What we're reading, February 18, 2016: one-third of clinical trial results are never published; Sandoz challenges rule for notices of biosimilar launches; and hepatitis C combination drug could reduce treatment to just 4 weeks.
Despite the money being invested in clinical trials, the results of one-third of trials were never published in a peer-reviewed journal or government registry online. A study of more than 4000 trials completed at 51 major US universities and academic hospitals found that within 2 years only 29% published results and 13% posted the results on ClinicalTrials.gov, according to Bloomberg Business. The researchers determined that results may not be published if the data is negative or not very interesting.
Sandoz has asked the United States Supreme Court to review the rules for a biosimilar launch and decide when a drug maker must give notice to the manufacturer of the brand name version. Sandoz, which won the right to sell Zarxio, a version of Amgen’s Neupogen, contends that the law allows a company to give notice of marketing plans 180 days before winning FDA approval, reported STAT. However, a federal appeals court ruled that biosimilar companies must receive approval first and then give the 180-day notice, which gives companies more time to prepare patent challenges that would delay a biosimilar launch.
Mid-stage data for a hepatitis C combination drug could reduce treatment duration from 12 weeks to 4 weeks. Reuters reported that Regulus Therapeutics tested its drug separately with Gilead Science’s Harvoni, Johnson & Johnson’s Olysio, and Bristol Myers Squibb’s Daklinza. If Regulus’ treatment does turn out to be more effective when combined with these drugs, Gilead could see its hepatitis C sales take a hit, according to analysts.