Archive for March 2016
Court Says Cashless Pay-for-Delay Deals Still Risk Antitrust Suits
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. Source: Generic Line
Read MoreFDA AdCommittee Backs 6 Indications for Celltrion’s Biosimilar of Remicade
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. Source: Generic Line
Read MoreHouse Members Push FDA, CMS on Biosimilars Guidance, Billing
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. Source: Generic Line
Read MoreReport Says U.S. and EU Generics Standards Should Be Synchronized
European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Source: Generic Line
Read MoreGuidance Revises Review Standard for Type II DMFs Linked to ANDAs
CDER is tightening up its protocols for companies submitting data about active pharmaceutical ingredients used in generic drugs. Source: Generic Line
Read MoreHouse Committee Grills Drug Executives Over Pricing Practices for Generics
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. Source: Generic Line
Read MoreBPCIA Notification Provision Takes Center Stage in Two Federal Cases
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. Source: Generic Line
Read MoreHigh Court Resistant to Changing Damages Standard in Patent Fights
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. Source: Generic Line
Read MoreFDA Issues 483 to Novo Nordisk for Inadequate Sterility Controls
The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures. Source: Drug GMP Report
Read MoreEU Issues Track-and-Trace Drug Packaging Rules
The European Medicines Agency and the European Commission today published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Source: Drug GMP Report
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