As a first step in developing a portfolio of COVID-19 therapies, the European Commission identified five promising candidates June 29, including four monoclonal antibodies under rolling review at the EMA and an immunosuppressant that could have its marketing authorization extended to include the treatment of COVID-19 infections.
Shares of Vir Biotechnology Inc. (NASDAQ:VIR) and Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) each rose modestly on June 21 as both delivered positive updates on their COVID-19 programs. Vir and its partner, Glaxosmithkline plc, shared final clinical data confirming the efficacy of their monoclonal antibody therapy, sotrovimab, following an FDA emergency use authorization for the therapy last month. Cumberland announced five case studies in which its antibiotic, Vibativ (telavancin), successfully treated hospital-acquired and ventilator-associated bacterial pneumonia in COVID-19 patients.
The U.S. government on June 17 announced plans for a multi-faceted $3.2 billion investment in the development and manufacture of new antivirals for preventing serious COVID-19 illness and death.
With shortages of the COVID-19 drug, remdesivir, being reported in several states in India, the country’s Central Drugs Standard Control Organization is calling on state regulators to “immediately initiate remedial action to ensure supply of remdesivir injection to public and private hospitals.”
In the debate over the interpretation of the U.S. government’s patent march-in rights under the Bayh-Dole Act, those arguing for march-in as a price control cite the billions of tax dollars being invested in scientific research at universities that may lead to marketable inventions.
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.”
U.S. lawmakers, advocacy groups and state officials who urged the Department of Health and Human Services (HHS) to march in on patents covering Gilead Sciences Inc.’s COVID-19 drug, Veklury (remdesivir), likely were disappointed, and perhaps surprised, by the Government Accountability Office’s (GAO) conclusion this week that, despite a $161.5 million taxpayer investment in the antiviral’s development, there are no government patents to march in on.
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.
The U.S. NIH’s Feb. 17 announcement that it’s funding a study of the effects of remdesivir in treating COVID-19 in pregnant women is welcome news, but it begs the question of why it took so long given the risk of more severe disease in that population.
It’s official. After a weekend of rumors and speculation, President-elect Joe Biden formally announced the nomination of California Attorney General Xavier Becerra Dec. 7 as secretary of the U.S. Department of Health and Human Services, along with Vivek Murthy as surgeon general.
