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The European Medicines Agency issued the first report on its open access policy for clinical data submitted by sponsors in their marketing applications for new drugs. Read More
A federal court issued a preliminary injunction against Dr. Reddy’s generics for Indivior’s addiction treatment Suboxone (buprenorphine and naloxone) pending the outcome of a patent challenge. Read More
A new report from four Democratic senators claims contacts between Novartis and President Donald Trump’s former personal attorney and Novartis were more extensive than previously disclosed. Read More
DOJ said the altered limits will incentivize opioid manufacturers to step up their vigilance on potential misuses of their products and better equip the DEA to respond to the addiction crisis, while in the meantime ensuring those opioids that are necessary for medical and research needs remain available. Read More
The CMC guidance outlines the necessary components of a gene therapy IND, including labeling and environmental analysis, noting that sponsors must provide a list of all materials used in manufacturing and a description of the quality and control of the materials. Read More
“I thought the efficacy data was very strong,” said committee member Dean Follmann, assistant director for biostatistics at the National Institute of Allergy and Infectious Diseases. “When we do a pooled analysis to compare it to primaquine we see they’re very similar.” Read More