With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.
The European Commission has approved Cstone Pharmaceuticals Ltd.’s PD-L1 monoclonal antibody, sugemalimab, in combination with platinum-based chemotherapy for first-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
Parvus Therapeutics Inc.'s PVT-201 has received orphan drug status from the U.S. FDA for the treatment of primary biliary cholangitis (PBC), an autoimmune disease of the liver.
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
Thermoablation of thyroid nodules meets the patient’s standard of minimal invasiveness and is supported by the literature as an effective treatment for these nodules, which may become cancerous.
As the U.S. FDA and the Advanced Research Projects Agency for Health (ARPA-H) move forward with new guidance and foundational data, they both recently issued requests for information (RFIs) to help them advance their agendas.
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
Biogen Inc. and partner Eisai Co. Ltd. said the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing bid for lecanemab in early Alzheimer’s disease (AD) and mild AD. The humanized anti-soluble aggregated amyloid-beta monoclonal antibody is approved in the U.S., Japan, China, South Korea, Hong Kong and Israel, and is being sold in the U.S., where it’s branded Leqembi, as well as Japan and China. Eisai, of Tokyo, will ask the CHMP to re-examine the matter.
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