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The FDA hit Apertus Pharmaceuticals with a Form 483 for data integrity lapses and other good manufacturing practice (GMP) violations observed during an inspection of its St. Louis, Missouri facility. Read More
The parallel use of human challenge trials and large-scale conventional trials could help accelerate the development of an effective vaccine for COVID-19, NIH vaccine experts say. Read More
A federal appeals court has ruled that two Amgen patents for its blockbuster anti-inflammatory drug Enbrel are valid, blocking the launch of a biosimilar by Novartis. Read More
Sanofi and Regeneron Pharmaceuticals have stopped a phase 3 clinical trial in the U.S. of their rheumatoid arthritis drug Kevzara (sarilumab) as a COVID-19 treatment after it failed to meet its primary endpoints. Read More
The Department of Justice (DOJ) has charged Indian drugmaker Glenmark Pharmaceuticals with allegedly conspiring to increase prices on the cholesterol drug pravastin. Read More
PhRMA has filed a lawsuit challenging a new Minnesota law that took effect on Wednesday that provides emergency access to long-term insulin for diabetics who cannot afford it. Read More
Drugmakers have continued to hike their drug prices during the COVID-19 crisis, increasing prices on average 23.8 percent for 245 drugs, many of which are used in COVID-19 treatments or research. Read More