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VIVUS seeks marketing approval of QNEXA in the EU

VIVUS, Inc. today announced that the company filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for QNEXA® (phentermine/topiramate) Controlled Release Capsules in the European Union (EU). The proposed indication in the EU is for the treatment of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a mildly hypocaloric diet.

20 Dec 2010

Chelsea completes successful NORTHERA pre-NDA assessment with FDA

Chelsea Therapeutics International, Ltd. announced it has completed a pre-NDA assessment with the U.S. Food and Drug Administration (FDA) and intends to accelerate its new drug application (NDA) for NORTHERA™(droxidopa) for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), a chronic and potentially debilitating drop in blood pressure upon standing commonly associated Parkinson's disease, multiple system atrophy and pure autonomic failure.

20 Dec 2010

Progress report on 'Strategy for Europe on nutrition, overweight and obesity'

December has been a busy month for the European Commission, and Despina Spanou, Principal Adviser at the Directorate General for Health and Consumers, talks to EUFIC, about Europe's Nutrition Strategy mid-term progress report, the evaluation of the EU Platform for Action on Diet, Physical Activity and Health, the OECD/EC report "Health at a Glance: Europe 2010", and the Belgian Presidency/EC Conference on Monitoring and Evaluation of EU and Member States' strategies on nutrition, overweight and obesity-related health issues.

20 Dec 2010

NAFC forms council to establish independent quality standards for incontinence products

The National Association For Continence (NAFC) is heading a newly formed council with the objective of establishing national, independent quality standards for disposable adult absorbent products provided by states to Medicaid waiver recipients cared for in their private homes rather than as residents of a state-funded nursing home.

20 Dec 2010

Comprehensive guidance for care providers on Dementia Care Mapping process

Dementia is a critical health concern, but are the current care services able to offer appropriate support? Only a few days ago, the review by the Royal College of Psychiatrists found many dementia patients were not getting the support on nutrition and mental health that they should. The need for improved care is higher than ever.

20 Dec 2010

Phadia to market diagnostic products in India

Import, sales and distribution of Phadia's allergy, asthma and autoimmunity diagnostics products, including ImmunoCAP and EliA, have been commercially approved by the Indian authorities.

20 Dec 2010

SEEK announces new joint venture entity with Pernix Therapeutics for antitussive drug development

SEEK, a leading UK privately-owned drug-discovery group, is pleased to announce the establishment of a new joint venture entity with Pernix Therapeutics Holdings, an integrated specialty pharmaceutical company focused primarily on the United States pediatric market.

20 Dec 2010

FVCG invests $175,000 in Celvive for stem cell research in spinal cord injury

Spinal cord injury (SCI) is a devastating neurological condition with limited therapeutic options. In the United States alone, there are more than 250,000 people living with SCI; approximately three million worldwide are affected.

20 Dec 2010

Novartis' Gilenya uptake to increase

A study published this week by ITG revealed that Novartis recently approved drug, Gilenya, has already taken share from market leaders in the multiple sclerosis (MS) market, and uptake is expected to increase significantly over the next year. Gilenya came onto the market in late September as the first FDA-approved oral disease-modifying MS drug, and Novartis initially faced safety concerns and monitoring requirements that deterred some physicians from adopting the new drug.

20 Dec 2010

Researchers demonstrate that monensin antibiotic prevents prostate cancer cell growth

Researchers from VTT Technical Research Centre of Finland and the University of Turku have demonstrated that an antibiotic called "monensin" prevents the growth of prostate cancer cells. Monensin is used in the meat and dairy industry, for example.

20 Dec 2010

Cardio3 BioSciences presents positive C3BS-GQR-1 results in patients with acute myocardial infarction

Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces positive pre-clinical results from its in-house product candidate C3BS-GQR-1, to treat patients suffering from acute myocardial infarction in order to protect cardiac tissue from damage and direct heart stem cells to mature and restore pump function.

20 Dec 2010

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

Inspire Pharmaceuticals, Inc. announced today that the results from its first Phase 3 clinical trial with denufosol tetrasodium for cystic fibrosis (CF), TIGER-1, have been published in the peer-reviewed publication, American Journal of Respiratory and Critical Care Medicine (AJRCCM). Denufosol is an investigational, inhaled, novel ion channel regulator currently in Phase 3 clinical development for the treatment of CF.

20 Dec 2010

Sanofi-aventis, Oxford University to conduct multi-phase oncology research in India

Sanofi-aventis US and Oxford University have entered into an agreement to conduct multi-phase oncology clinical and epidemiological research with INDOX, India's leading academic oncology network.

20 Dec 2010

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.

20 Dec 2010

EpiTherapeutics, Abbott to develop new anti-cancer drugs

EpiTherapeutics and Abbott today announced a collaboration agreement to develop new anti-cancer drugs by making small-molecule inhibitors against selected epigenetic oncology targets.

20 Dec 2010

Avila, sanofi-aventis enter global alliance to discover targeted covalent drugs for treatment of cancers

Avila Therapeutics, Inc. announced today that it has signed a worldwide strategic alliance with sanofi-aventis to discover targeted covalent drugs for the treatment of cancers. Under the alliance agreement sanofi-aventis obtains a worldwide exclusive license to develop and commercialize the compounds resulting from the discovery collaboration.

20 Dec 2010

$FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for drug refractory PAF$

FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for drug refractory PAF

Medtronic, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its Arctic Front® Cardiac CryoAblation Catheter system, the first and only Cryoballoon in the United States indicated for the treatment of drug refractory paroxysmal atrial fibrillation (PAF). The Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.

20 Dec 2010

State Roundup: UMass bone marrow registry practices probed; Insurance woes hit many Calif. middle income families

Bone marrow registries are usually noble efforts to find donors with the right genetic match to save the life of a terminally ill person, but one such program in New England is under investigation by attorneys general in two states (Greenberg, 12/17).

20 Dec 2010

RXi's dermal anti-scarring candidate selected to advance into development

RXi Pharmaceuticals Corporation, a recognized leader in RNAi-based therapeutic discovery and development, today announced the selection of its first RNAi therapeutic product candidate to advance into development.

20 Dec 2010

Researchers examine socio-economic consequences of hypersomnia

Danish sleep researchers at the University of Copenhagen and the Danish Institute for Health Services Research have examined the socio-economic consequences of the sleep disorder hypersomnia in one of the largest studies of its kind.

20 Dec 2010

Medical Condition News

VIVUS seeks marketing approval of QNEXA in the EU

Chelsea completes successful NORTHERA pre-NDA assessment with FDA

Progress report on 'Strategy for Europe on nutrition, overweight and obesity'

NAFC forms council to establish independent quality standards for incontinence products

Comprehensive guidance for care providers on Dementia Care Mapping process

Phadia to market diagnostic products in India

SEEK announces new joint venture entity with Pernix Therapeutics for antitussive drug development

FVCG invests $175,000 in Celvive for stem cell research in spinal cord injury

Novartis' Gilenya uptake to increase

Researchers demonstrate that monensin antibiotic prevents prostate cancer cell growth

Cardio3 BioSciences presents positive C3BS-GQR-1 results in patients with acute myocardial infarction

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

Sanofi-aventis, Oxford University to conduct multi-phase oncology research in India

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

EpiTherapeutics, Abbott to develop new anti-cancer drugs

Avila, sanofi-aventis enter global alliance to discover targeted covalent drugs for treatment of cancers

FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for drug refractory PAF

State Roundup: UMass bone marrow registry practices probed; Insurance woes hit many Calif. middle income families

RXi's dermal anti-scarring candidate selected to advance into development

Researchers examine socio-economic consequences of hypersomnia

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