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AZ, Daiichi's Enhertu shows early breast cancer prowess with another trial win, topping Roche's KadcylaAstraZeneca and Daiichi Sankyo’s star antibody-drug conjugate (ADC) Enhertu has chalked up another win in an early breast cancer setting, this time besting Roche’s Kadcyla in a phase 3 study. Enhertu2025/10/14
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GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke MielsThe first woman to helm a Big Pharma will be stepping down in January as GSK’s Emma Walmsley moves aside for her chief commercial officer Luke Miels. Walmsley, 56, who became the British pharma’s CEO2025/10/14
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Sanofi expands $35-per-month pricing to all insulin productsIn an expansion of its previous moves to cut insulin prices, Sanofi willcap the priceof each of its insulin products at $35 per month in the U.S. regardless of a patient's insurance status. The move,2025/10/9
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Asian generics powerhouse Lotus expands US presence with acquisition of AlvogenSerial entrepreneur Robert Wessman, who has had a golden touch creating, acquiring and spinning off companies that primarily sell generic drugs, has brought together two of his fastest-growing enterp2025/10/9
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FDA takes close look at mifepristone REMS program after request from Republican AGsIt was only about a year ago that the biopharma industryhaileda decision by the Supreme Court to preserve access to mifepristone, a drug most commonly known for its paired use with another medicine t2025/9/30
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Acadia grounds Prader-Willi candidate after trial failure, leaving the market to SolenoSoleno Therapeutics is breathing easier with a report from Acadia Pharmaceuticals that its candidate to treat hyperphagia in patients with Prader-Willi Syndrome (PWS) hascome up shortin a phase 3 tri2025/9/30
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FDA hands warning letter to J&J subsidiary over stopper issues, spotty reporting at Korean plantA Johnson & Johnson innovate medicine subsidiary, Janssen Vaccines, landed in hot water with the FDA this summer over a 2024 inspection of the company’s production facility in South Korea. In a w2025/9/25
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Biogen plots resubmission after FDA turns down high-dose Spinraza in SMA, requests more production infoDespite possessing a solid data package on the potential of high-dose Sprinraza in spinal muscular atrophy (SMA), Biogen will now need to revise its application if it hopes to secure an FDA nod. The2025/9/25
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Moderna says updated mNEXSPIKE induces strong immune response against rising COVID-19 strainModerna has early in-human data showing its next-generation COVID-19 vaccine, mNEXSPIKE, has the potential to offer strong immune protection against the latest rapidly spreading SARS-CoV-2 virus. Mod2025/9/23
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FDA to tweak Tylenol safety label, relabel decades-old GSK drug as 'autism symptom' treatmentU.S. health officials are quickly taking regulatory action to build on findings from the administration’s research push into the “autism epidemic,” including a label update for a decades-old GSK drug2025/9/23