Genzyme continues to build the large late-stage data package for teriflunomide, an oral multiple sclerosis drug that the company and its owner, Sanofi, are developing to compete in the blockbuster market for MS therapies that are swallowed rather than injected.
The company says in a release that the FDA and the EMA have given approval to a filling and finishing operation for Myozyme and Lumizyme, treatments for the enzyme deficiency known as Pompe disease.
In announcing the FDA approval of its new Gaucher disease treatment Elelyso, Pfizer put Genzyme firmly in its sights.
After initially being rebuffed at the FDA Pfizer and Protalix have snagged an FDA OK for their new Gaucher disease drug Elelyso (taliglucerase).
Sanofi had a good first quarter with higher revenues and profits, but executives acknowledge that the next 12 months will be tough.
Carl Icahn is turning up the heat on Amylin Pharmaceuticals' board of directors.
In an open letter, the feared raider lambasted the company for handing out stock options at $16 a share when it was keeping quiet about Bristol-Myers Squibb's $22 a share bid.
Sanofi ($SNY) has scooped up Pluromed in a buyout that benefits the biosurgery unit the company acquired from Genzyme. The French drug giant plans to add privately held Pluromed's FDA-approved surgical gel to its biosurgery product portfolio through the purchase. Financial details of the deal weren't revealed.
In a surprising turn of events, Shire ($SHPGY) announced late yesterday that it is jerking its application for Replagal, the rare genetic disorder drug that the FDA had pushed to get on the market as Genzyme sorted out its high-profile manufacturing problems. The reason for the sudden reversal? The FDA is indicating the need for new clinical studies before it stamps an OK on the treatment for Fabry disease. And that put any approval off to "the distant future," the company said.
Sanofi ($SNY) may want to thank its lucky stars that its new Genzyme plant won FDA approval when it did. The facility in Framingham, MA, will allow the French drugmaker's rare-disease unit to get back on track with its Fabry disease drug Fabrazyme. It may also have deterred Shire from pursuing its own Fabry drug application in the face of complications at the FDA.