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Lotus Pharmaceutical submits generic Xenical ANDA with FDA

Lotus Pharmaceutical Company Inc. has confirmed its submission of Abbreviated New Drug Application for Orlistat capsules, a generic version of Xenical, to the US Food and Drug Administration (FDA).

11 Dec 2012

Pomalidomide safe and effective in treating multiple myeloma

A new oral agent under review by the U.S. Food and Drug Administration (FDA) is safe and effective in treating relapsed and treatment-resistant multiple myeloma, according to a multicenter, Phase II study presented by Mount Sinai School of Medicine researchers at the American Society of Hematology (ASH) Annual Meeting. The meeting is taking place December 8-11, 2012 in Atlanta.

11 Dec 2012

Janssen announces U.S. prescribing information update for EDURANT tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a prescribing information update for EDURANT (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies, which evaluated the efficacy and safety of EDURANT for the treatment of human immunodeficiency virus type 1 (HIV-1) in antiretroviral treatment-naive adults.

11 Dec 2012

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

AMAG Pharmaceuticals, Inc. today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology's (ASH) annual meeting in Atlanta, Georgia.

11 Dec 2012

Ligand commences PG-free melphalan pivotal trial in multiple myeloma

Ligand Pharmaceuticals Incorporated announced today that it has initiated a pivotal trial of Captisol-enabled, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma.

11 Dec 2012

Almirall, Forest Laboratories' Tudorza Pressair now available in the U.S. pharmacies

Forest Laboratories, Inc. and Almirall, S.A. announced today that Tudorza Pressair (aclidinium bromide inhalation powder) 400mcg is now available in pharmacies throughout the United States.

11 Dec 2012

Auditory systems differ between sexes in sparrows depending on the season

Auditory systems differ between sexes in sparrows depending on the season, a Georgia State University neuroscientist has found. The work adds to our knowledge of how the parts of the nervous system, including that of humans, are able to change.

10 Dec 2012

FDA expands approved use of Janssen Biotech’s Zytiga to treat men with mCRPC

The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.

10 Dec 2012

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

Janssen announced today that the U.S. Food and Drug Administration (FDA) has approved a broader indication for the oral, once-daily medication ZYTIGA (abiraterone acetate).

10 Dec 2012

Childhood obesity: an interview with Professor Clodagh O’Gorman

Childhood obesity is harder to define than adult obesity. This is because any definition of obesity relies on measurements of both height and weight, and the calculation of body mass index (BMI) based on these measurements.

10 Dec 2012

Meals on wheels reduces nursing home strain

US states that have invested in community-based service networks, particularly home-delivered meals, have proportionally fewer nursing home residents with low-care needs, report researchers.

10 Dec 2012

FDA clearance for LENSAR Laser System

LENSAR Inc., developer of the next generation LENSAR Laser System™ for refractive cataract surgery, announced today that the company's laser system has received 510(k) clearance from the United States Food and Drug Administration (FDA) for executing corneal incisions during cataract surgery.

10 Dec 2012

Medical device tax repeal advocates feel momentum

Opponents of the health care law's tax on medical devices say they are making headway in their push to repeal the provision before it takes effect next year. But some also see delaying the implementation of the tax as a way to get around concerns about the cost of eliminating it if they're unable to fully repeal it before the end of the session.

10 Dec 2012

Project Peanut Butter and Hershey team up to reduce childhood malnutrition in rural Ghana

With funding from The Hershey Company, Project Peanut Butter announced today that it will make and distribute vitamin-enriched nutritional packets to impoverished children in rural Ghana.

10 Dec 2012

Feature stories dealing with fitness, diet, and nutrition

This is the latest in a series of topical feature packages PRN will carry as part of its regular Feature News Service. Coming up in 2012 are features on: Fitness, Diet and Nutrition Feature Package

10 Dec 2012

Cervical disc replacement: an interview with Joe Ross, VP of U.S. Marketing at LDR

Cervical disc replacement is a surgical procedure that involves removing a damaged or degenerated cervical disc and replacing it with an artificial disc device.

10 Dec 2012

Vorinostat reduces risk of graft-vs.-host disease from bone marrow transplant treatments

A new class of drugs reduced the risk of patients contracting a serious and often deadly side effect of lifesaving bone marrow transplant treatments, according to a study from researchers at the University of Michigan Comprehensive Cancer Center.

10 Dec 2012

New survival results from Genentech’s Perjeta Phase III combination study on HER2-positive mBC

Genentech, a member of the Roche Group, today announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy significantly extended the lives (overall survival) of people with previously untreated HER2-positive metastatic breast cancer (mBC), compared to Herceptin, chemotherapy and placebo.

10 Dec 2012

Wellcome Trust researchers discover how brain assesses confidence in its decisions

Wellcome Trust researchers have discovered how the brain assesses confidence in its decisions. The findings explain why some people have better insight into their choices than others.

10 Dec 2012

Perimenopausal lifestyle modifications could reduce risk of breast cancer in obese woman

Obese women might be able to eliminate their increased risk for postmenopausal breast cancer by taking measures during perimenopause to prevent weight gain and to therapeutically control the metabolic effects of their obesity, according to the results of a preclinical study published in Cancer Research, a journal of the American Association for Cancer Research.

10 Dec 2012

Food News and Research

Lotus Pharmaceutical submits generic Xenical ANDA with FDA

Pomalidomide safe and effective in treating multiple myeloma

Janssen announces U.S. prescribing information update for EDURANT tablets

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

Ligand commences PG-free melphalan pivotal trial in multiple myeloma

Almirall, Forest Laboratories' Tudorza Pressair now available in the U.S. pharmacies

Auditory systems differ between sexes in sparrows depending on the season

FDA expands approved use of Janssen Biotech’s Zytiga to treat men with mCRPC

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

Childhood obesity: an interview with Professor Clodagh O’Gorman

Meals on wheels reduces nursing home strain

FDA clearance for LENSAR Laser System

Medical device tax repeal advocates feel momentum

Project Peanut Butter and Hershey team up to reduce childhood malnutrition in rural Ghana

Feature stories dealing with fitness, diet, and nutrition

Cervical disc replacement: an interview with Joe Ross, VP of U.S. Marketing at LDR

Vorinostat reduces risk of graft-vs.-host disease from bone marrow transplant treatments

New survival results from Genentech’s Perjeta Phase III combination study on HER2-positive mBC

Wellcome Trust researchers discover how brain assesses confidence in its decisions

Perimenopausal lifestyle modifications could reduce risk of breast cancer in obese woman

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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