Apellis Pharmaceuticals Inc.’s CEO, Cedric Francois, said his firm’s phase III study called Pegasus testing pegcetacoplan, or APL-2, in paroxysmal nocturnal hemoglobinuria (PNH) “finally established that there is an important unmet medical need in this disease.”
Saluda Medical Pty. Ltd., of Artarmon, Australia, made waves in 2019, winning the CE mark for its Evoke closed-loop spinal cord stimulation (SCS) system. The good news kept coming following the publication of results from a pivotal study in The Lancet Neurology.
LONDON – A high level U.K. group, involving industry, academia, patients, health technology assessment and regulatory representatives, has set out guidelines for designing complex cancer trials and is calling for their rapid implementation to reduce clinical development timelines.
A closely watched bid by Incyte Corp. to tackle acute graft-vs.-host-disease (GVHD) with the JAK1 inhibitor itacitinib has fallen flat in pivotal testing, leaving analysts skeptical about the drug's future and pessimistic about the company's R&D chops.
While Novan Inc.’s phase III failure in treating molluscum contagiosum for patients ages 6 months and older battered its stock Friday, the company intends to take the positive data it gleaned to the FDA to discuss an NDA submission and a possible phase III trial for next year.
Nearly four years after its start, a phase III trial of Gamida Cell Ltd.'s ex vivo expanded cord blood candidate, omidubicel, for hematologic malignancies is fully enrolled, the company said.
With many on Wall Street transfixed by the three injectable calcitonin gene-related peptide (CGRP) therapies cleared in the prophylactic migraine market, Satsuma Pharmaceuticals Inc.’s prospects with STS-101 may have gone overlooked, at least until lately.
Check-Cap Ltd., of Isfiya, Israel, reported positive results from a U.S. pilot study of its C-Scan System, a preparation-free, ingestible scanning capsule-based technology aimed at preventing colorectal cancer (CRC) through early detection of precancerous polyps. The company is currently preparing an IDE submission with the U.S. FDA and plans to launch a pivotal clinical trial in late 2020.
Positive top-line data from two pivotal phase III studies of acne vulgaris treatment Twyneo from Sol-Gel Technologies Ltd. is doing the stock end-of the-year favors as shares closed up 19% at $17.50 on Tuesday.
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