Less than a month ago, Sanofi's multiple sclerosis treatment Lemtrada ran into problems with FDA staffers who were unconvinced of the drug's safety and efficacy. Now, it looks as if the U.K. may share some of those doubts. Its cost-effectiveness gatekeeper has asked the French pharma for more data, giving the company just over a month to submit the supplementary information.
A lack of exposure to infections early in life is one of many proposed contributing factors to development of multiple sclerosis. With this in mind, some have questioned whether giving the immune system a light workout could stave off the autoimmune disorder.
Teva's best-selling drug Copaxone will face generic competition next year, fully 18 months before the company had anticipated. That's gonna hurt. How much will it hurt? An Israeli publication thinks it has Teva's answer to that--a 42% cut to the drug's sizable profits.
The European Medicines Agency Friday granted Tecfidera just what Biogen has been waiting for--a "new active substance" designation, paving the way to even greater sales for the hot product.
After a scathing staff review, Sanofi walked away from an FDA panel with mixed messages on its long-delayed multiple sclerosis drug, as agency advisers said the injection wasn't too risky to approve but took issue with the drugmaker's trial design.
If you're a drug developer, which 6 words do you never, ever want to see in an FDA review of a potential new product? The 6 words applied to Sanofi's multiple sclerosis treatment Lemtrada: "serious and potentially fatal safety issues."
Sanofi's multiple sclerosis drug Lemtrada may be too dangerous to warrant FDA approval, agency staff said, potentially damning news for an injection that has slogged through 25 years of back-and-forth development.
Iron deposits have been thought to play a role in the pathology of multiple sclerosis, although it's not known whether deposits of certain metals are a cause or consequence of disease. New imaging research is helping to answer that question.
The head of the pharma division, Stefan Oschmann, tells the Financial Times that the Darmstadt-based drug developer is looking to stretch its $1.5 billion annual research budget with some additional cost-sharing deals that might include private equity groups as well as other industry partners.
When a 59-year-old woman who had used Biogen Idec's Tecfidera died in July, the company said it was investigating but declared it was unlikely her death was tied to its new multiple sclerosis pill. Now the company says her doctor has made the determination the drug is not to blame.