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The FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety and biosimilars development, and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research. Read More
The FDA is pushing ahead with efforts to spur development of hard-to-copy generics, this time sponsoring research into bioequivalence testing for long-acting periodontal drugs and developing methods for assessing generic, long-acting injectables. Read More
South Korea-based Celltrion launched its biosimilar of Janssen’s autoimmune disease therapy Remicade in another 12 European markets, bringing the product’s total presence to 31 countries. Read More
The branded version of Gilead’s pricey blockbuster hepatitis C therapy Sovaldi is expected on Indian pharmacy shelves in the second quarter of this year, distributed under an exclusive licensing agreement with Mylan’s Indian subsidiary. Read More
Generic launches of the antibiotic Zyvox and the blood-thinner Lovenox have bolstered Teva’s U.S. injectables portfolio, the Israeli generics maker said Feb. 17. Read More
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