Democrats in Michigan’s state legislature have introduced a bill to repeal the Michigan Product Liability Act, a 1995 law that gives pharmaceutical companies immunity from legal action relating to sale…

Remoxy ER, Pain Therapeutics’ new oxycodone pain relief candidate, failed to sway FDA advisory committee members this week. Source: Drug Industry Daily

The FDA hit Biologique Recherche with a warning letter after observing multiple violations at its Paris facility, noting inadequate testing methods, quality control concerns and a lack of validation for…

The Federal Trade Commission should examine the impact of “pay-for-delay” deals on the availability of cheaper biosimilars, two U.S. senators said in a letter Friday. Source: Drug Industry Daily

Two pharmacy benefit managers took in more than $223 million last year through their work with Ohio Medicaid plans, according to a new report commissioned by the state. Source: Drug…

In the coming weeks, CDER will publish online a list of surrogate endpoints that led to the approval of oncology drugs and biologicals for the first time, FDA Commissioner Scott…

In an effort to provide potential sponsors advice on critical topics for early drug development, CBER launched its Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meetings program.…

The FDA approved Ferring Pharmaceuticals’ NDA for Nocdurna (desmopressin), a nocturia treatment, rejecting petitions from Serenity Pharmaceuticals and Avadel requesting that it deny the application. Source: Drug Industry Daily

Representatives from the FDA and the European Medicines Agency discussed further opportunities for collaboration in their 2018 annual meeting last week. Source: Drug Industry Daily

For the second consecutive week, the House of Representatives passed a slew of bills addressing the opioid crisis, including one on Friday directing the FDA to assess non-addictive treatment options.…