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News

• 5 biotechs braving the commercial waters with product launches
  A growing number of biotechs are entering the market with newly launched medicines, a pattern indicative of “improving capital markets,” according to Jefferies’ Andrew Tsai.
  biospace · 3d ago
• Takeda leads wave of orexin drugs with potential to upend narcolepsy market
  The FDA’s August approval of Takeda’s Orzeyful for treating the full set of narcolepsy symptoms initiated a new era in the sleep market.
  biospace · 1mo ago
• 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 · 1mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo ago