Government

Gottlieb announced his intention to leave the FDA earlier this week. The Trump administration will have a list of candidates to choose from as it moves forward.
Biotech and pharma companies from across the globe share data and news in a weekly roundup.
FDA
Janssen believes the treatment works by restoring synaptic connections in brain cells in individuals with major depressive disorder.
The FY19 Defense Appropriation provides $8 million to the Department of Defense Military Burn Research Program to support a broad research portfolio in the treatment of burns and the trauma associated with burn injuries sustained during combat or combat-related activities.
Scott Gottlieb, the proactive commissioner of the U.S. Food and Drug Administration has resigned, according to reports. Gottlieb will leave the regulatory agency in about a month.
The U.S. Food and Drug Administration (FDA) accepted Celgene’s New Drug Application (NDA) for fedratinib for myelofibrosis. It also granted it a Priority Review, with a target action date of September 3, 2019.
On Friday, the FDA raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals.
Purdue Pharmaceuticals is seeking to dismiss a Massachusetts lawsuit filed by that state’s attorney general that has been highly critical of the company’s marketing of its opioid pain treatment OxyContin and has also placed blame on the company for 670 opioid-related deaths in the state since 2009.
With concerns over the costs of prescription drugs taking center stage in American politics during a time when there are shortages of insulin and medical devices like EpiPens, it’s no wonder that the general public is frustrated and is calling on the government to take action of some kind.
With its concerns over drug pricing and potential questions of “pay-to-play” for access to the White House, Congress did not miss the chance to question President Donald Trump’s former attorney about his relationship with Novartis.
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