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Tasigna gets the green light in the U.S. to treat Chronic Myeloid Leukemia

The Food and Drug Administration (FDA) in the U.S. has given approval for a new drug to treat chronic myeloid leukemia (CML).

30 Oct 2007

FDA issues communication on ongoing safety review of Aprotinin injection

Last week, FDA was notified that a Canadian research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to the other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding.

28 Oct 2007

Nasal flu vaccine given the green light for toddlers

A federal advisory panel in the U.S. has given the recommendation that a nasal influenza vaccine can be use in healthy children as young as two.

28 Oct 2007

FDA warns about 'stay awake drug' Provigil

The U.S. Food and Drug Administration (FDA) has issued a warning in connection with the drug Provigil because of dangerous side effects.

28 Oct 2007

Public not so sure about 'personalized medicine'

Ordinary people worry about the extra, and often burdensome, responsibilities which could come with scientists' promises of 'personalised medicine', according to evidence to be presented at a major two-day showcase of groundbreaking social science research into the whole field of genomics, funded by the Economic and Social Research Council (ESRC).

25 Oct 2007

Promising new tuberculosis drug given special status

Approximately one-third of the world's population is infected with Mycobacterium tuberculosis, the bacterium that causes TB, and an estimated 1.6 million people died of the disease in 2005.

25 Oct 2007

WHO aims to improve injection safety across the globe

In an effort to improve injection safety across the globe, the World Health Organization (WHO) has began a 3-day meeting with experts to explore strategies aimed at promoting the use of safer needles.

24 Oct 2007

Influenza vaccine production capacity on the rise

Recent scientific advances and increased vaccine manufacturing capacity have prompted experts to increase their projections of how many pandemic influenza vaccine courses can be made available in the coming years.

24 Oct 2007

Orexigen presents findings on obesity drug candidates

Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of central nervous system (CNS) disorders including obesity, has presented the results of a preclinical study that further supports the Company's understanding of an aspect of the mechanism of action of Contrave, one of its two late-stage obesity drug candidates.

24 Oct 2007

FDA approves approved Ixempra (ixabepilone) for advanced breast cancer

The U.S. Food and Drug Administration has approved Ixempra (ixabepilone), a new anti-cancer treatment, for use in patients with metastatic or locally advanced breast cancer who have not responded to certain other cancer drugs.

22 Oct 2007

Sanofi Pasteur receives FDA approval of Menactra meningococcal vaccine for children

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include children 2 years through 10 years of age.

22 Oct 2007

FDA approves change in storage conditions for Humate-P

The U.S. Food and Drug Administration has approved a change in the storage conditions for Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand Disease (vWD).

22 Oct 2007

Implicit wins $16.3 million U.S. government contract to develop its clinical stage drug oglufanide disodium

Implicit Bioscience has announced that it has been awarded a US$16.34 million (AU$18.2million) contract payable over 37 months from the United States Defense Threat Reduction Agency (DTRA) to develop its clinical stage drug oglufanide disodium as a broad spectrum therapeutic for the treatment of a number of intracellularbacterial diseases.

22 Oct 2007

GenVec receives extra funding for adenovector-based HIV vaccines program

GenVec, Inc. has announced that the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has executed its sixth option period (year seven) under its multi-year collaboration with GenVec to develop and manufacture novel adenovector-based HIV vaccines.

22 Oct 2007

Lilly and MacroGenics to develop and commercialize teplizumab

Eli Lilly and Company and MacroGenics, Inc. have announced that the two companies have entered into a global strategic alliance to develop and commercialize teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other potential next generation anti-CD3 molecules for use in the treatment of autoimmune diseases.

19 Oct 2007

FDA expands approved age range for Menactra, bacterial meningitis vaccine

The U.S. Food and Drug Administration has expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10 years.

19 Oct 2007

FDA approves doripenem injection to treat complicated urinary tract and intra-abdominal infections

The U.S. Food and Drug Administration has approved doripenem injection, 500 mg intravenous infusion, for the treatment of complicated urinary tract and intra-abdominal infections.

19 Oct 2007

European drug regulations need changing

European drug regulations need changing to ensure they meet the needs of patients and doctors, argue experts in this week's British Medical Journal.

19 Oct 2007

Abbott creates one molecule with two antibody functions

Abbott has reported that its scientists are the first to discover a proprietary technology that combines the function and specificity of two or more monoclonal antibodies (mAbs) into one molecular entity that demonstrates drug-like properties and manufacturing feasibility.

19 Oct 2007

Medsafe warns of "natural health" hazards

The New Zealand Ministry of Health's medicines and medical devices regulator Medsafe is warning New Zealanders to be aware of what they're buying when shopping for herbal remedies, following charges brought against a Chinese herbalist in Auckland.

19 Oct 2007