Shionogi & Co. Ltd.’s plan to make ensitrelvir, an oral antiviral for COVID-19, the first domestically approved COVID-19 treatment has hit a snag. Animal studies showed the drug, also known as S-217622, disturbed fetal development, according to media reports.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Affamed, Bharat Biotech, Biocardia, Blue Earth, Fera, Gilead, Henlius, Medilink, Myovant, Ocugen, Paradigm, Poxel, Secura, Vistagen, Xortx.
Pfizer Australia Holdings Pty Ltd. has made an offer to acquire digital health company Resapp Health Ltd. in all cash offer worth AU$100 million (US$74.25 million). The two companies have entered into a binding scheme that is contingent upon shareholder agreement and regulatory clearances in Australia. Shareholders will vote on the proposed acquisition in June, and directors have unanimously recommended that shareholders vote in favor of the acquisition.
NEC Corp. subsidiary NEC Oncoimmunity AS recently received $4.8 million from the Coalition for Epidemic Preparedness Innovations to fund the development of vaccines for SARS-CoV-2 variants and other betacoronaviruses.
Everest Medicines Ltd. has formed a partnership with China Resources Pharmaceutical Group (CR Pharma) to co-launch an independent company to focus on the development of messenger RNA (mRNA) vaccines.
Shares of Suzhou, China-based Kintor Pharmaceutical Ltd. (HKEX:9939) rose to HKD28.85 (US$3.68), up HKD14.87, or 106%, after the firm reported top-line data from the phase III multiregional trial with proxalutamide in people with mild to moderate COVID-19 infection, regardless of vaccination status or risk factors.
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