It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.
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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medalliance.
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.
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: 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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptitude Medical, Depuy Synthes, Sol-Millennium.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Clairvoyant, Domain, Origin, Tvardi.
Sinaptica Therapeutics Inc. received a U.S. FDA breakthrough device designation for its electromagnetic therapy for Alzheimer’s disease. Sinaptistim-AD combines neurostimulation, brain wave monitoring and artificial intelligence (AI) to address the cognitive and functional decline in patients with the neurological disorder.
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