Leading drug firms and PhRMA have weighed in on the FDA’s plan to study the risks and benefits of online prescription drug communications and the possible impact of space limitations…

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…

A federal judge validated Shire’s patent on its delayed-release Lialda, ruling that Mylan infringed two of the patent’s claims when seeking to launch a generic of the bowel disease drug.…

Eight Democratic senators have sent a letter to the FDA, airing their concerns over the effects of the government-wide hiring freeze on the agency’s mission. Source: Drug Industry Daily