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Elan and Biogen Idec announced that ENCORE, the second Phase III
induction trial of Tysabri for the treatment of moderately to severely active
Crohn's disease (CD) in patients with evidence of active inflammation, met the
primary endpoint of clinical response as defined by a 70 point decrease in baseline
Crohn's Disease Activity Index (CDAI) score at both weeks eight and 12.
Barrier Therapeutics, a pharmaceutical company developing and commercializing
products in the field of dermatology, has announced that its oral antifungal
product candidate, hyphanox, failed to reach the primary endpoint of therapeutic
cure in its Phase III noninferiority trial for the treatment of vaginal candidiasis,
commonly known as a vaginal yeast infection.
Join FDAnews Thursday, July 14, for a 90-minute audioconference on "Accelerate
Clinical Trial Enrollment: Performance Metrics for Recruiting Subjects on Time
and on Budget." Learn from a pro on how to populate your studies, achieve
spectacular results for your site- and study-specific needs, and optimize your
resources. On July 19, join FDAnews for "Change Control: Current
Best Practices for FDA-Compliant Systems." Learn about the FDA's latest
change control requirements for processes, facilities, utilities, equipment,
computers, raw materials and documents from compliance expert, Barbara Immel.
New River Pharmaceuticals has announced that it has submitted an investigational
new drug application to the FDA for NRP290, New River's second compound under
development.
Santarus announced that the FDA has accepted for filing the company's new drug
application (NDA) for Zegerid (omeprazole) capsules in 20- and 40-mg dosage
forms.
Teva Pharmaceutical and Active Biotech have submitted an investigational new
drug application to the FDA to initiate a clinical trial in the U.S. with laquinimod
to assess drug-drug interaction.
Orchid Chemicals & Pharmaceuticals, based in Chennai, India,
has received FDA approval for its abbreviated new drug application (ANDA) for
cephalexin capsules USP in 250-, and 500-mg dosage strengths.
Patients participating in a 12-week pilot study for the Type II diabetes
supplement HPB-84 successfully reduced blood glucose levels as well as their
dependence on oral medication, reported HEE Corporation, the manufacturer of
HPB-84.
MannKind Corporation focused on discovering, developing and commercializing
treatments for diabetes and cancer, has announced that it has initiated patient
enrollment in its pivotal Phase III safety trial of inhaled Technosphere Insulin
in the United States.