On the heels of the U.S. FDA clearance for Veopoz (pozelimab-bbfg) from Regeneron Pharmaceuticals Inc. to treat Chaple disease, the regulatory rollercoaster ride for the firm’s bid with higher-dose Eylea (aflibercept) ended with a green light for that compound as well. Eylea HD is indicated for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Read More
The impact of a black box warning on Neurocrine Biosciences Inc.’s expanded U.S. label for Ingrezza (valbenazine) to treat chorea associated with Huntington’s disease (HD) appears up for debate, following FDA approval late Aug. 18. But analysts agree that it is unlikely to affect sales of the VMAT2 inhibitor in tardive dyskinesia, for which the company recently raised 2023 guidance as high as $1.82 billion. Read More
Hutchmed (China) Ltd.’s sovleplenib (HMPL-523) met the primary endpoint of durable response rate and all secondary endpoints in the pivotal phase III trial in adults with primary immune thrombocytopenia (ITP) in China. Read More
As a cytokine used in the field of immuno-oncology, interleukin-2 (IL-2) can produce durable and even complete responses in some patients, as well as induce immune memory against tumors. However, its rapid metabolism within the body means it has a short serum half-life, so it needs to be given in high doses, which can trigger severe side effects. Read More
South Korean pharmaceutical firms LG Chem Ltd. and JW Pharmaceutical Corp. are recouping and pressing on with their respective novel gout drugs internationally, with each having faced regulatory setbacks from IND rejections overseas. Read More
The vast variety of tumors makes each cancer a world. For researchers, understanding the commonalities and divergences in their molecular underpinnings could help find successful treatments. Scientists from the Clinical Proteomic Tumor Analysis Consortium (CPTAC) have addressed these similarities and differences in 10 different types of cancer with two proteogenomic studies to unravel the genes that lead to cancer and the galaxy of interactions that regulate them. Read More
Guests Karen Carey, BioWorld’s managing editor, and Mike Ward, Clarivate’s global head of Life Sciences and Healthcare Thought Leadership, discuss the deals, financing and M&A landscape for the first half of 2023 and how U.K. biopharmas are faring post Brexit. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Carsgen, Etcembly, Krystal, Leo, Moderna, Timber. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, Calliditas, Can-Fite, Infex, Iveric,
Janssen, Leo.
