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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
The surcharge on pharmaceutical manufacturers and wholesale distributors will “punish those companies for the opioid epidemic, the roots of which are… Read More
The Healthcare Distribution Alliance has sued the state of New York over a new law that imposes a $600 million surcharge on opioid manufacturers and distributors. Read More
Citing favorable clinical trial data, an FDA advisory committee voted Thursday in favor of the safety and efficacy of GlaxoSmithKline’s new drug application for tafenoquine indicated for radical cure and prevention of relapse of malaria. Read More
Materials at the booth indicated that Crenolanib is safe and effective for AML treatment when combined “with chemotherapy at full doses,” despite a lack of safety and efficacy data. Read More