Biologics Drug / Agent News and Research

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Genetic and environmental factors impact chronic fatigue syndrome patients

People who suffer from chronic fatigue syndrome (CFS) have a genetic make up that affects the body's ability to adapt to change, according to a series of papers released last week by the Centers for Disease Control and Prevention (CDC).

2 May 2006

Sociocultural factors that affect pregnancy outcomes in two dissimilar immigrant groups in the United States

Since the number of people of Hispanic and Asian origins has been increasing in the United States, it is important for healthcare workers to assess the risk factors associated with pregnancy outcomes in these ethnic groups.

4 Apr 2006

Targeting the inflamed synovium: The quest for specificity

In the April 2006 issue of Arthritis & Rheumatism, noted rheumatology specialists with Kings College London, Dr. Toby Garrood and Dr. Costantino Pitzalis offer an overview of recent breakthroughs and a preview of future directions in this critical quest for specificity.

4 Apr 2006

First trial to combine a biologic agent with a conventional chemotherapy agent for the treatment of ovarian cancer

Researchers found the addition of thalidomide to topotecan for the treatment of recurrent ovarian cancer significantly increases the response to therapy and the duration of progression free survival without additional toxicity.

28 Mar 2006

Topical therapies show promise for Psoriasis

Psoriasis, a chronic skin condition characterized by thick, red, scaly patches that itch and bleed, not only makes the activities of daily life difficult, but also can affect a person's emotional well being.

6 Mar 2006

UCB submits application to FDA for new treatment in Crohn's disease

UCB has announced the submission of a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for the approval of CIMZIA (certolizumab pegol, CDP870) for the treatment of patients with Crohn's disease.

6 Mar 2006

Mangafodipir appears to increase the cancer-killing ability of some chemotherapy drugs

A contrast agent currently used in magnetic resonance imaging (MRI), called mangafodipir, may increase the cancer-killing ability of some chemotherapy drugs while protecting normal cells, according to a study in the Journal of the National Cancer Institute.

21 Feb 2006

Ovarian cancer responds to aspirin and chemotherapy drug cisplatin

A new study using ovarian cancer cell lines shows promise in treating the deadly disease by combining the chemotherapy drug cisplatin with an aspirin-like compound to make recurrent cancer cells less resistant to the chemotherapy.

17 Feb 2006

New FDA report says earlier meetings w/FDA make drug review process more efficient

The FDA has released a new report that takes carefully examines the way the agency reviews applications for drugs and biologics that have not previously been approved by the FDA.

16 Feb 2006

Statins show beneficial effect on rheumatoid arthritis

Statins, a class of drugs widely used to treat high cholesterol, have also recently been studied for their potential role in inflammation and other cell processes, including immune response.

13 Feb 2006

Lower survival rates of blacks with lung cancer may be explained by access to care

New research suggests that the lower survival rates of blacks with lung cancer may be explained by access to care. The study, by Wake Forest University Baptist Medical Center researchers and colleagues is reported in the January issue of the Journal of Clinical Oncology.

5 Feb 2006

Patent losses open up $30 billion biologics market to generic competition

With powerhouse biologics, such as human growth hormone and insulin, losing their U.S. patent protection in 2005 and many more set to expire within the next 4 years, generic competition in the lucrative biopharmaceutical market is imminent, according to a new study from Kalorama Information.

25 Jan 2006

FDA fast track status for Alfimeprase

Nuvelo Inc. today announced that it has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for its lead product candidate, alfimeprase, for the treatment of acute peripheral arterial occlusion (PAO), or "leg attack."

23 Jan 2006

Variation in IGF1 gene may play a role in prostate cancer risk

Two variations in the gene for insulin-like growth factor I (IGF-1) are linked to an increased risk of prostate cancer, according to research performed by scientists from the Keck School of Medicine of the University of Southern California, the Broad Institute of Harvard and MIT, and the University of Hawaii.

18 Jan 2006

Approval of first immune globulin for use beneath the skin

The U.S. Food and Drug Administration (FDA) has announced the approval of the first immune globulin product for subcutaneous injection for the prevention of serious infections in patients with Primary Immune Deficiency Diseases (PIDD).

10 Jan 2006

Evidence supports combination therapy for achieving remission of early rheumatoid arthritis

A chronic and potentially crippling inflammatory disorder, rheumatoid arthritis (RA) progressively wears away the cartilage and bone.

8 Jan 2006

MorphoSys signs agreement with Merck

MorphoSys AG announced today that it has signed a five-year license agreement with U.S. pharmaceutical company Merck & Co., Inc. for the use of MorphoSys’s HuCAL GOLD and AutoCAL technologies in research and development of human therapeutic antibodies.

14 Dec 2005

Cellular clues to vitamin A resistance in lung cancer

Vitamin A deficiency has been associated with the development of lung cancer in laboratory studies. However, clinical trials of natural and synthetic derivatives of vitamin A, called retinoids, for the prevention of lung cancer have been largely unsuccessful in the general population.

26 Nov 2005

Statins reduce the risk of stroke after carotid artery endarterectomy

Carotid artery endarterectomy (CEA) is the most commonly performed operation to prevent stroke in the United States. However, the operation itself carries a small risk of stroke.

13 Nov 2005

Unrelated adults, usually a male boyfriend, dramatically increase the risk of inflicted injury

Young children who live in households with one or more unrelated adults are nearly 50 times as likely to die from an inflicted injury, usually being shaken or struck, as children living with two biologic parents, report researchers from the University of Missouri-Columbia and the University of Chicago in the November 2005 issue of the journal Pediatrics.

7 Nov 2005