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.
Indian generics firm Dr. Reddy’s has filed the first patent challenge against Teva’s blockbuster multiple sclerosis drug Copaxone’s 40 mg, introducing a new chapter into the Israeli drugmaker’s efforts to protect its multibillion dollar product. Read More
A UK cost-effectiveness agency has recommended not covering Roche’s breast cancer drug Kadcyla because the treatment is too expensive, noting that a discount offered by the Swiss drugmaker wasn’t enough. Read More
Sponsors registering new drugs or updating existing drugs on the Australian Register of Therapeutic Goods will need to conduct biopharmaceutic studies and generate specific data on test results, the Therapeutic Goods Administration says. Read More
Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data? Read More
The EU-based Innovative Medicines Initiative is launching a $4.5 billion decade-long effort to improve the success rate of clinical trials for certain drugs by 30 percent and boost exclusivity to entice sponsors to develop the drugs. Read More
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More
Indian regulators have issued a uniform set of procedures that state drug authorities should follow when inspecting plants for good manufacturing practices and issuing certificates of pharmaceutical product (COPP) that clear drugs for export. Read More
The FDA has expanded its list of priority generics applications to include ANDAs filed under government purchasing programs and applications from filers who claim “extraordinary hardship,” such as catastrophic incidents or abrupt supply disruption. Read More