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Marshfield Clinic’s Heart Health Mobile app wins HSS competition

Marshfield Clinic Research Foundation, a division of Marshfield Clinic, announced today that its first completed mobile app has won a national competition that challenged competitors to develop a program that will help improve heart health in the U.S.

15 Feb 2013

Viewpoints: FDA needs more power to regulate compounding pharmacies; Time to revamp military benefits, including health

Traditionally, the licensing and control of pharmacies has been left to the states, but their performance has been uneven. The federal role has been thrown into question in recent years by lawsuits. ... compounding pharmacies are not generally required to inform the FDA that they are in business nor to register with the FDA or disclose what products they are making.

15 Feb 2013

Exposure to two common PFCs associated with increased risk of osteoarthritis

A new study has linked exposure to two common perfluorinated chemicals (PFCs) with osteoarthritis. PFCs are used in more than 200 industrial processes and consumer products including certain stain- and water-resistant fabrics, grease-proof paper food containers, personal care products, and other items.

15 Feb 2013

Mallinckrodt, Actavis enter settlement agreement to resolve Exalgo patent litigation

Actavis, Inc. today announced that it has reached a settlement with Mallinckrodt Inc. on outstanding patent litigation related to Actavis' generic version of the 32 mg dosage strength of Mallinckrodt's Exalgo (Hydromorphone Hydrochloride Extended-Release) tablets.

15 Feb 2013

FDA approves Teva’s generic Adderall XR ANDA for treatment of ADHD

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for the generic version of Shire's Adderall XR Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder.

14 Feb 2013

Santarus launches UCERIS for induction of remission in patients with ulcerative colitis

Santarus, Inc. announced today the U.S. commercial launch of UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

14 Feb 2013

Innophos reports net sales of $209 million for fourth quarter 2012

Innophos Holdings, Inc., a leading international producer of performance-critical and nutritional specialty ingredients, with applications in food, beverage, dietary supplements, pharmaceutical, oral care and industrial end markets, today announced its financial results for the fourth quarter and full year 2012.

14 Feb 2013

Second Sight Medical Products receives FDA approval for Argus II Retinal Prosthesis System

The U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP).

14 Feb 2013

Elemental diet may help adults with eosinophilic esophagitis

Results from a small study suggest that consumption of an elemental diet for 2–4 weeks results in a significant histologic improvement in adult patients with eosinophilic esophagitis.

14 Feb 2013

Researchers call for botulism testing in sick and healthy cows

Evidence of Clostridium botulinum and its toxin in milk and udder tissue samples from dairy cows has led German researchers to call for “statistically relevant testing of healthy and sick cows from healthy and affected farms.”

14 Feb 2013

Study finds strong preference among families and older pediatric patients for IV feeding

About 60 percent of pediatric cancer patients experience malnourishment during treatment. At that point, patients and families have a choice: tube feeding or IV nutrition supplement. Which would you choose? A study published this week in the Journal of Pediatric Oncology Nursing shows that families' perceptions, especially of the discomfort of tube feeding, leads to choosing IV over tube - despite the fact that tube feeding is usually the better choice, associated with better gut function and lower rates of infection.

14 Feb 2013

FDA acknowledges United Therapeutics’ oral treprostinil NDA to treat PAH

United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension.

14 Feb 2013

Fluke Biomedical receives FDA clearance for ESA615 Electrical Safety Analyzer

The United States Food and Drug Administration (FDA) announced today it has granted the new automated, multifunctional ESA615 Electrical Safety Analyzer 510(k) clearance.

14 Feb 2013

FDA grants IDE approval to STS and ACC to study alternative access approaches for TAVR

The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have received a unique investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to study "alternative access" approaches for transcatheter aortic valve replacement (TAVR) using the STS/ACC TVT Registry.

