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The Association for Accessible Medicines (AAM) has asked a federal appeals court to suspend California’s pay-for-delay ban pending an appeal of a lower court’s ruling. Read More
In a first for the Department of Justice, an electronic health records software vendor has agreed to a $145 million settlement over allegations that it created a kickback scheme aimed at prescribing opioids. Read More
The FDA unveiled seven guidances yesterday that clarify the agency’s policies for sponsors of gene therapy products for specific disease areas. Read More
New York Attorney General Letitia James and the Federal Trade Commission has filed suit against Martin Shkreli and Vyera Pharmaceuticals for an “elaborate anticompetitive scheme” to monopolize toxoplasmosis treatment Daraprim (pyrimethamine), the government officials announced yesterday. Read More
Allergan has agreed to sell off its investigational drug brazikumab and its pancreatic enzyme drug Zenpep (pancrelipase) to clear the way for its proposed $63 billion acquisition by AbbVie. Read More
FDA Commissioner Stephen Hahn yesterday announced actions the agency is taking to speed development of treatments and diagnostic tests for the novel coronavirus, as several drugmakers race to develop a vaccine. Read More
Contract API manufacturer Precise Packaging failed to test raw materials and to document out-of-specification investigations, the FDA found in an inspection of the firm’s Fall River, Massachusetts plant. Read More