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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
India regulators barred two drugmakers from doing business in the country for five years for submitting false information in new drug applications. Read More
Advocacy group Public Citizen is urging the FDA to pull oral forms of the antifungal drug ketoconazole from U.S. shelves due to serious health risks. 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
Novo Nordisk paid more than $9 million to physicians for promotion of its diabetes drug Victoza in the last five months of 2013, topping the list of drugs that were responsible for the most physician payments during the first reporting period covered by the CMS Open Payments database. Read More
The UK’s healthcare cost watchdog issued a mixed bag of recommendations Wednesday, supporting Pfizer’s Inlyta as a second-line treatment for advanced kidney cancer while nixing Dendreon’s Provenge for asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer. Read More
The FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety, biosimilars development and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research. Read More