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Medical Nutrition launches Diff-Stat pre- and probiotic supplement to prevent the onset of AAD and C-diff

Medical Nutrition USA, Inc., a developer and distributor of uniquely engineered, nutrition-medicine products, announced the introduction of Diff-Stat™, a new supplement containing pre- and probiotics to help restore and maintain beneficial bacteria that prevent the onset of antibiotic-associated diarrhea (AAD) and clostridium difficile (C-diff).

24 Nov 2009

Shire submits a MAA for velaglucerase alfa in Europe

Shire plc, the global specialty biopharmaceutical company, today announced that it has submitted a MAA to the European Medicines Agency for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.

24 Nov 2009

Pharmacy-based intervention improves antipsychotic adherence among patients with mental illnesses

Health systems should consider pharmacy-based interventions when involving patients who have poor follow-through taking medication.

24 Nov 2009

Cardiovascular risks associated with taking Vioxx could have been identified earlier, say researchers

Evidence of cardiovascular risks associated with taking Vioxx, the popular, nonsteroidal anti-inflammatory drug (rofecoxib), could have been identified nearly four years before its manufacturer, Merck & Co. Inc., voluntarily pulled the drug from the market.

24 Nov 2009

NCCN Guidelines adds ofatumumab and romidepsin as therapy options for CLL

Two recent FDA approvals have prompted the National Comprehensive Cancer Network (NCCN) to update the NCCN Clinical Practice Guidelines in Oncology(TM) for Non-Hodgkin's Lymphomas to include ofatumumab (Azerra(TM), GlaxoSmithKline) and romidepsin (Istodax(R), Gloucester Pharmaceuticals) as treatment options for select patients with two types of Non-Hodgkin's Lymphomas.

24 Nov 2009

Transcept Pharmaceuticals to discuss the Complete Response Letter for Intermezzo NDA

Transcept Pharmaceuticals, Inc. today announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, 2009, indicated that the FDA could not approve the NDA in its present form.

24 Nov 2009

New data indicates early association between anti-inflammatory medication and cardiovascular risk

Clinical trial data indicated an association between the anti-inflammatory medication rofecoxib and cardiovascular risk as early as December 2000, before the product was taken off the market in September 2004, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

24 Nov 2009

U.S. Court rules in Merck's favor in Flemings case involving FOSAMAX

Merck said today that U.S. District Court Judge John F. Keenan granted summary judgment in Merck's favor in Flemings v. Merck. Flemings is the second of three cases involving FOSAMAX (alendronate sodium) designated by the federal MDL court as a bellwether trial case.

24 Nov 2009

Older adults who take psychotropic medications more likely to experience falls

Older adults who take several types of psychotropic medications—such as antidepressants or sedatives—appear more likely to experience falls, according to an analysis of previous studies reported in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

24 Nov 2009

Clavis Pharma signs drug development and commercialisation agreement with Clovis Oncology

Clavis Pharma ASA, the clinical stage oncology focused pharmaceutical company, and Clovis Oncology, Inc., the newly formed oncology company led by former Pharmion Corporation executives, announced today an agreement for the further development and commercialisation of the Clavis Pharma drug candidate, CP-4126, currently in Phase II development in pancreatic cancer.

24 Nov 2009

Iowa State University's researcher develops and ships H1N1 vaccine for swine producers

The only swine vaccine available for the H1N1 virus has been sent to vaccinate a swine herd infected with the virus. The vaccination marks the first time vaccine has been sent to a swine herd diagnosed with the pandemic flu.

24 Nov 2009

Clavis Pharma announces $380 million agreement to develop its CP-4126 drug candidate

Clavis Pharma ASA, the clinical stage oncology focused pharmaceutical company, announced today a $380 million agreement for the further development and commercialisation of its drug candidate, CP-4126, currently in Phase II development in pancreatic cancer.

24 Nov 2009

New technology developed to rapidly identify compounds for the treatment of heart failure

Research conducted by University of Minnesota scientists, in collaboration with Celladon Corporation, has led to the invention of technology to more rapidly identify compounds for the treatment of heart failure.

24 Nov 2009

Breast cancer patients treated with chemotherapy drug Taxol more likely to develop chronic neuropathic pain

Breast cancer patients treated with the chemotherapy drug Taxol (paclitaxel) are more likely to develop chronic neuropathic pain, according to research published in The Journal of Pain, the peer review publication of the American Pain Society.

24 Nov 2009

Lysteda tablets to treat menorrhagia approved by the FDA

The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

24 Nov 2009

Treatment rates for hepatitis C virus declining, say researchers

Researchers from the University of Michigan determined that only 663,000 of the approximately 3.9 million Americans with hepatitis C virus (HCV) infection received antiviral therapy between 2002 and 2007.

24 Nov 2009

PX’Therapeutics sets up additional biomanufacturing unit

PX’Therapeutics SA (formerly known as Protein’eXpert) announces the set up of an additional biomanufacturing unit dedicated to the production of therapeutic proteins and monoclonal antibodies in mammalian cells.

24 Nov 2009

Neuromed discusses Exalgo NDA application with the FDA

Covidien today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc., a Covidien company, obtained the commercial rights to Exalgo in the United States from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd., in June 2009.

24 Nov 2009

DTCA linked with increased Medicaid pharmacy expenditures

Direct-to-consumer advertising (DTCA) for a commonly prescribed antiplatelet drug does not appear associated with increased use, but may be associated with increased drug costs and Medicaid pharmacy expenditures, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

24 Nov 2009

Jubilant Organosys, UAB and Southern Research Institute announce joint venture to accelerate global drug development

Jubilant Organosys, the University of Alabama at Birmingham (UAB), and Southern Research Institute today announced a joint venture that will focus on leveraging their collective innovation and enabling technologies in the areas of Oncology, Metabolic Disease and Infectious Diseases. It is a unique U.S.-India arbitraged and leveraged partnership that will accelerate the development of affordable therapies for patients worldwide.

24 Nov 2009

Pharmaceutical News

Medical Nutrition launches Diff-Stat pre- and probiotic supplement to prevent the onset of AAD and C-diff

Shire submits a MAA for velaglucerase alfa in Europe

Pharmacy-based intervention improves antipsychotic adherence among patients with mental illnesses

Cardiovascular risks associated with taking Vioxx could have been identified earlier, say researchers

NCCN Guidelines adds ofatumumab and romidepsin as therapy options for CLL

Transcept Pharmaceuticals to discuss the Complete Response Letter for Intermezzo NDA

New data indicates early association between anti-inflammatory medication and cardiovascular risk

U.S. Court rules in Merck's favor in Flemings case involving FOSAMAX

Older adults who take psychotropic medications more likely to experience falls

Clavis Pharma signs drug development and commercialisation agreement with Clovis Oncology

Iowa State University's researcher develops and ships H1N1 vaccine for swine producers

Clavis Pharma announces $380 million agreement to develop its CP-4126 drug candidate

New technology developed to rapidly identify compounds for the treatment of heart failure

Breast cancer patients treated with chemotherapy drug Taxol more likely to develop chronic neuropathic pain

Lysteda tablets to treat menorrhagia approved by the FDA

Treatment rates for hepatitis C virus declining, say researchers

PX’Therapeutics sets up additional biomanufacturing unit

Neuromed discusses Exalgo NDA application with the FDA

DTCA linked with increased Medicaid pharmacy expenditures

Jubilant Organosys, UAB and Southern Research Institute announce joint venture to accelerate global drug development

How does norepinephrine influence anxiety-related behaviours?

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

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