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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allakos, Amgen, Aprea, Astrazeneca, Beyondspring, BMS, Complexa, Horizon, Innovent, Janssen, Lilly, Novartis, Replimune, Spring Bank, Valerion.
HONG KONG – South Korea’s Qurient Co. Ltd., located in Gyeonggi-do, is preparing to send its novel drug, Q-702, into the clinic after receiving clearance from the U.S. FDA.
With some positive early data for an antibody to block the COVID-19 virus, Sorrento Therapeutics Inc. is now looking to test a product in a few dozen intensive care patients by the end of July or early August and move into a much broader pool of patients by October.
Medical science continues to define the relative risks of progressively smaller patient subsets across the disease spectrum, but this is particularly true of late in connection with aortic stenosis (AS).
Exact Sciences Corp., of Madison, Wis., detailed three studies of the Oncotype Dx Breast Recurrence Score test during the virtual 2020 American Society of Clinical Oncology Annual Meeting.
A key opinion leader (KOL) consulted by SVB Leerink deemed Roche Holding AG’s anti-TIGIT drug results “really huge” and “quite amazing,” affirming the Basel, Switzerland-based firm’s lead in the field. The phase II data from the study known as Cityscape rolled out at the virtual American Society of Clinical Oncology (ASCO) meeting.
Levosimendan's long story took a new turn with results from a phase II trial testing chronic administration of the calcium sensitizer in patients with pulmonary hypertension associated with heart failure and preserved ejection fraction (PH-HFpEF).
Investigators are working to develop electrogenetic devices that use remote-controlled electrical stimulation to elicit specific behaviors in engineered cells. They are following in the footsteps of optogenetics, which use specific wavelengths of light to control cell function remotely. A new study published in Science used such a device paired with encapsulated, engineered human pancreatic beta cells to express enough insulin to restore normal glycemic levels in mice models of diabetes.
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