Brace yourselves for the Teva Pharmaceutical Industries marketing blitz. The company won FDA approval Tuesday evening for its new, three-times-a-week Copaxone, and Teva needs to convert as many patients as possible to the new version before the original goes off patent in May.
Medtronic's Valiant Captivia thoracic stent graft system is now approved for type B aortic dissections, a deadly tear in the aorta, the body's main artery.
Merck skated through an FDA panel for its latest oral immunotherapy for allergies, as a group of agency advisers found the drug to be safe and effective for counteracting ragweed pollen.
Thanks to some high-profile failures to replicate preclinical findings in some of the world's leading journals, the call for reform has reached a fever pitch, and National Institutes of Health Director Francis Collins has taken up the baton.
When new drugs roll out, they meet the general population for the first time. Patients are no longer hand-picked as they are in clinical trials. And that often translates into a flurry of side-effect reports to the FDA. Last year's crop of new drugs is no exception.
The FDA's breakthrough therapy designation program has been up and running for more than a year, and while the industry's excitement has yet to wear off, it remains to be seen whether the initiative will be the boon drug developers expect, researchers say.
The FDA has banned four Ranbaxy Laboratories plants in 5 years, imposed a consent decree on the company and extracted guilty pleas and $500 million in penalties for selling subpar products. But in the last 7 years, the Drug Controller General of India has made only three inspections of Ranbaxy facilities and found little to worry about.
Covidien's Japanese subsidiary, Covidien Japan Inc., received Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Endo GIA Reinforced Reload with Tri-Staple technology.
Benvenue Medical secured U.S. clearance for its Kiva device designed to treat vertebral compression fractures. With the nod, the California company continues its turn into commercialization after about a decade of R&D.
The U.K.'s National Institute for Health and Care Excellence is known to change its mind. But this time, Britain's cost watchdog has set limitations on its recommendation for prostate cancer pill Xtandi--and maker Astellas is none too happy.