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Genzyme

Latest Headlines

Latest Headlines

Sanofi wins FDA's blessing for an oral Gaucher drug

Sanofi's rare ailment-focused Genzyme unit won FDA approval for a new Gaucher disease treatment, providing an oral alternative to its own trailblazing intravenous therapy.

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 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 expands Kynamro marketing team to spark up sales

Sanofi's Genzyme unit isn't offering details about its sales of Kynamro, the rare disease treatment approved last January. It's not allowing its development partner, Isis Pharmaceuticals, to dole out specifics, either. What is certain, according to Isis COO Lynne Parshall, is that the launch started off slowly, and Genzyme has expanded its sales force to step up the pace.

Sanofi grabs a $700M stake in Alnylam as it ups the ante on RNAi

Sanofi is doubling down on its RNAi development deal with Alnylam. The pharma giant says it will pay a hefty premium to buy up a 12% stake in the biotech, investing $700 million and greatly expanding its rights to Alnylam's lead drug along with a portfolio of current and prospective therapies.

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.

Sanofi's Genzyme nets FDA priority review for its oral Gaucher pill

Sanofi's Genzyme snagged a 6-month priority review from the FDA for what could become the first oral treatment for Gaucher disease, a rare genetic disorder that causes abnormal fat buildup in cells, enlarging organs in the body.

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.

Alnylam pockets $7M from Genzyme as RNAi program hums along

Gene-silencing expert Alnylam is $7 million richer thanks to some positive mid-stage results for its Genzyme-licensed RNA-interference candidate, and the Cambridge, MA, company is looking to be the first to market with the difficult-to-deliver class of treatments.

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.