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KV Pharmaceutical has received approval from the FDA to market six strengths of extended-release diltiazem HCl capsules, an AB-rated generic of Forest Laboratories' Tiazac, through its wholly owned generic subsidiary, ETHEX.
ZLB Behring has announced the start of the VIRTUE trial, a Phase IV trial of Vivaglobin (immune globulin subcutaneous, human), the first and only FDA-approved subcutaneous immunoglobulin treatment for patients with primary immunodeficiency.
ConjuChem Biotechnologies has announced that final data from its Phase I/II, single-escalating-dose study for the treatment of Type 2 diabetes using the company's proprietary PC-DAC:Exendin-4 compound shows an excellent tolerability profile, positive efficacy on glucose reduction and extended duration of activity.
Neurocrine Biosciences has announced positive safety and efficacy results from review of the second off-treatment three-month period of its six-month, proof-of-concept, safety, efficacy and dose-finding Phase II clinical trial using its proprietary, orally active, small-molecule gonadotropin-releasing hormone (GnRH) receptor antagonist (NBI-56418).
Synta Pharmaceuticals has released positive data from a Phase IIb study in metastatic melanoma for STA-4783, a first-in-class heat shock protein 70 (Hsp70) inducer that activates natural killer (NK) cell-mediated tumor killing.
New River Pharmaceuticals has announced that the enrollment numbers have been met for the company's NRP104.303 study, a Phase III trial to examine the safety and efficacy of NRP104 as a treatment for attention-deficit/hyperactivity disorder (ADHD) in adult populations (ages 18 to 52).
The Medicines Company has provided an update of its Phase III clinical trials of clevidipine, an intravenous, ultra-short-acting calcium channel blocker intended for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.