The Tamiflu kerfluffle continues in the British Medical Journal 's new issue, with dueling letters from Roche ($RHHBY) and its lead critic, the Nordic Cochrane Centre. The journal's open data campaign has a willing ally in Cochrane, whose director not only stepped up demands that Roche hand over every scrap of data on its flu-fighter, but also advised European governments to retaliate until it does so.
The British Medical Journal is on a crusade. Object: Twist Roche's ($RHHBY) arm enough to win full-and-complete access to Tamiflu data. The Swiss drugmaker did promise to hand over all of the data, after questions about safety and efficacy emerged in 2009, but three years later, the books are still closed.
Did Roche ($RHHBY) bungle tens of thousands of adverse-event reports? European regulators aim to find out. The European Medicines Agency says it has started an "infringement procedure" against the Swiss drugmaker, to probe allegations that it dragged its feet on reporting potential side effects.
After a series of Big Pharma letdowns, Roche's ($RHHBY) results announcement was a series of positives: An increase in 2011 net income, a sales-growth forecast in the "low to mid-single digits," and
Roche is on the firing line at the British Medical Journal. In a report from the Cochrane Collaboration research group, BMJ says Roche ($RHHBY) hasn't handed over all its data on Tamiflu, calling the
WOBURN, MA--Behind every drug expiration date is stability testing and, it is hoped, a stabilitarian--one who coordinates the functions that contribute to determining drug stability. "Stability is a
Both the U.S. National Stockpile of drugs and an FDA testing program used to extend the shelf life of stockpiled meds are enjoying renewed visibility thanks to a Monday Washington Post report.
Genentech and the FDA have revised the concentration of Tamiflu for oral suspension in an attempt for more accurate dosing. Although the changes are being made to reduce the possibility of
Among 8 drug shortages reported by the FDA on June 30 and July 1, 6 are injections, continuing at least part of the trend that most shortages involve generic injectables. Among the 8 are Thyrogen
Six weeks after the FDA added oral suspension Tamiflu to its drug shortages list, pharmacists are breaking open capsules to compound the liquid behind the counter. The capsule supply remains