With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues.
Clovis Oncology Inc. is trying to claw its way into ovarian cancer relevance against vastly larger competitors Astrazeneca plc and Glaxosmithkline plc with positive top-line phase III data from its study of PARP inhibitor Rubraca (rucaparib). The study’s monotherapy arm of Rubraca as a first-line maintenance treatment of ovarian cancer hit the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared to placebo. The median PFS was 20.2 months for Rubraca compared to 9.2 months for placebo in the intent-to-treat group.
Adagio Therapeutics Inc. plans to file for emergency use authorization in the second quarter of 2022 for its lead candidate, a monoclonal antibody (MAb) for preventing and treating COVID-19. With plenty of competing vaccines around, the company now thinks it has found the right group to receive it: the immunocompromised.
Results from the phase IIb challenge study with its intranasal immunomodulator for influenza A, REVTx-99a, in healthy volunteers sent Revelation Biosciences Inc. shares (NASDAQ:REVB) into a tailspin, and the stock closed at $1.32, down 82 cents, or 38.3%.
In a first of its kind phase I trial, Rejuvenate Biomed NV has secured ethical clearance to induce acute sarcopenia in 42 healthy subjects, aged 65 to 75 years old. That will be achieved by placing a cast on one leg to induce sarcopenia through muscle disuse. The volunteers in the double-blind trial will then receive either RJx-01, an oral small molecule for treating sarcopenia, or placebo.
Roche Holding AG’s attempt to find a next-generation cancer immunotherapy has suffered a setback after the first phase III readout for an anti-TIGIT drug, tiragolumab, turned out negative. With big pharma investing heavily in TIGIT (T-cell immunoreceptor with immunoglobulin and ITIM domains), results from the company’s Skyscraper-02 trial were closely watched.
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study.
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint.
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd., a company developing an oral a urate anion exchanger 1 inhibitor for the potential treatment of chronic gout, said results of a phase IIa trial show that its lead candidate, ABP-671, reduced serum uric acid levels to less than 6 mg/dL, below the clinically defined threshold of 7 mg/dL for hyperuricemia, or excess of uric acid in the blood, which leads to gout.
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
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