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.
Cue Biopharma Inc.’s Kenneth Pienta, acting chief medical officer, called “very strong” the latest phase Ib data with IL-2-based candidate CUE-101 in HPV-positive, recurrent head and neck squamous cell carcinoma (HNSCC), and “by midyear, we're going to have enough data to go forward to talk to the FDA to develop a strategy with them” for a registrational study, likely in third-line patients. Meanwhile, Wall Street sifted through the latest findings from Cambridge, Mass.-based Cue, which closed (NASDAQ:CUE) at $7.99, down $2.61, or 24%. The stock had been posting a gradual run-up for several days.
With phase Ib data published in The Lancet Microbe showing Suzhou Abogen Biosciences Co. Ltd.’s mRNA COVID-19 vaccine candidate ARCoV had acceptable safety and induced a strong immune response in the 120 people who received it, company partner Walvax Biotechnology Co. Ltd. is continuing to enroll participants in a large phase III test of the vaccine. If successful, the program could become the first of several Chinese-developed mRNA vaccines poised to take on the pandemic.
PERTH, Australia – As COVID-19 infections in Australia continue to mount, a dozen or so Australian compounds are winding their way through the pipeline that could offer additional protection to the vaccines and antivirals that are already provisionally approved by Australia’s Therapeutic Goods Administration.
Patients who received Intersect ENT Inc.’s Propel sinus implant had fewer doctor visits, emergency department and urgent care visits and subsequent endoscopies following surgery for chronic rhinosinusitis, a real-world evidence study found.
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