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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
One week after accusing Gilead Sciences of promoting an HIV drug off-label, an AIDS nonprofit is suing the company for allegedly “manipulating the patent system” to ward off generic competition for another medication. Read More
Eleven healthcare groups — including the Generic Pharmaceutical Association — are asking a Senate committee to examine alleged industry abuse of REMS safeguards as a possible cause of rising drug prices. Read More
Patent cases involving payments by brand drugmakers to delay generic competition have dropped 27 percent following a 2013 challenge to the practice, according to the Federal Trade Commission. Read More
Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for following the law. Read More
Boehringer Ingelheim has to hand over settlement papers to the FTC after the U.S. Supreme Court rejected the company’s assertion that the documents are protected communications. Read More
Drugmakers interested in establishing bioequivalence for their products have a treasure trove of data to dig through, as the FDA has just added 35 new product-specific guidances and updated 12 more. Read More