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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

Generic Trileptal (oxcarbazepine) approved in U.S.

The U.S. Food and Drug Administration has approved the first generic versions of Trileptal (oxcarbazepine), an anticonvulsant drug.

10 Oct 2007

HIV drug designed for children wins FDA approval

A pill containing 3 anti-HIV drugs designed specifically for children has been given tentative approval by the United States Food and Drug Administration (FDA). Its use in Sub-Saharan Africa will benefit thousands of children living with HIV.

10 Oct 2007

Cautious optimism for new Alzheimer's medications

Alzheimer's disease takes a long time to develop, which suggests that it may be possible to design drugs that work early in the disease process, to delay the start of symptoms.

10 Oct 2007

$Accentia announces investigational new drug application for Revimmune for refractory MS$

Accentia announces investigational new drug application for Revimmune for refractory MS

Accentia Biopharmaceuticals has announced that it met with the Food and Drug Administration (FDA) on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting on Revimmune.

10 Oct 2007

Warnings about drugs used with ultrasounds

The Food and Drug Administration (FDA) is reportedly about to issue "blackbox" warnings for drugs used to enhance the images of ultrasound machines in the diagnosing of heart problems.

8 Oct 2007

Wyeth Pharmaceuticals to acquire Haptogen

Wyeth Pharmaceuticals, a division of Wyeth has announced the signing of a definitive agreement under which it has acquired Haptogen Ltd., a Scottish company based in Aberdeen that is focused on the discovery of biopharmaceutical therapies.

8 Oct 2007

Fraunhofer pharmaceutical agent speeds drug development

It takes a great deal of time and money to develop a new drug. At Biotechnica in Hanover from October 9 to 11, the Fraunhofer Life Sciences Alliance will demonstrate how a pharmaceutical agent can make its way more quickly from the research laboratory to the pharmacy.

8 Oct 2007

Bayer HealthCare clear to acquire Citracal calcium supplements in the United States

Bayer HealthCare (BHC) has announced that its Consumer Care Division has received regulatory approvals necessary to acquire the Citracal line of over-the-counter (OTC) calcium supplements in the United States.

8 Oct 2007