Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fulcrum, GBT, Hemoshear, Imara, Innate, Mayne, Medigene, Neurorx, Novartis, Relief, Philogen.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alteogen, Berlin Cures, Brainstorm Cell, Chemocentryx, Delmar, Evotec, GW, Ignova, Immunomic, Inxmed, Kymera, La Jolla, Lion TCR, Mateon, Melior, Repertoire, Replicate, Roivant, Scancell, Zealand, Zelluna.
Countries and health care providers should hope for the best but prepare for the worst as a resurgence of COVID-19 is expected in the fall, just as the influenza season hits.
BEIJING – Chinese state-backed vaccine developer China National Biotec Group (CNBG), of Beijing, said on June 16 that its inactivated COVID-19 vaccine candidate produced a seroconversion rate of up to 100% in a phase I/II trial that enrolled 1,120 healthy subjects.
HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.”
Adarza Biosystems Inc.’s Ziva platform can simultaneously detect hundreds of proteins, antibodies, or substrates from a single drop of blood, plasma or serum, providing insight into an individual’s immune response. That could be critical for both surveillance and diagnostic purposes as the nation prepares for a likely second wave of the novel coronavirus in the fall when multiple respiratory pathogens will be circulating.
Sommetrics Inc. said Tuesday that it has requested emergency use authorization from the U.S. FDA to market its Aersleep II device for sleep apnea patients at risk of COVID-19. The aim is to reduce the transmission of SARS-CoV-2, the virus that causes COVID-19, by treating infected patients with sleep apnea with Aersleep instead of continuous positive airway pressure (CPAP) therapy.
The Senate Health, Education, Labor and Pensions (HELP) Committee met again June 23 to discuss the federal government response to the COVID-19 pandemic, and one clear signal that emerged from the hearing is that Congress will have to provide annual funding to build a sustainable infrastructure for vaccine development and manufacture if the nation is to deal appropriately with the next pandemic.
The importance of artificial intelligence and machine learning continues to be acknowledged by drug development companies. Recently, to help accelerate the discovery of therapies to treat COVID-19, several deals have been forged to deploy those tools.
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