This is a big day for Sanofi and Genzyme, its biologics arm in Boston. The FDA is slated to make a final ruling on Aubagio (teriflunomide), its new oral treatment for multiple sclerosis.
The move is seen as a sign that Sanofi is confident that the multiple sclerosis drug Lemtrada will be as lucrative as hoped.
Genzyme is pulling 9 lots of its kidney transplant drug Thymoglobulin after one lot failed a stability test. The company, which is Sanofi's ($SNY) U.S.-based rare disease division, pulled all lots made with raw material suspected to be the "root cause" of the potential shelf-life issue.
Sanofi ($SNY) is reporting another manufacturing problem, this time at one of the plants operated by its Genzyme subsidiary, causing it to recall a transplant-rejection drug.
Just weeks after Genzyme filed its application for Lemtrada as a new treatment for multiple sclerosis, regulators have handed the NDA back, telling the biologics arm of Sanofi that it needs to complete a rewrite before they can properly assess it.
The speculation about Genzyme's Campath is over. The company, now a unit of Sanofi, is pulling the plug. Why? To prepare the way for Lemtrada, a multiple sclerosis treatment that is, essentially, Campath by another name.
The next 5 or 6 weeks look big for potential approvals of new drugs.
A potential new Isis Pharmaceuticals ($ISIS) "anti-sense" drug helped restore normal muscle function in mice suffering from a form of muscular dystrophy. Credit new research spearheaded by Genzyme and the University of Rochester Medical Center with achieving the breakthrough.
Stop, thief! That's what Teva Pharmaceuticals is saying to Genzyme, in a dispute over sales reps. It seems a former Teva sales manager who defected to Genzyme is accused of poaching his former co-workers.
Genzyme CEO David Meeker must be smiling today. Sanofi CEO Chris Viehbacher is taking a page out of the Roche reinvention playbook. Just as Roche has restructured its Big Pharma R&D efforts around Genentech, Sanofi's Viehbacher sees its research ops being transformed by Genzyme's biotech example.