Acadia Pharmaceuticals Inc. President Serge Stankovic said the company was “kept completely in [the] dark” by the FDA regarding specifics about what the agency found wrong a month ago with the sNDA for Nuplazid (pimavanserin) – until, that is, the agency’s complete response letter (CRL) landed on the firm’s desk.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeon, Bio-Path, Corbus, Fibrogen, Innovation, Ionis, Teneobio, Uniqure.
BERLIN – Lindis Blood Care GmbH launched a multicenter clinical EU certification study for Catuvab, which is used to eliminate tumor cells from surgical blood. The experiment, dubbed Remove, aims to confirm that Catuvab can reliably remove epithelial cell adhesion molecules (EPCAM)-positive tumor cells from patient blood during cancer surgery.
At the end of March, JAMA Ophthalmology’s publication of first results from the NIH-sponsored, 328-patient trial with Regeneron Pharmaceuticals Inc.’s VEGF inhibitor, Eylea (aflibercept), in non-proliferative diabetic retinopathy bolstered investor hopes for wider use. But competitors loom for the compound, first approved in November 2011 for wet age-related macular degeneration.
Following the company’s COVID-19 manufacturing misstep, Emergent Biosolutions Inc. continued its struggle to rebalance as top-line data from a phase III study it participated in failed to hit its primary endpoints with statistically significant results. The data showed that adding anti-SARS-CoV-2 hyperimmunoglobulin to standard of care, inclusive of remdesivir, for hospitalized adult COVID-19 patients with symptoms for less than 12 days failed to provide clinical benefit when compared to standard of care plus placebo. The global, multicenter double-blind, placebo-controlled randomized study assessed the safety and efficacy of four immunoglobulin candidates, the SARS-CoV-2 immune globulin intravenous (human) (COVID-HIG) plus standard of care.
LONDON – A new route to the approval of drugs promises to smooth the path from clinical trials to approval, reimbursement and commissioning in the National Health Service, through closer and earlier collaboration between the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and health technology assessment bodies.
Unveiling short-of-the-mark top-line results from the phase IIb trial with MS-1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI), Azurrx Biopharma Inc. CEO James Sapirstein told investors during a conference call that “even if we had shown great success” in the study, more work had to be done for the enzyme to be commercialized. “We need to fix our formulation,” he said. “I’ve been saying this for a long time. It’s not a surprise to us.”
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Aptorum, Athersys, Biontech, Equillium, Flexion, Istari, Kamada, Nascent, Outlook, Pfizer, Pharnext, Regeneron.
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