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A European regulatory committee is recommending stronger restrictions on the use of valproate drugs by women and girls, citing risks of malformations and developmental problems during pregnancy. Read More
A key European health committee didn’t find enough evidence to confirm that testosterone-replacement (TRT) products create higher heart attack risk, but it did agree with FDA advisors that labeling for such products should change. Read More
Drugmakers in Europe are calling for the establishment of a new clinical trial portal and database, rather than modifying existing systems, to meet requirements for a single, streamlined submission process for clinical trial applications. Read More
Drug sponsors should find a more comprehensive way of recording and integrating patient outcomes data into their efficacy analyses, says a top FDA official who notes the lack of such data often presents a roadblock to making regulatory decisions. Read More
Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More
Drugmaker Chimerix said it may soon start testing its broad-spectrum antiviral drug brincidofovir against the Ebola virus, after the FDA this week approved the company’s emergency investigational new drug application. Read More
PhRMA is asking a D.C. federal court to once again strike down a price discount mandated by HHS for orphan drugs, when used to treat non-rare conditions at certain covered hospitals. Read More
Endo International will acquire Auxilium Pharmaceuticals in a move that is expected to bolster Endo’s pipeline of testosterone products, which FDA advisors have recently scrutinized. Read More
Canadian generics firm Apotex has asked the full U.S. Court of Appeals for the Federal Circuit to rehear a case alleging brandmaker UCB’s hypertension drug Univasc infringed on one of Apotex’s patents. Read More
The day after CDER unveiled a sweeping blueprint to create investigative teams to conduct quality inspections, experts praised the reorganization, saying it will result in more detailed inspections, better guidance on addressing problems and fewer erroneous Form 483 observations. Read More
A federal judge has dismissed some claims in a case alleging Teva and Pfizer-subsidiary Wyeth forged an anticompetitive agreement to delay generic competition on Wyeth’s antidepressant Effexor XR. Read More
Sponsors of research into cell therapies should conduct preclinical studies either in vitro or in animals to address potential risks and methods of delivery before initiating investigations into the use of the products, according to new recommendations from Health Canada. Read More