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FDA approves Boehringer Ingelheim's Pradaxa for stroke risk reduction in patients with non-valvular AF

The US Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate), Boehringer Ingelheim's novel, oral direct thrombin inhibitor for stroke risk reduction in patients with non-valvular atrial fibrillation (AF) marking the first approval of a new oral anticoagulant in the U.S. in more than 50 years.

20 Oct 2010

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

19 Oct 2010

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.

18 Oct 2010

Raloxifene drug may be useful in treating kidney disease in women: Study

The osteoporosis drug raloxifene may be useful in treating kidney disease in women, suggests a new study led by Michal Melamed, M.D., M.H.S., assistant professor of medicine and epidemiology & population health at the Albert Einstein College of Medicine of Yeshiva University.

7 Oct 2010

ADRCs cells improve survival in acute kidney injury animal model

Preclinical data was published today on research performed by Cytori Therapeutics (NASDAQ:CYTX) showing adipose (fat)-derived stem and regenerative cells (ADRCs), either fresh or banked, demonstrated statistically significant improvements in animal survival and kidney function in an acute kidney injury animal model.

6 Oct 2010

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

6 Oct 2010

Merck to appeal against jury verdict in retrial of federal FOSAMAX case

Merck & Co., Inc. today said it will appeal a decision by the U.S. District Court for the Southern District of New York that reduced the jury verdict from $8 million to $1.5 million but denied Merck's request for judgment in its favor or a new trial in the case of Boles v. Merck, a retrial of a federal FOSAMAX case.

5 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

Benicar better than Cozaar in reducing blood pressure: Study

New study results show that patients treated with Benicar® (olmesartan medoxomil) 40 mg once daily had significantly greater reductions in blood pressure and higher rates of goal attainment than patients receiving Cozaar® (losartan potassium) 100 mg once daily at week 8, according to findings of a new head-to-head study presented today at the late breaker session at the 23rd Scientific Meeting of the International Society of Hypertension (ISH) in Vancouver, Canada.

1 Oct 2010

FDA updates dosing recommendation for Valcyte medication

The U.S. Food and Drug Administration is notifying health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant.

16 Sep 2010

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

Moderate consumption of coffee benefits aortic distensibility in hypertensive elderly individuals

A detailed study conducted by a team from the University of Athens on the Aegean island of Ikaria has demonstrated that moderate consumption of coffee by hypertensive elderly individuals can lead to improvements in aortic distensibility. Distensibility is a measure of the elasticity of arteries, and low levels have long been recognised as an indicator of atherosclerosis and a reliable predictor of future cardiovascular events.

2 Sep 2010

FDA approves Novartis' Tekamlo for treatment of high blood pressure

The US Food and Drug Administration (FDA) approved Tekamlo™ (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna® (aliskiren), with the widely used calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

27 Aug 2010

Sport Endurance develops new formula that enables safe consumption of Creatine

Sport Endurance, Inc, a health supplement company, has developed a revolutionary formula that enables the safe consumption of Creatine, a proven muscle-building and performance enhancing dietary supplement.

17 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Study on link between SNP and concentrations of serum creatinine

Scientists at deCODE genetics and colleagues at Radboud University in the Netherlands today describe how the impact of a single letter variation in the sequence of the human genome conferring risk of kidney disease varies with age and with the onset of other diseases. The study provides independent confirmation of the association made in an earlier study between a version of the the SNP, located on chromosome 16p12, and risk of chronic kidney disease. It also confirmed the link between the SNP and concentrations of serum creatinine, a key indicator of kidney function.

30 Jul 2010

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

29 Jul 2010

Intensive chemotherapy may benefit elderly patients with acute myeloid leukemia

The prognosis for nearly three-quarters of elderly patients on intensive chemotherapy for acute myeloid leukemia (AML) is poor, with a median survival of less than six months, according to a study published online today in Blood, the journal of the American Society of Hematology. AML is the most common form of acute leukemia among adults and is a rapidly growing cancer of the bone marrow that requires immediate treatment. The average age at diagnosis is 67, and more than 12,000 people will be diagnosed with AML this year (according to the National Cancer Institute).