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Tentative approval for Lamivudine tablets

The U.S. Food and Drug Administration (FDA) has announced the tentative approval of Lamivudine Tablets manufactured by Aurobindo Pharma LTD. Hyderabad, India.

16 Jun 2005

Vical receives $12 Million HIV vaccine order

Vical Incorporated announced today the receipt of approximately $12.1 million in production orders for multiple clinical lots of DNA vaccines against HIV for the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases, under a subcontract managed by SAIC-Frederick, Inc.

16 Jun 2005

FDA recommends heart drug designed for blacks

The U.S. Food and Drug Administration have announced that a heart-failure drug manufactured for African-Americans significantly reduced deaths and hospitalizations and its side effects were similar to those of a placebo's.

16 Jun 2005

FDA approves Xeloda (capecitabine) oral chemotherapy

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Xeloda (capecitabine) -- an innovative oral chemotherapy -- for the adjuvant (post-surgery) treatment of patients with Dukes' C colon cancer.

15 Jun 2005

Promising new tuberculosis drug enters clinical trial

A promising new drug candidate that may be effective against both actively dividing and slow-growing Mycobacterium tuberculosis (M. tb) has begun testing in humans, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced this week.

15 Jun 2005

Report on Hispanics and genes, culture, and medicines highlights the rise of individualized medicine

"The FDA's review today of BiDil could make it the first drug approved specifically for African Americans and marks the end of 'one-size-fits-all' medicine," said Dr. Jane L. Delgado, President and CEO of the National Alliance for Hispanic Health (the Alliance), the nation's leading Hispanic health advocacy group.

15 Jun 2005

Panel advise limited use of heart drug Natrecor

An independent panel of experts say heart-failure drug Natrecor should be restricted and only used with acutely ill hospitalized patients.

15 Jun 2005

The most frequently used drugs for treating chronic insomnia have never been approved for that purpose

Vaughn McCall, M.D., M.S., professor and chairman of the Department of Psychiatry and Behavioral Medicine, told a special consensus panel at the National Institutes of Health (NIH) that he could find no evidence that randomized controlled clinical trials had ever been conducted for five of the 10 pharmaceuticals prescribed most often for chronic insomnia.

14 Jun 2005

FDA grants Vical orphan-drug designation

Vical Incorporated today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has designated the company's bivalent (two-plasmid) formulation of the company's vaccine against cytomegalovirus (CMV) as an orphan drug for the prevention of clinically significant CMV viremia, CMV disease and associated complications in at-risk hematopoietic cell transplant (HCT) and solid organ transplant (SOT) populations.

14 Jun 2005

Non-profit public-private partnership develops affordable, new drug regimens for tuberculosis

The Global Alliance for TB Drug Development (TB Alliance), a non-profit public-private partnership developing affordable, new drug regimens for tuberculosis, today announced the start of Phase I clinical trials for the lead TB drug in its pipeline, PA-824. The trials begin this month.

14 Jun 2005

Royal Pharmaceutical Society responds to over the counter medication report

Responding to the British Medical Association's (BMA) report, Over the counter medication, David Pruce, Director of Practice and Quality Improvement, the Royal Pharmaceutical Society of Great Britain, said:

14 Jun 2005

Doctors call for education programmes for health professionals and patients about available over-the-counter (OTC) medicines

In a British Medical Association (BMA) report launched today (14 June 2005) doctors are calling for education programmes for health professionals and patients about available over-the-counter (OTC) medicines.

13 Jun 2005

New diabetes drug has a double whammy and is a potential blockbuster

There are, according to the latest statistics, more than 18 million Americans with diabetes, and each year over a million new cases are diagnosed.

13 Jun 2005

West Nile virus vaccine may be ready by the end of the year

A Dutch biotechnology manufacturer says it has identified a human antibody which has proven effective against West Nile virus in animal studies.

12 Jun 2005

FDA approves whooping cough vaccine for adults

The U.S. Food and Drug Administration (FDA) has given drug company Sanofi-Aventis approval to sell Adacel, a vaccine against whooping cough for people ages 11 to 64.

12 Jun 2005

Crystal Meth Summit in Canada wants drug re-classified

Crystal meth, a powerful addictive drug has now become such a problem in Canada that law enforcement officials met in Regina last week for a Crystal Meth Summit.

12 Jun 2005

Survey highlights need for primary care guidance on NSAID use

New guidance on NSAID (non-steroidal anti-inflammatory drug) use is urgently needed to ensure the best patient care, European experts said today. The news coincides with the results from a European survey of 626 arthritis patients which found that many are confused and worried about the potential side-effects of their medication.

10 Jun 2005

Ibuprofen may cause heart attacks - full disclosure of all data - including industry safety data - is essential

Speaking at the annual European conference of rheumatology, EULAR 2005, in Vienna, Austria, today (Friday 10 June 2005), Dr. Gurkirpal Singh, from Stanford University, USA, said:

10 Jun 2005

Pharmacists support generic drug substitution, but need more information to advise customers

Pharmacists and their customers could benefit from having more information to help them understand and compare the costs of prescription drugs, according to a new AARP study that looks at attitudes and practices regarding the use of generic drugs.

10 Jun 2005

Claritin's switch to OTC status meant fewer prescriptions

After the allergy drug Claritin became available without a prescription in 2002, insurance plans and consumers spent less on the prescription form of its main ingredient, loratadine, and all similar allergy drugs, according to a new report published in this month’s The American Journal of Managed Care.

10 Jun 2005