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.
DUBLIN – Genentech has succeeded where Sanofi SA and its partner, Regeneron Pharmaceuticals Inc., have failed, in obtaining some sort of a positive signal from a clinical trial of an interleukin-6 (IL-6) inhibitor in COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Ampio, Arca, Astrazeneca, Crinetics, I-Mab, Merck, Otsuka, Harbour and Liminal.
The latest global regulatory news, changes and updates affecting biopharma, including: CDER lays out public speech rules for staff; Health Canada opens quicker path for COVID-19 drugs; EMA OKs COVID-19 use of dexamethasone.
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