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Latest From Sanofi

Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Gene Therapy Approvals

BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval

Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.

Europe Approvals

Argenx Eyes Hat-Trick Of Successful Launches For Vyvgart After CHMP Thumbs-Up

Anant Murthy, general manager of Argenx Europe, tells Scrip that the commercial infrastructure is in place for Vyvgart to enjoy a strong launch for the rare neuromuscular disorder which will mirror those seen in the US and Japan.

Launches Rare Diseases

Acer’s ‘Misunderstood Drugs’ Strategy Faces Regulatory Hurdles

Acer repurposes drugs with available data (like a 40-year-old European antihypertensive) into rare disease treatments (like Edsivo for vascular Ehlers-Danlos syndrome), but approval remains elusive, with a CRL for ACER-001 just as Edsivo is poised to enter a new clinical trial, armed with a new breakthrough designation. The Pink Sheet delves into regulatory history and strategy with CEO Chris Schelling.

Rare Diseases Complete Response Letters
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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Specialty Pharmaceuticals
    • Vaccines
  • Other Names / Subsidiaries
    • Ablynx N.V.
    • Acambis PLC
    • Avigen Inc.
    • Bioverativ Inc. (True North Therapeutics, Inc.)
    • BiPar Sciences Inc.
    • BMP Sunstone Corporation
    • Canderm Pharma Inc.
    • Celmed BioSciences, Inc.
    • Chattem, Inc.
    • Connaught Laboratories Ltd.
    • Fisons Ltd.
    • Fovea Pharmaceuticals, SA
    • Genfar S.A.
    • Genzyme Corporation
    • Groupe Sanofi
    • Hoechst Marion Roussel
    • Kadmon Holdings, Inc.
    • Kiadis Pharma B.V.
    • Kiadis Pharma N.V.
    • Pluromed
    • Principia Biopharma Inc. Protein Sciences Corporation
    • Rhone-Poulenc Rorer
    • Sanofi-Aventis
    • Sanofi-aventis Groupe
    • Sanofi Pasteur MSD
    • Shantha
    • Synthorx, Inc. (THOR)
    • TargeGen, Inc.
    • Thunder Acquisition
    • Tidal Therapeutics
    • Translate Bio
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