRegulatoryNeutral↗ source
  • Deaths of two Chinese children receiving CRISPR therapy spark safety debate
    Two children in China died after receiving experimental CRISPR-based gene therapies, according to a recent report. The fatalities have unsettled researchers in the United States who are developing…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • Novartis CAR-T trial deaths spark safety concerns for autoimmune applications
    Novartis disclosed that three participants in its CAR-T cell therapy trials for autoimmune disease have died. The company said the deaths were reported to health authorities and are under investiga…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy Tudriqev
    A senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…
    Endpoints · 10d agoApprovalPositive↗ source
  • FDA vows tighter review of foreign clinical trial data amid rising Chinese influence
    Top FDA officials announced that the agency will intensify its oversight of clinical trial data generated outside the United States. The move is aimed at ensuring that foreign data meet the same st…
    Endpoints · 10d agoRegulatoryNeutral↗ source
  • 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↗ source
  • 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
  • EMA starts voluntary data-sharing pilot to boost confidence in new approach methods and cut animal testing
    The European Medicines Agency announced a voluntary data submission pilot that allows drug developers to upload data generated by new approach methodologies (NAMs). The pilot is designed to build…
    raps · 10d agoRegulatoryPositive↗ 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 · 11d 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
  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 11d agoRegulatoryNeutral↗ source
  • FDA urges validation of digital health endpoints and clear missing-data plans
    FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
    raps · 11d agoRegulatoryNeutral↗ 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
  • Trump unveils pricing agreements with midsize biotech firms; Novartis halts CAR-T trial after patient deaths
    The White House announced that President Trump has struck new pricing agreements with a group of midsize biotechnology companies, aiming to adjust drug costs. Novartis disclosed that it is pausing…
    raps · 11d agoDealNeutral↗ 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 · 11d agoRegulatoryNeutral↗ source