Novartis AG won FDA clearance for the anti-CD20 monoclonal antibody Kesimpta (ofatumumab) in relapsing forms of multiple sclerosis (MS) in adults, with a label that includes clinically isolated syndrome and relapsing-remitting as well as active secondary progressive disease. Read More
Avoiding the political overtones that seem to be more viral than COVID-19 these days, Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, stressed that even though the agency is making decisions in real time in response to the urgency of the pandemic in the U.S., its decisions are being driven by scientific integrity, regulatory independence and the FDA’s historic commitment to ensuring the safety and efficacy of the products it regulates. Read More
Advanced talks between the European Commission and Curevac AG have positioned the company to potentially supply up to 405 million doses of its investigational mRNA-based COVID-19 vaccine to the bloc. News of the progress, following similar EU-level talks with an alliance of Sanofi SA and Glaxosmithkline plc, Johnson & Johnson and Astrazeneca plc, sent Curevac's recently-listed U.S. shares (NASDAQ:CVAC) climbing 16% to $66 on Aug. 20. Read More
Privately held Alzheon Inc. picked up a $47 million grant from the NIH’s National Institute on Aging that will last over five years to support a phase III clinical trial of its oral brain-penetrant small molecule ALZ-801 to treat Alzheimer’s disease. Read More
Karuna Therapeutics Inc. remains on track to launch a phase III study by the end of this year with Karxt against acute psychosis in schizophrenia by way of the broad-based program called Emergent, and the company continues planning for a phase II study testing the combo drug as adjunctive therapy with standard of care in the same indication. Read More
Columbia University professor and robotics engineer Hod Lipson knows the importance of artificial intelligence (AI) on a global level. “It permeates everything we do, from the stock market, from predicting the weather to what product you’re going to buy,” he said Wednesday during the second day of the virtual Ai4 2020 conference. “It’s even grading essays. You name it.” Read More
HONG KONG - Hua Medicine Ltd. has signed a commercialization and partnership deal with Bayer AG for a new diabetes treatment in China. Hua’s dorzagliatin, a first-in-class dual-acting glucokinase activator, is designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in patients with type 2 diabetes (T2D). Read More
Stimulator of interferon genes (STING) is a protein that senses DNA in the cytosol, where it comes from either an infectious invader or a damaged nucleus and sets off an immune response that ultimately results in the activation of T cells. STING agonists are among the strategies that have been tested in hopes they would increase the response rate to checkpoint blockade. Now, back-to-back papers in the Aug. 21, 2020, issue of Science have detailed the preclinical development of orally available STING agonists. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Ascletis, Aquestive, CNS, Entera, Immunic, Matinas, Orgenesis, Puma, Regeneron, Revive, Viiv. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Adaptive Phage, Atai, Centogene, Covistat, Cytovance, Daré, Dualogics, Ensysce, Evotec, Eyepoint, GT, Hackensack Meridian Health, Intelgenx, Jiangsu Nhwa, Junshi, Ocumension, Onconano, Trevena. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Gene Technologies, Amidebio, Axsome, Bristol Myers Squibb, Carsgen, Kubota, Lidds, Polaryx, Samsung Bioepis. Read More
