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Latest From Ferring Pharmaceuticals
When the sector worries about regulation it is usually about drug development and registration. But governments also regulate on monopolistic positions in life sciences. Adding to that, national security enforcement is now rising.
Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals
US FDA's Vaccines and Related Biological Products Advisory Committee endorses Rebyota for recurrent C. difficile infection; most panelists prefer a product whose manufacturing will be regulated, even one with lingering concerns about efficacy or safety, over the current landscape.
A 2013 FDA decision to allow certain fecal microbiota transplants for C. difficile infection without an investigational new drug application hurt Rebiotix’s Phase III trial enrollment and may ultimately leave it without strong enough data for advisory committee endorsement or FDA approval.
- Specialty Pharmaceuticals
- Drug Discovery Tools
- Other Names / Subsidiaries
- BioSurface Engineering Technologies, Inc. (BioSET)
- Cytokine PharmaSciences, Inc. (Subsidiary: Controlled Therapeutics Ltd.)
- Ferring Pharmaceuticals
- Rebiotix, Inc.