Legend Biotech Corp. is entering what it no doubt hopes will be another fruitful collaboration with big pharma. Legend’s wholly owned subsidiary, Legend Biotech Ireland Ltd., will work with Novartis AG in an exclusive global development and license agreement for chimeric antigen receptor T-cell therapies targeting DLL3. Read More
The blowup in phase II with Aclaris Pharmaceuticals Inc.’s oral MK2 inhibitor zunsemetinib (ATI-450) for moderate to severe rheumatoid arthritis (RA) sent shares (NASDAQ:ACRS) into a tailspin and sparked Wall Street speculation about the firm’s other mid-stage prospect. Wayne, Pa.-based Aclaris’ stock ended Nov. 13 at 64 cents, down $4.11, or 86%, after investors learned that ATI-450 missed the study’s primary and secondary endpoints. Development of the candidate, which was also under phase IIa investigation in psoriatic arthritis, will be stopped. Read More
For Verve Therapeutics Inc., the good news was the first human proof-of-concept data for a single-course in vivo base-editing treatment, presented at the American Heart Association Scientific Sessions over the weekend, showed treatment with VERVE-101 led to promising dose-dependent reductions in low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolemia. The bad news was to be found in the safety data for the 10 patients treated to date, which included a myocardial infarction in one patient deemed potentially related to treatment. Read More
More details of Novo Nordisk A/S’ phase III Select trial indicate that risk reductions in major adverse cardiovascular events were achieved regardless of age, gender, ethnicity and starting body mass index when obese and overweight patients were treated with Wegovy (semaglutide, 2.4 mg). Statistical significance was seen, however, only with the reduction of heart attacks and not other measures that were part of the trial. Read More
The gene for Huntington’s disease “was cloned in 1993, and everyone thought there was going to be a treatment right around the corner,” Sarah Tabrizi told the audience at the 2023 Annual Meeting of the Society for Neuroscience. Then, “it took 25 years for the first trial targeting the Huntington gene.” Read More
Immvira Group Co. plans to progress its intravenous oncolytic herpes simplex virus (oHSV) MVR-T3011-IV to phase II trials after completing a phase I study in the U.S. in patients with late-stage solid tumors. The Shenzhen, China-based company is the first to conduct clinical trials via intravenous administration of oHSVs. Read More
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review process has drawn fire from inventors as a patent-killing machine. The Senate is considering a new bill to address some of these concerns, but witnesses at a hearing this week were anything but united in their assessment of the status quo, making it difficult to forecast the fate of this latest effort at patent reform. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alfasigma, Aligos, Barinthus, Bryn, DBV, Immvira, Intercept, IO, JCR, Madrigal, Neurocrine, Novaris, Ocugen, Oncolytics, Pharma Two B, Scisparc, Takeda and Xenon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ankyra, Basilea, Cartesian, Ethris, Heqet, Pfizer, Ray, Regeneron, Selecta, Teva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Blueprint, Bristol Myers, Eli Lilly, Entera Bio, Lipella, Lyell, Maia, Merck & Co., Mirati, Pacira, Pharming, Rznomics, Sirius, Stada, Takeda, UCB, Valneva. Read More
