The Center for Biologics Research and Evaluation met or exceeded its PDUFA goals in fiscal 2017, according to CBER Director Peter Marks. Source: Drug Industry Daily

The Department of Health and Human Services’ Office of Inspector General sent a letter to PhRMA seeking help in contributing to drug co-payments after a nonprofit ended its financial grants…

Drug pricing will be a key healthcare issue for 2018, with state pricing and transparency laws pushing pharma and life science companies to reconsider strategies and business models, according to…

The FDA denied a request from Allergan to reject any ANDAs referencing Restasis unless the applicant proves bioequivalence through clinical endpoints. Source: Drug Industry Daily

The Native American tribe that entered a controversial patent deal with Allergan is questioning the impartiality of the Patent Trial and Appeals Board judges charged with reviewing the arrangement. Source:…

The FDA’s Office of Prescription Drug Promotion issued just three warning letters and one untitled letter in calendar year 2017 — a record low and down from a high of…

The FDA issued a warning letter to Fresenius Kabi for GMP violations observed at its manufacturing facility in Himachal Pradesh, India, citing a failure to investigate sterility issues. Source: Drug…

A group of investors sued Valeant Pharmaceuticals claiming the drugmaker cost them more than $80 billion through price-gouging. Source: Drug Industry Daily

Amid controversy over the high cost of its newly approved gene therapy Luxturna — $850,000 before discounts — Spark Therapeutics announced a series of initiatives to improve patient access to…

The Justice Department recovered more than $900 million from medical product manufacturers relating to False Claims Act violations in fiscal 2017, down from $1.2 billion in 2016. Source: Drug Industry…