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news.Luminex gets FDA approval for viral assay
Luminex said that xTAG respiratory viral panel (RVP) is a groundbreaking viral assay that, with a single patient sample, can assess the presence or absence of 12 viral
Luminex said that xTAG respiratory viral panel (RVP) is a groundbreaking viral assay that, with a single patient sample, can assess the presence or absence of 12 viral
The TIME registration program is designed to include two trials, a pivotal Phase III trial (TIME-1) and a smaller supportive trial. The TIME-1 trial is proceeding on track
The FDA grants orphan drug designation to products that are intended to treat rare or ‘orphaned’ diseases or conditions such as Lennox-Gastaut syndrome (LGS). Tim Cunniff, vice president,
According to WuXi, the acquisition of AppTec will allow the company to immediately obtain biologics capabilities and expertise, gain a significant US operational footprint and expand its customer
The company also announced its intention to build and operate a fill and finish manufacturing facility for VIAject, on the campus of its current headquarters in Danbury, Connecticut.
The company said that ANA598 demonstrates significant antiviral activity in vivo. Two animals chronically infected with hepatitis C virus (HCV) genotype 1b each received once-daily oral doses of
Bedford Laboratories is now the reference listed drug holder. Bedford Laboratories will supply latex-free Cafcit (caffeine citrate) injection as 60mg/3 mL single-use vials individually boxed and Cafcit oral
Alogliptin (SYR-322) was designed to selectively inhibit dipeptidyl peptidase-4 (DPP-4) taken orally once daily. The new drug application (NDA) submission was supported by six Phase III clinical trials
The debentures mature the earlier of November 1, 2012 or the sale of the company. The debentures, together with all accrued and unpaid interest thereon, may be repaid,
The new drug application (NDA) filing is based on global studies conducted in more than 20 countries. These studies evaluated more than 6,000 subjects with erosive and non-erosive