The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug ...
Tags: Otsuka Tolvaptan NDA, Medicine
Q. My Medigap policy was cheap when I bought it but it's expensive now that I'm 76. I tried to switch to a cheaper plan but was turned down because of some health conditions. Will health care reform prevent Medigap plans from doing this? ...
Tags: Health Reform, Medigap Plans, Medicine
Some common Chinese herbal remedies contain aristolochic acid, which has been linked to kidney disease and cancer. And despite efforts by the Food and Drug Administration to keep the ingredient out of herbal products sold in this country, ...
The US Food and Drug Administration (FDA) has accepted for review AMAG Pharmaceuticals' supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for Intravenous (IV) use. The sNDA filed is to expand the indication for ...
Tags: FDA, Pharmaceuticals, oral iron treatment
Multinational pharmaceutical and diagnostics company OPKO Health has signed a definitive agreement to acquire Cytochroma. Under the purchase, OPKO intends to include Cytochroma's Replidea and Alpharen, which are in Phase 3 clinical trials ...
Tags: OPKO Health, Cytochroma, CKD, pharmaceutical
Takeda Pharmaceuticals has entered into a deal with US-based DSI Renal for the supply of its OMONTYS (peginesatide) injection, designed for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. ...
Tags: OMONTYS injection, anemia, chronic kidney disease, CKD patients
Japan Tobacco (JT), Keryx Biopharmaceuticals' Japanese partner, has filed a new drug application (NDA) for the marketing approval of Ferric Citrate (Zerenex) in Japan for the treatment of hyperphosphatemia in chronic kidney disease (CKD) ...
Tags: Ferric Citrate, Tobacco, CKD, Pharmaceutical
The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application (ANDA) for calcium acetate capsules. The generic equivalent of Phoslo Gelcaps are used to treat hyperphosphatemia in patients with end stage ...
Tags: FDA, Perrigo ANDA, calcium acetate capsules
AMAG Pharmaceuticals has submitted a supplemental new drug application (sNDA) for intravenous (IV) use of Feraheme injection, to FDA. The company is seeking approval for the label expansion of Feraheme to include all iron deficiency ...
Tags: Feraheme Injection, AMAG, SNDA
(i)Policy and Administrative Rules Catalogue of Related Laws Foreign Trade Law of the People's Republic of China Customs Law of the People's Republic of China Law of the People's Republic of China on Import and Export Commodity ...
Tags: jiangsu province, survey, economy, investment
The Food and Drug Administration (FDA) has accepted Dynavax Technologies' heplisav biologics license application (BLA) for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of ...
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
Concert Pharmaceuticals has received US patent for CTP-499, its drug candidate being developed for the treatment of diabetic nephropathy. CTP-499 is a potential treatment developed on the basis of DCE Platform for diabetic nephropathy, a ...
Nestlé Health Science has purchased an undisclosed stake in Accera, a privately-held US-based company that is involved in the development and the commercialization of medical foods for neurodegenerative disorders such as Alzheimer's ...
US based pharmaceutical company, Amgen has acquired KAI Pharmaceuticals. The acquisition, which was initially announced on 10 April 2012, includes KAI's main product KAI-4169, an agent being studied to treat secondary hyperparathyroidism ...