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After A Bumper 2021, How French Biotech Is Surviving Market Doldrums

French Biotech In Focus: Amid a global biotech funding boom last year, French biotech saw a rise in the number of high-value financing rounds while its firms adopt savvy licensing strategies.

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Breakthrough Therapies: Failed Study Won’t Automatically Lead To Rescinded Designation

The decision to maintain or revoke breakthrough therapy status when trial results do not appear to support the original designation will depend on the facts specific to a development program, the US FDA says in new draft guidance. Since 2012, the agency has granted 475 breakthrough therapy designation requests and rescinded 35 designations.

Review Pathway Guidance Documents

Recent US FDA Breakthrough Therapy Designations, From Mass Market Vaccines To Rare Diseases

Merck’s latest pneumococcal vaccine and Pfizer’s RSV vaccine notched new BTDs, along with Zambon’s inhaled antibiotic for non-CF bronchiectasis, Acer’s vascular Ehlers-Danlos syndrome drug and Dizal’s targeted lung cancer candidate.

US FDA Performance Tracker Review Pathway

Finance Watch: HilleVax, Belite Bio Launch First Two Biopharma IPOs In Q2

Also, Cytovia will go public via SPAC merger, Nkarta capitalized on its positive early NK cell therapy data with a $230m offering, and venture capital mega-rounds include $220m for Reify, $110m for Satellite Bio and $100m for OMass Therapeutics. 

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  • Industry
  • Biotechnology
  • In Vitro Diagnostics
  • Medical Devices
  • Pharmaceuticals
  • Pharmaceuticals
    • OTC, Consumer
    • Drug Delivery
      • Topical Delivery
  • In Vitro Diagnostics
    • Chemistry, Immunoassay
    • Molecular Diagnostics & Genetic Testing
  • Other Names / Subsidiaries
    • Laboratoires Doliage
    • Eupharmed srl
    • Aciex Therapeutics, Inc.
    • AVEye Biotechnologie GmbH
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