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The FDA should create incentives to encourage manufacturers to include minorities and other underrepresented groups in clinical trials and delay approvals of products whose sponsors conducted less-inclusive trials, advocacy groups say. Read More
AbbVie has dropped two lawsuits against the EMA over the agency’s plans to disclose clinical trial data for its rheumatoid arthritis drug Humira (adalimumab), clearing a major hurdle for the EMA’s transparency initiative. Read More
European drug companies and transparency advocates alike are praising the clinical trials legislation advancing through the EU Parliament, with Europe’s largest pharma lobbying group saying the proposal as it now stands will dramatically improve clinical trial efficiency in the EU. Read More
GlaxoSmithKline has joined a list of drugmakers whose non-small cell lung cancer (NSCLC) drug candidates have failed in Phase III trials in the past year. 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
The European Medicines Agency has backed off of several controversial limitations that it was contemplating imposing on sponsors designing trials for treatments for chronic primary immune thrombocytopenia (ITP). 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
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
The European Medicines Agency plans to move forward with a controversial clinical trial transparency plan, but with new added redaction features to remove trial data that could allow companies to steal commercially confidential information. 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