Sanofi is walking away from any plans to appeal the FDA's emphatic rejection of the multiple sclerosis drug Lemtrada, at least for now. But rather than launching the added trial that the FDA demanded ahead of any possible approval, the company thinks it has a shot at answering the FDA's concerns with a new application.
The Supreme Court has agreed to hear an appeal of a lower court's decision to invalidate Teva's Copaxone patent, which if restored will shield the drug until September 2015. The decision may, in the least, leave competitors wary of proceeding with generics, giving Teva more time to convert patients to a new, long-acting version of the treatment.
The FDA said it needs three more months to consider Biogen Idec's Plegridy, an injectable multiple sclerosis treatment, delaying an expected midyear launch for the company's latest entrant in its blockbuster MS franchise.
Early progress doesn't always equal long-term success. But at least in the case of Teva Pharmaceutical Industries--which is firing on all cylinders to convert patients to a new, long-acting version of Copaxone--early results have some analysts thinking the Israeli company may deliver on its promise to switch 30% to 50% of patients.
Merck KGaA's multiple sclerosis treatment Rebif is holding its own. Considering that the German drugmaker's flagship product faces some formidable new competitors--including Biogen Idec's brand-new powerhouse, Tecfidera--that's not too shabby.
Biogen Idec's hot-selling multiple sclerosis drug Tecfidera has to win reimbursement in individual European countries where governments have gotten stingy about parting with healthcare dollars. A decision Thursday by U.K. price watchdog NICE is an indication of the cost hurdles to be faced.
A new therapeutic target involved in stimulating the growth of damaged brain cells could provide new ways to treat multiple sclerosis.
European regulators recommended against Teva Pharmaceutical's laquinimod, marring the Isreali company's odds of crossing the finish line with its once-promising multiple sclerosis treatment, a drug it hopes can dull the blow of the soon-to-go-generic Copaxone.
After a December flip-flop, the word from NICE on Sanofi's Aubagio is now final: The British cost watchdog has recommended the multiple sclerosis pill for use in Britain's National Health Service, tallying a victory for an MS franchise that has seen some recent ups and downs.
A small-molecule inhibitor developed by Innovimmune Biotherapeutics prevents multiple sclerosis from developing in mice.