Biologics Drug / Agent News and Research

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Scientists create human monoclonal antibody that neutralizes the Hepatitis C virus

Taking aim at a leading cause of liver failure in the United States, a team of scientists at the Massachusetts Biologic Laboratories (MBL) of the University of Massachusetts Medical School (UMMS) has developed a human monoclonal antibody that neutralizes the Hepatitis C virus (HCV).

5 May 2009

MR enterography eliminates unnecessary radiation exposure in patients with small bowel disease

MR enterography is an effective tool to evaluate and guide treatment of patients with Crohn's Disease (a common form of inflammatory bowel disease that typically affects young people) without exposing them to radiation, according to a study performed at the Warren Alpert School of Medicine/Brown University in Providence, RI.

23 Apr 2009

Collagen bioscaffolds used to treat diabetic ulcers, save limbs

San Diego surgeons report that they have been successfully utilizing a collagen bioscaffold material developed by Irvine-based Pegasus Biologics, Inc. to complement soft tissue repair and regeneration among high risk wound patients.

22 Apr 2009

New insights into how to combat avian flu

An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus.

22 Apr 2009

Chronic lymphocytic leukemia linked to seven different gene variants

A national team of researchers led by Mayo Clinic has found that patients with chronic lymphocytic leukemia (CLL) are more likely to have similar DNA changes or variants in up to six genes, compared to people who do not have the cancer.

21 Apr 2009

Overexpression of PEA-15 protein shrinks breast cancer tumors

Overexpression of PEA-15, which binds and drags an oncoprotein out of the cell nucleus where it fuels cancer growth, steeply reduced breast cancer tumors in a preclinical experiment, researchers at The University of Texas M. D. Anderson Cancer Center reported at the 100th annual meeting of the American Association for Cancer Research.

20 Apr 2009

Addition of dasatinib to standard chemo cocktail may enhance effect in certain ovarian cancers

The addition of a chemotherapeutic drug for leukemia to a standard regimen of two other chemotherapy drugs appears to enhance the response of certain ovarian cancers to treatment, according to a pre-clinical study led by researchers in the Duke Comprehensive Cancer Center.

20 Apr 2009

FDA imposes restrictions on Coast IRB due to violations

The U.S Food and Drug Administration has announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials.

14 Apr 2009

$Pharmacyclics starts clinical trial of novel oral Btk inhibitor for refractory B-cell non-Hodgkin's lymphoma$

Pharmacyclics starts clinical trial of novel oral Btk inhibitor for refractory B-cell non-Hodgkin's lymphoma

Pharmacyclics, Inc. has announced that it has begun treating patients in a Phase 1 dose-escalation study to evaluate the safety and tolerability of PCI-32765, an orally available, selective inhibitor of Bruton's tyrosine kinase, or Btk, as a potential treatment for patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).

13 Apr 2009

Health Canada approves Simponi (golimumab) for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis

Centocor Ortho Biotech Inc. and Schering-Plough Corporation has announced that Health Canada has granted approval of Simponi (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

13 Apr 2009

Tolera Therapeutics granted orphan drug status for organ transplant rejection lead candidate drug

Tolera Therapeutics, Inc., was granted orphan drug status by the United States Food and Drug Administration (FDA) for its initial lead candidate, TOL101, for prophylaxis of acute rejection of solid organ transplantation.

12 Apr 2009

Gene fusion discovery may lead to improved prostate cancer test

A newly discovered gene fusion is highly expressed in a subset of prostate cancers, according to a study by researchers at Weill Cornell Medical College.

12 Apr 2009

Trial of new biologic agent to treat psoriatic arthritis

Psoriatic arthritis affects about 11 percent of patients with psoriasis.

8 Apr 2009

FDA approves IXIARO for Japanese encephalitis

The U.S. Food and Drug Administration has approved IXIARO, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States.

30 Mar 2009

Senate measure would allow generic versions of biotechnology drugs after five years

Sens. Charles Schumer (D-N.Y.) and Susan Collins (R-Maine) on Thursday introduced legislation (S 726) that would allow FDA to approve generic versions of biotechnology drugs after a five-year period of brand-name patent exclusivity, the New York Times reports.

30 Mar 2009

Discovery of genetic markers for aggressive head and neck cancer

Scientists at Albert Einstein College of Medicine of Yeshiva University have identified genetic markers that signal poor outcomes for patients with head and neck cancer.

20 Mar 2009

Novel stimulation method sparks hope for Parkinson's disease sufferers

A novel stimulation method, the first potential therapy to target the spinal cord instead of the brain, may offer an effective and less invasive approach for Parkinson's disease treatment, according to pre-clinical data published in the journal Science by researchers at Duke University Medical Center.

20 Mar 2009

FDA looks at nanotechnology for the detection of anthrax

The U.S. Food and Drug Administration has completed a "proof-of-concept" study of a test that quickly and accurately detects the presence of even the smallest amount of the deadly anthrax toxin.

17 Mar 2009

Healthpoint intiates phase II clinical trial to evaluate effectiveness of HP802-247 in venous leg ulcers

Healthpoint announced that it has initiated a Phase II clinical trial investigating the efficacy of HP802-247 in venous leg ulcers.

16 Mar 2009

Promising results for 5-day stereotactic body radiation therapy in early stage prostate cancer

Preliminary results show that a shortened course of radiation therapy for prostate cancer called stereotactic body radiation therapy (SBRT) provides good PSA response for early-stage prostate cancer and has the same side effects as other treatments, according to a March 15 study in the International Journal of Radiation Oncology*Biology*Physics , the official journal of the American Society for Radiation Oncology (ASTRO).