Barr gets tentative approval for generic schizophrenia drug
The company anticipates receiving final approval following the expiration of the 30-month stay in April 2007. The Zyprexa Zydis patent expires on April 23, 2011. Barr’s Abbreviated New
Ultragenyx Pharmaceutical has received accelerated approval from the US Food and Drug Administration (FDA) for its gene therapy, Genglycos (pariglasgene brecaparvovec-opnr), to treat glycogen storage disease type Ia (GSDIa).
In previous studies, MKC-1 demonstrated broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models. Results from the preclinical studies demonstrated that