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Grassley introduced proposed legislation last year that would require the FTC to report to Congress on possibly anticompetitive prescription drug-pricing practices. Read More
On Thursday night, the Senate voted 68 to 31 to pass the long-awaited $1.5 trillion, 2,700-page omnibus package to fund the federal government for fiscal year 2022 — five months after FY22 started. Read More
Whether a company is primarily a drug manufacturer or a device manufacturer, if it starts making combination products, it will have new additions to its quality management system (QMS) and will “need to learn to speak the language for both sides of the combination product,” according to a former FDA official. Read More
FDA investigators observed many weaknesses in current good manufacturing practice (cGMP) procedures, among other quality lapses, during an inspection of Janssen’s drug manufacturing facility in Gurabo, Puerto Rico. Read More
Novartis has agreed to manufacture Carisma Therapeutics’ new line of bioengineered macrophages which, like CAR-T cells, can be reprogrammed to attack patient-specific tumors. Read More
U.S. Bankruptcy Judge Robert Drain for the Southern District of New York has approved a revised $6 billion opioid settlement negotiated between the Sackler family, owners of OxyContin maker Purdue Pharma, and several states that appealed a previously approved proposal. Read More