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Researchers proceed to develop vaccination to reverse neurological damage seen with Parkinson's disease

Researchers at the University of Nebraska Medical Center have taken a significant step forward in developing a vaccination approach to reverse the neurological damage seen with Parkinson's disease.

2 Mar 2010

ARIAD Pharmaceuticals' investigational pan-BCR-ABL inhibitor receives FDA and EMA orphan drug designation

ARIAD Pharmaceuticals, Inc. today announced that its investigational pan-BCR-ABL inhibitor, AP24534, has been granted orphan drug designation by both the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In the U.S., the orphan designation of AP24534 is for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and in the E.U., its orphan designation is for CML and acute lymphoblastic leukemia.

2 Mar 2010

Acorda Therapeutics' AMPYRA now available in the U.S. and Puerto Rico

Acorda Therapeutics, Inc. today announced that AMPYRA™ (dalfampridine) Extended Release Tablets, 10 mg is now available by prescription in the United States and Puerto Rico. AMPYRA was approved on January 22, 2010 by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA is indicated for use in all types of MS, and can be used either alone or with existing therapies, including disease-modifying agents.

1 Mar 2010

Scopolamine drug: A rapid-acting antidepressant for depression symptoms

Conventional antidepressant treatments generally require three to four weeks to become effective, thus the discovery of treatments with a more rapid onset is a major goal of biological psychiatry. The first drug found to produce rapid improvement in mood was the NMDA glutamate receptor antagonist, ketamine.

1 Mar 2010

ChemGenex Pharmaceuticals' OMAPRO review: FDA reschedules ODAC meeting to 22 March, 2010

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has rescheduled the previously postponed Oncologic Drugs Advisory Committee (ODAC) meeting to 22 March 2010.

1 Mar 2010

OPA encourages Ontarians to discuss travel-related health questions with their pharmacists

Every spring, thousands of Ontarians embark on vacations and, along with luggage and family members, many bring medication. While your passport and camera may seem like the most important things to remember, ensuring you have a backup supply of your prescription medication should be at the top of your to-do list as well.

1 Mar 2010

McGill University and RI MUHC secure $300,000 CIHR grant to develop VLP vaccines

The Canadian Institutes of Health Research (CIHR) have awarded a $300,000 grant for research focusing on the nature of the immune response induced by the action mechanisms of plant-made Virus-Like Particles (VLP) to Dr. Louis Vezina, Chief Scientific Officer of Medicago and to Dr. Brian Ward and Dr. Ciriaco Piccirillo of the Research Institute of the McGill University Health Centre (RI MUHC) and McGill University.

1 Mar 2010

Isis Pharmaceuticals reports revenues of $32.3M for fourth-quarter 2009

Isis Pharmaceuticals, Inc. today announced its 2009 financial results and reviewed the highlights of the year. Isis achieved its 2009 financial guidance with pro forma net income of $166.9 million and a pro forma net operating loss (NOL) of $14.2 million compared with its guidance for the year of pro forma net income of more than $145 million and a pro forma NOL in the low to mid $20 million range. Isis also achieved its cash guidance by ending 2009 with $574.3 million of cash, cash equivalents and short-term investments significantly in excess of the $550 million projected.

1 Mar 2010

COMP issues positive opinion for Æterna Zentaris' perifosine orphan medicinal product designation

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today announced that it has received a positive opinion for orphan medicinal product designation for its compound perifosine from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of multiple myeloma.

1 Mar 2010

AMAG Pharmaceuticals reports fourth-quarter 2009 net product revenues of $12.8M attributable to Feraheme

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2009.

1 Mar 2010

Biodel seeks FDA marketing approval for VIAject

Biodel Inc. announced today that the U.S. Food and Drug Administration has accepted for review the company’s new drug application (NDA) seeking approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs.

1 Mar 2010

FDA accepts for filing VIVUS' Qnexa NDA

VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa®, for the treatment of obesity. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.

1 Mar 2010

Bayer HealthCare Pharmaceuticals' RECOTHROM solution receives Health Canada approval

Bayer HealthCare Pharmaceuticals announced today that RECOTHROM(R) (Thrombin alfa (Recombinant)), the first recombinant, plasma-free thrombin approved by Health Canada, is now available for use as a topical hemostatic solution. According to a recent clinical study, RECOTHROM(R) was found to successfully stop 80 per cent of surgical bleeding within three minutes and 95 per cent of bleeding within 10 minutes.

