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Therapure Biopharma to fill/finish nimotuzumab at its Canadian GMP certified fill suite

David Allan, Chairman and CEO of YM BioSciences Inc. and Thomas Wellner, President and CEO of Therapure Biopharma Inc. today announced the signing of an agreement under which Therapure Biopharma will provide fill and finish services for nimotuzumab, the humanized monoclonal antibody licensed to YM's majority-owned Canadian subsidiary, CIMYM BioSciences Inc., by the Centre of Molecular Immunology (CIM).

17 Dec 2009

Labopharm commences regulatory approval process in Europe for its twice-daily tramadol-acetaminophen

Labopharm Inc. today announced it has initiated the regulatory approval process for its twice-daily tramadol-acetaminophen formulation in Europe under the Decentralized Procedure (DCP). The DCP provides an efficient mechanism that allows a company to simultaneously pursue regulatory approval for a medicinal product in multiple jurisdictions in Europe.

17 Dec 2009

Prophylactic misuse of NSAIDs cause more harm than good

Athletes' superstitions and rituals can help them get psyched up for contests, but when these rituals involve non-steroidal anti-inflammatory drugs (NSAIDs), which many athletes gobble down before and during events, they could be causing more harm than good.

17 Dec 2009

Promising breakthrough in adjuvant development may lead to cost-effective therapeutic vaccines

It should be possible to use therapeutic vaccines to create both cheap and effective drugs for diseases like cancer and allergies. One problem in developing such vaccines has previously been the lack of adjuvants, substances that make vaccines more effective. However, there has now been a major breakthrough in this area. The study, led by Swedish scientists at Uppsala University, is published in the December issue of the journal Vaccine.

17 Dec 2009

Three H1N1 influenza vaccination clinics scheduled to offer vaccines free of charge

2010 is just over two weeks away. Make a New Year's resolution for you and your family members and start the new year out right by getting your H1N1 influenza shot at one of the available clinics in southeast Michigan.

17 Dec 2009

Forest Laboratories Holdings and Almirall to develop, market and distribute LAS100977 in the US

Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. and Almirall, S.A. (ALM.MC) today announced that they have entered an agreement to develop, market and distribute LAS100977 in the United States.

17 Dec 2009

FDA Advisory Committee votes against the approval of Tarceva

OSI Pharmaceuticals, Inc. and Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one recommending against approval of the daily pill Tarceva® (erlotinib) for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has not progressed (grown or spread) following first-line treatment with platinum-based chemotherapy.

17 Dec 2009

ODAC to review Cell Therapeutics' NDA for pixantrone

Cell Therapeutics, Inc. (CTI) announced today that on February 10, 2010 the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).

17 Dec 2009

ODAC to conduct public advisory meeting to review ChemGenex Pharmaceuticals’ NDA for Omapro

ChemGenex Pharmaceuticals Limited announced today the U.S. Food and Drug Administration (FDA) has notified the company that the Oncologic Drugs Advisory Committee (ODAC) will conduct a public advisory meeting on 10 February 2010 to review the Company’s NDA for Omapro™ (omacetaxine mepesuccinate) for injection.

17 Dec 2009

GSK and NanoBio sign license agreement for nanoemulsion technology

GlaxoSmithKline and Ann Arbor-based NanoBio Corporation announced today that they have signed an exclusive over-the-counter licensing agreement for NanoBio's unique nanoemulsion treatment for cold sores in the United States and Canada.

17 Dec 2009

New licensing agreement to develop and commercialize prophylactic vaccine against MRSA signed

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that it has entered into an exclusive, world-wide licensing agreement with Syntiron to develop and commercialize its prophylactic vaccine against Staphylococcus, including Methicillin-Resistant Staphylococcus aureus or MRSA.

17 Dec 2009

Group of drugs used to treat heart failure shows promise for fighting colon cancer

Scientists in Sweden are reporting for the first time that a group of drugs used to treat heart failure shows promise for fighting colon cancer. The study is in ACS' Journal of Natural Products, a monthly publication. Colon cancer is the third most common cancer in the United States, with more than 150,000 cases diagnosed in the U.S. each year.

17 Dec 2009

Also in global health news: Kenya HIV/AIDS; Uganda bill; water project in Philippines; U.N. appeal for Yemen

U.S. Ambassador Michael Ranneberger on Wednesday announced the U.S. would provide $26.5 million (2.7 billion Kenyan shillings) between 2009 and 2013 to fight HIV/AIDS in Kenya, the Daily Nation reports (Sinundu, 12/16). In related news, the Standard reports the Kenyan government will be begin the gradual phase out of the antiretroviral drug, Stavudine, which is known to cause adverse side effects (Mwai, 12/15).

