Biologics Drug / Agent News and Research

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FDA approves RiaSTAP for bleeding in patients with congenital fibrinogen deficiency

The U.S. Food and Drug Administration has licensed RiaSTAP, an orphan drug for the treatment of bleeding in patients with a rare genetic defect known as congenital fibrinogen deficiency. Without treatment, these patients are at risk of potentially life-threatening bleeding.

18 Jan 2009

Study shows surgery provides good long-term outcomes for patients with gastrointestinal cancers

New research published in the January issue of the Journal of the American College of Surgeons shows that laparoscopic removal of gastrointestinal stromal tumors (GISTs) is safe and effective, with a disease-free survival rate of nearly 80 percent after an average follow-up time of three and a-half years.

15 Jan 2009

Cell Therapeutics targeting potential Zevalin label expansion,

In meetings held in association with the JP Morgan Healthcare Conference in San Francisco, Cell Therapeutics, Inc. (CTI) reviewed 2009 targeted milestones and 2008 accomplishments.

15 Jan 2009

Pegloticase BLA filing accepted for priority review by FDA

Savient Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Application (BLA) for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients.

30 Dec 2008

FDA issues complete response letter to Ipsen for Dysport BLA

Ipsen has announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport.

30 Dec 2008

FDA issues complete response to biologics license application for ustekinumab

Centocor, Inc., has announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab.

21 Dec 2008

FDA to review Barr Pharmaceutical's BLA for adenovirus type 4 and 7 live oral vaccines

Barr Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral Vaccines Biologics License Application (BLA).

14 Dec 2008

Rituxan in combination with chemo improves survival in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec have announced that two global Phase III studies in chronic lymphocytic leukemia (CLL), CLL8 and REACH, showed Rituxan (rituximab) plus chemotherapy significantly increased the time patients lived without their disease advancing, as defined by the primary endpoint of progression-free survival (PFS), when compared to chemotherapy alone.

8 Dec 2008

MedImmune starts phase 2 trial of antibody targeting IL-5 receptor

MedImmune has announced that it has initiated a Phase 2 clinical trial in patients with chronic asthma to determine the safety of subcutaneous dosing of a humanized monoclonal antibody (MAb) that targets the interleukin-5 receptor (IL-5R).

8 Dec 2008

Tobacco plants grown in novel mist bioreactor system provide new soure of interleukin-12

Interleukin-12 is a naturally occurring protein essential for the proper functioning of the human immune system.

3 Dec 2008

Risk factors for chronic disability after back injury

A wide range of factors-including variables related to health care and job characteristics-affect the risk of long-term disability for workers with back injuries, reports a study in the December 1 issue of Spine.

3 Dec 2008

ViroPharma Inc. submits sBLA for Cinryze to treat acute attacks of hereditary angioedema

ViroPharma Inc. has announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Cinryze C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema (HAE).

1 Dec 2008

FDA accepts Zevalin supplemental biologics license application

Cell Therapeutics, Inc. (CTI) has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review, and has granted priority review status for, the supplemental Biologics License Application (sBLA) for use of Zevalin ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need.

1 Dec 2008

Better management of arthritis more important than new drugs

Although there has been an increase in the number of new arthritis treatments in recent years, the best results will come from more effective use of the drugs we have.

26 Nov 2008

MorphoSys and Galapagos enter alliance to co-develop novel therapeutic antibodies in bone and joint disease

MorphoSys AG and Galapagos NV announced today the launch of a long term co-development alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis and osteoarthritis.

26 Nov 2008

Ustekinumab receives positive opinion in Europe for treatment of plaque psoriasis

Janssen-Cilag announced today that ustekinumab, the first in a new class of biologics, has received a positive opinion for the treatment of moderate to severe plaque psoriasis from the European Committee for Medical Products for Human Use (CHMP).

24 Nov 2008

FDA accepts filing and grants priority review for DX-88 for hereditary angioedema

Dyax Corp. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) and has designated the application for Priority Review.

21 Nov 2008

Non-pharmacologic interventions for the control of osteoporosis and obesity

The Department of Biomedical Engineering at Stony Brook University received a $1.8 million grant from the National Institutes of Health (NIH) to investigate the biologic and physical mechanisms of very low-magnitude mechanical signals and how they strengthen bone and muscle.

20 Nov 2008

Gefitinib just as effective as chemotherapy for lung cancer

Gefitinib, also known as Iressa, the once-promising targeted therapy for the treatment of non-small cell lung cancer, has proven as effective as chemotherapy as a second-line therapy for the disease with far fewer side effects, according to an international Phase III clinical trial, led by researchers at The University of Texas M. D. Anderson Cancer Center.