More than a dozen pharmaceutical industry leaders agreed to work together to develop new painkillers without the harmful addictive effects of opioid medicines — and to use the NIH as…

To help relieve uncertainty among sponsors about its role in regulatory decisions, the FDA will publish guidance on its application of real-world evidence to drug approvals and post-market evaluations, FDA…

A federal judge signed off on a $15 million settlement to close out claims of anticompetitive behavior by Allergan and its subsidiary Warner Chilcott. Source: Drug Industry Daily

A federal judge in Pennsylvania threw out AbbVie’s patent suits against generic competitors, strengthening the Federal Trade Commission’s pay-for-delay case against the drugmaker. Source: Drug Industry Daily

The FDA posted only 60 ANDA approvals in August — slightly below the year’s monthly average of 63 — plus 17 tentative approvals, an overall dip after a strong showing…

To curb abuse of the Hatch-Waxman system, the FDA should consider allowing generic drug manufacturers to create their own REMS, according to CVS Health. Source: Drug Industry Daily

Pharmaceutical wholesalers are meeting nearly all the product tracing information exchange requirements of the Drug Supply Chain Security Act, according to the HHS inspector general’s office. Source: Drug Industry Daily

Two FDA advisory committees grappled with the proposed addition of information from a pediatric study to labels for Purdue Pharma’s opioid patch Butrans (buprenorphine), without coming to a clear consensus.…

The European Medicines Agency said it may become more difficult for UK firms to have GMP non-compliance statements lifted following Brexit. Source: Drug Industry Daily

The U.S. government sided with Sandoz on the residual claims from the biosimilar manufacturer’s Supreme Court case with Amgen — arguing the federal law outlining the biosimilar approval process should…