17 Dec 2009

Opinions: HIV prevention; PEPFAR; H1N1 vaccine donation; developing country R&D; climate change

"For nearly 30 years scientists have been trying to break the back of the AIDS epidemic," but the recent microbicide gel study and an AIDS vaccine trial in Thailand "show just how difficult and how distant that goal is," according to a Washington Post editorial. "While scientists continue searching for a vaccine or a cure, prevention remains paramount," the Washington Post concludes (12/16).

16 Dec 2009

New study to evaluate the effectiveness of H1N1 and seasonal flu vaccines in pregnant women conducted

Abt Associates will conduct a study for the Centers for Disease Control and Prevention (CDC) to evaluate the effectiveness of the H1N1 and seasonal flu vaccines among pregnant women, one of the high risk populations identified by CDC.

16 Dec 2009

WHO using new bivalent oral polio vaccine in Afghanistan

The WHO on Tuesday launched a vaccination campaign in Afghanistan that will use "a new and more effective polio vaccine" for the first time, Reuters reports (Nebehay, 12/15).

16 Dec 2009

Syntiron grants sanofi pasteur exclusive world-wide license to its human vaccine against MRSA

Syntiron today announced that it has granted sanofi pasteur an exclusive world-wide license to its human vaccine against Staphylococcus aureus. The agreement includes an undisclosed initial licensing fee, milestone payments and royalty payments on future sales of the product. Staphylococcus aureus, or MRSA (pronounced Mer-sa) is an important hospital-acquired infection and is a major cause of illness and death resulting in excess of 18,000 US deaths a year and a half million hospitalizations, creating a significant economic burden of approximately $3.4 billion annually to the American health care system.

16 Dec 2009

NanoBio, GSK partner to develop and commercialize novel cold sore treatment compound

GlaxoSmithKline plc and NanoBio Corporation today announced an exclusive licensing agreement in the United States and Canada for the over-the-counter (OTC) use of NB-001, a novel, patented compound representing the next advance in the treatment of cold sores. Developed by NanoBio, NB-001 provides significant antimicrobial activity against the virus that causes cold sores, herpes labialis.

16 Dec 2009

Amendment to allow drug importation fails in Senate

A bipartisan plan to allow Americans to buy cheaper prescription drugs from suppliers in other countries, such as Canada, failed Tuesday in the Senate. The Wall Street Journal reports the two top supporters of the plan, Sens. Byron Dorgan, D-N.D., and John McCain, R-Ariz., said shopping overseas via the Internet and mail-order companies could save consumers up to $80 billion over a decade if their amendment were added to the health overhaul legislation.

16 Dec 2009

Walgreens offers H1N1 vaccine in 27 states

Walgreens, the nation’s largest drugstore chain and an industry leader with more than 17,000 certified or licensed immunizers, today announced it is offering H1N1 vaccine at more than 1,500 Walgreens pharmacies and select Take Care Clinics in 27 states, as well as the District of Columbia.

16 Dec 2009

Pharmaceutical News

Therapure Biopharma to fill/finish nimotuzumab at its Canadian GMP certified fill suite

Labopharm commences regulatory approval process in Europe for its twice-daily tramadol-acetaminophen

Prophylactic misuse of NSAIDs cause more harm than good

Promising breakthrough in adjuvant development may lead to cost-effective therapeutic vaccines

Three H1N1 influenza vaccination clinics scheduled to offer vaccines free of charge

Forest Laboratories Holdings and Almirall to develop, market and distribute LAS100977 in the US

FDA Advisory Committee votes against the approval of Tarceva

ODAC to review Cell Therapeutics' NDA for pixantrone

ODAC to conduct public advisory meeting to review ChemGenex Pharmaceuticals’ NDA for Omapro

GSK and NanoBio sign license agreement for nanoemulsion technology

New licensing agreement to develop and commercialize prophylactic vaccine against MRSA signed

Group of drugs used to treat heart failure shows promise for fighting colon cancer

Also in global health news: Kenya HIV/AIDS; Uganda bill; water project in Philippines; U.N. appeal for Yemen

Opinions: HIV prevention; PEPFAR; H1N1 vaccine donation; developing country R&D; climate change

New study to evaluate the effectiveness of H1N1 and seasonal flu vaccines in pregnant women conducted

WHO using new bivalent oral polio vaccine in Afghanistan

Syntiron grants sanofi pasteur exclusive world-wide license to its human vaccine against MRSA

NanoBio, GSK partner to develop and commercialize novel cold sore treatment compound

Amendment to allow drug importation fails in Senate

Walgreens offers H1N1 vaccine in 27 states

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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