Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Leo, Pharmather, Ractigen, Siren, Tris, Vir.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Appili, Bayer, Beigene, Biolojic, Bristol Myers, Cytokinetics, Intas, Lindis, MSN Pharmaceuticals, Neurogene, Pharmanovia, SK Biopharmaceuticals, Telix, Xbrane.
New hires and promotions in the biopharma industry, including: Avenzo, C4, Conduit, Eikon, Eli Lilly, Flagship Pioneering, Hutchmed, Metaphore, Pfizer, Rondo, Seaport, Thryv, Unnatural Products.
Advertisements for Rezdiffra (resmetirom, Madrigal Pharmaceuticals Inc.), which was approved by the U.S. FDA in March 2024, adorned the lobby of The Liver Meeting 2024 being held at the San Diego Convention Center as well as the trolley stop across the street and other areas that doctors attending the meeting might be swayed. But inside the ballrooms of the convention center, companies were making presentations of data from clinical trials testing their drugs in patients with metabolic dysfunction-associated steatohepatitis (MASH) in hopes of potentially competing with Rezdiffra in a few years.
Incyte Corp.’s mention of would-be “backup molecules” could bode well for findings yet to roll out with Mas-related G protein-coupled receptor X2 antagonist INCB-000262 in chronic spontaneous urticaria. Meanwhile, though, the news is not good, as Incyte said in a terse press release that it will pause enrollment in the ongoing phase II study with the drug because of in vivo preclinical toxicology findings.
IL-23 receptor antagonist icotrokinra hit co-primary phase III endpoints in moderate to severe plaque psoriasis, positioning the oral peptide at the forefront of a multibillion-dollar franchise for partners Protagonist Therapeutics Inc. and Johnson and Johnson.
Vaginal microbiome specialist Freya Bioscience ApS has added $11.8 million to its series A, bringing the total for the round to $50 million. Of the additional $11.8 million, $10.4 million comes from the Gates Foundation and is designated for the development of vaginal microbiome-based immunotherapies for treating bacterial vaginosis, a cause of preterm birth and other pregnancy complications.
China’s National Medical Products Administration (NMPA) has accepted Ascentage Pharma Group Corp. Ltd.’s NDA for its in-house-developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which could be the first domestically approved Bcl-2 inhibitor in China and the second global approval.
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