The latest global regulatory news, changes and updates affecting biopharma, including: Convalescent plasma trials expand; CBD public meeting, generics; ICER updates in CF in MM.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Cryosystem, Athenex, Athersys, Bluebird, Eagle, GW, Neurorx, Novartis, Pfizer, Sinovac, Symbio.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Actinium, Afimmune, Bridge, Clearside, Cytokinetics, Dr. Reddy's, Durect, Enterome, Genentech, J&J, Macrogenics, Morphic, Neximmune, Nicox, Oncimmune, Selecta, Sobi, Takeda, Verona, Vtv.
Early stage investment strategies and dealmaking in the age of COVID-19 became topics during the Biopharm America meeting, itself held virtually this year because of the pandemic. Kevin Johnson, partner and co-founder of European life sciences backer Medicxi, hailed an “unprecedented upswing” on the financial front. “There is no winter,” he said. “It’s amazing.”
The latest global regulatory news, changes and updates affecting biopharma, including: New TGA service to ease the burden of biowaivers; FDA formalizes outside experts program; FDA unveils Digital Health Center of Excellence; FDA updates clinical trial guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, BMS, Crispr, Emmetrope, Genocea, Knight, Lilly, Medeor, Mustang, Nicox, Ocumension, Redhill, Therapeuticsmd, UCB, Vertex.
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