With phase Ib data published in The Lancet Microbe showing Suzhou Abogen Biosciences Co. Ltd.’s ARCoV had acceptable safety and induced a strong immune response, partner Walvax Biotechnology Co. Ltd. is continuing to enroll participants in a large phase III test of the vaccine.
Sio Gene Therapies Inc. is retrenching the business as it terminated the company’s AXO-Lenti-PD license agreement with Oxford Biomedica plc for treating Parkinson’s disease. Also, Sio’s CEO, Pavan Cheruvu, is leaving the company. Sio said it is deprioritizing its Parkinson’s disease program due to several factors, including resource requirements and development timelines “to reach meaningful value inflection for the program and an increasingly challenging market and regulatory environment” for the indication.
Anavex Life Sciences Corp. reported top-line data from the 33-subject phase III study with Anavex 2-73 (blarcamesine) in adult females with Rett syndrome, turning up a statistically significant improvement over placebo for the primary efficacy endpoint as well as for all the secondary efficacy endpoints. The sigma-1 receptor activator, given as a once-daily, oral liquid, proved well-tolerated, too, with good compliance by patients, Anavex said.
Last week, Incyte Corp. said it was pulling its NDA seeking accelerated approval for the PI3K-delta inhibitor parsaclisib in three non-Hodgkin lymphoma subtypes, a move that followed recent decisions by Gilead Sciences Inc. and Secura Bio Inc. to withdraw from U.S. commercialization their respective PI3K-delta inhibitors in indications for which they’d received accelerated approval. But the recent spate of headlines is hardly “a condemnation” on the entire class of drugs, said Dan Gold, CEO of MEI Pharma Inc., which is aiming for a potential accelerated approval filing of its own PI3K-delta drug, zandelisib, this year.
LONDON – After six years in development, EMA’s new clinical trials information system (CTIS) was switched Jan. 31, bringing to life a law enacted in 2014 to create a single, harmonized regulatory system across the EU. As the embodiment of the Clinical Trial Regulation, CTIS will underpin a long-awaited simplification of the process for approving trials. Rather than separate applications to different national regulators, a single application delivered via CTIS can lead to simultaneous regulatory and ethics approvals in up to 30 countries.
Galvani Bioelectronics Ltd. reported the first patient implanted with its experimental direct splenic nerve stimulation therapy for rheumatoid arthritis (RA). The first-in-human implant is part of a small trial at the NHS Greater Glasgow & Clyde Health Board in Scotland.
A wearable biosensor developed by Scottish startup Pneumowave Ltd. has been tapped for a clinical trial investigating respiratory depression at King’s College London (KCL). Pneumowave’s respiratory monitoring platform will be used to collect breathing data from patients at risk of experiencing slow and shallow breathing as a side effect of opioid medication.
Mighty Libtayo has stumbled. Because Regeneron Pharmaceuticals Inc. and Sanofi SA couldn’t find common ground with the FDA on postmarketing studies, the two are voluntarily withdrawing the sBLA for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer. Discussion about the matter continues outside the U.S., the companies said.
Oric Pharmaceuticals Inc.’s preclinical data at last December’s meeting of the American Society of Hematology didn’t please everyone but infused the CD73 drug space with more rationale for the target, and a number of other prospects continue to move through pipelines. Previous early stage findings also have suggested favorable knockdown of adenosine in comparison to Astrazeneca plc’s oleclumab and Arcus Biosciences Inc.’s small molecule, AB-680, also known as quemliclustat. Companies developing CD73 therapies also include Corvus Pharmaceuticals Inc. and Novartis AG.
Molecular diagnostics could dramatically improve care for one of the most common infections women face, vaginitis. A study by Becton, Dickinson and Co. (BD) found that clinicians miss more than 45% of positive cases and misidentify an additional 12% of negative cases as positives when compared to diagnostic findings.
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