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Alnylam Pharmaceuticals, a leading RNAi therapeutics company, announced a collaboration
with researchers from the University of Georgia to discover and develop a Direct
RNAi therapeutic for the treatment and prevention of respiratory infection from
newly emerging, highly pathogenic strains of influenza (flu) virus.
Data from the community-acquired pneumonia (CAP) outcome in high bacterial resistance
areas (COBRA) study, a randomized clinical superiority trial, showed that the
clinical efficacy of telithromycin (marketed as KETEK) in outpatients with CAP
is superior to that of local standard first-line oral antibiotic therapy in
areas with a high prevalence of penicillin or macrolide-resistant Streptococcus
pneumonia.
Corgentech has begun treating patients in a multicenter Phase I/II clinical
trial of its NF-kappaB Decoy (NF-kB Decoy) drug candidate for the treatment
of atopic dermatitis, a chronic skin disease also known as eczema that affects
about 15 million adults in the U.S.
Nuvelo has announced the completion of patient enrollment in its Phase IIa clinical
trial of recombinant nematode anticoagulant protein c2 (rNAPc2), showing that
rNAPc2 has an acceptable safety profile and is well-tolerated in doses up to
10 mcg/kg, in patients with non-ST-elevation acute coronary syndromes (ACS).
Dendreon has announced results of an open-label Phase II study of Provenge (APC8015)
as a monotherapy in men with rising PSA post definitive local therapy (androgen-dependent
prostate cancer).
Teva Pharmaceutical has received final approval from the FDA for its abbreviated
new drug application for clarithromycin extended-release tablets in a 500-mg
dosage form.
Depomed has received FDA approval for Proquin XR, a once-daily, extended-release formulation of ciprofloxacin HCl for the treatment of uncomplicated urinary tract infections (UTIs).
The FDA has granted Ivax tentative approval for its abbreviated new drug application
for levofloxacin tablets in 250-, 500- and 750-mg dosage strengths.