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  • FDA urges biosimilar makers to adopt alternatives to clinical efficacy trials
    FDA's Office of Therapeutic Biologics and Biosimilars, led by director Sarah Yim, announced that the agency is working to help sponsors rely less on clinical efficacy studies when developing biosim…
    raps · 5d agoRegulatoryPositive↗ source
  • Sanofi halts development of Nurix's STAT6 degrader program
    Sanofi announced it will stop work on an experimental drug that targets STAT6, a protein involved in immune signaling. The compound, known as SAR448272 and developed in partnership with Nurix, was…
    Endpoints · 5d agoNegative↗ source
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  • Novo says launch of obesity drug CagriSema in Europe delayed by a couple of years
    Novo Nordisk announced it will not bring its obesity candidate CagriSema to European markets for the next few years. The statement came from the company's outgoing chief financial officer, Karsten…
    Endpoints · 5d agoNeutral↗ source
  • Kamau Therapeutics presents first clinical data from its updated sickle-cell gene-editing program
    Kamau Therapeutics, a biotech company that entered the scene in 2023, has released clinical data from its reengineered sickle‑cell gene‑editing program for the first time. The disclosure marks the…
    Endpoints · 5d agoNeutral↗ source
  • Pfizer raises 2026 outlook as oncology and migraine growth balances Covid product decline
    Pfizer announced it has increased its financial guidance for 2026, citing stronger performance in its cancer and migraine divisions. The company said sales of its Covid-19 related products have fa…
    Endpoints · 6d agoEarningsPositive↗ source
  • Servier’s $1.5 billion muscular dystrophy drug sevasemten fails pivotal trial
    Servier announced that its experimental muscular dystrophy therapy sevasemten did not meet its goals in a pivotal Phase III study. The trial, named GRAND CANYON, evaluated the drug’s ability to im…
    Endpoints · 6d agoNegative readoutNegative↗ source
  • Ultragenyx cuts 20% of workforce and abandons Wilson disease gene therapy after mixed Q3 results
    Ultragenyx said it will cut about 20% of its workforce, marking a second round of layoffs this year. The reductions will affect roughly a fifth of the company's employees. At the same time, the fi…
    Endpoints · 6d agoLayoffsNegative↗ source
  • Live discussion to assess how US midterm elections could reshape biopharma policy
    Drew Armstrong, executive editor of PharmaFDA+, announced a live webcast at 1:30 pm ET on November 3, 2026 to discuss the impact of the US midterm elections on biotech and pharma. The program will…
    Endpoints · 6d agoNeutral↗ source
  • Merck KGaA sells its CDMO business and US sites to Lonza
    Merck KGaA announced it will divest its contract development and manufacturing organization (CDMO) operations, transferring ownership of five U.S. manufacturing facilities to Lonza. The transactio…
    Endpoints · 6d agoDealNeutral↗ source
  • Legal experts advise European healthcare manufacturers on navigating complex environmental regulations
    At the RAPS Regulatory Intelligence Conference Europe in Barcelona, two legal specialists highlighted the difficulty of Europe’s environmental and sustainability rules for companies that make healt…
    raps · 6d agoRegulatoryNeutral↗ source
  • FDA reports rise in unannounced drug inspections in China and India for FY 2026
    A senior FDA enforcement official said the agency carried out more surprise drug facility inspections in India and China during fiscal year 2026 than it did in the prior year. The unannounced visi…
    raps · 6d agoRegulatoryNeutral↗ source
  • Stakeholders submit over 500 comments urging FDA to shape regulation of generative AI medical devices
    Over 500 comments have been filed in response to the FDA's discussion paper on generative AI-enabled medical devices. The feedback reflects a wide range of viewpoints. Some participants recommend…
    raps · 6d agoRegulatoryNeutral↗ source
  • Bayer CEO says company is negotiating a most-favored-nation trade pact with US administration
    Bayer chief executive Bill Anderson announced the drugmaker is actively pursuing a most-favored-nation (MFN) agreement with the United States. The comment signals that Bayer is in talks with the T…
    Endpoints · 6d agoRegulatoryNeutral↗ source
  • Pfizer CEO says Democratic gains unlikely to alter Trump-era MFN pricing agreements
    Pfizer chief Albert Bourla told reporters that he does not anticipate any changes to the most‑favored‑nation pricing arrangements that were put in place under the Trump administration, even if the…
    Endpoints · 6d agoRegulatoryNeutral↗ source
  • Novartis ends discovery-stage collaboration with BioArctic amid broader biotech updates
    Novartis announced it is terminating its discovery-stage partnership with Swedish biotech BioArctic. The decision ends joint work that was focused on early‑stage research. BioArctic is best known…
    Endpoints · 6d agoNeutral↗ source
  • Endpoints Announces Second Annual Health Tech Day with Virtual Sessions
    On Thursday, Endpoints will hold its second Health Tech Day, an event that brings together leaders in digital health. Lydia Ramsey Pflanzer, the deputy editor, says she looks forward to traveling…
    Endpoints · 6d agoNeutral↗ source
  • Recon: Merck KGaA to exit CDMO business; Karyopharm to sell itself in bankruptcy
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 6d ago↗ source
  • WuXi Biologics and Fresenius strike major deal for up to 37 biosimilars over the next decade
    WuXi Biologics and German drugmaker Fresenius have agreed to collaborate on the development and manufacturing of up to 37 biosimilar medicines over the next ten years. The agreement is described a…
    Endpoints · 7d agoDealPositive↗ source
  • FDA issues final guidance on potency standards for cell and gene therapy developers
    The U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency. The document requir…
    raps · 7d agoRegulatoryNeutral↗ source
  • FDA sets May 1 decision deadline for UniQure’s Huntington’s disease gene therapy after advisory committee meeting
    The U.S. Food and Drug Administration announced that it has set a review date and scheduled an advisory committee meeting for UniQure’s gene therapy aimed at treating Huntington’s disease. The age…
    Endpoints · 7d agoRegulatoryNeutral↗ source
  • FDA places Bright Minds seizure drug BMB-101 on partial hold over mouse toxicity, shares plunge
    The U.S. Food and Drug Administration issued a partial clinical hold on BMB-101, an experimental seizure treatment from Bright Minds Biosciences, after regulators identified toxicity concerns in pr…
    Endpoints · 7d agoRegulatoryNegative↗ source
  • AbbVie signs up to $757M deal with Beijing's Brise Pharma for two preclinical migraine candidates
    AbbVie announced a discovery and commercialization agreement with Brise Pharma, a Beijing-based biotech company. The partnership covers two preclinical migraine programs and is valued at up to $75…
    Endpoints · 7d agoDealNeutral↗ source
  • FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns
    The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…
    raps · 7d agoApprovalNeutral↗ source
  • Karyopharm Therapeutics to merge with Ayrmid as it enters bankruptcy
    Karyopharm Therapeutics, a commercial-stage biotech focused on blood cancers, announced it will pursue a merger with Ayrmid while navigating a bankruptcy process. The move aims to combine the two c…
    Endpoints · 7d agoDealNeutral↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 7d agoDealNeutral↗ source