$FATEFATE THERAPEUTICS INC

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• Capricor, Replimune illustrate why FDA must listen to rare disease specialists
  Last month’s FDA advisory committee meetings for therapies developed by Capricor Therapeutics and Replimune effectively illustrate the different outcomes for patients when the agency prioritizes sp…
  biospace · 1mo ago
• Autoimmune CAR-T faces tough questions after Novartis, Bristol Myers study halts
  Wall Street analysts believe that a more cautious approach to manufacturing, study enrollment and side effect management could help developers avoid future safety hazards.
  biopharma_dive · 1mo ago
• UniQure, after setbacks, seeks FDA approval of Huntington’s gene therapy
  The company is now hoping for an affirmative answer on its application after an unusually turbulent year dealing with U.S. regulators.
  biopharma_dive · 1mo ago
• As MAHA champions nutrition, it’s ignoring the experts, dietitians say
  A key aspect of the Make America Healthy Again agenda could be hampered by a shrinking and underpaid workforce of registered dietitians.
  stat · 1mo ago
• UPDATED: Novartis halts autoimmune CAR-T trials after 3 deaths, as BMS also pauses studies
  Three deaths have forced Novartis to pause development of its CD19 CAR-T candidate in autoimmune diseases, just as Bristol Myers Squibb has halted a similar program due to immune-related adverse ev…
  fiercebiotech · 1mo ago
• Capricor investor calls for change as company awaits decision on Duchenne candidate
  Kaos Capital in a letter to other Capricor Therapeutics shareholders called for “an immediate meeting, board change, and capital-preservation plan.” The biotech recently put all other pipeline work…
  biospace · 1mo ago
• Scientists deploy Merck’s Ebola vaccine in DRC
  Prostate cancer therapy, Meta glasses in hospital settings, and more health news from Morning Rounds
  stat · 1mo ago
• Scribe’s early-stage IPO standout defies biotech’s derisking trend
  Scribe Therapeutics’ one-time epigenetic treatment is designed to slash the adherence burden of chronic cholesterol-lowering therapies while sidestepping the irreversibility of gene editing.
  biospace · 1mo ago
• Opinion: Capricor’s Duchenne muscular dystrophy drug and the countless tiny decisions that can make or break a study
  “Regulatory flexibility can be exercised in rare disease without sacrificing rigor,” writes Mindy Leffler, whose son has Duchenne muscular dystrophy.
  stat · 1mo ago
• Kolon TissueGene shrinks workforce after pivotal osteoarthritis trial miss
  Following a phase 3 knee osteoarthritis failure that its CEO acknowledged caused “great disappointment and concern,” Kolon TissueGene is laying off 37 employees at its Maryland headquarters.
  fiercebiotech · 1mo ago