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Boston Scientific gets FDA approval for ACUITY X4 Quadripolar Left Ventricular leads

Boston Scientific has received U.S. Food and Drug Administration approval for the ACUITY X4 Quadripolar Left Ventricular (LV) leads. The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the leads – to the U.S. market.

23 Feb 2016

Pfizer’s IBRANCE (palbociclib) now approved for use in women with HR+, HER2- metastatic breast cancer

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of IBRANCE (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy.

23 Feb 2016

Consuming dried plums can protect from radiation-induced bone loss

Dr. Nancy Turner, a Texas A&M AgriLife Research scientist in College Station, was one of a team of researchers who recently studied different interventions to protect from radiation-induced bone loss.

23 Feb 2016

FDA-approved VENTANA anti-ALK CDx more accurate than commonly used IHC assay for patient selection

The U.S. Food and Drug Administration approved VENTANA anti-ALK(D5F3)CDx performed more accurately than another commonly used immunohistochemistry (IHC) assay, based on the use of the 5A4 clone, for the selection of patients eligible to receive ALK tyrosine kinase inhibitor (TKI) treatment.

23 Feb 2016

Astellas, Medivation announce acceptance of XTANDI sNDA for review by FDA

Astellas Pharma Inc. and Medivation, Inc. today announced that the U.S. Food and Drug Administration has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication.

22 Feb 2016

FDA approves Lannett's ANDA for Sumatriptan Nasal Spray USP

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray, the therapeutic equivalent to the reference listed drug Imitrex Nasal Spray, of GlaxoSmithKline.

22 Feb 2016

Understanding risk factors that contribute to childhood obesity

As the rate of obesity in the U.S. population has risen dramatically, more and more children are becoming overweight at younger and younger ages. Understanding the factors that contribute to childhood obesity and identifying ways to prevent its development are critical to stemming the historically high prevalence of childhood obesity and of associated health problems like type 2 diabetes.

22 Feb 2016

Fight cravings and maintain a healthy weight

Many of us think that we are taking the right steps in being healthy, which means it can be frustrating when we are not feeling as energetic and happy as we would like. There are many factors that you may not even think about, such as stress, which can lead our bodies to release glucose to the blood stream quickly, which usually gets converted into energy and with many of us living inactive lifestyles the glucose turns to fat.

22 Feb 2016

Organic meat and milk contain more beneficial omega-3 fatty acids than conventional

In the largest study of its kind, an international team of experts led by Newcastle University, UK, has shown that both organic milk and meat contain around 50% more beneficial omega-3 fatty acids than conventionally produced products.

22 Feb 2016

Mylan announces FDA's acceptance of ANDA filing for generic Advair Diskus

Mylan N.V. today announced that its abbreviated new drug application (ANDA) for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder has been accepted for filing by the U.S. Food and Drug Administration.

22 Feb 2016

BistroMD, Fitness Icon Denise Austin partner to create branded meal-delivery program

BistroMD, the leader in home diet meal delivery, announced a licensing partnership today with Fitness Icon Denise Austin to create a branded meal-delivery program. The program is a natural extension of bistroMD's mission to empower people to lose weight while eating great tasting, nutritious foods, and blends with Denise's healthy lifestyle philosophy.

22 Feb 2016

Briviact (brivaracetam) approved for treatment of partial onset seizures in patients with epilepsy

The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.

22 Feb 2016

Research proposes new contract scheme for flu vaccine distribution

Research co-authored by Fuqiang Zhang, professor of operations and manufacturing management at Washington University in St. Louis' Olin Business School, proposes a new contract scheme for the vaccine supply chain that could reduce patient wait time.

19 Feb 2016

Regular DBT imaging can increase cancer detection and reduce call backs

The increased cancer detection and reduced call backs associated with 3D mammography, also known as Digital Breast Tomosynthesis (DBT), can be maintained years after a patient's first DBT screening with regularly scheduled DBT imaging, according to a JAMA Oncology study published online today from researchers at the Perelman School of Medicine at the University of Pennsylvania.

19 Feb 2016

Novartis receives FDA Breakthrough Therapy designation for PKC412 (midostaurin)

Novartis announced today that the United States Food and Drug Administration has granted Breakthrough Therapy designation to PKC412 (midostaurin). PKC412 (midostaurin) is an investigational treatment for adults with newly-diagnosed AML who are FLT3 mutation-positive, as detected by an FDA-approved test, and who are eligible to receive standard induction and consolidation chemotherapy.

19 Feb 2016

Study: 94% of older adults in the U.S. have at least one sensory deficit

The first study to measure the full spectrum of age-related damage to all five senses found that 94 percent of older adults in the United States have at least one sensory deficit, 38 percent have two, and 28 percent have three, four or five.

18 Feb 2016

Chronic low-dose exposure to organochlorine pesticides linked to future cognitive impairment

Individuals subjected to chronic low-dose exposure to organochlorine pesticides show and increased risk to obtain a future diagnosis of cognitive impairment. This is shown in a study now published in Environmental International.

18 Feb 2016

Cornell Food and Brand Lab researchers develop online Global Healthy Weight Registry

To shed light on the health behaviors of those who maintain a healthy weight, Cornell Food and Brand Lab researchers developed an online Global Healthy Weight Registry (formerly named the Slim by Design Registry). Adults of healthy weight were invited to sign up for the registry and then answer questions about diet, exercise, and daily routines (see the infographic for more details about registry participants).

18 Feb 2016

FDA issues new guidance to reduce risk of Zika blood transmission

As a safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.

18 Feb 2016

Local neighbourhoods strongly influence health behaviour and obesity risk

Where you live and how you view your neighbourhood is strongly related to your health behaviour and your risk of developing obesity, according to research published this week.

18 Feb 2016

Food News and Research

Boston Scientific gets FDA approval for ACUITY X4 Quadripolar Left Ventricular leads

Pfizer’s IBRANCE (palbociclib) now approved for use in women with HR+, HER2- metastatic breast cancer

Consuming dried plums can protect from radiation-induced bone loss

FDA-approved VENTANA anti-ALK CDx more accurate than commonly used IHC assay for patient selection

Astellas, Medivation announce acceptance of XTANDI sNDA for review by FDA

FDA approves Lannett's ANDA for Sumatriptan Nasal Spray USP

Understanding risk factors that contribute to childhood obesity

Fight cravings and maintain a healthy weight

Organic meat and milk contain more beneficial omega-3 fatty acids than conventional

Mylan announces FDA's acceptance of ANDA filing for generic Advair Diskus

BistroMD, Fitness Icon Denise Austin partner to create branded meal-delivery program

Briviact (brivaracetam) approved for treatment of partial onset seizures in patients with epilepsy

Research proposes new contract scheme for flu vaccine distribution

Regular DBT imaging can increase cancer detection and reduce call backs

Novartis receives FDA Breakthrough Therapy designation for PKC412 (midostaurin)

Study: 94% of older adults in the U.S. have at least one sensory deficit

Chronic low-dose exposure to organochlorine pesticides linked to future cognitive impairment

Cornell Food and Brand Lab researchers develop online Global Healthy Weight Registry

FDA issues new guidance to reduce risk of Zika blood transmission

Local neighbourhoods strongly influence health behaviour and obesity risk

Understanding cultivated meat and its global potential eBook

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

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