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Sponsors that fail to address all pediatric age groups or indications in their initial pediatric study plans would have 30 days to address any deficiencies and submit a new plan, FDA says. Read More
Amarin Pharmaceuticals will be able to promote its cholesterol drug Vascepa for off-label uses after resolving differences with the FDA in a free speech case involving off-label promotion of the capsules. Read More
Pay-for-delay deals don’t have to be in cash form for them to be at risk of an antitrust suit, according to a recent federal appellate panel ruling. Read More
European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Read More
Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief before the U.S. Court of Appeals for the Federal Circuit. Read More
In a case with broad implications for medical patent litigation, the U.S. Supreme Court showed little enthusiasm for lowering a strict appellate standard for enhanced damages during oral arguments Feb. 23. Read More
House members are growing impatient with the FDA over a lack of guidance on biosimilars, with several venting their frustrations during a hearing last month. Read More
Democrats and Republicans of the House Oversight Committee took executives of Valeant Pharmaceuticals and Turing Pharmaceuticals to task Feb. 4 over what members called a strategy of buying old drugs with no generic competition and “jacking up” the prices for profits. Read More
An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six different indications. Read More
PhRMA is claiming that the activists involved failed to legally acquire a sufficient number of signatures to submit the petition to the General Assembly. Read More