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.
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.
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.
Unilife is at it again. This time it's Novartis signing a deal with the injectable technology provider, adding to Unilife's impressive list of recent agreements with top pharmaceutical companies Sanofi, MedImmune and Hikma.
Lantus is the best-selling diabetes drug in the world right now and the top-selling drug for Sanofi. But the drug goes off patent in 2015, so the French drugmaker is coming on strong with its Lantus successor, known as U300.
Sanofi has peeled back the cover on another chapter of Phase III data for U300, advancing its case that its next-gen diabetes therapy can be safer and just as effective as its blockbuster Lantus as it sets the stage for a regulatory pitch next year. But analysts may be left wondering if the long-acting insulin can successfully beat back rivals with a better set of data.
At a time when its Big Pharma peers have sold noncore assets, Sanofi has diversified, with multibillion-dollar acquisitions of Genzyme and Merial adding biotech and animal health assets, respectively. Now, CEO Chris Viehbacher is looking for smaller, bolt-on deals to boost the vaccine business.
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.
Merrimack Pharmaceuticals and its partners at Sanofi are back with another trial failure to report on the biotech's lead drug, MM-121. Combined with exemestane, the drug failed to improve progression-free survival among a group of ER/PR+, HER2 negative breast cancer patients.
Which drugmakers are likely to be the biggest dealmakers of 2014? The direct evidence is trickling in. Sanofi CEO Chris Viehbacher, for instance, says he's looking to spend up to €2 billion on deals next year, or about $2.7 billion.