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Intellipharmaceutics artificially inflated its stock prices during the NDA process for its oxycodone product Rexista, a new class-action lawsuit claims. Read More
A third-party evaluator should be used to assess the expanded communications program proposed in the next generation of the FDA’s biosimilar user fees, according to BIO. Read More
As part of the Trump administration’s deregulatory push, the FDA has withdrawn nine planned regulations for the pharmaceutical industry, some in the works for years. Read More
A White House commission on opioid abuse, established in March by executive order, delivered its initial set of recommendations to President Trump, urging him to declare an immediate, national state of emergency. Read More
The U.S. District Court for the Eastern District of Tennessee entered a permanent injunction against Crown Laboratories of Johnson City and its CEO, Jeffrey Bedard, after accusations of distributing unapproved and misbranded drugs. The company’s products, which include urea creams and lotions intended to treat dermatological problems, were sold and distributed without FDA approval or a sufficient demonstration of their safety and efficacy, according to the complaint the Justice Department filed in March at the request of the FDA. Read More
Pharmaceutical and medical device companies will not get tax breaks after the Republican effort to repeal the Affordable Care Act came to a halt in the Senate early Friday morning, with nays from Sens. Lisa Murkowski (R-Alaska), Susan Collins (R-Maine) and John McCain (R-Ariz.). Read More
The FDA established a public docket so companies can nominate drug products or categories for the agency’s Difficult to Compound List — which blocks pharmacies from compounding certain products unless they are listed as a manufacturer. Read More
Sen. Claire McCaskill (D-Mo.) expanded her congressional investigation into opioid manufacturers and distributors, sending document requests to an additional four drugmakers. Read More