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FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Forest Laboratories, Inc. announced today that Teflaro(ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

Teflaro receives FDA approval for treatment of bacterial infections

The U.S. Food and Drug Administration today approved Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

FDA approves Sprycel for treatment of adults with Ph+ CP-CML

The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

29 Oct 2010

Tips to prevent lead poisoning in children

California Poison Control System is observing National Lead Poisoning Prevention Week and warns consumers that lead can be found in a variety of products available to children.

27 Oct 2010

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.

26 Oct 2010

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Cephalon, Inc. today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL (armodafinil) Tablets [C-IV] and PROVIGIL (modafinil) Tablets [C-IV] have been approved by the U.S. Food and Drug Administration (FDA).

25 Oct 2010

Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

Takeda Canada, Inc. is pleased to announce that ULORIC® (febuxostat), an innovative oral urate-lowering therapy to lower serum uric acid levels in patients with gout is now available in Canada. This medication is the first new treatment option in more than 40 years for the approximately three per cent of Canadians who have hyperuricemia associated with gout.1 ULORIC was discovered by Teijin Pharma Limited of Tokyo and licensed to Takeda for the Canada market.

21 Oct 2010

More education and attention needed on inflammatory breast cancer

Inflammatory breast cancer (IBC), an aggressive and rare malignancy, is often initially misdiagnosed as an infection or rash. However, getting the correct diagnosis quickly is critical for patients because the disease spreads beyond the breast in a matter of just days or weeks.

20 Oct 2010

ISI launches initiative to create translation glossary for healthcare providers

Phrases like "Grandfathered Health Plan" or "Biosimilar Biological Products" are hard enough to understand in English, let alone trying to accurately translate those concepts into Spanish, Chinese or any other of the dozens of languages in which healthcare providers must communicate.

19 Oct 2010

Researchers determine genetic blueprint of 13 strains of Lyme disease causing bacteria

Benjamin Luft, M.D., Professor of Medicine, Stony Brook University Medical Center, and a team of medical researchers have determined the genetic blueprint of 13 strains of the bacteria that cause Lyme disease. The finding is crucial to advancing research on Lyme disease, the most frequent tick-borne infection in North America and Europe, and may lead to better diagnostics and a vaccine.

14 Oct 2010

Food allergies are becoming more common in U.S. children

The scary reality is that food allergies are becoming more and more common in the United States. In the last 10 years there has been an 18 percent increase in children with food allergies. In fact, one in 22 children has a food allergy. That means most likely there is at least one child in each classroom with a food allergy. Halloween parties and trick or treating are just a few of the end of fall activities that can heighten the danger for kids with food allergies.

13 Oct 2010

Boehringer Ingelheim announces results from afatinib clinical trials at 35th ESMO

Boehringer Ingelheim Pharmaceuticals, Inc. announced today results from two clinical trials for its investigational cancer compound afatinib* (BIBW 2992) presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

11 Oct 2010

Attorney Keith Jensen announces $3.78 million settlement with Pfizer on TEN case

Attorney Keith Jensen of the Fort Worth, Texas-based law firm of Jensen, Belew & Gonzalez is announcing a $3.78 million settlement with pharmaceutical manufacturer Pfizer Inc. on behalf of the family of a nine-year-old New York girl who died in June 2004 as the result of a drug-induced disease known as Stevens Johnson Syndrome, which caused all of her skin to peel off.

11 Oct 2010

Allos announces favorable survival data from FOLOTYN Phase 2b study

Allos Therapeutics, Inc. today announced the presentation of favorable survival data from the Company's international, randomized Phase 2b investigational study of FOLOTYN relative to erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC). In this study, patients receiving FOLOTYN had a 16 percent reduction in the risk of death compared to erlotinib in the overall (intent-to-treat) population.

11 Oct 2010

Researchers determine genetic structures of bacteria that cause Lyme disease

Researchers Dr. Steven E. Schutzer of UMDNJ-New Jersey Medical School and Dr. Claire M. Fraser-Liggett of the Institute for Genome Sciences, University of Maryland, and their collaborators have made a major achievement toward better understanding Lyme disease, by determining the complete genetic structures of 13 strains of the bacteria that cause the disease.

11 Oct 2010

Amgen announces PRIME '203' and '181' Phase 3 trial results

Amgen today announced that results from the PRIME '203' and '181' pivotal Phase 3 trials evaluating Vectibix (panitumumab) in combination with chemotherapy (FOLFOX or FOLFIRI) as a first and second-line treatment for metastatic colorectal cancer (mCRC), respectively, were published online in the Journal of Clinical Oncology.

5 Oct 2010

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

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

4 Oct 2010

Suspected hand, foot and mouth disease on Denver flight

Two children arrived on a flight from Mexico to Denver showing symptoms of the contagious illness called ‘hand, foot and mouth’ disease (HFMD) and were checked by paramedics. They were allowed to leave after experts said they were no threat to public health.

4 Oct 2010

ZymoGenetics announces positive survival data from IL-21 Phase 2a clinical trial

ZymoGenetics, Inc. today announced positive survival data from a Phase 2a clinical trial in metastatic melanoma with recombinant Interleukin 21 (IL-21) as a single agent. Median overall survival was 12.4 months, and the percentage of patients surviving at 12 months was 53%.

29 Sep 2010

Rash News and Research

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Teflaro receives FDA approval for treatment of bacterial infections

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

FDA approves Sprycel for treatment of adults with Ph+ CP-CML

Tips to prevent lead poisoning in children

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

More education and attention needed on inflammatory breast cancer

ISI launches initiative to create translation glossary for healthcare providers

Researchers determine genetic blueprint of 13 strains of Lyme disease causing bacteria

Food allergies are becoming more common in U.S. children

Boehringer Ingelheim announces results from afatinib clinical trials at 35th ESMO

Attorney Keith Jensen announces $3.78 million settlement with Pfizer on TEN case

Allos announces favorable survival data from FOLOTYN Phase 2b study

Researchers determine genetic structures of bacteria that cause Lyme disease

Amgen announces PRIME '203' and '181' Phase 3 trial results

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Suspected hand, foot and mouth disease on Denver flight

ZymoGenetics announces positive survival data from IL-21 Phase 2a clinical trial

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