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The Supreme Court Tuesday refused to hear Maryland’s appeal to revive a state law aimed at preventing drug companies from “price-gouging” consumers. Read More
CBER on Wednesday issued its list of guidance it expects to release in 2019, including final versions of several gene therapy drafts issued in 2018. Read More
The Federal Trade Commission has reached a global settlement resolving three antitrust lawsuits against Teva Pharmaceuticals subsidiaries. Once approved by the courts, the settlement will bar the drugmaker from reverse-payment patent deals that restrict patient access to less expensive generics. Read More
The agency’s approval followed an Oct. 12 meeting of the Anesthetic and Analgesic Product Advisory Committee, which voted 10 to 3 that the drug’s benefits outweighed its risks. Read More
Several comments expressed concern over the agency’s suggestion that it might be open to using data from observational studies that “replicate” randomized trial results and worried that the word is too vague. Read More
A federal judge in New Jersey ruled that a class of diabetes patients cannot sue insulin manufacturers under the Racketeer Influenced and Corrupt Organizations (RICO) Act because they did not buy the drugs directly from the manufacturers. Read More
The MHRA’s National Institute for Biological Standards and Control (NIBSC) released guidance in anticipation of a no-deal Brexit on March 29, including a flow chart biologic drugmakers can use to determine if their batches require UK certification. Read More
Canada has opted not to use four-digit suffixes in its naming conventions for biologics, making the United States the convention’s only adherent. Read More
Chairman Richard Neal (D-Mass.) said that Congress “will need to change policies and incentives in the FDA, CMS, and potentially even look in the tax code,” to address high drug prices. Read More