Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
With financings, U.S. FDA approvals and mergers and acquisitions all tracking behind last year, why would clinical data be any different? According to BioWorld research, clinical trial reports are down by 16.2% this year. The number of efforts targeting the COVID-19 pandemic, as well as the proportion of data focused on infectious diseases, are also dropping.
As Novartis AG works to streamline the company and finalized a long-considered plan to separate its Sandoz Inc. business by creating a standalone company, it temporarily stopped dosing in a study of branaplam for treating Huntington’s disease. Several findings from the phase IIb study suggested the presence of peripheral neuropathy in some participants. An independent data monitoring committee recommended the dosing halt but fell short of recommending the study be terminated. The VIBRANT-HD steering committee agreed with the committee’s recommendation.
Interim analysis of a phase III trial testing a single dose of Pfizer Inc.'s bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in older adults has revealed efficacy good enough to support a planned BLA submission for the vaccine to the U.S. FDA in fall 2022, the company said. Preparation for further submissions to other regulatory agencies are underway.
As the PDUFA date looms for Bristol Myers Squibb Co. with its candidate, deucravacitinib, for psoriasis, others – notably Dice Therapeutics Inc. – strive for new solutions to the skin disease, which has remained problematic for many patients despite approvals of multiple drugs in various classes.
Nuvectis Pharma Inc. has been in business for barely two years, but thanks to a business model involving in-licensing promising late preclinical drug candidates, it has already begun a trial with a molecule targeting a little-known pathway that cancer cells depend on for protection. The firm is also close to the clinic with a drug that could give a new twist to tyrosine kinase inhibition after a $16 million financing round in early August.
Additional deaths believed to be associated with one of Foghorn Therapeutics Inc.'s lead candidates led the U.S. FDA to put a full clinical hold on its phase I study in relapsed and/or refractory acute myelogenous leukemia and myelodysplastic syndrome.
Likely to garner attention at the upcoming European Society of Medical Oncology meeting are the MAGE-A4 and PRAME antigens which, although well-known and validated, have proved evasive for drug developers – a situation that may soon change.
The first randomized placebo-controlled trial assessing the effectiveness of the antiviral drug Tpoxx (tecovirimat) in treating monkeypox has begun in the U.K., with the first patients enrolled on Aug. 21.
Alterity Therapeutics Ltd. has begun phase II trials with its lead candidate, ATH-434, in multiple system atrophy, a rare and highly debilitating Parkinsonian disorder.
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