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Aptose Biosciences Inc.

http://www.aptose.com/

Latest From Aptose Biosciences Inc.

US FDA Advisory Committees As The Court Of Appeals

The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.

Advisory Committees Drug Review

User Fee Bill’s Accelerated Approval Reform Provisions Watered Down, But Could Speed Withdrawals

Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.

User Fees Legislation

Makena Accelerated Approval Hearing Will Be Virtual, Likely In September Or October

Presiding officer Celia Witten denies Covis’ request for an in-person hearing, saying it is unclear at this time how COVID would affect a proceeding in the fall. Hearing agenda spans two-and-a-half days and is modeled, in part, on the Avastin hearing, but with twice the time for public comment.

Advisory Committees Review Pathway

Finance Watch: Blackstone Closes $1.6bn Fund To Back Commercial-Stage Companies

Public Company Edition: Blackstone Life Sciences Yield will finance approved products, while the firm’s prior fund supports late-stage programs. Also, Coeptis will merge with a SPAC, Bausch + Lomb secured post-IPO debt, and BioXcel revealed a $260m financing and new subsidiary.

Financing Business Strategies
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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Antisense, Oligonucleotides
    • Large Molecule
  • Other Names / Subsidiaries
    • GeneSense Technologies
    • Lorus Therapeutics Inc.
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