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An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.
Recent submissions include what could be the fourth novel agent approved under the RTOR pilot.
Rabia Khan, managing director of discovery sciences at Sensyne Health, talks to In Vivo about pairing biology with technology in the most effective way, managing COVID-19 challenges and what the future leaders of biopharma might look like.
Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.