The FDA served Auro Pharmacies — a California-based compounder — with a warning letter after the agency determined the firm produced products under insanitary conditions. Source: Drug Industry Daily

A federal court invalidated four of Teva’s patents that protect its multiple sclerosis drug Copaxone from generic competition. Source: Drug Industry Daily

Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to…

The FDA hit CTX Lifesciences with a warning letter for several failures at its India-based drug manufacturing facility and the quality of its active pharmaceutical ingredients. Source: Drug Industry Daily

FDA investigators handed two drug manufacturing facilities warning letters after inspections revealed a litany of cGMP violations. Source: Drug Industry Daily

PhRMA is urging the USPTO to reevaluate patent eligibility for prescription drugs to provide the drug industry a better framework for interpreting regulations and recent case law. Source: Drug Industry…

Democratic members of Congress have asked President Trump how the federal hiring freeze will affect the FDA’s user fee program, which are set to be reauthorized later this year. They…