Heart Disease News and Research

Latest Heart Disease News and Research

Third-quarter financial results of Boston Scientific announced

Boston Scientific Corporation today announced financial results for the third quarter ended September 30, 2009, as well as guidance for net sales and earnings per share (EPS) for the fourth quarter and full year 2009.

20 Oct 2009

Boehringer Ingelheim's TWYNSTA approved by FDA for the treatment of hypertension

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved TWYNSTA®, a new highly effective single pill combination therapy of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]). TWYNSTA® is indicated for the treatment of hypertension, alone or with other antihypertensive agents, and as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

20 Oct 2009

FDA approves new oral medication for renal cell carcinoma

The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.

20 Oct 2009

UCB reports on the outcome of Cimzia and MTX treatment for rheumatoid arthritis

UCB today announced data that showed rapid and sustained improvements in ACR20, physical function, pain and fatigue of rheumatoid arthritis (RA) as early as the first week, and inhibition of progression of structural joint damage (seen at week 24) following treatment with Cimzia (certolizumab pegol), together with methotrexate (MTX), was sustained up to 100 weeks.

19 Oct 2009

Scientists find cause for lupuslike disease in mice

Macrophages, the scavenger cells of the body's immune system, are responsible for disposing of dying cells. Stanford University School of Medicine researchers have identified one pathway in this important process in mice that, if disrupted, causes a lupuslike autoimmune disease.

19 Oct 2009

More details emerging on health reform's proposed changes to Medicare

The Dallas Morning News reports on some of health reform's proposed changes to Medicare and local consumer reactions. "The 10.4 million beneficiaries with private insurers' Medicare Advantage plans will still get coverage at least comparable to regular Medicare, but some will see fewer extra benefits or higher out-of-pocket costs. For most of Medicare's 45 million beneficiaries, an overhaul will improve coverage by beefing up drug benefits, preserving access to physicians, paying for more preventive care and putting Medicare on firmer financial footing."

19 Oct 2009

FDA approves Boehringer Ingelheim's MICARDIS for the reduction of risk of heart attack

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved a new indication for MICARDIS® (telmisartan) for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors. MICARDIS® is the first treatment in its class to be approved for this indication.

19 Oct 2009

Amarin selects Medpace as CRO for its Phase 3 AMR101 MARINE clinical study

Amarin Corporation plc today announced that it has executed an agreement with Medpace, Inc. (‘Medpace’), a leading Contract Research Organization (CRO) with expertise in conducting clinical trials in cardiovascular and metabolic disease, to engage their services in the execution of its Phase 3 clinical trials with AMR101 in patients with very high triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia.

19 Oct 2009

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.(1) MICARDIS is the most studied ARB in this high-risk patient population and has been commercially available to treat hypertension (high blood pressure) since its approval in 1998.

19 Oct 2009

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

New long-term data from two pivotal, Phase 3 clinical trials showed that patients with active rheumatoid arthritis (RA) receiving SIMPONI(TM) (golimumab) every four weeks achieved sustained improvements in signs and symptoms and physical function response through one year. These new data were presented today at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting.

19 Oct 2009

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

Endo Pharmaceuticals today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for FORTESTA(TM) (testosterone) 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.

19 Oct 2009

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis.

19 Oct 2009

Amarin raises $70 million through private placement

Amarin Corporation plc today announced it has closed its $70 million private placement. The transaction was led by existing investor, Fountain Healthcare Partners, on behalf of funds affiliated with other existing investors Sofinnova Ventures, Orbimed Advisors and Longitude Capital. The new investor group was led by funds affiliated with Abingworth LLP and included APG Asset Management, Great Point Partners, Tavistock Life Sciences Company and RA Capital. Cowen and Company, LLC acted as the exclusive placement agent for the transaction.

19 Oct 2009

PLC Systems' RenalGuard to be utilized in a live case transmission at the GISE 2009 conference

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today announced that its RenalGuard System(TM) will be utilized as part of a live case transmission from the Clinica Mediterranea, Naples, Italy, to the 30th Congresso Nazionale della Societa' Italiana di Cardiologia Invasiva (GISE) during the conference.

19 Oct 2009

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Schering-Plough announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.

19 Oct 2009

Hansen Medical announces its plan to restate its previous financial results

Hansen Medical, Inc. today announced that it plans to restate its financial statements for the year ended December 31, 2008 and for the quarters ended March 31, 2008, June 30, 2008, September 30, 2008, March 31, 2009 and June 30, 2009 in order to correct certain errors, some of which arose from potential irregularities occurring outside of the accounting department, regarding the timing of revenue recognition on the sale of some of its Sensei® Robotic Catheter Systems.

19 Oct 2009

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

XenoPort, Inc. announced today that it has initiated a Phase 2b clinical trial of arbaclofen placarbil (AP), also known as XP19986, in patients with gastroesophageal reflux disease (GERD) who remain symptomatic despite treatment with a proton pump inhibitor (PPI). The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AP as adjunctive therapy to PPIs.

19 Oct 2009

Metabolic master switch sets the biological clock in body tissues

Our body's activity levels fall and rise to the beat of our internal drums-the 24-hour cycles that govern fundamental physiological functions, from sleeping and feeding patterns to the energy available to our cells. Whereas the master clock in the brain is set by light, the pacemakers in peripheral organs are set by food availability. The underlying molecular mechanism was unknown.

19 Oct 2009

Chinese SFDA approves China Medical Technologies' SPR System

China Medical Technologies, Inc., a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, today announced that the Company has received approval for its SPR- based analysis system (the "SPR System") from the State Food and Drug Administration of China (the "SFDA").

19 Oct 2009

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009