Biologics Drug / Agent News and Research

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Musculoskeletal Center wins $2.2 million to study biologics safety

The UAB Center for Education and Research on Therapeutics has won a $2.2 million federal grant to study the risks and benefits of a class of drugs called ‘biologics' -- genetically engineered agents targeting the immune system of patients with rheumatoid arthritis, Crohn's disease, psoriasis and other autoimmune disorders.

18 Nov 2008

Combination of carboplatin and paclitaxel with bevacizumab and cetuximab proves safe for lung cancer treatment

The four drug-combination of carboplatin and paclitaxel, with the targeted therapies bevacizumab (Avastin) and cetuximab (Erbitux), is safe and may improve survival for patients with advanced lung cancer, according to a cooperative group study led by The University of Texas M. D. Anderson Cancer Center.

16 Nov 2008

Xolair (Omalizumab) shows promise in treating allergic asthma inadequately controlled by inhaled corticosteroid

Data presented today at the American College of Allergy, Asthma & Immunology (ACAAI) show that Xolair (Omalizumab) for Subcutaneous Use significantly reduced asthma attacks in children aged six through 11 with moderate or severe persistent allergic asthma inadequately controlled with inhaled corticosteroids.

10 Nov 2008

Dermatitis management

Although the variety of substances that can cause contact dermatitis is almost limitless, it often can be effectively managed with the proper diagnosis and treatment according to investigators presenting the latest research at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Seattle.

7 Nov 2008

BioLife Solutions submits FDA master file on HypoThermosol preservation and storage media for cells, tissues

BioLife Solutions Inc. has announced that it has submitted a Master File to the United States Food and Drug Administration (FDA) for the Company's HypoThermosol preservation media product.

6 Nov 2008

Medicaid policies vary widely for biologic disease-modifying antirheumatic drugs

Patients with inflammatory diseases such as rheumatoid arthritis now have many more treatment options than in the past, including biologic disease-modifying antirheumatic drugs (DMARDs).

5 Nov 2008

$Review of research into how cells and proteins repair fractured bones$

Review of research into how cells and proteins repair fractured bones

A review of research into how cells and proteins repair fractured bones published in the November 2008 issue of The Journal of the American Academy of Orthopaedic Surgeons demonstrates that understanding the biology behind this healing process may lead to improved and less invasive treatments for fractures.

4 Nov 2008

Post-traumatic stress disorder symptoms linked to increased risk of death after heart events

Individuals who receive implantable cardiac defibrillators after a sudden heart event appear more likely to die within five years if they experience symptoms of post-traumatic stress disorder, regardless of the severity of their disease, according to a report in the November issue of Archives of General Psychiatry.

4 Nov 2008

Phase 2 trial of treatment of C-difficile-associated diarrhea shows promise

Medarex, Inc. and The Massachusetts Biologic Laboratories (MBL) of the University of Massachusetts Medical School (UMMS) today announced that a Phase 2 trial of an anti- C. difficile antibody combination treatment in patients with C.

4 Nov 2008

MedImmune starts phase 1/2a clinical trial for respiratory syncytial virus vaccine

MedImmune today announced that it has initiated a Phase 1/2a clinical trial of a live, attenuated intranasal vaccine in healthy children one month to 12 months of age to help prevent severe respiratory syncytial virus (RSV) infections. RSV is the most common respiratory infection in infants and can cause disease in otherwise healthy infants and children.

3 Nov 2008

Genentech submits application to FDA for Avastin in the most aggressive form of brain cancer

Genentech has announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Avastin (bevacizumab) as a therapy for people with previously treated glioblastoma. If accepted by the FDA, the application would be considered for an accelerated approval that allows provisional approval of medicines for cancer or other life-threatening diseases based on preliminary evidence suggesting clinical benefit.

3 Nov 2008

Cimzia study shows reduction of symptoms and progression of rheumatoid arthritis

UCB has announced pivotal RAPID 1 (RA PreventIon of structural Damage) data published in Arthritis & Rheumatism shows CIMZIA (certolizumab pegol), the only PEGylated anti-TNF (Tumour Necrosis Factor alpha), together with methotrexate (MTX), rapidly reduced symptoms of disease and inhibited progression of joint damage in adult patients with active rheumatoid arthritis (RA), with sustained results for up to one year.

31 Oct 2008

FDA licenses Kogenate FS to prevent joint damage in children with hemophilia A

The U.S. Food and Drug Administration has approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

12 Oct 2008

FDA licenses for marketing Cinryze for hereditary angioedema

The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.

12 Oct 2008

Lilly to acquire ImClone Systems for $6.5 billion

Eli Lilly and Company and ImClone Systems Inc. today announced that the boards of directors of both companies have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion.

6 Oct 2008

FDA accepts ATryn biologics license application

The US Food and Drug Administration, or FDA, has accepted for review GTC Biotherapeutics, Inc.'s Biologics License Application, or BLA, for ATryn.

6 Oct 2008

Experts confront cancer trend: aging population, new challenges

A growing cadre of specialists - geriatric oncologists - is the latest group of medical pioneers to meet the challenge of a rising cancer incidence among older adults. They are investigating how to fill the gaps in the way oncology is practiced today, which sometimes neglects the special needs of the elderly.

2 Oct 2008

Pathways to clinical goals speeds cancer therapy approval

Although cancer remains a leading cause of death in America, it can take up to 12 years to bring a new anti-cancer agent before the FDA and the success rate for approval is only five to 10 percent. That means many research hours and dollars are wasted chasing avenues that will not bring fruit.

15 Sep 2008

FDA approves expanded uses for Gardasil for vaginal and vulvar cancer caused by HPV

The U.S. Food and Drug Administration has announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26.

14 Sep 2008

FDA approves Gamunex for chronic inflammatory demyelinating polyneuropathy

The U.S. Food and Drug Administration has announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms.

14 Sep 2008

Biologics Drug / Agent News and Research

Musculoskeletal Center wins $2.2 million to study biologics safety

Combination of carboplatin and paclitaxel with bevacizumab and cetuximab proves safe for lung cancer treatment

Xolair (Omalizumab) shows promise in treating allergic asthma inadequately controlled by inhaled corticosteroid

Dermatitis management

BioLife Solutions submits FDA master file on HypoThermosol preservation and storage media for cells, tissues

Medicaid policies vary widely for biologic disease-modifying antirheumatic drugs

Review of research into how cells and proteins repair fractured bones

Post-traumatic stress disorder symptoms linked to increased risk of death after heart events

Phase 2 trial of treatment of C-difficile-associated diarrhea shows promise

MedImmune starts phase 1/2a clinical trial for respiratory syncytial virus vaccine

Genentech submits application to FDA for Avastin in the most aggressive form of brain cancer

Cimzia study shows reduction of symptoms and progression of rheumatoid arthritis

FDA licenses Kogenate FS to prevent joint damage in children with hemophilia A

FDA licenses for marketing Cinryze for hereditary angioedema

Lilly to acquire ImClone Systems for $6.5 billion

FDA accepts ATryn biologics license application

Experts confront cancer trend: aging population, new challenges

Pathways to clinical goals speeds cancer therapy approval

FDA approves expanded uses for Gardasil for vaginal and vulvar cancer caused by HPV

FDA approves Gamunex for chronic inflammatory demyelinating polyneuropathy

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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