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Lemtrada

Latest Headlines

Latest Headlines

Sanofi misled investors with rosy Lemtrada predictions, lawsuit alleges

Sanofi investors are fed up with disappointing news on the multiple sclerosis drug Lemtrada. Vaunted as a potential blockbuster, the drug hasn't even made it to market in the U.S. Now, some investment funds are suing the French drugmaker, saying executives talked up Lemtrada in public--and kept bad news from the FDA private.

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.

Sanofi's MS pill Aubagio wins final thumbs-up from U.K. cost-effectiveness watchdogs

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.

FDA says nada to Lemtrada; will Sanofi be willing to invest in additional trials?

Sanofi intends to appeal the FDA's denial of Lemtrada, its multiple sclerosis drug that was a key reason it paid $20.1 billion to buy Genzyme two years ago. But will the company invest more money in the drug, given that after three more years of trials it will be far behind competitors?

UPDATED: FDA spurns Sanofi's MS drug Lemtrada on fatally flawed PhIII design

Sanofi has been slammed against the regulatory wall at the FDA, picking up a stinging rejection of its multiple sclerosis drug Lemtrada with orders to go back to the clinic for a major round of new trial work if the company ever expects to get the drug over the U.S. finish line at some point.

The day after its Lemtrada snub, NICE blesses Sanofi's Aubagio

Thursday, Sanofi's multiple sclerosis drug Lemtrada was stymied by the U.K.'s cost-effectiveness gatekeeper, which asked for more data on the med before it could determine its worth. But just one day later, the regulatory body gave Sanofi's MS franchise a boost: It has recommended Aubagio, its oral treatment, for use in Britain's National Health Service.

Sanofi's MS drug Lemtrada tripped up again, this time in U.K.

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.

UPDATED: Sanofi gets mixed FDA blessing for MS drug Lemtrada

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.

FDA staffers throw cold water on Sanofi's Lemtrada hopes

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."

UPDATED: FDA casts 'fatal' doubts on Sanofi's long-stalled MS drug Lemtrada

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.