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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 to cover patient co-pays. Read More
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 a new report from the PwC Health Research Institute. Read More
In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
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. Read More
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 156 in 1998. Read More
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 drug, including outcomes-based arrangements with Harvard Pilgrim and Express Scripts. Read More