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Telik reported positive interim data from two ongoing, multicenter Phase II
clinical studies evaluating Telcyta (TLK286) in combination with standard chemotherapy
in the first-line treatment of advanced non-small cell lung cancer (NSCLC).
Salix has begun enrolling and dosing subjects in a Phase III study to evaluate
the efficacy and safety of Xifaxan (rifaximin) 200-mg tablets for the prevention
of travelers' diarrhea (TD).
BioSante recently unveiled Phase III safety and efficacy results for its Bio-E-Gel
(bioidentical estradiol transdermal gel) for the treatment of moderate-to-severe
hot flashes in menopausal women.
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.
Barr Laboratories has received final approval from the FDA for its generic version
of DDAVP (desmopressin acetate) tablets in 0.1- and 0.2-mg dosage strengths.
Teva Pharmaceutical has received final approval from the FDA to market mirtazapine
orally disintegrating tablets in 15-, 30- and 45-mg dosage strengths.
Helix BioMedix, a developer of synthetic bioactive peptides, announced that
research published in the July 2005 issue of Antimicrobial Agents and Chemotherapy
shows that small bioactive peptides have the potential to attack two of
the components -- infection and inflammation -- responsible for the progression
of lung damage in cystic fibrosis (CF) disease.
New data presented at the European Neurological Society Meeting demonstrated
the clinical and magnetic resonance imaging (MRI) effects of Copaxone (glatiramer
acetate injection) in the treatment of relapsing-remitting multiple sclerosis
(RRMS).