Generics maker Mylan sued the FDA to allow companies to sell generic copies of Pfizer’s Lipitor starting June 28, the date when pediatric exclusivity periods for some of the cholesterol-lowering drug’s US patents expire. That’s five months prior to when Ranbaxy, which has said it deserves 180-day marketing exclusivity as the first generic filer, was scheduled to begin marketing its copy, and 11 months earlier than other generic manufacturers would have been permitted to introduce their versions. In 2008 Ranbaxy reached an agreement with Pfizer to begin atorvastatin sales Nov. 30, although the FDA has yet to clear any generic firm’s copy cat drug as equivalent. Mylan claimed the Indian generics firm isn’t entitled to marketing exclusivity on Lipitor because of a pattern of submitting drug applications to the FDA containing “false and unreliable data” from an Indian manufacturing site. If FDA were to void Ranbaxy’s exclusivity, the firm could lose about $585 million in revenue, according to an average of four analyst estimates cited by Bloomberg.
Henry Schein, Inc. launchedBioTherapeutics Quarterly Journal, designed to serve as a quick information source for office-based practitioners on prevention, diagnosis and treatment of disease, in addition to new drug approvals and clinical news. Debuting in print last December, the journal was published in February, and will subsequently be published in May, August and November, with an online version slated for 2012.
Online physician community Sermo said it is partnering with J&J unit Janssen Global Services on a mobile platform for physicians. The platform will allow physicians to “move their patients more easily and efficiently through the healthcare system,” Sermo said a statement. In a Sermo survey of 600 physicians, a majority of respondents recognized a significant portion of referrals never result in scheduled appointments. A separate study revealed growing skepticism among physicians that EMRs and EHRs reduce medical errors.
Sage is partnering with the Literacy Research Association to publish the group’s official journal, the quarterly Journal of Literacy Research. Association members will receive the publication free. The JLR, launched in 1969, is ISI ranked among the top educational research and educational psychology journals, according to a Sage press release.
