Clinical research
Biogen and Eisai reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency had decided not to recommend the drug for its MAA.
The agreement between the two companies includes a lead, potential first-in-class preclinical candidate, and research collaboration to jointly develop the additional novel candidates.
Biogen and Eisai released an update on the Phase IV post-marketing confirmatory study and plan to submit the final protocol to the FDA in March 2022 and launch patient screening in May 2022.
Nodexus and Aramis Biosciences will use their funds to expand their company’s pipeline and build their commercialization capabilities.
Researchers have published a study describing how chemotherapy and a drug used to treat cardiac failure is able to regress tumor growth of patients with triple negative breast cancer.
Biopharmaceutical companies across the world are fighting an increasingly important battle against COVID-19: the struggle to treat the disease.
The FDA said Orencia is the first drug approved as prophylaxis for aGVHD prevention that included real-world evidence as one component of clinical efficacy.
The FDA approved the latest indication for Rinvoq (upadacitinib) based on data from two Phase III studies, SELECT-PsA 1 and SELECT-PsA 2.
These results set Lilly up well to submit a Biologics License Application (BLA) in the first half of 2022.
The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
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