The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Hipra Human Health SLU’s recombinant COVID-19 vaccine, Bimervax, as a booster in people ages 16 and older who have been vaccinated with an mRNA COVID-19 vaccine.
U.S. lawmakers have been busy writing to government agencies demanding answers and explanations on a range of issues, including drug shortages, gain-of-function research and thickets of duplicative patents that extend patent protection well beyond 20 years for some prescription drugs.
During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Baudaxbio, Eyepoint, Imvax, Ionis, Janssen, Neuraly, Novartis, Novo Nordisk, Nrx, Ocugen, Olix, TME, Unity, Yishengbio.
COVID-19 complications involve activated T cells that contribute to inflammation. Foralumab, a fully human anti-CD3 monoclonal antibody, targets the T-cell receptor and regulates T-cell function to suppress inflammation. In a pilot trial, foralumab reduced lung inflammation, serum IL-6 and C-reactive protein in cases of moderate COVID-19.
China’s NMPA granted conditional approval for a COVID-19 oral pill to treat adult patients with mild to moderate cases of the virus to a unit of Guangdong Zhongsheng Pharmaceutical Co. Ltd. RAY-1216 is a peptidomimetic inhibitor of SARS-CoV-2 main protease (Mpro), which is also known as a 3C-like protease (3CLpro).
CSPC Pharmaceutical Group Ltd.’s COVID-19 mRNA vaccine, SYS-6006, has been included for emergency use by the NMPA, the company said on March 22, marking the first domestically developed COVID-19 mRNA vaccine approved for use in China.