Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apellis, Bold, Caladrius, CSL, Emergent, Gilead, Grifols, Pfizer, Rigel, Sobi, Sumitomo Dainippon, Takeda, University of Oxford.
The ongoing pandemic brought about several challenges for investors looking for the next big thing, but some areas still have experienced growth. Experts addressed this topic and other issues during a panel discussion Oct. 6 at the Cleveland Clinic’s 2020 Medical Innovation Summit.
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada explains COVID-19 disclosures; TGA on changing sponsor details; FDA awards research grants for rare diseases; Se habla español.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerecin, Eton, Neurocrine, Regeneron, Revelation, Rhythm AI, X4, Xenon, Xortx.
With an ongoing phase II trial showing that a pair of its SARS-CoV-2 neutralizing antibodies has so far reduced viral load, symptoms and COVID-19-related hospitalization and ER visits, Eli Lilly and Co. has asked the FDA to consider an emergency use authorization (EUA) for one of the components, LY-CoV555.
With COVID-19 cases once again surging across the globe and several countries considering targeted lockdowns, vaccines remain the best hope of restoring a sense of normalcy amidst the pandemic. For vaccines to work though, people must have enough confidence in the efficacy and safety that they’re willing to get vaccinated when the vaccines become available. That’s why the emergency use authorization (EUA) guidance the FDA released Oct. 6 for COVID-19 vaccines is so important.
LONDON – Industry is calling on the government to set out a plan for the safe and sustainable restart of non-COVID-19 clinical studies that were put on hold when the pandemic struck.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprea, Arca, Arch, Biomarin, Eton, Lilly, OWP, Pluristem, Polarean, TLC, Y-Mabs.
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