A phase III failure of Swedish Orphan Biovitrum AB's oral thrombopoietin receptor agonist avatrombopag to effectively outperform a placebo in treating chemotherapy-induced thrombocytopenia, or low platelet counts, sent company shares down 17.9% on Oct. 9.
With an ongoing phase II trial showing that a pair of its SARS-CoV-2 neutralizing antibodies has so far reduced viral load, symptoms and COVID-19-related hospitalization and ER visits, Eli Lilly and Co. has asked the FDA to consider an emergency use authorization (EUA) for one of the components, LY-CoV555.
In a valuable new deal for Cstone Pharmaceuticals Co. Ltd., Pfizer Inc. is taking a 9.9% stake in the company and licensing exclusive rights to commercialize its lead asset, the anti-PD-L1 antibody sugemalimab, in mainland China.
New data from a global phase II trial of Kiniksa Pharmaceuticals Ltd.'s monoclonal antibody, mavrilimumab, in the rare chronic inflammatory disease giant cell arteritis showed a 62% lower risk of flare in patients receiving the candidate vs. those given a placebo.
Shares of Corvus Pharmaceuticals Inc. (NASDAQ:CRVS) climbed 19.4% to $4.86 Oct. 5 after the company said updated data from an ongoing phase I study of CPI-006 as an immunotherapy for COVID-19 continued to support its development in that area.
Synthetic Biologics Inc. said a phase IIb trial of one of its two lead candidates, SYN-010, in people with constipation-predominant irritable bowel syndrome (IBS-C) will be discontinued after an interim futility analysis suggested it was unlikely to meet the study's primary endpoint.
FDA enforcement of clinical research regulations has often been "light-handed, slow-moving, and secretive," a new look at the agency's enforcement track record concludes. Published today in the journal Science, the analysis said the shortcomings may be harming both patients and trial integrity.
In a valuable new deal for Cstone Pharmaceuticals Co. Ltd., Pfizer Inc. is taking a 9.9% stake in the company and licensing exclusive rights to commercialize its lead asset, the anti-PD-L1 antibody sugemalimab, in mainland China.
A revised U.S. label for Glaxosmithkline plc's Nucala (mepolizumab) has expanded the first-in-class anti-IL-5 treatment's approval to hypereosinophilic syndrome (HES), a group of rare disorders associated with persistent eosinophilia. It's the new therapy approved for Americans with HES in nearly 14 years, according to the FDA. An EMA filing in HES is expected later this year.
