Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nobel Biocare.
The U.S. FDA’s emergency use authorization for two oral antivirals to be used to treat individuals at high risk of progressing to severe disease is just one hurdle cleared, as Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir still have many more laps to run.
Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested.
A U.S. price-slashing Trump-era rule establishing a most-favored nation (MFN) model for part B drugs is officially dead. The death of the interim final rule that originally was scheduled to go into effect Jan. 1, 2021, comes as no surprise. Following court challenges that resulted in a preliminary injunction against the launch of the seven-year mandatory pricing model, the Biden administration proposed a rule rescinding the model in August.
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.
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