Positive COVID-19 efficacy numbers from Vir Biotechnology Inc. and Glaxosmithkline plc (GSK) has prompted them to immediately seek an emergency use authorization (EUA) with the FDA and similar authorizations in other countries for their monoclonal antibody, VIR-7831. Meanwhile, the phase III Remdacta study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir) vs. placebo plus Veklury, from Roche Holding AG and Gilead Sciences Inc., missed its primary endpoint in treating hospitalized patients with severe COVID-19 pneumonia receiving standard of care. Read More
What started with Austrian regulators suspending use of one batch of Astrazeneca plc’s COVID-19 vaccine has expanded into precautionary holds in Denmark and other EU countries as PRAC, the EMA’s safety committee, investigates whether blood clots, which have resulted in at least two deaths in Europe, are connected to the vaccine. Read More
LONDON – The largest study of its kind to date has identified new biomarkers of inflammation that are both indicators of severe COVID-19 infection and distinguish it from severe influenza. Read More
Shares of Israeli drug delivery specialist Entera Bio Ltd. (NASDAQ:ENTX) led the U.S. market March 11, in both percentage gain and volume, climbing 152.5% to $4.04 after a report that its oral parathyroid hormone candidate, EB-613, significantly boosted levels of P1NP, a biomarker indicating new bone formation vs. placebo at three months in an ongoing phase II osteoporosis study. Read More
Aveo Oncology Inc. CEO Michael Bailey said the shifting treatment paradigm in renal cell carcinoma (RCC) represents “an advantageous opportunity” for the company with Fotivda (tivozanib), approved March 10 for adults with relapsed or refractory, advanced disease who have received two or more systemic therapies. Read More
PERTH, Australia – Sydney-based Azura Ophthalmics Ltd. has moved into a registration trial following positive phase II results for lead candidate AZR-MD-001 in Meibomian gland dysfunction, the leading cause of dry eye disease. Read More
HONG KONG – Privately held Wugen Inc. of St. Louis has inked an exclusive deal with Shanghai-based Alpha Biopharma Ltd. to manufacture, develop and commercialize allogeneic cell products in Asia. Read More
Oncology drugs that have racked up a number of indications through accelerated approvals are losing some of those indications as the result of an FDA industrywide evaluation of confirmatory trials that didn’t back up the approvals. Read More
BioWorld looks at translational medicine, including: Fungal culprit in Crohn’s disease; Targeting membrane protein starves pancreatic tumors; Linking antiphospholipid antibodies to autoimmunity. Read More
Biopharmas raising money in public or private financings, including: Delonix, Frontier Acquisition, Hoth, Humanigen, Matrisys, Savara, Touchlight, Xeris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Astellas, Aveo, Biocryst, Biohaven, Bioxcel, Denali, Eli Lilly, J&J, Kadmon, Longeveron, Marius, Nouscom, Nuvation, RDIF, Spectrum. Read More
