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FDA Commissioner Scott Gottlieb announced a revised agreement between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too low. Read More
Against a backdrop of declining sales for its branded hepatitis drugs, Gilead announced plans to launch its own “authorized generics” of two of its hep C treatments. Read More
Generic drugmakers are suing New York state over its law imposing surcharges on distributors and manufacturers of opioids, arguing the tax disproportionately hurts generic manufacturers. Read More
The European Medicines Agency (EMA) is considering revisions to its guidance for sponsors of medicines for neonates and is seeking input from stakeholders by Dec. 16. Read More
The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan. Read More
Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far, BMJ reported. Read More
The EMA lowered its estimate for the number of centrally authorized drugs that may face post-Brexit supply disruptions from 108 to 39 — including 25 human medicines. Read More
The pharma giant says the policy changes will increase payment transparency and improve its sharing of new product data with healthcare professionals. Read More
The European Medicines Agency wants to develop a common data model (CDM) to help speed Europe’s drug development and it’s looking for a hybrid because no current system can answer all the questions posed by the product life cycle. Read More
As the midterm elections approach, several gubernatorial candidates have released plans for how their administrations would limit drug price hikes and improve transparency. Read More