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Oscient Pharmaceuticals Corporation

Latest From Oscient Pharmaceuticals Corporation

Bluebird’s Eli-Cel Gene Therapy Among Myriad New Drugs Seeking EU Approval

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.

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Recent submissions include what could be the fourth novel agent approved under the RTOR pilot.

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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.

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Antifungal Drug Sponsors Seek Clearer Regulatory Pathway, Less Burdensome Trials

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.

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