The labeling logo is designed to encourage doctors and patients to report side effects, as part of a new effort to more closely monitor drug safety. The list of 100-plus products includes all new drugs and biologics approved since January 2011.
Novartis is thinking young. The Swiss drugmaker is using a cheeky ad campaign, targeted at 20- and 30-somethings not only in magazines, but via websites and social media. Novartis needs to find a new edge in the MS market, where it faces not only well-established injectable drugs, but two new oral rivals.
Biogen Idec's ($BIIB) newly approved Tecfidera has a wholesale price of $54,900 per year, the biotech giant revealed on Friday. With the U.S. market debut of the oral multiple sclerosis drug set for Monday, Biogen plans to hit the market for MS pills with a lower price than Novartis' ($NVS) Gilenya, which is arguably the company's top competition.
Novartis' multiple sclerosis drug Gilenya (fingolimod) could treat or even prevent colitis-associated cancer, if preclinical findings from U.S. researchers can be confirmed in later studies.
Teva Pharmaceutical Industries ($TEVA) is very proud of its multiple sclerosis drug Copaxone. Thing is, Copaxone goes off patent in 2015.
Theoretically, the advent of oral MS treatments was supposed to drain sales away from less-convenient injectables--and quickly. In practice, patients and doctors have proven more cautious about the newer drugs, The Wall Street Journal reports.
Novartis is touting a new data analysis suggesting that early treatment with its multiple sclerosis drug Gilenya can ward off relapses--and even prevent the loss of brain volume that often plagues MS patients. It's just one of the studies Novartis hopes will support increased use of its MS pill, the first oral therapy for the disease when it was launched last year.
Three contenders in the oral multiple sclerosis drug race have spotlighted their rival therapies this week. Biogen Idec, which revealed analysis from two Phase III studies of its blockbuster hopeful BG-12, is providing the new data points as the biotech heavyweight seeks approval of the oral med in the U.S. and Europe.
In these days of patent losses, falling revenues and massive layoffs, Sanofi could use some good news, and it got some late Wednesday with the FDA approval of its new multiple sclerosis (MS) drug Aubagio, a possible blockbuster if it can sweep up market share from some tough competitors.
The FDA's balancing act is no easy feat. In fact, it just might be impossible. As soon as the agency gets Congressional direction to revamp and speed up approvals, experts in other quarters conclude that approvals are coming too fast.