Sanofi decides to take a second shot on Lemtrada app
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.
Biogen hits an FDA speed bump with its next-gen MS drug
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.
Teva stands by its MS pill after yet another setback
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.
- Dec 30, 2013 UPDATED: FDA spurns Sanofi's MS drug Lemtrada on fatally flawed PhIII design
- Nov 13, 2013 UPDATED: Sanofi gets mixed FDA blessing for MS drug Lemtrada
- Nov 08, 2013 UPDATED: FDA casts 'fatal' doubts on Sanofi's long-stalled MS drug Lemtrada
- Oct 14, 2013 Merck KGaA scouts for deep-pocketed partners to leverage its R&D budget