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Latest From Biohaven Pharmaceutical Holding Company Ltd.

Senators Pressure US FDA To Issue New Guidance On Social Media Drug Promotion

Senators ask the agency to address the “regulatory loophole” permitting telehealth companies to promote prescription drugs without disclosing side effects and question if FDA has enforcement authority over third-party social media influencer promotions.

Advertising, Marketing & Sales Enforcement

Orphan Drugs Dominate Latest EU Filings

Sotatercept, marstacimab, elafibranor, eplontersen, mirvetuximab soravtansine, troriluzole and tiratricol are among the latest products that the European Medicines Agency has started reviewing for potential EU marketing approval.

Europe Drug Review

Finance Watch: Public Companies Pursue All Options To Fund R&D, Launches

Public Company Edition: Follow-on offerings may not be the favored path to funding development programs or product launches after major milestones in the current environment. Amicus secured $430m in a deal with Blackstone, while OPKO’s Modex garnered up to $168m from BARDA.

Finance Watch Financing

US FDA Versus Its Own Precedents

The US FDA has shown astonishing flexibility in approving new drugs for neurodegenerative diseases based on efficacy evidence that falls well short of historical standards. Now the agency faces the delicate challenge of demonstrating that there are still some lines it will not cross.

Advisory Committees Drug Approval Standards
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
      • Macromolecule
  • Biotechnology
    • Large Molecule
  • Other Names / Subsidiaries
    • Biohaven Pharmaceuticals, Inc.
    • Biohaven Therapeutics Ltd.
    • BioShin
    • Kleo Pharmaceuticals Inc.
    • Portage Biotech Inc.
    • Portage Glasgow Limited (PGL)
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