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.
Merck’s effort to expand its footprint in the lucrative hepatitis C market stumbled, with an experimental four-week, triple-therapy regimen proving largely ineffective. Read More
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development.
Read More
Drug sponsors need to find more thoughtful, comprehensive ways of recording and integrating patient outcomes data into their efficacy analyses, but long questionnaires may not be the solution, a top FDA official says.
Read More
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age, as more women than men suffer from migraines, according to FDA draft guidance on trial design expectations for the pain drugs. Read More
A new Society for Clinical Research Sites white paper outlines a set of best practices that members of industry group TransCelerate hope will eventually help clinical trial sites improve their compliance. Read More
Clinical trial sites need to brush up on their good clinical practice training specs and shouldn’t expect sponsors to compensate them for doing so, says Christine Pierre, president of the Society for Clinical Research Sites. Read More
India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. Read More
The FDA oncology-drug advisory committee turned down Novartis’ investigational multiple myeloma drug Farydak by a 5-2 vote, citing safety concerns that largely overwhelmed benefits. Read More
Sales of orphan drugs are expected to grow more than twice as fast as non-orphan drugs in the U.S., Europe and Japan in the coming years, as drugmakers take advantage of lower costs for clinical trials and higher prices when products launch, a new report shows. Read More
The FDA is seeking industry feedback on burdens related to its regulations of clinical investigations on the safety and effectiveness of unapproved new drugs and biologics. Read More
Nymox Pharmaceutical’s investigational treatment for enlarged prostate failed to meet primary endpoints in two Phase III tests, after posting stronger results in previous trials. Read More
Gilead Sciences could soon lose its dominance of the hepatitis C market, as payers hint they may abandon the company’s blockbuster Sovaldi in favor of lower-cost alternatives that are expected to launch in the coming months. Read More