The Russian Ministry of Health issued the 14th version of its guidelines on preventing, diagnosing and treating COVID-19 infections. Released Dec. 28, the latest version includes information about the Omicron variant and provides updates on new therapies, including two new oral drugs: Pfizer Inc.’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s siRNA drug molnupiravir, which will be marketed in Russia as Mir-19.
A U.S. federal jury convicted Charles Lieber, the former chair of Harvard University’s chemistry and chemical biology department, on charges related to lying to federal authorities about his affiliation with China’s Thousand Talents Plan and the Wuhan University of Technology, as well as failing to report the income he received from the institute.
Antengene Corp. Ltd. received marketing approval from China’s NMPA for ATG-010 (selinexor), a drug that was in-licensed from Karyopharm Therapeutics Inc. It was approved for use in combination with dexamethasone to treat adults with relapsed or refractory multiple myeloma.
China’s NMPA has given thumbs up to Cstone Pharmaceuticals Co. Ltd.’s Cejemly (sugemalimab), an anti-PD-L1 monoclonal antibody. It was approved for use in treatment-naïve metastatic (stage IV) non-small-cell lung cancer (NSCLC) patients in combination with chemotherapy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amniotics, Astrazeneca, Cstone, Daiichi, Leo, Novavax, Regor.
French remote monitoring and software startup Implicity SAS won FDA clearance for its ILR ECG Analyzer, a medical algorithm that analyzes electrocardiogram data from implantable loop recorders (ILRs). The company plans to launch the artificial intelligence (AI)-powered algorithm, which also is CE marked, in both the U.S. and Europe beginning next month.
The FDA went from zero to two oral antivirals to treat COVID-19 in the space of two days, granting emergency use authorizations last week to Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir. Both five-day regimens are authorized for use, within five days of COVID-19 symptom onset, in individuals at high risk of progressing to severe disease, including hospitalization and death.
Biopharma is getting another reprieve, as Canada once again delays the implementation of major changes to its Patented Medicines Regulations. Set to take effect Jan. 1, the implementation of the drug pricing changes has now been pushed back to July 1.
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