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Theratechnologies Inc.

www.theratech.com

Latest From Theratechnologies Inc.

US Marks Biologics Transition Day

Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.

Regulation Review Pathway

Transition Day In The US: 96 Drugs Make The Move To Biologics Regulation

Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.

Biologics Biosimilars

The Last Days Of NDAs: Uncertainties Remain Ahead Of 23 March Move From Drugs To Biologics

Exactly how many NDAs ultimately will make the switch, the impact of pending applications on 'Orange Book' listings, and the ramifications for ‘authorized generics’ are areas of focus as the regulatory transition date looms.

Biosimilars Biologics

EU 2019 Approvals: Novel Therapies Make Strong Showing

Bluebird bio’s gene therapy Zynteglo, Akcea’s antisense drug Waylivra and BioMarin’s enzyme substitution therapy Palynziq were among the novel innovative medicines that were approved in Europe in 2019. 

Europe Approvals
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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
  • Pharmaceuticals
  • Therapeutic Areas
  • Infectious & Viral Diseases
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • Canada
  • Parent & Subsidiaries
  • Theratechnologies Inc.
  • Senior Management
  • Luc Tanguay, Pres. & CEO
    Philippe Dubuc, SVP, CFO
    Lyne Fortin, SVP, Chief Commercial Officer
    Christian Marsolais, PhD, SVP, CMO
  • Contact Info
  • Theratechnologies Inc.
    Phone: (514) 366-7800
    2015 Peel Street 5th Fl.
    Montréal, H3A 1T8
    Canada
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