Biologics Drug / Agent News and Research

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FDA approves new test for West Nile virus in donors

The U.S. Food and Drug Administration (FDA) has announced the approval of a license supplement for the first fully automated West Nile Virus (WNV) nucleic acid test for donor screening.

4 Mar 2007

Study underscores importance of cholesterol levels as a risk factor for stroke in women

Healthy women with no history of heart disease or stroke significantly increase their chances of having a stroke if they have high cholesterol, according to a study of more than 27,000 women published in the February 20, 2007, issue of Neurology, the scientific journal of the American Academy of Neurology.

20 Feb 2007

Legislation introduced that would give FDA authority to approve generic versions of biotechnology drugs

Lawmakers in the House and Senate on Wednesday introduced a bill that would allow FDA to approve generic versions of biotechnology medications, USA Today reports.

19 Feb 2007

Drinking coffee does not increase the risk of heart attacks in women

Researchers in the United States have found that drinking coffee does not increase the risk of heart attacks in women.

14 Feb 2007

Cancer breakthrough - first treatment to directly target tumor supply

For the first time, physician-scientists at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City have demonstrated in patients the ability of an antibody to directly target the blood supply of a wide variety of tumors, leaving healthy tissues unharmed.

12 Feb 2007

Alphanate approved to treat Von Willebrand disease

The U.S. Food and Drug Administration (FDA) has announced the approval of Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate.

4 Feb 2007

FDA and VA to share information on safe use of medical products

The U.S. Food and Drug Administration (FDA) in the U.S. Department of Health and Human Services and the Veterans Health Administration (VHA) in the U.S. Department of Veterans Affairs (VA) announced today that they have signed a memorandum of understanding (MOU) to share information and expertise related to the review and use of FDA-regulated drugs, biologics and medical devices (medical products).

30 Jan 2007

FDA issues guidance on license applications for placental/umbilical cord blood products

The Food and Drug Administration (FDA) has issued a draft guidance recommending a streamlined path to licensure for establishments that manufacture cord blood for certain medical conditions.

16 Jan 2007

Acupuncture in patients with osteoarthritis of the knee or hip

Osteoarthritis (OA) has a major impact on patients' mobility and quality of life but the anti-inflammatory drugs used to treat it are associated with a number of side effects.

30 Oct 2006

New biologic treatment for tennis elbow

A person suffering from tennis elbow may not have to look any further than his or her own body for the most effective treatment, according to a study published in the November issue of The American Journal of Sports Medicine.

23 Oct 2006

Calls for FDA to pay more attention to products made with nanotechnology

At a meeting called by the U.S. Food and Drug Administration (FDA), consumer and environmental groups have called for the FDA to pay more attention to products made by using nanotechnology.

11 Oct 2006

Going deaf and blind happens simultaneously in old age

According to Australian scientists, vision and hearing loss happens almost simultaneously in older people.

11 Oct 2006

Lower PSA in obese men could be a warning

Researchers in the U.S. say that obese men have lower levels of a protein used to screen for prostate cancer risk, and doctors should take weight into account when determining a man's risk.

10 Oct 2006

FDA approves FluLaval

The U.S. Food and Drug Administration (FDA) today approved FluLaval, an influenza vaccine to immunize people 18 years of age and older against the disease caused by strains of influenza virus judged likely to cause seasonal flu in the Northern Hemisphere in 2006-2007.

5 Oct 2006