Tag:

Lemtrada

Latest Headlines

Latest Headlines

The bright side to Sanofi's Lemtrada delay? Its support-to-sell marketing plan

Sanofi's Genzyme has found a silver lining to last winter's FDA snub of Lemtrada. For starters, Genzyme is fielding an extensive provider-and-patient support program, developed based on feedback from a range of stakeholders.

Sanofi tags newly OK'd MS drug Lemtrada at $158K, ready to tout head-to-head Rebif data

Sanofi finally has its FDA approval for Lemtrada. The multiple sclerosis drug, previously rejected by the agency, will hit the market after a trio of new oral treatments. It will come with a boxed warning and faces tight controls on prescribing and distribution.

FDA reverses an embarrassing rejection of Sanofi's Lemtrada, OKs MS drug

Late on Friday the FDA put out the word that it has reversed its earlier decision against Sanofi's multiple sclerosis drug Lemtrada, agreeing to allow the pharma giant the right to market the treatment--with some tight controls on just who will get this drug for the relapsing form of the disease.

Sanofi keeps the faith in MS and eyes a new dawn for Genzyme

Despite an FDA rejection and changing winds in the field of multiple sclerosis, Sanofi believes its Genzyme unit is on an upward trajectory, talking up potential deals and could-be blockbusters for its pricey acquisition.

FDA will hear Sanofi's second plea for Lemtrada approval

On Friday, the FDA accepted Sanofi's supplemental application for its once-rejected multiple sclerosis treatment Lemtrada for consideration, and a 6-month review period follows.

Sanofi rolls the dice again on Lemtrada after an FDA rejection

Sanofi has resubmitted Lemtrada, its long-in-development multiple sclerosis treatment, for FDA approval, gambling that a new analysis of the same data will sway regulators in a second review.

Sanofi's new MS med scores a spot on U.K.'s NHS formulary

Sanofi felt the sting of lost sales potential when the FDA nixed its multiple sclerosis treatment Lemtrada in December. But the EU sees things a bit differently, and now a new nod from Britain's cost watchdog has unlocked some new top-line potential.

Sanofi's MS team rebuilds its case for the FDA-rejected MS drug Lemtrada

Late last year, Sanofi's MS drug Lemtrada was slapped down by the FDA. Sanofi investigators now tell FierceBiotech that two years after patients in Phase III studies received their last course of treatment, many are still clearly benefiting from the drug.

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.