Biomedical investment and business development chatter
FDA/Regulatory
Blow to Biogenerics: Genzyme Can’t Scale Myozyme
(From The Boston Globe via PharmaLot)
The FDA set an extremely high bar yesterday for biosimilars when it ruled Genzyme could not get clearance to manufacture Myozyme (alglucosidase alfa) to treat Pompe disease (a rare genetic disease that inhibits the breakdown of glycogen in muscles into glucose) at the 2000L scale as opposed to the 160L [...]
Treximet… Finally!
I’ve been having migraines lately, well for the last few years. Terrible migraines. Migraines so debilitating only a combination of acutely acting medicines could even touch the pain. The problem was, up until now (finally, after a two year delay), I had to open two bottles of medicine, remove a few pills [...]
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