Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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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.
Intrinsic Imaging, a global medical imaging core lab for clinical trials, announces that it recently underwent an extensive 5-day high priority Bioresearch Monitoring Program inspection by the U.S. Food and Drug Administration Center for Drug Evaluation and Research.
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.
Esperion announced that the company has successfully completed important and key global marketing applications including the submission of two New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet to the U.S. Food and Drug Administration.
Recipharm, the contract development and manufacturing organisation, has achieved the new ISO 45001 certification at its Wasserburg facility in Germany.