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Immune Response has announced preliminary Phase II study results suggesting that both Remune and IR103, its first- and second-generation HIV vaccine candidates, stabilize CD4+ T-cell counts compared with placebo in HIV patients who have not started antiretroviral therapy.
BioMarin Pharmaceutical announced results from its Phase IIa, placebo-controlled, double-blind study of 6R-BH4 in patients with poorly controlled hypertension.
Schering-Plough has announced the publication of a multicenter Phase II clinical trial in the February issue of Annals of Oncology, which found treatment with Caelyx (pegylated liposomal doxorubicin hydrochloride), in combination with carboplatin, to be highly effective in patients with advanced ovarian cancer that had been previously treated.
Auxilium Pharmaceuticals has announced positive final results from a Phase III study of its lead product AA4500 in the treatment of Dupuytren's contracture, a disabling and recurring condition in which the joints in the hand contract.
Mylan Laboratories announced that Mylan Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application for generic propranolol hydrochloride extended-release capsules, 60, 80, 120 and 160 mg.
Tibotec Pharmaceuticals announced that the European Commission (EC) has granted a conditional marketing authorization for Prezista (darunavir), a protease inhibitor for the treatment of HIV-1.
GPC Biotech announced it has completed the rolling submission of a new drug application (NDA) to the FDA for satraplatin for the treatment of patients with androgen-independent prostate cancer who have failed prior chemotherapy.
Gilead Sciences announced that the FDA has accepted for filing and granted priority review to its new drug application (NDA) for ambrisentan, 5 and 10 mg, for the once-daily treatment of pulmonary arterial hypertension (PAH).