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Baxter files FEIBA NF BLA with FDA for prophylactic treatment of hemophilia A or B

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) supplement to the U.S. Food and Drug Administration (FDA) for the approval of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors.

From Baxter International Inc. 26 Feb 2013

Bayer receives FDA approval for Stivarga to treat advanced gastrointestinal stromal tumors

The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.

26 Feb 2013

Omalizumab fast, safe and well-tolerated in teens and adults with chronic spontaneous urticaria

An international team of researchers has found that a once-a-month, high-dose injection of a commonly used asthma drug is highly effective in treating teens and adults chronically afflicted with hives and severe, itchy rash. The drug, omalizumab, was tested on 323 people at 55 medical centers for whom standard antihistamine therapy failed to quell their underlying, allergy-like reaction, known as chronic idiopathic urticaria or chronic spontaneous urticaria.

25 Feb 2013

No difference in TEWL between newborns bathed in water alone or with baby wash

The findings by academics at The University of Manchester, published in the Journal of Obstetric, Gynecologic and Neonatal Nursing, compared Johnson's Baby Top-to-Toe wash against plain bath water on 307 newborn babies over a four week period.

From The University of Manchester 19 Feb 2013

Measles: an interview with Dr. Robert Perry, World Health Organization

Measles is a disease marked by fever, rash, and cold symptoms (red eyes, cough, runny nose) that results in a temporary suppression of the immune system and a drop in vitamin A levels.

4 Feb 2013

Mental health in young people: an interview with Professor Colum Dunne

Ireland, and many other countries, is witnessing increases in problematic and complex youth mental health challenges. In Ireland, specifically, there has been a rash of high profile cases where young people have unfortunately not been able to deal with stress, bullying and other issues.

1 Feb 2013

Asthma linked to atopic dermatitis persistence

Asthma is associated with rash persistence in children with atopic dermatitis, US researchers report.

28 Jan 2013

FDA updates metal-on-metal hip replacement advice

The US Food and Drug Administration has updated its advice on the use of metal-on-metal hip replacement prostheses.

25 Jan 2013

NIH's candidate vaccine safe in treating dengue

A candidate dengue vaccine developed by scientists at the National Institutes of Health (NIH) has been found to be safe and to stimulate a strong immune response in most vaccine recipients, according to results from an early-stage clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The trial results were published online on January 17 in the Journal of Infectious Diseases.

23 Jan 2013

Bevacizumab QoL impact highlighted in ovarian cancer patients

The ICON7 study results suggest that improved progression-free survival with bevacizumab therapy for high-risk ovarian cancer may come at the cost of health-related quality of life.

21 Jan 2013

Boehringer Ingelheim receives FDA Priority Review for afatinib to treat EGFR mutation-positive NSCLC

Boehringer Ingelheim today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA).

17 Jan 2013

Antibiotics do not help lower-respiratory tract infections

The antibiotic amoxicillin fares no better at reducing symptoms in patients with lower-respiratory tract infections than a placebo drug, indicate data from a dozen European countries.

28 Dec 2012

Proteins detected in urine may enable diagnosis of Kawasaki disease

A set of proteins detected in urine by researchers at Boston Children's Hospital may prove to be the first biomarkers for Kawasaki disease, an uncommon but increasingly prevalent disease which causes inflammation of blood vessels that can lead to enlarged coronary arteries and even heart attacks in some children.

20 Dec 2012

Antibiotic amoxicillin ineffective for treating cough according to European trial

The antibiotic amoxicillin, that doctors typically prescribe for common lower respiratory tract infections (LRTI) such as cough and bronchitis, is no more effective at relieving symptoms than the use of no medication, even in older patients. The findings from the largest randomised placebo controlled trial of antibiotics for acute uncomplicated LRTI to date are published Online First in The Lancet Infectious Diseases.

20 Dec 2012

US FDA approves raxibacumab for treating inhalational anthrax

The US Food and Drug Administration have approved the monoclonal antibody raxibacumab for treatment of inhalational anthrax, caused by breathing in spores of Bacillus anthracis.

19 Dec 2012

Lapatinib benefits found for HER2-positive early-stage patients

Women with early-stage, HER2-positive breast cancer who are unable to use trastuzumab may benefit from adjuvant lapatinib treatment, suggest phase III trial findings published in Lancet Oncology.

17 Dec 2012

Ibrutinib continues to show unprecedented results in patients with mantle cell lymphoma

An international study of ibrutinib in people with relapsed or refractory mantle cell lymphoma (MCL) continues to show unprecedented and durable results with few side effects.

15 Dec 2012

Iclusig gets FDA approval for two rare blood and bone marrow diseases

The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.

15 Dec 2012

FDA approves GSK’s raxibacumab to treat inhalational anthrax

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

14 Dec 2012

GSK receives FDA approval for raxibacumab to treat inhalational anthrax

The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

14 Dec 2012