The ruling stalls generics until at least September.
Patient advocates lobbied the FDA to approve the MS drug and Sanofi subsidiary Genzyme says their voice will be part of the consumer outreach when DTC rolls out next year.
Novartis released Phase-III study results Monday.
Phase-III results of the AbbVie-Biogen Idec experimental multiple sclerosis shot Zinbryta (daclizumab) indicate the drug bests Avonex (interferon beta-1a) on some measures among relapse-remitting MS patients.
The plan is to bring in-house products to the market as well as through acquisitions.
Plegridy is the only pegylated beta-interferon drug approved for relapsing multiple sclerosis.
The Supreme Court denied Teva's request to keep branded Copaxone off the market while the appeals process shakes out.
The price watchdog said Sanofi's oral MS drug Aubagio is a go. The decision follows a September directive to prove the drug's cost-effectiveness.
The MS pill saw rapid uptake in the US last year, but its overseas launch won't be as quick, CEO George Scangos conceded this week at an analyst conference.
Our year-end list captures the 10 that sparked heaviest interest.
The firm has vowed to appeal an FDA rejection that otherwise complicates its bid to expand in multiple sclerosis.
Famous from his reality show, "The Osbournes," Jack narrates his life with MS in a web documentary series.
The company released two financial scenarios. The key is generic Copaxone.
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.
Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.
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