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Latest From Biohaven Pharmaceutical Holding Company Ltd.
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.
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.
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.
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.
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- Other Names / Subsidiaries
- Biohaven Pharmaceuticals, Inc.
- Biohaven Therapeutics Ltd.
- Kleo Pharmaceuticals Inc.
- Portage Biotech Inc.
- Portage Glasgow Limited (PGL)
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