Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
The FDA awarded clinical trial grants, totaling more than $23 million over four years, for research on 21 rare diseases, including amyotrophic lateral sclerosis, brain tumors, cystic fibrosis and drug-resistant HIV. Read More
The United Nations High-Level Panel on Access to Medicine is proposing that governments rely on compulsory licenses to improve patient access to medicines in a highly anticipated report that has been met with dismay from industry. Read More
Diabetes drugs carry special development challenges and can be the riskiest sector in pharmaceuticals, with one in 13 investigational drugs achieving U.S. approval, according to a report from the Tufts Center for the Study of Drug Development. Read More
Kite Pharma announced positive interim results from a Phase II clinical trial of its immunotherapy in patients with aggressive non-Hodgkin’s lymphomas and said the study would form the basis of its marketing submissions to the FDA. Read More
Three pharmaceutical companies announced Phase III trial results from their injectable psoriasis treatments — with one delivering better head-to-head clinical results than international top-selling drug Humira, which reached over $14 billion in sales in 2015. Read More