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Opioid makers and 37 Attorneys General told an Ohio federal court that proposed attorney fees could derail a global settlement in the opioid multidistrict litigation. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave its blessing for European Commission approval of two drugs at its February meeting, including a generic version of Pfizer’s skin infection medication Tygacil (tigecycline). Read More
The FDA unveiled a pilot program last week that will use plain language and podcasts to explain its guidance documents in snapshots posted to its website. Read More
The FDA reported the first U.S. drug shortage linked to the novel coronavirus outbreak — but did not name the drug. It is likely pindolol, a beta blocker for treatment of blood pressure manufactured by Mylan and Sun Pharma. Read More
A Kansas federal judge has certified two classes in an antitrust suit against Pfizer and Mylan over an alleged scheme to raise the price of EpiPen (epinephrine injection USP). Read More
Participation of women in clinical trials of drugs approved by the FDA increased dramatically in the past year, rising from 56 percent of trial participants in 2018 to 72 percent in 2019, but ethnic diversity in trials overall remained steady, according to the agency’s latest Drug Trials Snapshot Summary Report. Read More
The FDA should seek authority from Congress to require drug companies to disclose the “complete physical path” of products through the supply chain, HHS Office of Inspector General (OIG) recommended in a new report. Read More
Drugs approved through the FDA’s Unapproved Drug Initiative could potentially cost $29 billion in extra healthcare costs, Vizient said in a new analysis released this week. Read More
FDA Commissioner Stephen Hahn yesterday said the agency has identified 20 products that are either made in finished-dosed or source their active pharmaceutical ingredients solely in China. The agency has reached out to the 183 drugmakers in China and none have reported shortages tied to the COVID-19 outbreak so far, he said. Read More