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FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

23 Feb 2010

Pediatric patients face number of cardiac conditions that can impact their health

While heart disease is traditionally associated with adults, pediatric patients face a number of cardiac conditions that can impact their health.

18 Feb 2010

Anti-seizure medication prevents seizures in patients following bleeding stroke: Study

A study by researchers at the University of Cincinnati Neuroscience Institute at University Hospital supports the use of an alternative medication to prevent seizures in patients who have suffered a life-threatening traumatic brain injury or bleeding stroke.

18 Feb 2010

Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

Talecris Biotherapeutics announced today that it has received approval from Health Canada for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more purified and concentrated version of PROLASTIN® produced using advances in manufacturing technology. A similar approval for PROLASTIN-C was granted by the U.S. Food and Drug Administration on October 17, 2009.

17 Feb 2010

CPS supports NACI recommendations for new shingles vaccine

The Canadian Pain Society (CPS) supports the National Advisory Committee on Immunization (NACI) recommendations for the use of a vaccine to significantly reduce the risk of developing herpes zoster (shingles) and post herpetic neuralgia in adults over the age of 60 without contraindications.

3 Feb 2010

FDA approves new drug combination for hormone positive and HER2-positive advanced breast cancer

The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

30 Jan 2010

GlaxoSmithKline's Lamictal XR Extended-Release Tablets receive FDA approval

laxoSmithKline announced today that the U.S. Food and Drug Administration has approved Lamictal®XR™ (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures.

29 Jan 2010

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST.

27 Jan 2010

Antibiotic drops are safe and effective for treating swimmer's ear

When treating the pain and inflammation of swimmer's ear, antibiotic drops are the most effective — and safest - therapy, finds a new review of studies.

20 Jan 2010

U.S. DOD awards LUHS $1.6M to continue burn research

Loyola University Health Systems (LUHS) has received a $1.6 million contract from the U.S. Department of Defense (DOD) to research burn injuries, the care of burn wounds and infections and how burns affect the immune system.

18 Jan 2010

Increased doses of erlotinib drug may lead to better outcomes in lung cancer patients

Although erlotinib is an approved second-line therapy for lung cancer, its management is complicated by side effects that get worse as the dose increases.

12 Jan 2010

Biomarker may enable personalized GVHD treatment for bone marrow transplant patients

University of Michigan researchers have identified the first biomarker of graft-versus-host disease of the skin. The discovery makes possible a simple blood test that should solve a treatment dilemma facing doctors with patients who frequently develop rashes after bone marrow transplants.

9 Jan 2010

Study examines relationship between parental vaccine refusal and risk of varicella infection in children

Children of parents who refuse vaccines are nine times more likely to get chickenpox compared to fully immunized children, according to a new study led by a vaccine research team at Kaiser Permanente Colorado's Institute for Health Research.

5 Jan 2010

NMA urges parents to protect their children from meningococcal disease

This winter, while many parents are focused on influenza prevention, the National Meningitis Association (NMA) is urging parents to also protect their families from meningococcal disease, a deadly but potentially vaccine preventable bacterial infection.

22 Dec 2009

FDA Advisory Committee votes against the approval of Tarceva

OSI Pharmaceuticals, Inc. and Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one recommending against approval of the daily pill Tarceva® (erlotinib) for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has not progressed (grown or spread) following first-line treatment with platinum-based chemotherapy.

17 Dec 2009

Pfizer announces results from studies evaluating neratinib

Pfizer Inc. today announced results from studies evaluating neratinib (HKI-272), an investigational, orally administered, pan-ErbB inhibitor, in patients with human epidermal growth factor receptor-2 (HER2, also known as ErbB2) positive breast cancer at the 2009 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).

14 Dec 2009

Combination therapy improves overall survival in women with advanced breast cancer

In a clinical study, women with an aggressive form of breast cancer experienced a median survival of 14 months when treated with an investigational combination of TYKERB® (lapatinib) plus HERCEPTIN® (trastuzumab). The results of the Phase III study in HER2-positive metastatic breast cancer were presented during the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held in San Antonio, Texas (Dec. 9 - 13).

14 Dec 2009

Incyte announces positive results from ongoing Phase I/II clinical trial for INCB7839

Incyte Corporation announced today positive results from an ongoing Phase I/II clinical trial for its selective oral sheddase inhibitor, INCB7839, involving 46 patients with HER2 positive metastatic breast cancer.

14 Dec 2009

Positive interim results of ARRY-380 in Phase 1 trial announced

Array BioPharma Inc. today announced positive interim results of its novel, small molecule HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in advanced cancer patients.

13 Dec 2009

Modified blood adult stem-cell transplant regimen reverses sickle cell disease

A modified blood adult stem-cell transplant regimen has effectively reversed sickle cell disease in 9 of 10 adults who had been severely affected by the disease, according to results of a National Institutes of Health study in the Dec. 10 issue of the New England Journal of Medicine.

13 Dec 2009

Rash News and Research

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Pediatric patients face number of cardiac conditions that can impact their health

Anti-seizure medication prevents seizures in patients following bleeding stroke: Study

Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

CPS supports NACI recommendations for new shingles vaccine

FDA approves new drug combination for hormone positive and HER2-positive advanced breast cancer

GlaxoSmithKline's Lamictal XR Extended-Release Tablets receive FDA approval

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Antibiotic drops are safe and effective for treating swimmer's ear

U.S. DOD awards LUHS $1.6M to continue burn research

Increased doses of erlotinib drug may lead to better outcomes in lung cancer patients

Biomarker may enable personalized GVHD treatment for bone marrow transplant patients

Study examines relationship between parental vaccine refusal and risk of varicella infection in children

NMA urges parents to protect their children from meningococcal disease

FDA Advisory Committee votes against the approval of Tarceva

Pfizer announces results from studies evaluating neratinib

Combination therapy improves overall survival in women with advanced breast cancer

Incyte announces positive results from ongoing Phase I/II clinical trial for INCB7839

Positive interim results of ARRY-380 in Phase 1 trial announced

Modified blood adult stem-cell transplant regimen reverses sickle cell disease

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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