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Drug Research

FDA approves UCB's anti-epileptic drug Vimpat as monotherapy The US Food and Drug Administration (FDA) has granted approval for UCB's supplemental new drug application (sNDA) for Vimpat (lacosamide) C-V as monotherapy to treat partial-onset seizures in patients with epilepsy. Drug Research > Drug Delivery > News

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Drug Delivery

FDA accepts to review Merck and Sanofi Pasteur’s BLA for pediatric hexavalent vaccine
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Merck and Sanofi Pasteur's Biologics License Application (BLA) filed for their investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB.
Ampio reports results of multiple intra-articular injections (MI) study of Ampion in patients with osteoarthritis of the knee
Ampio Pharmaceuticals, announced updates for the STRUT and STRIDE multiple injection studies that are proceeding simultaneously.

Drug Discovery & Development

Apricus expands development pipeline with in-licensing of US rights for fispemifene
Apricus Biosciences has licensed the U.S. development and commercialization rights for a novel selective estrogen receptor modulator ("SERM"), fispemifene, an investigational treatment for urological conditions in men, from Forendo Pharma, a private therapeutics company based in Finland.
EYLEA injection shows better gains in visual acuity than both bevacizumab and ranibizumab in NIH-sponsored DME study
Regeneron Pharmaceuticals, has announced that in the National Institutes of Health (NIH) sponsored, Diabetic Retinopathy Clinical Research Network comparative effectiveness study in patients with Diabetic Macular Edema (Protocol T), EYLEA (aflibercept) Injection demonstrated a significantly greater improvement in mean change in best-corrected visual acuity (BCVA) from baseline at 52 weeks compared to both bevacizumab (Avastin/Genentech) and ranibizumab injection (Lucentis/Genentech), the primary endpoint of the study.