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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 6, 2020.
It’s a relatively slow month ahead for July in terms of PDUFA dates for the U.S. FDA. However, there are several dates pending throughout the month. Here’s a look at three for the next two weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.
The U.S. Justice Department charged Glenmark Pharmaceuticals, headquartered in India, with conspiring with other generic drug companies to increase and hold prices for the cholesterol drug pravastatin between May 2013 and December 2015.
FDA
Bavencio is an anti-PD-L1 checkpoint inhibitor co-developed by Merck KGaA, Darmstadt, German and Pfizer via EMD Serono, a business unit of the two companies.
The FDA guidelines also indicated a vaccine would not be approved unless it had “clearly demonstrated” proof of the vaccine’s safety and effectiveness in a clinical trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 1, 2020.
FDA
The anti-PD-1 therapy was approved by the U.S. Food and Drug Administration alone for first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
The U.S. Food and Drug Administration (FDA) issued Heron Therapeutics a Complete Response Letter (CRL) for its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 29, 2020.
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