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.
Novartis said Monday it has halted the Phase III trial of its chronic heart failure drug LCZ696 after being notified by a data monitoring committee that the drug met its composite primary endpoint of delayed cardiovascular death and reduced heart failure hospitalizations. Read More
Companies designing medical device trials for children can use age as a starting point to categorize the patient population, but other physiological and developmental factors should be taken into consideration as well, an FDA final guidance says. Read More
GlaxoSmithKline has launched a new research partnership designed to help improve the targeting of new drugs in development, a signal that manufacturers may be growing more comfortable divulging clinical trials data. Read More
Manufacturers of stem cell and cell-based products (SCCPs) should perform stability tests during early phases of clinical trials to establish the products are sufficiently stable for the period required by the study, a draft guidance by India’s Central Drugs Standard Control Organization advises. Read More
Sponsors may be asked to provide the European Medicines Agency with additional data from failed trials to hone in on subpopulations where the treatment may be effective. Read More
The FDA wants sponsors submitting bioavailability (BA) and bioequivalency (BE) data in support of an orally administered new drug to conduct pharmacokinetic studies of their products. Read More
Purdue Pharma is reporting positive results for an investigational once-daily analgesic that could compete with Zogenix’s controversial painkiller Zohydro ER, which, unlike Purdue’s candidate, lacks abuse-deterrent properties. Read More
Beginning with the 2015/2016 flu season, drugmakers producing vaccines in the EU to protect against annual flu strains will not need to conduct preapproval clinical studies to support vaccine applications. Read More
The FDA is asking sponsors of antiretroviral drugs to submit clinical trial data sets that include patient, endpoint, genotypic and phenotypic data when reporting on HIV-1 resistance in support of the drug. Read More
An FDA report using new data collection methods shows that more drugs than previously thought need to meet their postmarketing requirements and postmarketing commitments, which include Phase IV clinical trials. Read More
The European Medicines Agency is asking sponsors to give two months’ advance notice of their intent to file orphan drug applications to help the agency meet its 90-day review deadline. Read More