With favorable data from the phase III trial testing izokibep, a small protein therapeutic designed to inhibit IL-17A, in hidradenitis suppurativa (HS), Acelyrin Inc. CEO Mina Kim said the firm will “look at all the options and do what’s best for the program.” The phase III trial hit its primary endpoint of Hidradenitis Suppurativa Clinical Response 75 at 12 weeks. At the same time, the Los Angeles-based firm made known a refocused pipeline strategy that prioritizes lonigutamab in thyroid eye disease (TED) and is projected to extend its cash runway. Read More
Preliminary results from a phase II study of Verrica Pharmaceuticals Inc.’s oncolytic peptide for basal cell carcinoma showed half of the participants had lesions reach complete histologic clearance with no tumor cells left behind. Those who still had tumors saw them shrink 71%. Every participant that received the treatment had a tumor-size reduction of 86%. Read More
The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline), reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.” Read More
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler. Read More
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boundless, Citius, Lexicon, Novartis, Ovid. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Daiichi Sankyo, Cybin, Galderma, Insignis, Kyverna and Mabwell. Read More
