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CTSA institutions receive NIH grants to study drug safety and efficacy in children

Studying drugs in pediatric populations is challenging because drugs often affect children differently than they do adults. The scarcity of pediatric studies limits the ability of doctors and scientists to predict drug dosing, safety and efficacy in children. To address this gap, the National Institutes of Health announced today 18 grants to help determine outcome measures and increase the likelihood of success of future trials of treatments for children.

18 Nov 2009

Tel Aviv University develops new wound dressing packed with infection-fighting antibiotics

Despite advances in treatment regimens and the best efforts of nurses and doctors, about 70% of all people with severe burns die from related infections. But a revolutionary new wound dressing developed at Tel Aviv University could cut that number dramatically.

18 Nov 2009

Ongoing Phase 1 study results of XMT-1001 announced by Mersana Therapeutics

Mersana Therapeutics, a platform-based cancer therapeutics company, announced today additional preliminary results from an ongoing Phase 1 study of its lead development candidate, XMT-1001, in patients with advanced solid tumors.

18 Nov 2009

FDA approves Qutenza, a pain relief product for patients who suffer from PHN

The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.

18 Nov 2009

SIRO Clinpharm and Mediscis team up to expand clinical development plans

SIRO Clinpharm, a global Contract Research Organization (CRO) with bases in India, US, Europe and Israel today announced their alliance with Mediscis, an early drug development company based in Poitiers and La Rochelle, France.

18 Nov 2009

China, WHO to collaborate on flu research center

Chinese and WHO officials last week agreed to open a flu research center in Beijing, Bloomberg reports. "The new collaborating center for reference and research on influenza will join a network of WHO-affiliated labs in Atlanta, London, Tokyo and Melbourne that monitor flu strains and make recommendations on vaccines to fight the virus," the news service writes

17 Nov 2009

Abbott and BG Medicine announce a development and commercialization agreement for galectin-3 biomarker

Abbott and BG Medicine, Inc. today announced a development and commercialization agreement for galectin-3, a novel biomarker that may play a role in detecting the development and progression of heart failure. The assay will be developed for Abbott's ARCHITECT immunochemistry instrument platform, specifically the company's i1000SR and i2000SR instruments. The agreement grants Abbott a license to BG Medicine's intellectual property related to galectin-3.

17 Nov 2009

Cancer pain drug market to be $3.7 billion in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, driven by the continued dominance of opioids that include immediate-release morphine and novel fast acting opioid reformulations, the cancer pain drug market will increase from $2.3 billion in 2008 to $3.7 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

17 Nov 2009

Bavarian Nordic awarded a new contract for developing a freeze-dried version of its IMVAMUNE smallpox vaccine

Bavarian Nordic A/S announced today that BARDA (Biomedical Advanced Research and Development Authority) has awarded a new contract to Bavarian Nordic for the development of a freeze-dried version of its IMVAMUNE(R) smallpox vaccine with a total prospective value of USD 40 million.

17 Nov 2009

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

Pharmaceutical News

CTSA institutions receive NIH grants to study drug safety and efficacy in children

Tel Aviv University develops new wound dressing packed with infection-fighting antibiotics

Ongoing Phase 1 study results of XMT-1001 announced by Mersana Therapeutics

FDA approves Qutenza, a pain relief product for patients who suffer from PHN

SIRO Clinpharm and Mediscis team up to expand clinical development plans

China, WHO to collaborate on flu research center

Abbott and BG Medicine announce a development and commercialization agreement for galectin-3 biomarker

Cancer pain drug market to be $3.7 billion in 2018

Bavarian Nordic awarded a new contract for developing a freeze-dried version of its IMVAMUNE smallpox vaccine

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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