This morning the regulatory and research team at Aegerion Pharmaceuticals were hunkered down preparing for Wednesday's FDA panel review of their new drug for rare cases of homozygous familial hypercholesterolemia, encouraged by an FDA review of lomitapide that focused considerable attention on the right kind of risk evaluation and mitigation strategy that could keep the risk/benefit profile in proper proportion.
Novartis is touting a new data analysis suggesting that early treatment with its multiple sclerosis drug Gilenya can ward off relapses--and even prevent the loss of brain volume that often plagues MS patients. It's just one of the studies Novartis hopes will support increased use of its MS pill, the first oral therapy for the disease when it was launched last year.
Three contenders in the oral multiple sclerosis drug race have spotlighted their rival therapies this week. Biogen Idec, which revealed analysis from two Phase III studies of its blockbuster hopeful BG-12, is providing the new data points as the biotech heavyweight seeks approval of the oral med in the U.S. and Europe.
No question about it, Copaxone is still Teva Pharmaceutical Industries' ($TEVA) leading drug. And Teva wants to keep sales up--and not just until generic competition arrives in 2015. That's why it's been investing so heavily in developing a new, less-frequent dosing schedule. If the new, higher-dose Copaxone version can grab a foothold, then Teva stands to keep more of the multibillion-dollar drug's share of the MS market.
The Cambridge, MA-based unit of the French drug giant turned in upbeat data from the first Phase III study of the closely watched eliglustat tartrate, an oral drug for the rare genetic disorder that is typically treated with infusions of enzyme therapies.
Many biologics are notoriously expensive to produce, but genetically modified corn offers a potential alternative for producing complex protein drugs. And veteran Reuters scribe Ben Hirschler has chronicled one of the latest feats in "molecular farming," with scientists growing an enzyme drug for a rare genetic disease in transgenic corn.
Neither strike threats nor angry government ministers have stopped Sanofi from pushing ahead with deep job cuts in France. The French newspaper Le Figaro reports that the pharma giant will unveil a cutback of 1,500 to 2,500 jobs on September 25.
This is a big day for Sanofi and Genzyme, its biologics arm in Boston. The FDA is slated to make a final ruling on Aubagio (teriflunomide), its new oral treatment for multiple sclerosis.
The move is seen as a sign that Sanofi is confident that the multiple sclerosis drug Lemtrada will be as lucrative as hoped.
Genzyme is pulling 9 lots of its kidney transplant drug Thymoglobulin after one lot failed a stability test. The company, which is Sanofi's ($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.