Regeneron Pharmaceuticals Inc. scored U.S. FDA clearance for Eylea HD (aflibercept) to treat wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. At 8 mg for injection, it’s the higher-dose version of the Tarrytown, N.Y.-based firm’s VEGF inhibitor, first approved in November 2011. The green light comes after a complete response letter that in late June cited unresolved observations during the May 2023 FDA pre-approval inspection of a third-party contract manufacturing organization, Catalent Inc., engaged by Regeneron to complete vial filling for Eylea HD.
Neurocrine’s Ingrezza clears US hurdle for chorea associated with HD
Neurocrine Biosciences Inc. is expanding use of Ingrezza (valbenazine) to treat chorea associated with Huntington’s disease (HD) following U.S. FDA approval late Aug. 18. While approval was largely expected, a black box warning caught some by surprise, though it falls in line with a similar warning from competing product Austedo (deutetrabenazine, Teva Pharmaceutical Industries Ltd.). Meanwhile, Neurocrine has raised 2023 guidance for sales of the VMAT2 inhibitor in tardive dyskinesia.
Hutchmed’s sovleplenib meets primary, secondary endpoints in China phase III ITP trial
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. The pivotal Eslim-01 trial was a randomized, double-blinded, placebo-controlled phase III trial of sovleplenib in 188 adult patients with primary ITP who received at least one prior line of standard therapy. Full data will be reported at an upcoming conference. Shanghai-headquartered Hutchmed said it plans to submit the NDA to China’s NMPA around the end of 2023.
Newco news: Aulos raises $20 million in series A to further alternative IL-2 approach
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. One company – Aulos Bioscience – believes it has found a way to avoid IL-2-induced toxicities by developing a human IgG1 monoclonal antibody that binds to a different part of IL-2 than the receptor. The firm has secured $20 million in an extension to its series A round to advance the antibody, AU-007, through a phase II study in solid tumors.
LG Chem, JW Pharma go toe-to-toe in Asia gout drug race
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. After withdrawing IND applications in Spain and China, LG Chem said it is trying again for a European phase III study of its gout drug, tigulixostat (LC-350189), only this time filing the application with the Italian Medicines Agency. On Aug. 18, JW Pharma said that the Taiwan FDA accepted the redo IND application of its gout drug URC-102 (epaminurad) after meeting an initial rejection in March 2023.
Pan-cancer studies take pan-oramic view on proteogenomics
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 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.
BioWorld Insider Podcast – The struggle is real: The first half of 2023 was an uphill climb
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.
Also in the news
Abivax, Akeso, Amber Ophthalmics, Amicus, Apogee, Arcutis, Astellas, Astrazeneca, Astrocyte, Aurinia, Calliditas, Can-Fite, Carsgen, Coya, Etcembly, Genesis, Infex, Inmagene, Johnson & Johnson, Krystal, Leo, Merck, Moderna, Mysthera, Qilu, Supernus, Timber