Hoping its drug, daprodustat, can succeed in the U.S. where two other hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) have failed so far, GSK plc will present its case Oct. 26 to the FDA’s Cardiovascular and Renal Drugs Advisory Committee for the drug's potential use as a treatment for anemia in patients with chronic kidney disease regardless of dialysis dependency.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Ars, Bristol Myers Squibb, Eli Lilly, GSK, Regeneron, Silverback.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biontech, Covis, Leo, Moderna, Novavax, Pfizer, Revance, Tvardi.
Expanding its mandate to accelerate access to essential medicines to people in low- and middle-income countries, the Medicines Patent Pool signed its first voluntary licensing agreement for a cancer treatment, Novartis AG’s Tasigna (nilotinib). A twice-daily oral drug, Tasigna is a tyrosine kinase inhibitor included on the World Health Organization’s Model List of Essential Medicines as a second-line treatment for adult and pediatric chronic myeloid leukemia.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Clairvoyant, Domain, Origin, Tvardi.
The U.S. FDA wants more data on PTC-518 before PTC Therapeutics Inc.'s phase II study of Huntington’s disease can continue enrollment. While stopped in the U.S., the study of the oral, small-molecule splicing modifier still is enrolling participants at sites in several European countries and in Australia.
In a bit of déjà vu, the U.S. FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee once again voted that Makena (hydroxyprogesterone caproate) should be withdrawn from the U.S. market while a second confirmatory trial is designed and conducted. But this time around, the committee’s 14-1 vote was much more decisive than its 9-7 vote in 2019.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: .Amryt, Carsgen, Intelgenx, Jaguar, Kite, Kyverna, Lexeo, Nkgen, Noema, Prelude, Roche, Vitti, Zhiyu.
The White House laid out several timelines Oct. 18 as part of a national biodefense strategy for countering biological threats and enhancing global pandemic preparedness.
South Korea’s drug regulator should consider revising orphan drug definitions or allow more new innovative drugs to be excluded from pharmacoeconomic assessments, which are required for new drugs to be reimbursed under Korea’s single-payer system, the European Chamber of Commerce in Korea said.
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