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• Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy
  The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10 to 3 in favor of Replimune’s immunotherapy for advanced melanoma in combination with Bristol Myers Squibb’s Opdivo, but tri…
  biospace · 6h ago
• Replimune melanoma drug wins support of FDA panel
  The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier rejections.
  biopharma_dive · 7h ago
• Replimune’s twice-rejected melanoma drug prevails in FDA adcomm
  Following a pair of FDA rejections of its melanoma drug, Replimune’s fortunes flipped today after an advisory committee voted 10 to 3 in favor of the candidate’s effectiveness.
  fiercebiotech · 10h ago
• J&J nabs option to buy ‘in vivo’ CAR-T maker Sail for nearly $2.6B
  The deal with the buzzy Flagship Pioneering-backed startup makes J&J the latest large drugmaker to bet that the technology might be able to treat autoimmune conditions.
  biopharma_dive · 12h ago
• BMS’ ‘big beat’ clouded by Cobenfy, heart disease data delays
  Strong quarterly results are prompting Bristol Myers Squibb to lift its 2026 outlook, though the company is facing another delay for key Cobenfy Alzheimer’s data and a pushed-back readout for milve…
  biospace · 13h ago
• Takeda, Regeneron, Sanofi and Bristol Myers trim pipelines
  Biopharma earnings season is also pipeline update season. On Wednesday, Takeda, Regeneron, Sanofi and Bristol Myers Squibb all announced program cuts as part of their quarterly updates. Some of the…
  endpoints · 13h ago
• BMS CEO Boerner doesn’t ‘feel any compulsion to chase deals’ despite lack of M&A this year
  BMS may have been absent from the dealmaking spree of some of its Big Pharma peers this year, but that might not change anytime soon.
  fiercebiotech · 17h ago
• Bristol Myers delays Cobenfy Alzheimer’s psychosis readout again amid another quarterly beat
  Investors awaiting Bristol Myers Squibb’s key Alzheimer’s psychosis readout for Cobenfy and atrial fibrillation data for milvexian will have to wait a little longer.
  fiercebiotech · 18h ago
• Attovia, Braveheart and Vogenx seek more than $500M across trio of IPOs
  Attovia Therapeutics, Braveheart Bio and Vogenx have set target ranges for their IPOs, positioning the trio to collectively net more than $500 million from public investors.
  fiercebiotech · 19h ago
• Biogen validated the Alzheimer’s tau theory. CEO Viehbacher still isn’t betting the store
  With so many unknowns, Biogen is carefully eyeing its next-gen Alzheimer’s treatment diranersen as a high-risk, high-reward project with the potential for a major payout around 2030.
  biospace · 1d ago