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D-Pharm has announced the successful completion of the Phase IIb trial for its neuroprotective compound DP-b99 in the treatment of acute ischemic stroke patients.
Genentech has announced results from a randomized, Phase II study comparing pertuzumab plus gemcitabine to gemcitabine alone in women with platinum-resistant ovarian, primary peritoneal or fallopian tube cancer.
Vical has begun a Phase III pivotal trial of the company's Allovectin-7 cancer immunotherapeutic as first-line therapy in chemotherapy-naive patients with recurrent stage III or IV metastatic melanoma.
Join FDAnews Tuesday, Jan. 9, for "Pharma Marketing Laws: State by State: Strategies for Compliance with Patchwork Regulations." In this 90-minute interactive audioconference, Keith Korenchuk, attorney with Covington & Burling, will deliver clear guidance on the regulations in the three states (California, Florida and New Hampshire) that enacted new drug marketing laws in 2006, along with the states that already have drug marketing laws in place.
Lupin Pharmaceuticals announced that the FDA has granted tentative approval to the company's abbreviated new drug application (ANDA) for sertraline HCl tablets, 25, 50 and 100 mg.
Daiichi Sankyo has filed a supplemental new drug application (sNDA) with the FDA for WelChol (colesevelam HCl) to improve glycemic control in patients with Type 2 diabetes.
Genzyme announced it has filed a new drug application (NDA) with the FDA seeking approval of sevelamer carbonate for the control of serum phosphorus in patients with chronic kidney disease on dialysis.