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.
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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. Read More
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." Read More
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. Read More
With an increasingly aging global population, neurological disorders have become a major cause of death and disability worldwide. Despite the significant investments that continue to be made in research and development in the neurological field, the discovery of new drugs targeting many CNS disorders, including Alzheimer’s and Parkinson’s diseases, has proved to be difficult. Read More
The latest FDA report card on the quality of drugs being sold in the U.S. is nothing to brag about. On a grading scale where 90% to 100% is an “A” and anything below 60% is failing, the average manufacturing site inspection score for drugs marketed in the U.S. in fiscal 2019 would be a solid “C” – or 7.4 on the FDA’s 10-point grading scale. But at least 10 sites had failing marks with scores of 5. Read More
In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the FDA said, “All of these scores indicate an acceptable level of compliance to CGMPs [current good manufacturing practices] on average.” Read More
All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work. Read More
HONG KONG – Korea’s Celltrion Inc. aims to wrap up its first major M&A deal with Japan’s Takeda Pharmaceutical Inc. by the end of 2020, pending approvals. Read More
Two months earlier than expected, Pharmamar SA and partner Jazz Pharmaceuticals plc received an accelerated FDA approval of Zepzelca to treat relapsed metastatic small-cell lung cancer patients. Read More
New hires and promotions in the biopharma industry, including: Alligator, Aptorum, Catalyst, Epsilen, Marinus, Sensei, Syncona, Vaxart, Ziopharm. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Academy of Dermatology's annual meeting, including: Concert, Brickell, Janssen, Kaken, Leo, Eli Lilly, Principia. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Diabetes Association's 80th Scientific Sessions, including: Cirius, Diasome, Dompé, Hua, Lilly, Mannkind, Novo, Oramed, Vtv, Xeris, Zealand. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Aldeyra, Genocea, Merck, Neoimmunetech, Sunovion, Viiv. Read More
