Takeda and Ajinomoto Pharmaceuticals have received approval from Japan's Health, Labour and Welfare Ministry for their Actonel 75 mg tablets and Benet 75 mg tablets, a once-monthly formulation of risedronate sodium hydrate to treat ...
Tags: Takeda and Ajinomoto Pharmaceuticals, Japan, Ajinomoto, tablet
Astellas Pharma and UCB have announced the marketing approval of Cimzia (certolizumab pegol) to treat rheumatoid arthritis (RA) in Japan. The Japanese Ministry of Health, Labor and Welfare has approved Cimzia as a 200mg syringe for ...
Tags: Astellas Pharma, UCB, marketing approval, rheumatoid arthritis, RA, Japan
When you talk with the executives of most U.S. companies the subject often turns to the global market and the opportunities for growth that countries like China offer. However, as that conversation continues the next thing you often hear is ...
Tags: China, opportunities, Intellectual Property, theft of IP
University of California San Francisco (UCSF) Medical Center has purchased BSD Medical's BSD-2000 hyperthermia system. UCSF Medical Center is involved in providing advanced technology and care to patients suffering with cancer. By ...
Tags: UCSF, BSD Medical, BSD-2000 hyperthermia system, cancer
The Antiviral Drugs Advisory Committee of the FDA has recommended the approval of Gilead's Quad to treat HIV-1 infection in treatment-naive adults. The Quad is a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine ...
Tags: gilead's quad, HIV-1, quad NDA
The European Commission has granted marketing authorization for Pharmaxis' Bronchitol as an add on therapy to cystic fibrosis (CF). The company developed Bronchitol to aid clear the airways of CF patients. Pharmaxis CEO Alan Robertson ...
Tags: cystic fibrosis, CF, Pharmaxis'Bronchitol
Astellas Pharma has received Japanese marketing approval for Kiklin capsules to treat hyperphosphatemia in patients on dialysis with chronic kidney disease. Kiklin capsules, amine-functional polymers, bind to phosphate in the ...
Tags: Kiklin capsules, hyperphosphatemia, chronic kidney disease
Pharmaceutical Research and Manufacturers of America (PhRMA), and Analysis Group (AG), an economic consulting firm, have selected Medidata Solutions' (MDSO) cost databases for clinical trial analysis. PhRMA and AG are analyzing the costs ...
Tags: PhRMA, Analysis Group, MDSO, CROCAS databases
Pharmaceutical firm Merck has reported a 4% decline in its net sales in the third quarter 2012 to $11.5bn, as against $12.02bn for the same quarter in 2011. The firm's GAAP net income for the third quarter declined to $1.79bn, down from ...
Tags: Pharmaceutical firm Merck, Merck's pharmaceutical sales
Astellas Pharma's Gonax drug used in the treatment of prostate cancer, has been awarded marketing rights in Japan. Based on the positive results from phase I, II studies in Japan and phase III studies in abroad, Astellas has applied for ...
BioTime has signed an exclusive sublicense agreement and a supply agreement with Jade Therapeutics for ophthalmological drug delivery applications of HyStem technology. According to the agreement, BioTime will provide Jade with ...
Tags: HyStem technology, Biotime, Jade Therapeutics, ophthalmological drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended SkyePharma's flutiform (fluticasone propionate/formoterol fumarate) for European marketing approval. Flutiform is a ...
Tags: Skyepharma Flutiform, SkyePharma, long-acting beta-agonist
Wockhardt, a pharmaceutical and biotechnology company, has received final FDA approval for marketing 100mg, 150mg and 200mg 12 hour extended release tablets of Bupropion HCl indicated for depression. Wockhardt has announced the immediate ...
The US FDA has accepted ThromboGenics'biologics license application for ocriplasmin intravitreal injection,2.5mg/ml and granted it priority review. The company proposed the injection for the treatment of symptomatic Vitreomacular ...
ArQule and Daiichi Sankyo have signed a special protocol assessment (SPA) agreement with the FDA for Phase 3 trial of Tivantinib in hepatocellular carcinoma (HCC). The SPA process enables FDA to offer official evaluation and written ...
Tags: ArQule, Daiichi Sankyo, SPA, FDA