China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
Pfizer Inc. is calling on the Australian government to establish priorities for the life sciences sector to attract more investment into research, clinical trials and manufacturing in Australia. The new report recommends that the government issue a life sciences vision akin to the one issued by the U.K. in 2021 to make the country more competitive to attract investment.
In the wake of shortages for Novo Nordisk A/S’ Ozempic (semaglutide), Australia’s Therapeutic Goods Administration has announced that Wegovy, which has the same active ingredient, is now available in Australia and is advising prescribers to stop prescribing Ozempic off-label for weight loss.
China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
The U.S. FDA accepted Telix Pharmaceuticals Ltd.’s new drug application for TLX-007-CDx, a new cold kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer.
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.
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
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.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, gained U.S. FDA approval of Epysqli (eculizumab-aagh) as the second biosimilar product to Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) to treat two rare diseases. The regulatory clearance July 22 grants use of Epysqli to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome – two rare hematologic- and kidney-related disorders known to affect about 50,000 and 5,000 patients in the U.S., respectively.
The U.S. FDA approved 28 new drugs in June, marking the third-highest month in BioWorld’s records, following March 2024’s 30 approvals and June 2020's 29 approvals, and a significant increase from May’s 11 FDA drug approvals. For context, the FDA approved an average of around 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
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