With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug.
LONDON – Verona Pharma plc reported positive phase IIb results for the nebulized formulation of its dual phosphodiesterase (PDE) 3 and 4 inhibitor, ensifentrine (RPL-554), as an add-on to standard bronchodilation therapy in chronic obstructive pulmonary disorder (COPD).
LONDON – Kandy Therapeutics Ltd. has announced positive results for its nonhormonal treatment for menopause symptoms, showing a reduction in the number of hot flashes and night sweats, and a positive effect on secondary endpoints relating to mood and quality of life.
BEIJING – China-based Innovent Biologics Inc. will need to get on two new tasks this year: Preparing for the first clinical trial for an anti-TIGIT antibody in China and investigating the combination therapy of its PD-1 antibody, Tyvyt (sintilimab), and Sirnaomics Inc.’s RNAi drug candidate, STP-705.
The prospects for Ultragenyx Pharmaceutical Inc.'s adeno-associated virus (AAV) gene therapy, DTX-301, in patients with ornithine transcarbamylase (OTC) deficiency weren't looking too great after treatment of the first two cohorts in a phase I/II study.
Applied Therapeutics Inc. (ATI) CEO Shoshana Shendelman said positive top-line findings with aldose reductase inhibitor AT-007 in galactosemia were “the data we needed, and we’re going to move as quickly as we can to get in and speak to the FDA about this, not only to firm up our NDA filing but also to get into the pediatric study.”
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.”
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.
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