Theravance announced that the diversified biopharmaceutical company’s oral drug candidate for the possible treatment of ulcerative colitis failed to meet the primary endpoint of a Phase IIb study.
Sierra Oncology, a late-stage biopharmaceutical firm specializing in treatments for rare cancers, signed an exclusive deal to use AstraZeneca’s product to develop a potential new drug for myelofibrosis.
Eli Lilly is in the news for positive Olumiant data in Covid-19, a drop in Covid-19 product sales for second-quarter 2021, and a protest of one of the company’s ads.
Galapagos announced new post-hoc analyses for the Belgium-based company’s Phase III SELECTION program for the JAK1 inhibitor filgotinib for ulcerative colitis, touting rapid symptom improvement and sustained steroid-free remission.
Pfizer Inc. said on April 7 the U.S. Food and Drug Administration extended the review of the company’s experimental atopic dermatitis drug by three months, the latest regulatory setback for a class of treatments known as JAK inhibitors.
Pfizer announced in a statement that the prespecified non-inferiority criteria for a post-marketing safety study of the rheumatoid arthritis drug Xeljanz (tofacitinib) were not met, but the company remains hopeful that future analyses of the study will be more promising.
A little more than one year after Gilead Sciences Inc. and Galapagos NV announced intentions to seek regulatory approval for Jyseleca (filgotinib) as a treatment for rheumatoid arthritis, the companies pulled the plug on that goal as well as others following a Complete Response Letter issued in August 2020.
AbbVie’s Phase III induction study, U-ACHIEVE, of Rinvoq (upadacitinib) in moderate to severe ulcerative colitis hit the primary endpoint of clinical remission at week 8 and also met all ranked secondary endpoints.
The U.S. Food and Drug Administration granted Emergency Use Authorization to a combination of Eli Lilly’s and Incyte’s rheumatoid arthritis drug Olumiant (baricitinib) and Gilead Sciences’ remdesivir as a treatment for hospitalized patients diagnosed with Covid-19 who require supplemental oxygen or ventilation.
Pfizer received positive top-line results from the Phase III JADE REGIMEN study, examining the investigational oral once-daily Janus kinase 1 (JAK1) inhibitor abrocitinib for the treatment of severe atopic dermatitis.
