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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
Generic drug developers that use patches, inhalers, drops or similar means to deliver meds should create separate clinical trials to test for potential side effects like skin irritation and, in the case of patches, adhesion quality, the FDA says. Read More
Consumers look to generic drugs for their cheaper price tags. But a new study finds sudden price spikes for generics are becoming more common. Read More