Despite not agreeing on primary endpoints with the FDA before beginning clinical trials for a new sleep disorder drug, Vanda was able to get an almost unanimous recommendation from an advisory committee earlier this month. Read More

With EU lawmakers and the European Council expected to reach a compromise on the Clinical Trial Regulation before Christmas, pharma, researchers and patient groups are pleading with them to ensure the timelines for submissions are predictable and no longer than those already established in the current directive. Read More

The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction nor postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying Square Pharmaceuticals’ citizen petition requesting a waiver and change to GDUFA’s statutory language. Read More

The FDA has handed Forest Laboratories and Gedeon Richter a complete response letter asking for more data on cariprazine, the companies’ drug candidate to treat schizophrenia and manic or mixed episodes of bipolar I disorder in adults. Read More

Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More

President Barack Obama Nov. 27 signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More

Amgen is the latest drugmaker caught up in the FDA’s recent flurry of enforcement letters for false or misleading promotional materials. Read More