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• Capricor CEO won’t rule out legal action against FDA after negative adcomm
  After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior mot…
  biospace · 6h ago
• Lilly and Resilience invest $750M in diabetes and obesity drug device supply
  The investment will expand Resilience’s U.S. capacity to make the KwikPen device Eli Lilly uses to deliver its injectable diabetes and obesity medicines.
  biospace · 8h ago
• Opinion: We once praised the American Diabetes Association’s courage. How things have changed
  “The ADA is no longer what we’d call a profile in courage,” write Adam Marcus and Ivan Oransky of Retraction Watch.
  stat · 16h ago
• Alnylam plunges as earnings deliver ‘one-two punch’
  The RNA-focused biotech shed 30% of its market value — or close to $12 billion — amid growing investor concerns about its main drug business.
  biopharma_dive · 1d ago
• Chutes & Ladders—Legend CEO departs without successor in place
  Legend Biotech CEO Ying Huang, Ph.D., has left the company suddenly, without a predecessor in place. Huang was elevated from CFO to CEO in 2020 after a Chinese customs investigation was opened on f…
  fiercebiotech · 1d ago
• J&J secures right to take the helm in up to $925M Sail CAR T pact
  As part of the collaboration, Johnson & Johnson will have an exclusive option to acquire Sail Biomedicines for an additional $2.58 billion.
  biospace · 1d ago
• Opinion: Ten years after WHO recognition, mycetoma remains one of the world’s most neglected diseases
  “The next 10 years of mycetoma care will determine whether it remains a story of neglect or becomes one of collective action,” writes Borna Nyaoke-Anoke.
  stat · 1d ago
• New funding, new jobs: 4 biotechs hiring after series B raises
  Biotechs that announced series B financing this year and are looking for employees as they grow include one that received over $100 million and another that has a partnership with a Big Pharma comp…
  biospace · 1d ago
• Is it safe to drink Red Bull and alcohol? Questionable research tied to energy drink giant has shaped policy
  Studies tied to Red Bull helped block warning labels about drinking alcohol along with energy drinks. Independent studies report risks in mixing the two.
  stat · 1d ago
• FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
  During a perplexing advisory committee meeting in which FDA reviewers focused largely on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, experts pointed to “very fragile” data. T…
  biospace · 2d ago