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Bayer's NEXAVAR approved in over 70 countries for the treatment of liver cancer

Bayer Inc. announced today that its international trial known as SHARP (Sorafenib HCC Assessment Randomized Protocol), led by Study Manager and Bayer Canada employee Tom Giannaris, has been selected as the winner in the 'Best International Trial' category for the Global Clinical Practice Journal Awards.

17 Nov 2009

Scientists solve 50-year-old thalidomide puzzle

Research into the controversial drug thalidomide reveals that the mechanism through which the drug causes limb defects is the same process which causes it to damage internal organs and other tissues. The article, published in Bio-Essays, outlines the challenges surrounding thalidomide research and claims that confirmation of a 'common mechanism' could lead to new treatments for Leprosy, Crohn's Disease, AIDS and some forms of cancer..

17 Nov 2009

Total of 1,686,100 doses of H1N1 vaccine allocated to Pennsylvania to date: Department of Health

The federal Centers for Disease Control and Prevention, or CDC, has allocated a total of 1,686,100 doses of H1N1 vaccine to Pennsylvania to date, the Department of Health said today.

17 Nov 2009

AACR-NCI-EORTC conference highlights major expansion in cancer drug pipeline

To highlight results of more recent research, the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics International Conference will host a press briefing on "Drugs in the Pipeline." Sara A. Courtneidge, Ph.D., D.Sc., professor and director of the Tumor Microenvironment Program, and director of academic affairs at the Burnham Institute for Medical Research, will moderate this press briefing.

17 Nov 2009

New, reversible antiplatelet drug not superior than irreversible one in patients undergoing PCI

A new, reversible antiplatelet drug did not demonstrate superiority over a current irreversible one in reducing the composite of death, heart attack or ischemia-related revascularization in the 48 hours after angioplasty, researchers reported in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

17 Nov 2009

Shire publishes new study results on INTUNIV Extended-Release Tablets

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone.

17 Nov 2009

LEAD Therapeutics discovers orally available PARP inhibitor

LEAD Therapeutics, a privately held drug discovery company, today announced the discovery of a novel, orally available, PARP inhibitor with potent anti-tumor activity both as single-agent treatment and in combination with chemotherapy drugs.

17 Nov 2009

Genzyme receives FDA complete response letter for its Lumizyme marketing application

Genzyme Corporation announced today that it has received a complete response letter from the FDA regarding its application to market Lumizyme™ (alglucosidase alfa) for the treatment of Pompe disease. In its letter, the agency stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved.

17 Nov 2009

Genentech submits sBLAs to the FDA for Avastin

Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that investigated Avastin in combination with docetaxel chemotherapy.

17 Nov 2009

FDA provides feedback on the pending NDA for EXALGO tablets

CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, 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, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA).

17 Nov 2009

BioSante Pharmaceuticals applauds Boehringer Ingelheim for developing a therapy to treat HSDD

BioSante Pharmaceuticals, Inc., a specialty pharmaceutical company developing products for female sexual health, including LibiGel® for the treatment of hypoactive sexual desire disorder (HSDD), applauds the efforts of Boehringer Ingelheim to develop a therapy to treat this unmet medical need.

17 Nov 2009

Antidepressant drug is effective in treating women with low libido

The drug flibanserin, which was originally created as an antidepressant, is effective in treating women with low libido, pooled results from three separate clinical trials have found.

17 Nov 2009

FDA approves NeurogesX's Qutenza patch for postherpetic neuralgia treatment

NeurogesX, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles.

17 Nov 2009

FDA approves Par Pharmaceutical's new painkiller drug

Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER.

17 Nov 2009

Statin therapy should still be used first to reach blood cholesterol levels before considering niacin

Heart experts at Johns Hopkins are calling premature the early halt of a study by researchers at Walter Reed Army Medical Center and Washington Hospital Center on the benefits of combining extended-release niacin, a B vitamin, with cholesterol-lowering statin medications to prevent blood vessel narrowing. Cardiovascular atherosclerosis, as it is also known, is believed responsible for one in three deaths in the United States each year.

17 Nov 2009

ARCA biopharma provides financial and Gencaro NDA update

ARCA biopharma, Inc. today announced its planned next steps in response to the May 29, 2009 Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for ARCA’s New Drug Application (NDA) seeking approval for GencaroTM (bucindolol hydrochloride) for the treatment of patients with chronic heart failure. Following receipt of the CRL, the Company and the FDA have held a series of meetings to discuss how best to address the requirements identified in the CRL.

17 Nov 2009

FDA approves CSL's seasonal and H1N1 flu vaccines for children

The U.S. Food and Drug Administration has approved the use of the CSL Limited's seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older. These vaccine were previously approved for use in adults, ages 18 years and older

17 Nov 2009

Researchers attempt to slow the pace of infectious organisms' evolution to keep today's drugs effective

Infectious organisms that become resistant to antibiotics are a serious threat to human society. They are also a natural part of evolution. In a new project, researchers at the University of Gothenburg are attempting to find substances that can slow the pace of evolution, in order to ensure that the drugs of today remain effective into the future.

17 Nov 2009

Handwashing: A simple, effective way to prevent the spread of communicable diseases

In this day and age, with the latest in medical equipment and scientific advances adding both quantity and quality to our lives, it is easy to forget that the simplest actions can provide some of the most important results. In fact, your mother's instructions to "wash up before dinner" should be considered some of the soundest medical advice ever offered.

17 Nov 2009

Reorganizing the FDA could save Americans trillions of dollars over the next decade, says legal expert

While Congress and the rest of the nation turn the battle over healthcare reform into a pro-wrestling-style steel cage death match with enough rhetoric to choke an English professor, at least one expert is looking beyond the bills on the table for a different solution.

17 Nov 2009

Pharmaceutical News

Bayer's NEXAVAR approved in over 70 countries for the treatment of liver cancer

Scientists solve 50-year-old thalidomide puzzle

Total of 1,686,100 doses of H1N1 vaccine allocated to Pennsylvania to date: Department of Health

AACR-NCI-EORTC conference highlights major expansion in cancer drug pipeline

New, reversible antiplatelet drug not superior than irreversible one in patients undergoing PCI

Shire publishes new study results on INTUNIV Extended-Release Tablets

LEAD Therapeutics discovers orally available PARP inhibitor

Genzyme receives FDA complete response letter for its Lumizyme marketing application

Genentech submits sBLAs to the FDA for Avastin

FDA provides feedback on the pending NDA for EXALGO tablets

BioSante Pharmaceuticals applauds Boehringer Ingelheim for developing a therapy to treat HSDD

Antidepressant drug is effective in treating women with low libido

FDA approves NeurogesX's Qutenza patch for postherpetic neuralgia treatment

FDA approves Par Pharmaceutical's new painkiller drug

Statin therapy should still be used first to reach blood cholesterol levels before considering niacin

ARCA biopharma provides financial and Gencaro NDA update

FDA approves CSL's seasonal and H1N1 flu vaccines for children

Researchers attempt to slow the pace of infectious organisms' evolution to keep today's drugs effective

Handwashing: A simple, effective way to prevent the spread of communicable diseases

Reorganizing the FDA could save Americans trillions of dollars over the next decade, says legal expert

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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