07:00 , Mar 21, 2011 |  BC Week In Review  |  Clinical News

Avelox moxifloxacin regulatory update

FDA updated the labels for antimicrobial fluoroquinolones to include a boxed warning that the drugs may exacerbate muscle weakness in patients with myasthenia gravis. The agency said that postmarketing adverse events, including deaths and the...
08:00 , Jan 31, 2011 |  BC Week In Review  |  Company News

aRigen, Green Cross deal

aRigen granted Green Cross exclusive rights in Korea to develop and commercialize WAP-8294A2 . Green Cross will begin a Korean Phase II trial of the injectable depsipeptide antibiotic to treat infections caused by methicillin-resistant Staphylococcus...
07:00 , Jul 20, 2009 |  BC Week In Review  |  Clinical News

Fluidosomes tobramycin regulatory update

FDA granted Orphan Drug designation for Axentis' Fluidsomes tobramycin to treat pulmonary infections caused by Burkholderia cepacia in patients with cystic fibrosis (CF). The inhalable liposomal formulation of tobramycin already has Orphan designation in the...
07:00 , Jun 29, 2009 |  BC Week In Review  |  Clinical News

Factive gemifloxacin mesylate regulatory update

Menarini said it withdrew an MAA for Factive gemifloxacin to treat mild to moderate community-acquired pneumonia (CAP) and acute exacerbation of chronic bronchitis. The company said it withdrew the application after EMEA's CHMP indicated that...
07:00 , May 11, 2009 |  BC Week In Review  |  Clinical News

Fluidosomes Tobramycin regulatory update

FDA granted Orphan Drug designation for Axentis' Fluidosomes Tobramycin to treat pulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis (CF). The fluid liposomal-tobramycin formulation is in Phase II testing for the indication....
07:00 , Sep 8, 2008 |  BC Week In Review  |  Clinical News

Fluidosomes Tobramycin: Phase IIa started

Axentis began an international Phase IIa trial to evaluate 2 dosages of ARB-CF0223 in 24 patients with CF. The company licensed the product, which has European Orphan designation for the indication, from aRigen in December...
08:00 , Dec 11, 2006 |  BC Week In Review  |  Clinical News

Sorivudine: Phase II data

In the Phase II ARYS-0502 trial, twice-daily treatment with ARYS-01 cream led to a 30% reduction in rash area during initial 3 days of treatment vs. placebo. The trial was not powered to show significance....
07:00 , Apr 11, 2005 |  BC Week In Review  |  Clinical News

JA-001: IND submitted

Janus submitted an IND to begin by mid-year an open-label, U.S. Phase I trial in 16 healthy volunteers. aRigen Inc. , Tokyo, Japan   Janus Pharmaceuticals Inc. , Pasadena, Calif.   Product: JA-001   Business:...
07:00 , Sep 27, 2004 |  BC Week In Review  |  Clinical News

WAP 8294A2: Phase I started

aRigen began a single-dose, double-blind, placebo-controlled, U.S. Phase I trial in 40 healthy volunteers. aRigen Inc. , Tokyo, Japan   Product: WAP 8294A2   Business: Infectious   Molecular target: NA   Description: Depsipeptide antibiotic  ...