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Genentech, Inc.

http://www.gene.com

Latest From Genentech, Inc.

Deal Watch: GSK Gets Rights To Spero’s Phase III Antibiotic

GSK takes equity stake in Spero, and global rights to tebipenem except for certain Asian markets. Merck KGaA gets rights to Nerviano’s next-generation PARP inhibitor for cancer.

Deal Watch Business Strategies

‘On-And Off-Ramps’ For Cancer Accelerated Approvals: FDA Suggests Earlier Randomized Trials

Leaders of FDA’s oncology center say sponsors could initiate a single randomized trial prior to receiving accelerated approval or conduct a single-group AA study concurrently with a randomized trial. FDA and sponsor could agree in advance on criteria for approval and withdrawal.

Review Pathway Clinical Trials

Finance Watch: VC Mega-Rounds Surge Again, Led By Acelyrin’s $300m Series C

Private Company Edition: Acelyrin will use its latest funding for Phase III development of izokibep in inflammatory diseases. Also, ArsenalBio raised $220m to take its programmable cell therapies into the clinic and RayzeBio’s $160m series D round will fund clinical trials for its radiopharmaceuticals. 

Financing Innovation

Amylyx’s ALS Pledge Vs. FDA’s Obscure Withdrawal Authority: Which Holds More Power?

Office of Neuroscience Director Billy Dunn touted FDA’s ability to withdraw approval for AMX0035 if subsequent data indicate a lack of substantial evidence of effectiveness. However, this provision appears to have been infrequently used and involves a potentially time-consuming hearing.

Advisory Committees Drug Approval Standards
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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Tanox
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