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FzioMed receives FDA approval for independent review of PMA for Oxiplex Gel

FzioMed, a medical device company that recently celebrated the 17th anniversary of its founding, has received approval from the Commissioner of the U.S. Food and Drug Administration of its Petition for an independent review of its premarket approval application for Oxiplex Gel.

4 Nov 2013

Study examines impact of sleep on children's eating behaviors

It seems everyone is looking for a culprit when it comes to childhood obesity: fast food, sugary drinks, super-sized everything. But it turns out part of the blame may lie with the simple matter of turning out the lights and rolling into bed.

4 Nov 2013

Research roundup: States struggling with Medicaid expansion "complex issues"

We conducted a secondary analysis of data (2005 to 2010) from the Medical Expenditure Panel Survey. ... Comparisons were made between 2 groups to reflect likely movements in insurance status after the Patient Protection and Affordable Care Act implementation: (1) the uninsured who will be Medicaid eligible afterward versus Medicaid insured, and (2) the uninsured who will be Medicaid ineligible afterward versus the privately insured. ...

4 Nov 2013

Simple tool to identify patients at risk of engaging in "medication tradeoffs" after liver transplantation

Researchers at Northwestern University and Emory University propose a simple tool to identify patients who are at risk of engaging in "medication tradeoffs." The study authors address the problem of patients with financial hardship who make the regular choice of meeting basic needs such as buying food rather than paying for medications after receiving a liver transplant.

4 Nov 2013

New therapeutic approach for treating type 2 diabetes

Scientists from the Helmholtz Zentrum München (HMGU) and the Technische Universität München (TUM), together with scientists in the USA, have developed a new therapeutic approach for treatment of type 2 diabetes.

31 Oct 2013

Array BioPharma reports net loss of $0.13 per share for first quarter of fiscal 2014

Array BioPharma Inc. today reported results for the first quarter of its fiscal year ending June 30, 2014.

31 Oct 2013

Actavis seeks FDA approval to market Isotretinoin Capsules

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Isotretinoin Capsules, 10 mg, 20 mg, 30 mg and 40 mg.

31 Oct 2013

Mylan's revenues decrease 2% to $1.77B in third quarter 2013

Mylan Inc. today announced its financial results for the three and nine months ended September 30, 2013.

31 Oct 2013

ARIAD temporarily suspends commercial distribution of Iclusig drug in US

ARIAD Pharmaceuticals, Inc. today announced that it is temporarily suspending the marketing and commercial distribution of Iclusig® (ponatinib), a treatment for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), in the United States, while it continues to negotiate updates to the U.S. prescribing information for Iclusig and implementation of a risk mitigation strategy.

31 Oct 2013

Researchers explore strategies that would optimize fresher blood for patients

Although clinical evidence is lacking on the relationship between the storage time of red blood cells and outcomes in transfused patients, the authors of a review article in the November 2013 issue of The Annals of Thoracic Surgery are advocating for a modernized blood management system—similar to inventory management systems seen in the retail sector—to potentially reduce patient complications.

31 Oct 2013

Meal replacements and high protein diet can help weight loss maintenance

New research shows that there are several effective strategies available to people wanting to avoid regaining weight after a successful diet. Anti-obesity drugs, meal replacements and a high protein diet can help weight loss maintenance, according to a meta-analysis published in the scientific periodical The American Journal of Clinical Nutrition.

31 Oct 2013

Viewpoints: House Republicans help themselves, and the country, with smart, tough questions to Tavenner; Kentucky senators out of step with eager constituents; replace health law with single payer system

When House Republicans direct their opposition to Obamacare toward aggressive oversight rather than apocalyptic budget shenanigans, they can do themselves and the country a lot of good. That was obvious when the House Ways and Means Committee posed some smart, tough questions about HealthCare.gov to Marilyn Tavenner, who, as the administrator of the Centers for Medicare and Medicaid Services, is perhaps the person most directly responsible for the fiasco. Yes, there were a few "gotcha" questions meant to showcase individual representatives' hatred of the health-care law. But for the most part, the queries seemed designed to find a path toward more competent management of the Patient Protection and Affordable Care Act (10/29).

31 Oct 2013

Listeria's resistance to disinfectants

Recent years have seen significant outbreaks of listeriosis on both sides of the Atlantic. Although the disease can usually be treated successfully, it is occasionally fatal, most frequently in pregnant women or immunocompromized people.

31 Oct 2013

EcoHealth Alliance discovers new SARS-like coronavirus in Chinese horseshoe bats

EcoHealth Alliance, a nonprofit organization that focuses on local conservation and global health issues, announced the discovery of a new SARS-like coronavirus (CoV) in Chinese horseshoe bats.

31 Oct 2013

Losing weight not always have positive effect on romantic relationship

Losing weight is generally beneficial for human health, but when one partner in a romantic relationship loses weight, it doesn't always have a positive effect on the relationship.

31 Oct 2013

Researchers highlight presence of specific antibodies that regulate appetite in obese patients

Obesity affects more than 15% of adults in France, and its constitutive mechanisms are still not completely explained. Normally, fine control of weight and food intake is coordinated by a specialised part of the brain (the hypothalamus).

31 Oct 2013

Scientists develop new therapeutic approach for treatment of type 2 diabetes

Scientists from the Helmholtz Zentrum Muenchen and the Technische Universitaet Muenchen, together with scientists in the USA, have developed a new therapeutic approach for treatment of Type 2 diabetes. A novel single molecule hormone, which acts equally on the receptors of the insulin-stimulating hormones GLP-1 and GIP, was observed to reduce weight and improve blood sugar.

31 Oct 2013

CytoDyn submits protocol to FDA for Phase IIb clinical trial of PRO 140

CytoDyn Inc. ("CytoDyn") (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, today announced that CytoDyn Chief Medical Officer David Feigal, M.D., has submitted a revised protocol to the U.S. Food and Drug Administration relating to an upcoming Phase IIb clinical trial of PRO 140, CytoDyn's leading product under development as a treatment for Human Immunodeficiency Virus (HIV) infection.

31 Oct 2013

Some safety questions remain unanswered in expedited FDA drug approvals

Fewer patients were studied as part of expedited reviews of new drugs approved by the U.S. Food and Drug Administration (FDA) in 2008 and some safety questions remain unanswered, according to a study published by JAMA Internal Medicine, a JAMA Network publication.

30 Oct 2013

MiMedx Group reports record revenue in third quarter 2013

MiMedx Group, Inc., an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today its results for the quarter ended September 30, 2013.

30 Oct 2013