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Alkermes initiates ALKS 37 phase 2b study in opioid-induced constipation

Alkermes plc today announced the initiation of a phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation.

3 Oct 2011

HeartWare announces updated clinical data from BTT study, ADVANCE and CAP

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced updated clinical data from its bridge to heart transplantation (BTT) study, ADVANCE, and the Continued Access Protocol.

3 Oct 2011

General anesthesia linked to learning disabilities in children

Every year millions of babies and toddlers receive general anesthesia for procedures ranging from hernia repair to ear surgery. Now, researchers at Mayo Clinic in Rochester have found a link among children undergoing multiple surgeries requiring general anesthesia before age 2 and learning disabilities later in childhood.

3 Oct 2011

FDA releases new PSA on safe medication use

The U.S. Food and Drug Administration (FDA) Office of Women's Health today released a new public service announcement (PSA) titled, "Use Medicines Wisely," to help raise awareness about safe medication use.

3 Oct 2011

CSL pays heed to FDA observations on faulty manufacturing processes

Australia’s biggest pharmaceutical company CSL has taken steps to address most manufacturing flaws highlighted by the US Food and Drug Administration (FDA) and promised that the remaining concerns are being resolved.

2 Oct 2011

Smoking worst among miners, hoteliers and construction workers: CDC report

A new Centers for Disease Control and Prevention (CDC) report reveals that miners, construction workers and people in the hotel and food service industry have the highest smoking rates, while those in education have the lowest.

2 Oct 2011

FDA warns regarding danger of Listeria germs

If you eat food contaminated with bacteria called Listeria, you could get so sick that you have to be hospitalized. And for certain vulnerable people, the illness could be fatal.

1 Oct 2011

Regulatory, commercial considerations are the primary drivers for biosimilar development

Regulatory and commercial considerations are the primary drivers for successful biosimilar clinical development, according to a new report from Quintiles, titled An Integrated Approach to Biosimilar Development & Commercialization. In addition, the report states that successful biosimilar companies will be those who collapse their clinical, commercial, and regulatory thinking into a streamlined cohesive function as they proceed with developing biosimilars.

1 Oct 2011

The US Oncology Network affiliate treats advanced prostate cancer patients with PROVENGE

David, a 67-year-old father of three and soon to be first-time grandfather, felt too young to be diagnosed with prostate cancer. "I felt great," he said. "I had no symptoms." David, under the advisement of his oncologist, decided to be treated with PROVENGE (sipuleucel-T), the first in a new therapeutic class known as autologous cellular immunotherapies.

1 Oct 2011

Less toxic amounts of chemotherapy medicine slows tumor growth: Scientists

University of Georgia scientists have found that smaller, less toxic amounts of chemotherapy medicine given frequently to mice with human prostate cancer noticeably slowed tumor growth.

1 Oct 2011

Literacy Bridge launches program to improve health of women, at-risk children across rural Ghana

Literacy Bridge is responding to the need for a comprehensive solution in global health and hunger by kicking off its Health & Agriculture Communication for Women & Children Program, which is designed to improve the health of 24,000 women and at-risk children in 75 low-literate communities across rural Ghana.

1 Oct 2011

New analyses from Phase III studies of VICTRELIS to be presented at AASLD 2011

Merck, known as MSD outside of the United States and Canada, announced today that several new analyses from Phase III studies of VICTRELIS (boceprevir), the company's first-in-class, oral hepatitis C virus NS3/4A protease inhibitor will be presented at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases.

1 Oct 2011

Nutrition experts participated in PN Safety Summit to discuss safety of PN therapy, patient care

Recent safety concerns in the preparation and delivery of parenteral nutrition, commonly referred to as intravenous nutrition, prompted leaders from several major organizations to participate in a PN Safety Summit on September 23, 2011.

From Baxter International Inc. 1 Oct 2011

Circadian subsidiary submits IND application to FDA to initiate VGX-100 study against cancer

Circadian Technologies Limited is extremely proud to announce that its 100% owned subsidiary, Vegenics Pty Ltd, has submitted an investigational new drug application to the U.S. Food and Drug Administration to initiate clinical studies of VGX-100.

1 Oct 2011

Baxter seeks European marketing authorization for HyQ to treat PI

Baxter International Inc. announced today that it has submitted an application to the European Medicines Agency's Committee for Human Medicinal Products seeking marketing authorization for HyQ. HyQ is Baxter's investigational immunoglobulin (IG) therapy administered subcutaneously and facilitated by recombinant human hyaluronidase, a dispersion and permeation enhancer, for use in patients with primary immunodeficiencies.

From Baxter International Inc. 1 Oct 2011

ADVENTRX holds Type A meeting with FDA to discuss Exelbine NDA

ADVENTRX Pharmaceuticals, Inc. announced today that it held a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) it received in August from the FDA regarding the Company's New Drug Application (NDA) for Exelbine (vinorelbine injectable emulsion) for the treatment of non-small cell lung cancer.

1 Oct 2011

Weeds are an integral part of our ecosystem

Weeds, which are widely deemed as a nuisance plant, are vital to the existence of many farmland species according to a new University of Hull study published in the journal Biological Conservation today.

30 Sep 2011

Walter Reed employees moved to Bethesda without adequate parking, transportation plan

The American Federation of Government Employees is voicing its concern over the lack of progress in securing parking for thousands of Walter Reed Army Medical Center employees who have been transferred to the new Walter Reed Military Medical Center in Bethesda.

30 Sep 2011

Study demonstrates how the intestine maintains 'immune tolerance' under healthy conditions

Imagine a single drug that would treat most, if not all, autoimmune disorders, such as asthma, inflammatory bowel disease, and Lupus. That might not be so hard to do thanks to a team of researchers who have discovered a molecule normally used by the body to prevent unnecessary immune reactions.

30 Sep 2011

BEN has garnered the White House's support to help fight childhood obesity

Want to double fruit sales in schools? A new Cornell University study shows it is as easy as putting the fruit in a colorful bowl. According to research presented this week at the American Dietetic Association Conference in San Diego, CA by Brian Wansink, Professor at Cornell University, "Moving the fruit increased sales by 104%."

30 Sep 2011