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The U.S. Deputy Attorney General has asked the House to vote by a Feb. 6 deadline to extend an emergency order that categorizes all fentanyl analogues as Schedule I drugs. Read More
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
The plaintiffs are seeking an injunction, arguing that the alleged behavior will “continue unchecked” and “put an unbearable strain on third-party payers.” Read More
Trials for hematologic malignancies can use measures of minimal residual disease (MRD) as a biomarker, according to a final guidance issued by the FDA that specifies the types and uses of measures the agency will accept. Read More
Gilead fired back at HHS’s patent infringement suit over its HIV drugs Truvada and Descovy, claiming that the patents the department is suing over are invalid. Read More