Biologics Drug / Agent News and Research

RSS

Enbrel safety data for up to 8 years in patients with juvenile rheumatoid arthritis

Amgen and Wyeth Pharmaceuticals, a division of Wyeth have announced the presentation of additional data that showed that the safety profile of Enbrel, (etanercept) was maintained with long-term use in patients with moderate-to-severe juvenile rheumatoid arthritis (JRA) who completed up to eight years of therapy.

17 Jun 2007

New rheumatoid arthritis genes identified

Researchers at the University of Manchester have identified evidence of several new genes behind the chronic inflammatory disease rheumatoid arthritis (RA), which affects 387,000 people in the UK.

16 Jun 2007

Researchers find new mechanism of action of the anti-cancer drug sorafenib

Virginia Commonwealth University Massey Cancer Center researchers have uncovered a new mechanism of action of the anti-cancer drug sorafenib, which could stimulate the development of novel regimens in which it is combined with other molecularly targeted agents for patients with blood cancers and solid tumors.

15 Jun 2007

FDA releases report on Human Tissue Task Force

The U.S. Food and Drug Administration (FDA) has released a report that concludes there are no significant industrywide problems in the recovery of human tissues used for transplantation.

14 Jun 2007

FDA scrutinise companies selling human tissue

Following an inspection blitz by the Food and Drug Administration (FDA) on companies which handle a variety of human material from deceased donors, no serious problems have apparently been unearthed.

13 Jun 2007

New genes involved in rheumatoid arthritis discovered

Researchers at the University of Manchester have identified evidence of several new genes behind the chronic inflammatory disease rheumatoid arthritis (RA), which affects 387,000 people in the UK.

From The University of Manchester 8 Jun 2007

Findings from study of immunotherapy vaccine in prostate cancer patients

Data from an ongoing study designed to explore the biologic and clinical activity of cancer immunotherapy sipuleucel-T, or Provenge, in patients with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic disease will be presented by Oregon Health & Science University Cancer Institute researchers.

5 Jun 2007

Axitinib shows promise in treatment of advanced thyroid cancer

The investigational drug axitinib produced tumor regression or stable disease in almost three-out-of-four patients with advanced thyroid cancer, a research team reported at the annual meeting of the American Society for Clinical Oncology in Chicago.

5 Jun 2007

Results of phase II studies of pazopanib

GlaxoSmithKline (GSK) has announced results from ongoing Phase II studies of pazopanib in advanced or metastatic renal cell carcinoma (RCC) and ovarian cancer.

5 Jun 2007

FDA provides guidance to help increase supply of influenza vaccines

The U.S. Food and Drug Administration (FDA) has issued final recommendations to increase the supply of safe and effective influenza vaccines for both seasonal and pandemic use.

3 Jun 2007

Existence of muscle-building stem cells points to regenerative therapies for muscular disease

A new report in the June 1 issue of the journal Cell, a publication of Cell Press, confirms the existence of some apparently uncommitted stem cells amongst cells responsible for generating the bulging biceps of body builders and the rippling abs of fitness buffs.

1 Jun 2007

FDA completes review of FluMist

MedImmune, Inc. has announced that the U.S. Food and Drug Administration (FDA) has stated the agency has completed its review of all submissions made related to the supplemental biologics license application (sBLA) to extend the age indication of FluMist (Influenza Virus Vaccine Live, Intranasal).

28 May 2007

FDA approves treatment for bacterial vaginosis

Mission Pharmacal has announced that the U.S. Food and Drug Administration (FDA) approved Tindamax (tinidazole) for the treatment of bacterial vaginosis (BV), the most common vaginal infection among women of childbearing age in the United States.

28 May 2007

Researchers look at benefits of aspirin for colon cancer prevention

A colon cancer researcher at the Ireland Cancer Center of University Hospitals Case Medical Center (UHCMC) has laid out the roadmap for how medical science should employ aspirin and new aspirin-like drugs for use in preventing colon cancer in certain high-risk individuals.

24 May 2007

New report aims to provide better understanding of the biology of sex differences

The Society for Women's Health Research, a Washington, D.C., based advocacy organization, has issued a report to aid the Food and Drug Administration's Critical Path Initiative in its efforts to advance research on sex and gender differences and enhance the contributions of that research to improve therapeutic product development.

17 May 2007

FDA approves Evicel Fibrin surgical sealant

The U.S. Food and Drug Administration (FDA) has approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from small blood vessels during surgical procedures.

16 May 2007

Catheter-based aortic valve replacement is set to take off

Twenty years ago, few interventional cardiologists could have imagined that during their professional careers it would be possible to replace a diseased aortic valve using catheter-based techniques, rather than open-chest surgery.

11 May 2007

Sigma-Aldrich acquires Molecular Medicine BioServices

Sigma-Aldrich Corporation has announced that it has acquired Molecular Medicine BioServices Inc. (MMB), a biopharmaceutical contract manufacturing organization (CMO) located in Carlsbad, California, to further enhance the biologics capabilities within its SAFC Pharma business segment.

9 May 2007

FluMist may help reduce the burden of seasonal influenza

MedImmune, Inc. has announced research results showing that use of FluMist(R) (Influenza Virus Vaccine Live, Intranasal) in daycare and school settings may help reduce the burden of seasonal influenza.

9 May 2007

Abbott seeks U.S. and E.U. approvals for Humira as a treatment for juvenile rheumatoid arthritis

Abbott has announced it has simultaneously submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA (adalimumab) as a treatment for juvenile rheumatoid arthritis (JRA) in the U.S. and juvenile idiopathic arthritis (JIA) in the European Union (EU).

9 May 2007