1 Mar 2010

Habits of modern life may shorten life-span of the Millennium Generation

All parents dream of a better life for their children, but because of the habits of modern life, the Millennium Generation may be the first to suffer a shorter life-span.

1 Mar 2010

Chitosan put forward as effective alternative to growth-promoting antibiotics in the diet of ruminants

The natural-occurring biopolymer known as chitosan is being put forward as an effective alternative to growth-promoting antibiotics in the diet of ruminants, according to research carried out by scientists at the Basque technological centre, Neiker-Tecnalia.

1 Mar 2010

Pharmacist workforce: Work characteristics and contributions

Results released today from the Pharmacy Manpower Project’s 2009 National Pharmacist Workforce Survey indicate shifts in the pharmacy profession toward more patient care. This 2009 report also provides insight into how the nation’s current economic situation has influenced the dynamics of the U.S. pharmacy workforce as nearly a quarter of pharmacists are practicing part-time and more are working past retirement age. This study is the third in a series of surveys commissioned by the Pharmacy Manpower Project, Inc. (PMP) since 2000 and has been highly anticipated throughout the industry.

1 Mar 2010

Ipsen’s 2009 performance: Azzalure, Dysport and Decapeptyl approval, Adenuric partnership, drug sales up 7.6%

The Board of Directors of Ipsen, chaired by Jean-Luc Bélingard, met on 26 February 2010 to review the Group’s results for 2009, published today.

1 Mar 2010

Aprepitant drug can reduce nausea and vomiting when combined with other anti-nausea drugs

Bone marrow transplant patients say two of the most debilitating side effects of the treatment are nausea and vomiting caused by chemotherapy and radiation.

1 Mar 2010

ADVENTRX' ANX-530 NDA: FDA issues refuse to file letter

ADVENTRX Pharmaceuticals, Inc. announced today that it received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion). In the letter, the FDA indicated that the data included in the initial submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. FDA identified only the one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX plans to meet with the FDA as soon as possible to discuss its response.

1 Mar 2010

Short-term dose of losartan-M6PHSA reduces liver inflammation and fibrosis: Study

A recent study found that rats with advanced fibrosis that were administered a short-term dose of losartan-M6PHSA had reduced liver inflammation and fibrosis. Those animals treated with oral losartan alone did not experience a similar reduction in disease activity. Results of this study appear in the March issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.

1 Mar 2010

Pharmaceutical News

Researchers proceed to develop vaccination to reverse neurological damage seen with Parkinson's disease

ARIAD Pharmaceuticals' investigational pan-BCR-ABL inhibitor receives FDA and EMA orphan drug designation

Acorda Therapeutics' AMPYRA now available in the U.S. and Puerto Rico

Scopolamine drug: A rapid-acting antidepressant for depression symptoms

ChemGenex Pharmaceuticals' OMAPRO review: FDA reschedules ODAC meeting to 22 March, 2010

OPA encourages Ontarians to discuss travel-related health questions with their pharmacists

McGill University and RI MUHC secure $300,000 CIHR grant to develop VLP vaccines

Isis Pharmaceuticals reports revenues of $32.3M for fourth-quarter 2009

COMP issues positive opinion for Æterna Zentaris' perifosine orphan medicinal product designation

AMAG Pharmaceuticals reports fourth-quarter 2009 net product revenues of $12.8M attributable to Feraheme

Biodel seeks FDA marketing approval for VIAject

FDA accepts for filing VIVUS' Qnexa NDA

Bayer HealthCare Pharmaceuticals' RECOTHROM solution receives Health Canada approval

Habits of modern life may shorten life-span of the Millennium Generation

Chitosan put forward as effective alternative to growth-promoting antibiotics in the diet of ruminants

Pharmacist workforce: Work characteristics and contributions

Ipsen’s 2009 performance: Azzalure, Dysport and Decapeptyl approval, Adenuric partnership, drug sales up 7.6%

Aprepitant drug can reduce nausea and vomiting when combined with other anti-nausea drugs

ADVENTRX' ANX-530 NDA: FDA issues refuse to file letter

Short-term dose of losartan-M6PHSA reduces liver inflammation and fibrosis: Study

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