14 Feb 2013

Probiotics shows promise in reducing both incidence and severity of necrotizing enterocolitis

"Good" bacteria that live in our intestines have been linked with a variety of health benefits, from fighting disease to preventing obesity. In a new study, Kriston Ganguli of Massachusetts General Hospital for Children and Harvard Medical School and her colleagues have discovered another advantage to these friendly microscopic tenants: Chemicals secreted by good bacteria that typically live in the intestines of babies could reduce the frequency and severity of a common and often-lethal disease of premature infants.

14 Feb 2013

FOXC2 vital to epithelial-mesenchymal transition in breast cancer

Researchers have identified a pivotal protein in a cellular transformation that makes a cancer cell more resistant to treatment and more capable of growing and spreading, making it an inviting new target for drug development.

14 Feb 2013

Traumatic brain injury investigational treatment from BHR Pharma receives EMA orphan medicinal product designation

BHR Pharma, LLC announced today the European Medicines Agency (EMA), responsible for evaluating medicines developed for use in the European Union, granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its proprietary intravenous progesterone infusion agent, BHR-100. The agent currently is being evaluated as a neuroprotective treatment for severe traumatic brain injury (TBI) in the global, Phase III SyNAPSe® clinical trial.

14 Feb 2013

FDA grants orphan drug status to Lentigen’s LG631-CD34 for treatment of glioblastoma multiforme

Lentigen Corporation, a biotechnology company specializing in the development and manufacture of lentiviral gene delivery products, announced today that that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to P140K methylguanine methyltransferase (MGMT) transduced human CD34 cells for bone marrow protection in the treatment of glioblastoma multiforme.

14 Feb 2013

Viewpoints: Obama prescription for Medicare is 'modest;' GOP doubts entitlement plan is serious

Somewhat more substantively, he called for a larger deficit-reduction deal built around loophole-closing tax reform and what he called "modest" reforms to Medicare and entitlements. In an apparent effort to rally Democrats to this cause, he called on "those of us who care deeply about programs like Medicare" to "embrace" reform.

14 Feb 2013

FDA grants final approval to Breckenridge’s Pioglitazone Hydrochloride ANDA

Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Pioglitazone Hydrochloride Tablets. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and supplied by Synthon Pharmaceuticals, Inc., and will be available in 15 mg, 30 mg, and 45 mg strengths.

14 Feb 2013

Food News and Research

Marshfield Clinic’s Heart Health Mobile app wins HSS competition

Viewpoints: FDA needs more power to regulate compounding pharmacies; Time to revamp military benefits, including health

Exposure to two common PFCs associated with increased risk of osteoarthritis

Mallinckrodt, Actavis enter settlement agreement to resolve Exalgo patent litigation

FDA approves Teva’s generic Adderall XR ANDA for treatment of ADHD

Santarus launches UCERIS for induction of remission in patients with ulcerative colitis

Innophos reports net sales of $209 million for fourth quarter 2012

Second Sight Medical Products receives FDA approval for Argus II Retinal Prosthesis System

Elemental diet may help adults with eosinophilic esophagitis

Researchers call for botulism testing in sick and healthy cows

Study finds strong preference among families and older pediatric patients for IV feeding

FDA acknowledges United Therapeutics’ oral treprostinil NDA to treat PAH

Fluke Biomedical receives FDA clearance for ESA615 Electrical Safety Analyzer

FDA grants IDE approval to STS and ACC to study alternative access approaches for TAVR

Probiotics shows promise in reducing both incidence and severity of necrotizing enterocolitis

FOXC2 vital to epithelial-mesenchymal transition in breast cancer

Traumatic brain injury investigational treatment from BHR Pharma receives EMA orphan medicinal product designation

FDA grants orphan drug status to Lentigen’s LG631-CD34 for treatment of glioblastoma multiforme

Viewpoints: Obama prescription for Medicare is 'modest;' GOP doubts entitlement plan is serious

FDA grants final approval to Breckenridge’s Pioglitazone Hydrochloride ANDA

The future is bioengineered: Synthetic biology and global sustainability 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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