J&J’s Janssen Pharmaceutical released new long-term data from the open-label period of the Phase III VOYAGE 1 study.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
A little more than a week after announcing plans to acquire Ra Pharmaceutical for $2.1 billion, UCB’s psoriasis drug bimekizumab met all endpoints in the first of three Phase III studies.
Eli Lilly and Co.’s experimental pancreatic cancer treatment in combination with chemotherapy drugs failed to meet the main goal of overall survival in a late-stage study.
Reata Pharmaceuticals Inc.’s Part 2 portion of the MOXIe Phase 2 trial of omaveloxolone in patients with Friedreich’s ataxia (FA) met the primary endpoint of change in the modified Friedreich’s Ataxia Rating Scale relative to placebo after 48 weeks of treatment.
Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib in Phase 3 Studies for Rheumatoid Arthritis
Gilead Sciences Inc. and Galapagos NV announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib – an investigational, oral, selective JAK1 inhibitor for the treatment of moderately to severely active rheumatoid arthritis (RA) – are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier during 2019.
Novartis’ Cosentyx hit the mark in treating patients with non-radiographic axial spondyloarthritis (nr-axSpA) in a Phase III trial.
Heron Announces Positive Topline Results from Phase 3b Clinical Study of HTX-011 in Total Knee Arthroplasty
Heron Therapeutics Inc. announced positive topline results of a multi-center postoperative pain management study in which 51 patients undergoing total knee arthroplasty surgery received the investigational agent HTX-011 together with a scheduled postoperative regimen of generic, oral analgesics (acetaminophen and celecoxib).
Shionogi Reports Positive Results from Cefiderocol Phase III Study in Adults with Pneumonia Caused by Gram-negative Pathogens
Shionogi & Co. Ltd. announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).
A new blood test in development from GRAIL Inc. and studied by investigators at the Dana-Farber Cancer Institute has the ability to accurately screen for numerous types of cancer.
AstraZeneca presented results for a late-stage clinical trial of Lynparza against prostate cancer, which the company hopes could lead to wider regulatory approval for more forms of the disease.