Biologics Drug / Agent News and Research

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FDA forms task force on human tissue safety

The Food and Drug Administration (FDA) today announced the formation of a multidisciplinary FDA task force on human cell and tissue safety.

30 Aug 2006

A tissue marker of poor prognosis in clear cell renal cell carcinoma

The search for molecular markers that further advance our knowledge of the biology of renal cell carcinoma (RCC) and assist in evaluating the diagnosis and prognosis of patients remains the subject of intense investigation.

20 Aug 2006

FDA orders two companies to cease manufacturing human cells and tissues

FDA orders Donor Referral Services (DRS), a human tissue-recovery firm, of Raleigh, NC, and its owner, Philip Guyett, to immediately cease all manufacturing operations.

20 Aug 2006

Formation of an internal FDA Nanotechnology Task Force

Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., today announced the formation of an internal FDA Nanotechnology Task Force.

9 Aug 2006

FDA approves next seasons flu vaccines

The Food and Drug Administration (FDA) has announced that it has approved this year's seasonal influenza (flu) vaccines that include the new strains of virus judged likely to cause flu in the Northern Hemisphere in 2006-2007.

2 Aug 2006

NICE backs use of Enbrel and Raptiva to treat severe psoriasis

NICE has today issued guidance for the use of the targeted biological therapies, Enbrel (etanercept) and Raptiva (efalizumab), to treat adult patients with severe plaque psoriasis.

26 Jul 2006

Nexavar approved in Europe for treatment of advanced kidney cancer

Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc have announced that the European Commission has granted marketing authorization to Nexavar (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma.

24 Jul 2006

Anomalous renal effects of tin protoporphyrin in a murine model of sickle cell disease

Researchers have unexpectedly shown that sickle cell-associated kidney injury may be reduced by inhibiting the enzyme activity of a protein that commonly confers protection in other diseased states.

19 Jul 2006

FDA approves fully automated screening tests for hepatitis B surface antigen

The Food and Drug Administration (FDA) has announced the approval of the first fully automated product that combines both screening and confirmatory tests for hepatitis B surface antigen (HBsAg).

18 Jul 2006

First-in-class biologics poised to drive malignant melanoma drug market

Decision Resources, Inc., a research and advisory firm focusing on pharmaceutical and healthcare issues, finds that first-in-class targeted biologics will enter the malignant melanoma market during the next five years.

27 Jun 2006

Study of fetal DNA in serum and disease activity during pregnancy in women with inflammatory arthritis

During pregnancy, women with inflammatory arthritis usually experience disease improvement or even remission, while a disease flare regularly occurs within 3 to 4 months after delivery.

27 Jun 2006

FDA announces new initiative to modernize regulation of clinical trials

FDA announces new policy and regulatory developments to strengthen the Agency's oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency's approach to bioresearch monitoring as part of the Critical Path Initiative.

26 Jun 2006

Low-dose exposure to arsenic in drinking water increases risk for skin lesions

Mailman School of Public Health study provides evidence that a population exposed to well water with arsenic concentrations of as little as 50 ug/l is at risk for skin lesions.

14 Jun 2006

Burkitt lymphoma gene expression signature identified

An international research study involving the University of Nebraska Medical Center, the National Cancer Institute and 10 other institutions has successfully identified the gene expression signature for Burkitt lymphoma.

14 Jun 2006

FDA approval of Gardasil to prevent cervical cancer

The Food and Drug Administration (FDA) has announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18.

8 Jun 2006

Milstein gift seeks cure for antibiotic-resistant TB and malaria

A $7.25 million gift to Weill Medical College of Cornell University will establish the Abby and Howard P. Milstein Chemistry Core Facility and the Abby and Howard P. Milstein Program in Chemical Biology.

5 Jun 2006

Experimental treatment increases response rates in advanced lung cancer

An early phase study pairing an experimental targeted therapy with a common anti-inflammatory produced promising results in patients with advanced lung cancer, researchers at UCLA's Jonsson Cancer Center reported.

1 Jun 2006

New vaccine reduces the risk of shingles

A new vaccine which reduces the risk of shingles (herpes zoster) for use in people 60 years of age and older has won approval from the U.S. Food and Drug Administration.

29 May 2006

Arthritis drug wins approval for use in children with Crohn's disease

The Food and Drug Administration in the U.S. has given approval for the drug Remicade for use in children with active Crohn's disease(CD), a chronic and debilitating condition.

21 May 2006

The efficacy and safety of Rituximab in patients with active rheumatoid arthritis

Drugs aimed at suppressing inflammation-provoking cytokines--specifically those linked to T-cells--have improved the treatment of rheumatoid arthritis (RA), a chronic, inflammatory autoimmune disease. Still, the frequency of remission achieved by these biologic agents remains below 50 percent.

3 May 2006