AXSOME

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• The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
  The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
  biospace · 14d ago
• Rapport ‘fully prepared’ to launch seizure drug solo, CEO says
  In a wide-ranging interview, Abe Ceesay detailed how Rapport built an investor syndicate and why the company is confident it can join the ranks of successful, commercial-stage brain drugmakers.
  biopharma_dive · 1mo ago
• Otsuka showcases kidney drug data; Pfizer cuts an AI deal
  Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
  biopharma_dive · 2mo ago
• Axsome pushes back generic entry for narcolepsy drug until 2040
  Axsome Therapeutics has successfully delayed generic competition for its narcolepsy drug Sunosi until 2040. The company announced on Wednesday that it has reached a settlement with the last applica…
  endpoints · 2mo ago
• STAT+: A new attack on AMA’s billing codes
  A key GOP lawmaker is broadening the party's efforts to combat health care fraud.
  stat · 3mo ago
• STAT+: Are analysts too quick to gloss over Lilly’s liver case?
  Cytokinetics' Myqorzo's trial results, Johnson & Johnson's IBD therapy, and more biotech news from The Readout
  stat · 3mo ago
• STAT+: Cytokinetics drug Myqorzo meets twin efficacy goals in study of genetic heart disease
  A Cytokinetics heart disease drug — already approved in one indication — succeeded in another Phase 3 trial, a potential boost for sales.
  stat · 3mo ago
• STAT+: Johnson & Johnson advances IBD therapy, despite trial miss
  A closely watched therapy developed by Johnson & Johnson failed to show a statistically meaningful improvement for IBD patients.
  stat · 3mo ago
• STAT+: Pump the brakes on AI, buddy; and deposition deadlock
  It's tough to write nuanced headlines, but a new study on AI in emergency rooms is getting way overhyped.
  stat · 3mo ago
• UCB to acquire maker of antibody treatments for autoimmune diseases
  A second shot at gene therapy for Huntington's, China's tightening grip on pharma supply chains, and more Readout biotech updates
  stat · 3mo ago