Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients.
With a Nov. 6 FDA adcom meeting on Biogen Inc.'s Alzheimer's candidate, aducanumab, creeping ever closer, the candidate's prospects stole the show in its third-quarter earnings report, even outshining attention to the cloud of generics raining on the company's years-long Tecfidera (dimethyl fumarate) parade. FDA acceptance for aducanumab's BLA lines the candidate up for a priority review and regulatory action by March 7, the company said. Furthermore, global progress remains underway, with an EU marketing application now made and one in Japan on deck.
Belong.Life has expanded its digital clinical trial matching program to include patients with multiple sclerosis (MS). The technology uses advanced artificial intelligence (AI) that processes a patient's medical data and determines which trials in its global database are appropriate. The app typically returns results, which are prescreened by a clinical trial coordinator, in less than two days. More than 8,000 cancer patients have used the program so far.
As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation.
Sanofi SA is acquiring Principia Biopharma Inc. in a $3.68 billion deal that brings Sanofi three clinical-stage BTK inhibitors and simplifies a partnership that began three years ago. Paris-based Sanofi plans to acquire all outstanding Principia common stock shares for $100 each at a $3.36 billion enterprise value. Sanofi will get SAR-442168 (PRN-2246), the brain-penetrant candidate at the heart of the deal. The agreement now gives Sanofi full control of the program, bringing a three-year partnership between the two companies to an end
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
TORONTO – Edmonton’s University of Alberta is lending its neuromotor research smarts to a wearable, machine learning driven sensors platform developed by Menlo Park, Calif., and Calgary, Alberta-based Protxx Inc. for better managing the future care of patients suffering from neurodegenerative conditions such as multiple sclerosis (MS).
San Diego-based Autobahn Therapeutics Inc.’s $76 million series B round will let the firm advance lead candidate ABX-002, a thyroid hormone receptor beta agonist therapy for multiple sclerosis and adrenomyeloneuropathy, a rare genetic disorder, plus a portfolio of central nervous system programs that leverage the company’s brain-targeting chemistry platform.
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
Barely a day after its PDUFA date, despite the unfolding COVID-19 pandemic, the FDA has approved Bristol Myers Squibb Co.'s immunomodulator, ozanimod, an oral treatment for adults with relapsing-remitting multiple sclerosis (MS) and active secondary progressive disease branded as Zeposia. The win, a much-anticipated milestone precipitated by the company’s multibillion-dollar acquisition of ozanimod developer Celgene Corp. in November 2019, gives patients a new treatment option amid a growing field of therapies for MS.
