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NICE recommends FIRMAGON for treating advanced hormone-dependent prostate cancer in adults with spinal metastases

The National Institute for Health and Care Excellence (NICE) today issued its Final Appraisal Determination (FAD) recommending FIRMAGON (degarelix) as an option for treating advanced hormone-dependent prostate cancer, only in adults with spinal metastases who present with signs or symptoms of spinal cord compression. [More]
Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Halozyme Therapeutics, Inc. today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment. [More]
Bayer enrolls patients for Phase III trial of Stivarga (regorafenib) tablets in colorectal cancer

Bayer enrolls patients for Phase III trial of Stivarga (regorafenib) tablets in colorectal cancer

Bayer HealthCare today announced that the company has begun to enroll patients in the COAST trial studying Stivarga® (regorafenib) tablets in colorectal cancer (CRC) patients with resected liver metastases. [More]
Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt today announced the commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the treatment of the pain of osteoarthritis of the knees. [More]
Erosive GERD treatments: an interview with Professor Joaquim Moraes-Filho, University of São Paulo Medical School

Erosive GERD treatments: an interview with Professor Joaquim Moraes-Filho, University of São Paulo Medical School

Gastroesophageal Reflux Disease (GERD) is a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. [More]

FDA approves New Drug Application for PENNSA 2%

Mallinckrodt today announced that the U.S. Food and Drug Administration has approved the New Drug Application for PENNSAID (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug approved for use in the treatment of the pain of osteoarthritis of the knee(s). [More]
GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. [More]

Supraglottic index, teaching program validated

A scoring system known as the supraglottic index is valuable in assessing patients with asthma complicated by laryngopharyngeal reflux, researchers report. [More]
Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

Teva Pharmaceutical Industries Ltd. and Takeda Pharmaceutical Company Limited (Takeda) today announced the signing earlier this year of an agreement in which Teva licensed to Takeda the right to commercialize Teva's innovative glatiramer acetate ( active ingredient) formulation for the treatment of multiple sclerosis, in Japan. [More]
Novartis to present updates on broad cancer portfolio at ASH and SABCS symposiums

Novartis to present updates on broad cancer portfolio at ASH and SABCS symposiums

Novartis will present updates on its broad cancer portfolio with more than 240 abstracts at the upcoming American Society of Hematology (ASH) annual meeting and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). [More]
House dust mite allergy treatment: an interview with Steve Harris, CEO & Co-founder of Circassia

House dust mite allergy treatment: an interview with Steve Harris, CEO & Co-founder of Circassia

House dust mite allergy is a surprisingly prevalent problem. Something like 27% of the U.S. population and 20% of the European population are what’s called skin-prick test positive for house dust mites, which is a test for sensitivity to allergens to find out if a person is likely to get that allergy. [More]
Research: Sunscreen provides 100% protection against skin cancer

Research: Sunscreen provides 100% protection against skin cancer

Next time your kids complain about putting on sunscreen, tell them this: Sunscreen shields a superhero gene that protects them from getting cancer. [More]
Strategic analysis on opportunities in the US blood banking market

Strategic analysis on opportunities in the US blood banking market

Reportlinker.com announces that a new market research report is available in its catalogue: 2014 Opportunities in the US Blood Banking Market [More]
European Commission approves Stivarga tablets for treatment of patients with mCRC

European Commission approves Stivarga tablets for treatment of patients with mCRC

Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the European Commission has approved Stivarga® (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC). [More]
FDA approves Galderma's Mirvaso topical gel for facial erythema of rosacea

FDA approves Galderma's Mirvaso topical gel for facial erythema of rosacea

Galderma Laboratories, L.P. announced that the U.S. Food and Drug Administration has approved Mirvaso (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. Galderma expects Mirvaso to be available in pharmacies September 2013. [More]
Nuvo: FDA accepts to review New Drug Application for PENNSAID 2%

Nuvo: FDA accepts to review New Drug Application for PENNSAID 2%

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10 today announced that its U.S. licensee for PENNSAID (diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2% (diclofenac sodium topical solution) 2% w/w, Mallinckrodt has advised that the U.S. Food and Drug Administration has accepted for filing and review the New Drug Application for PENNSAID 2% submitted by Mallinckrodt on August 7, 2013. [More]
Novartis starts shipment of 2013-2014 seasonal influenza vaccines to US customers

Novartis starts shipment of 2013-2014 seasonal influenza vaccines to US customers

Novartis announced today that it has begun shipment of its seasonal influenza vaccines to customers in the US market for the 2013-2014 season. Novartis plans to ship a minimum of 30 million doses of its influenza vaccines to the US market, including Fluvirin (Influenza Virus Vaccine), approved for use in people 4 years of age and older, and Flucelvax (Influenza Virus Vaccine), approved for use in adults 18 years of age and older. [More]
First lots of 2013-2014 seasonal influenza vaccine released for U.S. distribution

First lots of 2013-2014 seasonal influenza vaccine released for U.S. distribution

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the first lots of Fluzone (Influenza Virus Vaccine) for the 2013-2014 season have been released by the U.S. Food and Drug Administration for U.S. distribution and were shipped July 24. [More]
Clinical trial finds that sleep quality impacts skin function and aging

Clinical trial finds that sleep quality impacts skin function and aging

In a first-of-its-kind clinical trial, physician-scientists at University Hospitals (UH) Case Medical Center found that sleep quality impacts skin function and aging. [More]
FDA approves Novartis' Exelon Patch for treatment of severe Alzheimer's disease

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. [More]