Shares of South Korea-based Celltrion were down more than 5 percent after the company announced it received a warning letter from the U.S. Food and Drug Administration after the regulatory agency inspected a company drug manufacturing facility.
The U.S. FDA approved two doses of Pfizer Inc.’s medicine Xeljanz for treating active psoriatic arthritis.
Merck & Co. reported profit ahead of Street estimates on strong sales of its cancer drug Keytruda, but total revenue fell in third-quarter 2017 from disruptions due to the NotPetya cyber attack and loss of market share for many of the company’s older drugs.
Incyte Corporation will have an abstract published at the European Society for Medical Oncology (ESMO) meeting in early September with new and updated data from its ongoing Phase I/II trial of epacadostat in combination with Merck & Co.’s Keytruda in advanced melanoma.
A biosimilar version of AbbVie Inc.’s blockbuster arthritis drug Humira, produced by a joint venture of Biogen Inc. and Samsung Biologics, was approved by EU regulators.
GSK’s new chief executive announced plans to narrow the focus of the group’s drug research by ditching 30-plus projects to improve returns in its core pharma business.
Novartis’ generics unit Sandoz said the European Commission approved Erelzi – the company’s biosimilar to Amgen’s Enbrel – to treat inflammatory diseases such as rheumatoid arthritis, psoriasis, and psoriatic arthritis.
European regulators recommended approval of a second copy of AbbVie’s rheumatoid arthritis drug Humira, the world’s top-selling medicine.
Boehringer Ingelheim presents phase III results demonstrating clinical equivalence of adalimumab biosimilar candidate to Humira
Boehringer Ingelheim announced results from the pivotal Phase III VOLTAIRE-RA1 study, confirming that its adalimumab biosimilar candidate BI 695501 and Humira have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis.