Shares of Humanigen Inc. (NASDAQ:HGEN) climbed 30.2% to $5.31 on Monday after the company disclosed that, when treated with the company's anti-GM-CSF antibody, lenzilumab, 12 hospitalized patients with severe or critical pneumonia as a result of COVID-19 showed "rapid clinical improvement."
Just 80 days after first issuing an emergency use authorization (EUA) for oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) in treating COVID-19, the FDA is revoking that authorization in light of clinical data and scientific literature that raised questions about whether benefits of the treatment outweigh the risks.
BEIJING – Nasdaq-listed Chinese vaccine developer Sinovac Biotech Ltd., of Beijing, said the preliminary results of the phase I/II trials of its COVID-19 inactivated vaccine candidate, Coronavac, demonstrated favorable immunogenicity and safety profiles.
LONDON - The EU has secured a supply of the most advanced COVID-19 vaccine in development, in a deal with Astrazeneca plc for up to 400 million doses of AZD-1222, with deliveries starting by the end of 2020.
Policymakers in the U.S. are grappling with a disastrous pandemic as well as long-standing political tensions, but one aspect of the COVID-19 pandemic that might unify them is the need to ensure that patients in the U.S. are not at the mercy of other nations for needed diagnostics and therapies.
Now that Roche Holding AG has digested its Foundation Medicine and Flatiron acquisitions from a few years ago, it has looked to add more digital capabilities in a couple of recent deals. The earlier big-ticket tie-ups by the Basel, Switzerland-based pharma added genomic and real-world data analytics to deepen the knowledge driving Roche’s R&D efforts, particularly in oncology.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cue Health.
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