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The FTC is demanding Cephalon pay as much as $4 billion as punishment for profiting illegally from pay-for-delay deals that put off generic versions of the company’s wakefulness drug Provigil from 2006 to 2012. Read More
Santarus and Cosmo Technologies have sued Actavis, charging that its Paragraph IV ANDA against Santarus’ ulcerative colitis therapy Uceris infringes the drug’s patents. Read More
A U.S. patent office review board has struck three of Sanofi subsidiary Genzyme’s patents in what appears to be the first time such a review has nixed a biologics patent. Read More
The FDA has postponed an advisory committee meeting that had been scheduled to consider Celltrion’s application for a biosimilar to Janssen’s Remicade — just the second advisory committee meeting to consider a biosimilar application in the U.S. Read More
Postmarket monitoring results on Hospira’s biosimilar of Janssen’s Remicade continue to show comparable patient response to the reference, the generics maker says. Read More
Mexican regulators have laid out rules for older biosimilars registered prior to Oct. 19, 2011, when the country’s biosimilarity rules were first established, mandating that companies conduct clinical trials to prove biosimilarity. Read More
Canada has fired back in its dispute with Eli Lilly over court rulings that invalidated patents covering two of the drugmaker’s therapies, charging that Lilly has grossly mischaracterized the country’s patent policies.
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The FDA is seeking additional comment from industry on its highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More
The FDA has accepted Apotex’s BLA for a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen, the Canadian generics maker said Feb. 17, making it the fifth publicly disclosed biosimilar application in the U.S. Read More
A German regulator says European Medicines Agency plans for implementing its clinical trials database lets drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercial confidentiality. Read More
Sponsors spend upwards of 23 million hours complying with clinical trial requirements, from requests for INDs to submission of NDAs, the FDA says. Read More