Otsuka Pharmaceutical / SAMSCA™ Tablets 15mg (tolvaptan), Vasopressin V2-Receptor Antagonist, Receive Regulatory Approval in Japan

October 27, 2010 – Otsuka Pharmaceutical Co., Ltd. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved SAMSCA™ (nonproprietary name: tolvaptan), a vasopressin V2-receptor antagonist, for the treatment of excess water retention in patients with cardiac failure when the treatment by other diuretics including loop diuretics is ineffective.

SAMSCA is a nonpeptide vasopressin V2-receptor antagonist discovered by Otsuka Pharmaceutical in 1991 with a unique mechanism of action that selectively blocks the binding of vasopressin to the V2-receptors in the collecting duct of the kidney. The binding of vasopressin with V2-receptors can cause water retention. By inhibiting the effects of vasopressin at the V2-receptor, SAMSCA increases the excretion of free water and reduces the re-absorption of water from urine into the blood without directly affecting the excretion of sodium and other electrolytes.

"Our research and development on vasopressin V2-receptor antagonists, that began in the early 1980s, was in response to requests from the medical profession for a diuretic that excretes only water," said Taro Iwamoto, Ph.D., President and Representative Director, Otsuka Pharmaceutical... Otsuka Pharmaceutical's Press Release -

Takeda: European Marketing Authorisation Application for Azilsartan Medoxomil, an Investigational Compound for the Treatment of Essential Hypertension

October 20, 2010 – Takeda Pharmaceutical Company Limited (Takeda) announced that Takeda Global Research & Development Centre (Europe), Ltd. submitted a Marketing Authorisation Application (MAA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB), to the European Medicines Agency (EMA) for the treatment of essential hypertension. The EMA has confirmed that the submission has been validated for assessment.

High blood pressure, or hypertension, was responsible for 7.6 million preventable deaths worldwide in 2001. Almost half (44 percent) of the adult population in Europe is affected by hypertension - much (approximately 60 percent) higher than in the United States and Canada. Discovered by Takeda, azilsartan medoxomil is a prodrug of the active moiety azilsartan, which lowers blood pressure by blocking the action of a vasopressor hormone, angiotensin II. The discovery and development of azilsartan medoxomil continues Takeda’s commitment to the treatment of hypertension, and builds upon the company’s long-standing clinical experience with its previously discovered antihypertensive agent candesartan.

The MAA submission for azilsartan medoxomil monotherapy was supported by positive results from a clinical development program which included nine phase 3 clinical trials in which approximately 7000 subjects with essential hypertension were enrolled of whom 4814 unique subjects received at least 1 dose of azilsartan medoxomil. The safety and efficacy of azilsartan medoxomil was studied for initial therapy as a once-daily oral monotherapy or for co-administration with other antihypertensive medications, including the diuretics chlorthalidone and hydrochlorothiazide, and the calcium channel blocker, amlodipine. It was also studied in comparison with olmesartan medoxomil, valsartan6 and ramipril... Takeda' Press Release -

SynCardia Systems : UCSD Medical Center to Begin Certification for Total Artificial Heart

Oct. 14, 2010 - World Renowned Heart Surgeon Dr. Jack Copeland Brings World's Only Approved Total Artificial Heart to La Jolla – SynCardia Systems, Inc. announced that the University of California, San Diego (UCSD), led by Stuart W. Jamieson, M.B., F.R.C.S., Head of Cardiothoracic Surgery, will begin certification to implant the SynCardia temporary Total Artificial Heart. Efforts to bring the Total Artificial Heart to UCSD were led by world renowned heart surgeon, Dr. Jack Copeland, who joined the faculty in July.
"One of my main goals is to help support the heart transplant and ventricular assist device program at UCSD," said Dr. Copeland. "Many patients who need a heart transplant won't live long enough to receive one. The Total Artificial Heart is the only device capable of saving even the sickest patients and bridging them to transplant. At UCSD, I hope to achieve, if not surpass, the level of success we experienced with the Total Artificial Heart at University Medical Center in Tucson."
In 1990, UCSD performed its first heart transplant and has performed 180 overall with excellent results. In 2011, construction is expected to be completed for UCSD's new $227 million Sulpizio Family Cardiovascular Center, a 128,000-square-foot facility which will house heart and stroke care in one location... SynCardia Systems' Press Release -

Welch Allyn : Connex® ProBP™ 3400 to Markets Outside the US and Canada

2010-10-04 - Welch Allyn Introduces Handheld Digital Blood Pressure Device to Markets Outside the United States and Canada - Connex® ProBP™ 3400 delivers fast, reliable, EMR-ready blood pressure readings using company’s patented SureBP™ technology and Bluetooth® wireless technology
Welch Allyn, a leading global provider of frontline medical products and solutions, today introduced the Connex® ProBP™ 3400, an automated digital blood pressure device designed to fit in the palm of the hand. Borrowing Welch Allyn SureBP™ technology from the company’s multiparameter vital signs devices, the Connex ProBP delivers fast, accurate blood pressure readings with the durability of Welch Allyn’s popular hospital-grade vital signs devices. Now available in markets outside the United States and Canada, the Welch Allyn Connex ProBP is easy to use and provides a portable option for capturing reliable blood pressure readings in virtually any hospital or primary care environment.
“In today’s demanding healthcare environment, providers sometimes need a single, simple and easy-to-use blood pressure device that can capture readings quickly, easily and accurately... Welch Allyn's Press Release -