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The European Medicines Agency is planning a series of May meetings with industry to unveil the process it plans to use to determine whether clinical trial data is considered confidential under its new transparency rules or whether it must be disclosed. Read More
Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions. Read More
The UK’s pharma regulator Monday began accepting applications for its Early Access to Medicines Scheme to allow not-yet-approved drugs for life-threatening diseases quicker interim approvals so they can be distributed to patients. Read More
Advocates for minorities and other patient groups that are underrepresented in clinical trials want the FDA to create incentives for drugmakers that include those groups in studies and become more aggressive in delaying drugs that don’t include them. Read More
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
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 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
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The FDA released a draft guidance last month outlining requirements for submitting clinical study data in electronic format. Once finalized, submissions that do not conform to the standards, formats and terminologies outlined in the agency’s Data Standards Catalog will not be filed, the guidance warns. Read More
Drugmakers in the EU are pushing back against a proposal moving through the EU Parliament that would grant clinical trial participants the right to demand that their trial data — including data shared between regulators and other entities — be deleted. Read More
India’s Ministry of Health and Family Welfare on Friday began releasing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial, with the first wave of published data focusing on payouts for trial-related deaths between 2010 and 2013. Read More