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Merck is reporting strong mid-stage trial results for a drug combo to treat hepatitis C, which may position it to be the strongest alternative to Gilead’s Sovaldi. Read More
India is proposing revisions to its patent system that drugmakers say will chill innovation and further undermine the drug industry’s ability to protect its intellectual property in the country. Read More
The EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
The European Medicines Agency last month launched a pilot program to speed new therapies to patients by authorizing products in stages for targeted populations. Read More
The FDA is asking sponsors of INDs, NDAs and NDA supplements to submit bioavailability and bioequivalency data from pharmacokinetic studies of their products. Read More
FDA inspectors berated a clinical investigator at New York’s Columbia University Medical Center for failing to properly oversee a clinical trial, despite the university having shut down the study after discovering the violations. Read More
Supportive data gathered from two definitive clinical trials may be sufficient to establish efficacy for drugs proposed to treat chronic fatigue syndrome/myalgic encephalomyelitis, the FDA says. Read More
Drugmakers balked at the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing. Read More
The FDA should incentivize sponsors to include minorities and other underrepresented groups in clinical trials and delay approving products whose evidence is based on less-inclusive trials, activists say. Read More
The European Medicines Agency has backed off of several controversial limitations it was considering imposing on sponsors of trials for treatments for chronic primary immune thrombocytopenia. Read More
Shortly after the EMA announced it would consider redacted clinical trial reports in its proposed transparency plan, AbbVie said it was dropping two lawsuits against the agency. Read More