We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
AbbVie’s hepatitis C drug combo Viekira Pak was 100 percent effective in patients with genotype 1b and liver cirrhosis without the additional use of the antiviral ribavirin, the company said Wednesday. Read More
The Congressional Budget Office is estimating that provisions in the proposed drug overhaul bill, if implemented by the FDA, would cost $872 million from 2016-2020, according to a report issued Tuesday. Read More
Canadian drugmaker Tekmira has stopped recruiting patients for its Phase 2 clinical trial of TKM-Ebola-Guinea, citing lack of overall therapeutic benefit in Ebola virus patients. Read More
An interim Phase 3 analysis of idarucizumab shows the drug reverses the anticlotting effect of Pradaxa within minutes in patients requiring urgent procedures or with serious bleeding complications, Boehringer Ingelheim reports. Read More
Aimmune Therapeutics has won FDA breakthrough therapy designation for AR101, an oral immunotherapy for children and adolescents with peanut allergies. Read More
The FDA is taking steps toward getting more patient input during the drug development process, a move that puts the agency more in line with its EU counterparts, agency officials said Thursday at the DIA annual meeting. Read More
The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court ruling that Celgene did not infringe on a Teva subsidiary’s patent when it marketed its cancer drug Abraxane. Read More
The agency will let drugmakers create clinical trials that allow a higher tolerance for risk, depending on a patient’s age and condition severity. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More