In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Arch, Bridge, Cynata, Cytokinetics, Junshi, Pluristem, Redhill, Sesen, Takeda.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acadia, Arcturus, Beroni, Fortress, Oncogenuity, Sorrento, Zyus.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Cytodyn, Daewoong, Five Prime, Flexion, Kadmon, Lundbeck, Millendo, Protagonist, Revance, Savara, Scholar Rock.
Just days after Foster City, Calif.-based Gilead Sciences Inc. gained emergency use authorization (EUA) from the FDA for antiviral Veklury (remdesivir) for the treatment of patients with SARS-CoV-2 infection, the virus that causes COVID-19, Japan invoked its own exceptional approval pathway to give the drug the green light to treat patients with severe COVID-19.
CEO Carsten Brunn said Selecta Biosciences Inc. has “not seen a material impact” from the COVID-19 pandemic and remains on track to report in the third quarter phase IIb data from a head-to-head trial comparing its refractory gout candidate, SEL-212, with Krystexxa (pegloticase), from Horizon Therapeutics plc, of Dublin.
CAJICA, Colombia – A research team at the Autonomous University of Queretaro (UAQ), Mexico, is working to develop a COVID-19 vaccine, joining about 100 other teams working toward a similar goal. Unlike other teams, however, this one is being led by veterinarians.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Bexion, Canbridge, Daiichi, Genelux, Gilead, Immunicum, Nanobiotix, Novartis, Sapience, Twi.
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