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FDA clears Breathe Technologies' Sleep System for treatment of OSA

Breathe Technologies, Inc., a manufacturer of innovative medical devices for people with respiratory conditions today announced the Food and Drug Administration has granted the company 510(k) clearance to market its Sleep System (Continuous Positive Airway Pressure, or CPAP & Interface) in the US for treatment of Obstructive Sleep Apnea.

30 May 2013

Popular artificial sweetener can modify how the body handles sugar, find researchers

Researchers at Washington University School of Medicine in St. Louis have found that a popular artificial sweetener can modify how the body handles sugar.

30 May 2013

First Edition: May 30, 2013

Today's early morning highlights from the major news organizations include stories about a new study on immigrants' financial impact on the Medicare program and a new federal regulation on wellness programs.

30 May 2013

Endovascular stroke therapy should be limited to use within clinical trials, say physicians

Devices snaked into the brain artery of a patient experiencing a stroke that either snatch and remove the offending clot or pump a dissolving drug into the blockage should primarily be used within a clinical trial setting, say a team of vascular neurologists at Mayo Clinic in Florida.

30 May 2013

Injectable drugs used in TPN to be imported into US, says FDA

The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition in critical shortage will be imported into the United States and available to patients this week.

30 May 2013

Study finds link between childhood abuse and addiction-like eating behaviors in women

Women who experienced severe physical or sexual abuse during childhood are much more likely to have a food addiction as adults than women who did not experience such abuse, according to a new study published in the journal Obesity.

30 May 2013

Tafinlar, Mekinist get FDA approval to treat patients with advanced melanoma

The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

30 May 2013

Pacira Pharmaceuticals reports results of EXPAREL Phase 2/3 clinical trial for TKA

Pacira Pharmaceuticals, Inc. today announced findings from the completed first part of its Phase 2/3 clinical trial assessing the use and administration of EXPAREL (bupivacaine liposome injectable suspension) as a single-dose injection femoral nerve block for total knee arthroplasty surgery.

29 May 2013

EMA grants Sucampo orphan drug designation for unoprostone isopropyl to treat retinitis pigmentosa

Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, today announced that it has received orphan drug designation in the European Union for unoprostone isopropyl for the treatment of retinitis pigmentosa (RP). RP is a genetic disease characterized by progressive, irreversible vision loss and decreasing visual acuity, and there are no drugs or therapeutic procedures currently approved for the treatment of RP today.

29 May 2013

UCLA researchers show that bacteria ingested in food can affect brain function

UCLA researchers now have the first evidence that bacteria ingested in food can affect brain function in humans. In an early proof-of-concept study of healthy women, they found that women who regularly consumed beneficial bacteria known as probiotics through yogurt showed altered brain function, both while in a resting state and in response to an emotion-recognition task.

29 May 2013

Patented nicotinamide riboside launched by Chromadex

ChromaDex Corporation, an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, animal health, cosmetic and pharmaceutical industries, announced today the launch of NIAGEN, its novel, patented, branded nicotinamide riboside.

29 May 2013

Teh Seng’s generic Lidoderm manufacturing facility in Taiwan successfully completes FDA cGMP audit

TWi Pharmaceuticals, Inc., today announced that Teh Seng Pharmaceutical Mfg. Co., the manufacturing partner for its generic version of Lidoderm (5% lidocaine patch) located in Taiwan, has completed the cGMP audit and pre-approval inspection by US Food and Drug Administration and been granted "acceptable" status under the FDA's regulatory guidelines.

29 May 2013

FDA approves iTrace for Blood Centers to assist in enhancing blood safety

iTrace for Blood Centers, (Version 1.0.924.0), the first application to use Radio Frequency Identification technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by the U.S. Food and Drug Administration.

29 May 2013

HHS sees cost savings in the cloud

The U.S. Health and Human Services Department is looking for cost savings in the cloud as it weathers painful budget cuts.

29 May 2013

Medical researchers identify genetic marker associated with sporadic breast cancer

Medical researchers at the University of Alberta have pinpointed a genetic marker for sporadic breast cancer - one of a handful identified to date in Caucasians.

29 May 2013

Valeant Pharmaceuticals receives Complete Response Letter from FDA for efinaconazole NDA

Valeant Pharmaceuticals International, Inc. today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for efinaconazole for the treatment of onychomycosis.

28 May 2013

First Edition: May 28, 2013

Today's headlines include stories about the strategies of some businesses -- small and large -- to blunt the health law's impact.

28 May 2013

Asfotase alfa gets Breakthrough Therapy designation from FDA for treatment of patients with HPP

Alexion Pharma International Sàrl, a subsidiary of Alexion Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to asfotase alfa for the treatment of patients with hypophosphatasia (HPP) whose first signs or symptoms occurred prior to 18 years of age, including perinatal-, infantile-, and juvenile-onset forms of the disease.

28 May 2013

Highly-infectious sickness bug can be killed by copper and copper alloys

New research from the University of Southampton shows that copper and copper alloys will rapidly destroy norovirus - the highly-infectious sickness bug. The virus can be contracted from contaminated food or water, person-to-person contact, and contact with contaminated surfaces, meaning surfaces made from copper could effectively shut down one avenue of infection.

28 May 2013

Common sugar molecule promising target for development of broad-spectrum vaccine

Developing new vaccines to protect against diseases that plague humans is fraught with numerous challenges-one being that microbes tend to vary how they look on the surface to avoid being identified and destroyed by the immune system. However, researchers from Brigham and Women's Hospital (BWH) have discovered a sugar polymer that is common on the cell surface of several pathogens.

28 May 2013

Food News and Research

FDA clears Breathe Technologies' Sleep System for treatment of OSA

Popular artificial sweetener can modify how the body handles sugar, find researchers

First Edition: May 30, 2013

Endovascular stroke therapy should be limited to use within clinical trials, say physicians

Injectable drugs used in TPN to be imported into US, says FDA

Study finds link between childhood abuse and addiction-like eating behaviors in women

Tafinlar, Mekinist get FDA approval to treat patients with advanced melanoma

Pacira Pharmaceuticals reports results of EXPAREL Phase 2/3 clinical trial for TKA

EMA grants Sucampo orphan drug designation for unoprostone isopropyl to treat retinitis pigmentosa

UCLA researchers show that bacteria ingested in food can affect brain function

Patented nicotinamide riboside launched by Chromadex

Teh Seng’s generic Lidoderm manufacturing facility in Taiwan successfully completes FDA cGMP audit

FDA approves iTrace for Blood Centers to assist in enhancing blood safety

HHS sees cost savings in the cloud

Medical researchers identify genetic marker associated with sporadic breast cancer

Valeant Pharmaceuticals receives Complete Response Letter from FDA for efinaconazole NDA

First Edition: May 28, 2013

Asfotase alfa gets Breakthrough Therapy designation from FDA for treatment of patients with HPP

Highly-infectious sickness bug can be killed by copper and copper alloys

Common sugar molecule promising target for development of broad-spectrum vaccine

Enhancing confidence in chemical ionization spectrometry data eBook

Managing vibration in IVF laboratories

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence

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