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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

FDA approves raltegravir new HIV drug

The U.S. Food and Drug Administration (FDA) has approved raltegravir tablets for treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

17 Oct 2007

AHF challenges Merck over Isentress AIDS drug pricing

AIDS Healthcare Foundation (AHF) has criticized Merck and Co. Pharmaceuticals, for the announced price for its key new HIV/AIDS drug, Isentress (raltegravir), an integrase inhibitor approved by the Food and Drug Administration (FDA) Friday, and priced by the company at nearly $9,900 per patient yearly.

17 Oct 2007

Contraceptive pill with no side-effects in the pipeline

Scientists in the United States are developing a new contraceptive pill with no side-effects.

17 Oct 2007

Vaginal microbicide coated condom partnership between Durex and Starpharma

Starpharma Holdings Ltd today announced the signing of an agreement with SSL International plc, owner of Durex, the world's leading condom brand.

16 Oct 2007

AMDL submits data to FDA for clearance to market its diagnostic test to monitor colorectal cancer patients

AMDL, Inc., developer and marketer of tests for the early detection of cancer and other serious diseases, announced today that it has filed with the U.S. Food & Drug Administration (FDA) for clearance to market its unique, proprietary DR-70 (FDP) ELISA tumor marker test for use as an aid in monitoring patients previously diagnosed with colorectal cancer. AMDL used the guidance provided at the meeting they had with the FDA on January 25, 2007.

15 Oct 2007

Biopharmaceutical infrastructure key to lower drug development costs

Improvements to the technology infrastructure for researching and developing new biopharmaceuticals would be expected to save the industry hundreds of millions of dollars annually, according to a new economic study sponsored by the National Institute of Standards and Technology (NIST).

12 Oct 2007