The PTO’s Patent Trial and Appeal Board once again ruled that a patent for AbbVie’s Humira was invalid and unpatentable, responding to additional challenges by Boehringer Ingelheim. Source: Drug Industry…
The FDA on Friday approved Endari, the first new drug in nearly 20 years to treat sickle cell anemia complications. Source: Drug Industry Daily
Unable to resolve persistent manufacturing problems, New Jersey-based drugmaker Pacira Pharmaceuticals is ending production of its DepoCyt chemotherapy drug and closing the California plant where it is made. Source: Drug…
The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials — as well as establish a new framework for regenerative…
A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Source: Drug Industry Daily
Sen. Amy Klobuchar (D-Minn.) wrote to the CEOs of Novo Nordisk, Sanofi and Eli Lilly asking them to justify recent steep price hikes for insulin medication. The cost of insulin…
The European Medicines Agency is putting off plans for GMP inspections in the U.S. when possible, an EMA spokesperson confirmed this week, in anticipation of the November launch of a…
Endo will withdraw Opana ER from the market, following an FDA request in June. Source: Drug Industry Daily
CBER added several topics to its guidance agenda for 2017 in its mid-year update, including blood donor requalification and the use of certain serum tests in reducing infection transmission. Source:…
An industry-funded group has petitioned the FDA to fully transition to opioid painkillers with abuse-deterrent labeling, and to require manufacturers to convert their non-deterrent products. Source: Drug Industry Daily