Reviewers supported the drug's approval, but concerns about REMS and clinical trial integrity indicate the vote was not a roaring endorsement.
Most patients would advise today's FDA Lemtrada panel to allow doctors to gauge the drug's risk-benefit profile, although there was strong sentiment on either side of the issue.
Safety reviewers' reservations about the MS drug's risk profile, unveiled in briefing documents ahead of an ad-com meeting, suggest it won't be smooth sailing for the drug in the US.
The drug maker says a patient's physician did not link the MS drug to her death.
BI cancer drug lands breakthrough therapy designation; Sanofi tallies two European MS drug approvals; GSK terminates testing for a Crohn's drug; and Teva joins cancer collaboration
The FDA and Novartis are investigating reports that a patient has contracted the rare virus.
Novartis prepares for a strategic review that hints at scuttling lesser-performing businesses; Regeneron's Eylea sales prompt expansion; Pfizer targets diabetes and obesity; and the FDA approves an MS stem cell trial
Biogen Idec raised its full-year guidance on Tecfidera launch sales, as the MS market continues its growth trajectory.
AbbVie lays off 100 R&D staff; Teva looks to expand Copaxone footprint; researchers crack HIV protein code; monitors may be misleading diabetics and a prototype sensor turns iPhones into virus hunters.
Execs unveiled 10% sales growth and told investors the safety news does not implicate their just-approved MS pill.
Doctors call out Novartis on drug prices; Aubagio shows strong top-line data in trials; and overseas docs increasingly turn to digital.
MS patients have an "insatiable appetite" for information about treatments online, particularly the new class of oral treatments, whose manufacturers could be doing more to prep them for switch conversations, a survey suggests.
A study in the New England Journal of Medicine said patients had a significant relapse reduction over two years on the oral drug.
The move expands patient options, but industry watchers tell MM&M it's not going to spur a radical change in treatment.
A cancer drug being developed by Medivation and Astellas gets its closeup, and Teva launches in to Phase III trials of its oral MS drug laquinimod.
Five patients will document their challenges and triumphs online in this project developed by the National MS Society and Sanofi's Genzyme unit.
Biogen Idec and Elan, which market Tysabri for multiple sclerosis, won approval to add new safety information to the drug's label that could boost sales by helping doctors avoid a serious adverse event.