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FDA approves Gilotrif for patients with late stage non-small cell lung cancer

Companion test also approved to identify appropriate patients The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Lung cancer is the leading cause of cancer-related death among men and women.

16 Jul 2013

ARIAD Pharmaceuticals' Iclusig gets EC marketing authorization for CML and Ph+ ALL treatment

ARIAD Pharmaceuticals, Inc. today announced that the European Commission has granted a marketing authorization for Iclusig (ponatinib) as an orphan medicinal product for two indications.

2 Jul 2013

EMA's CHMP issues positive opinion for approval of Genzyme's LEMTRADA in Europe

Genzyme, a Sanofi company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for approval of LEMTRADA (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features.

28 Jun 2013

FDA approves Novartis' Exelon Patch for treatment of severe Alzheimer's disease

The US Food and Drug Administration has expanded the approved indication for Exelon Patch (rivastigmine transdermal system) to include the treatment of people with severe Alzheimer's disease with Exelon Patch 13.3mg/24h.

28 Jun 2013

Ibrutinib shows remarkable promise for treatment of mantle cell lymphoma

In a major international study led by researchers at The University of Texas MD Anderson Cancer Center, the targeted therapy ibrutinib continues to show remarkable promise for the treatment of relapsed or refractory mantle cell lymphoma (MCL).

20 Jun 2013

State highlights: Budgets reflect 'modest' Medicaid increases; Calif. health care companies deal with data breaches; Nevada faces 'patient dumping' lawsuit

In addition, while states are budgeting for modest increases in Medicaid spending next year, those expenditures are poised to increase in future years, he said. Health care costs are rising at a slower rate than in the past, but it is unclear how long that will last (Fletcher, 6/12).

14 Jun 2013

First Edition: June 13, 2013

Today's headlines include reports about how employers are preparing for some parts of the health law to kick in.

13 Jun 2013

Investigational all-oral interferon-free combination from Boehringer Ingelheim achieves 95% viral cure rates in genotype-1b hepatitis C patients

New data from Boehringer Ingelheim’s interferon-free SOUND-C3 study were presented during the APASL Liver Week in Singapore. The Phase IIb study investigated the efficacy and safety of faldaprevir+ and deleobuvir+ (BI 207127) plus ribavirin in treatment-naïve patients with genotype-1b (GT-1b) hepatitis C virus (HCV),1 one of the most common types of HCV globally.2

13 Jun 2013

Faldaprevir+ achieves viral cure in 88% of treatment-naïve genotype-1 hepatitis C patients in Asia

New findings presented today during the APASL Liver Week in Singapore, highlighted the efficacy and safety of faldaprevir+ plus pegylated interferon and ribavirin (PegIFN/RBV) in treatment-naïve patients with genotype-1 hepatitis C virus (HCV) in Asia.1 This post-hoc sub-analysis of the Phase III STARTVerso™1 and 2 trials showed that both doses of faldaprevir were associated with high viral cure rates and a shorter treatment duration in this particular patient group.1

10 Jun 2013

New drug shows promising results with manageable side effects for treating melanoma

Researchers from UCLA's Jonsson Comprehensive Cancer Center report that a new drug in preliminary tests has shown promising results with very manageable side effects for treating patients with melanoma, the deadliest form of skin cancer.

3 Jun 2013

Lambrolizumab shows significant antitumor activity in patients with advanced melanoma

Researchers from UCLA's Jonsson Comprehensive Cancer Center led by Dr. Antoni Ribas, professor of medicine in the division of hematology-oncology, report preliminary results showing significant antitumor activity with very manageable side effects from a new drug being tested in patients with advanced melanoma, the deadliest form of skin cancer.

3 Jun 2013

Sorafenib stops tumor growth, provides effective treatment for thyroid cancer patients

The kidney and liver cancer drug sorafenib holds metastatic thyroid cancer at bay for nearly twice as long as a placebo, according to results of a randomized phase III trial, which will be presented today by a researcher from the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania in a plenary session during the American Society of Clinical Oncology's annual meeting.

3 Jun 2013

Renowned pathologist warns about possible consequences of silicone use in breast reconstruction

The public and the press were electrified in early May when superstar actress and filmmaker Angelina Jolie announced in a New York Times opinion piece that she had received a double mastectomy and follow-up breast reconstruction. Renowned pathologist Rahim Karjoo M.D ., F.C.A.P., F.A.S.C.P., is an expert in the diagnosis and treatment of Morgellons disease, an illness that is little known or acknowledged in the mainstream medical community.

1 Jun 2013

Taking precautions to protect health during summer

Summer is a time for enjoying warm weather, but spending time outside also increases the risk of contracting serious conditions like Lyme disease, poison ivy rashes, West Nile virus and allergic reactions to bee stings.

31 May 2013

Tafinlar, Mekinist get FDA approval to treat patients with advanced melanoma

The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

30 May 2013

Lab-based skin test eliminates risk of adverse reactions to new drugs, cosmetics

A simple lab-based skin test which eliminates the risk of adverse reactions to new drugs, cosmetics and household chemicals has been developed by a Newcastle University, UK team.

28 May 2013

FDA approves Novartis' Ilaris for treatment of active systemic juvenile idiopathic arthritis

Novartis announced that the US Food and Drug Administration has approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis in patients aged 2 years and older.

10 May 2013

Academy of Nutrition and Dietetics encourages people to learn about celiac disease

Celiac disease is estimated to affect one out of 141 of Americans, or just under 1 percent of the population.

8 May 2013

Immunoglobulin fails to meet co-primary endpoints in Phase III clinical study, Baxter reports

Baxter International Inc. today announced that its Phase III clinical study of immunoglobulin did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease.

From Baxter International Inc. 8 May 2013

FDA approves sNDA for SUSTIVA for treatment of HIV-1 infected pediatric patients

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for SUSTIVA (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg.

4 May 2013

Rash News and Research

FDA approves Gilotrif for patients with late stage non-small cell lung cancer

ARIAD Pharmaceuticals' Iclusig gets EC marketing authorization for CML and Ph+ ALL treatment

EMA's CHMP issues positive opinion for approval of Genzyme's LEMTRADA in Europe

FDA approves Novartis' Exelon Patch for treatment of severe Alzheimer's disease

Ibrutinib shows remarkable promise for treatment of mantle cell lymphoma

State highlights: Budgets reflect 'modest' Medicaid increases; Calif. health care companies deal with data breaches; Nevada faces 'patient dumping' lawsuit

First Edition: June 13, 2013

Investigational all-oral interferon-free combination from Boehringer Ingelheim achieves 95% viral cure rates in genotype-1b hepatitis C patients

Faldaprevir+ achieves viral cure in 88% of treatment-naïve genotype-1 hepatitis C patients in Asia

New drug shows promising results with manageable side effects for treating melanoma

Lambrolizumab shows significant antitumor activity in patients with advanced melanoma

Sorafenib stops tumor growth, provides effective treatment for thyroid cancer patients

Renowned pathologist warns about possible consequences of silicone use in breast reconstruction

Taking precautions to protect health during summer

Tafinlar, Mekinist get FDA approval to treat patients with advanced melanoma

Lab-based skin test eliminates risk of adverse reactions to new drugs, cosmetics

FDA approves Novartis' Ilaris for treatment of active systemic juvenile idiopathic arthritis

Academy of Nutrition and Dietetics encourages people to learn about celiac disease

Immunoglobulin fails to meet co-primary endpoints in Phase III clinical study, Baxter reports

FDA approves sNDA for SUSTIVA for treatment of HIV-1 infected pediatric patients

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