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Health Highlights: Nov. 26, 2014

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Lower Ozone Emission Limits Proposed by EPA New regulations to reduce emissions of the smog-causing pollutant ozone from power plants and factories are expected to be released Wednesday by the U.S. Environmental Protection Agency. Ozone has been linked to asthma, heart disease and premature death. The new...

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Turkey Fryer Mishaps Can Cause Serious Burns

Posted today in Medical

THURSDAY, Nov. 27, 2014 -- Celebration can quickly turn to tragedy if popular turkey fryers are misused on Thanksgiving Day, experts say. Over the last decade, more than 141 serious fires and hot-oil burns have occurred while people were using turkey fryers, according to the U.S. Consumer Product Safety Commission. "I have actually cared for a patient who tried to deep fry the turkey indoors, which absolutely...

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Want Kids to Eat Better? Get Them Cooking

Posted today in Medical

THURSDAY, Nov. 27, 2014 -- Getting kids involved in the kitchen, through cooking classes or at home, may make them more likely to choose healthy foods, according to a recent review. Cooking programs and classes for children seem to positively influence children's food preferences and behaviors, according to the new research. And, although the review didn't look at long-term effects of such programs, the findings...

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Don't Let Chronic Heartburn Spoil Your Thanksgiving Feast

Posted today in Medical

THURSDAY, Nov. 27, 2014 -- Planning on seconds at Thanksgiving Day dinner this year? If you suffer from chronic heartburn -- clinically known as gastroesophageal reflux disease (GERD) -- a few steps may help minimize the aftereffects. Dr. Jordan Josephson, an ear, nose and throat specialist at Lenox Hill Hospital in New York City, offers up these tips to help manage GERD on Thanksgiving: Pace yourself. Rather...

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Expert Shares Gluten-Free Thanksgiving Tips

Posted today in Medical

THURSDAY, Nov. 27, 2014 -- Thanksgiving meals can pose a challenge for people who have to eat a gluten-free diet, an expert says. Many traditional Thanksgiving dishes -- such as turkey, corn, sweet potatoes and cranberry sauce -- are gluten-free, but "when it comes to pies, stuffing, gravy, etc., gluten-free substitutes may need to be considered," Dr. Anca Safta, director of the Gluten and Allergic Digestive...

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Valeant Pharmaceuticals Announces FDA Approval of Onexton Gel for Acne Vulgaris

Posted 2 days ago in New Drug Approvals

LAVAL, Quebec, Nov. 25, 2014 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. announced today that it has received approval from the Food and Drug Administration (FDA) for Onexton Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older. Acne vulgaris is a common skin disorder that affects 40...

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FDA issues additional guidance for outsourcing facilities that compound sterile human drugs

Posted 6 days ago in Pharma Industry News

November 21, 2014 -- Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013. The DQSA added section 503B to the Federal Food, Drug,...

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FDA Approves Hysingla ER - Extended-Release Hydrocodone with Abuse-Deterrent Properties

Posted 7 days ago in New Drug Approvals

November 20, 2014 -- The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s...

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Keryx Biopharmaceuticals Announces Trade Name Auryxia for Ferric Citrate

Posted 10 days ago in New Drug Approvals

NEW YORK, Nov. 17, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc., a biopharmaceutical company focused on bringing innovative therapies to market for patients with renal disease, today announced that the U.S. Food and Drug Administration (FDA) has approved the trade name Auryxia (ferric citrate) for its FDA-approved ferric citrate. Auryxia, an iron-based phosphate binder, was approved by the FDA to control...

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Study Comparing Opdivo (nivolumab) to Chemotherapy Demonstrates Survival Benefit

Posted 11 days ago in New Drug Applications

PRINCETON, N.J., November 16, 2014 -- Bristol-Myers Squibb Company (NYSE:BMY) today announced results from CheckMate -066, a Phase 3 randomized double blind study, comparing Opdivo, an investigational PD-1 immune checkpoint inhibitor, to the chemotherapy dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma (n=418). The study met the primary endpoint of overall survival (OS) with the...

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FDA Approves Lemtrada (alemtuzumab) for Relapsing Forms of Multiple Sclerosis

Posted 13 days ago in New Drug Approvals

CAMBRIDGE, Mass., November 14, 2014 --(BUSINESS WIRE) --Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs...

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FDA Approves Avastin (bevacizumab) Plus Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer

Posted 13 days ago in New Drug Approvals

South San Francisco, Calif. -- November 14, 2014 -- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved Avastin in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer. The approval was based on results from the Phase III AURELIA study that showed Avastin plus chemotherapy reduced the risk of disease...

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Chimerix's Brincidofovir Selected for Use in Ebola Clinical Trial in West Africa

Posted 2 weeks ago in New Drug Applications

DURHAM, N.C., Nov. 13, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its investigational broad-spectrum antiviral brincidofovir has been selected as one of two investigational agents to be evaluated in a clinical study in patients with confirmed Ebola Virus Disease in west Africa. Chimerix and the...

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FDA Concerns About Therapeutic Equivalence with Two Generic Versions of Concerta Tablets

Posted 2 weeks ago in Pharma Industry News

November 13, 2014 -- Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug. The two approved generic versions of Concerta are manufactured by Mallinckrodt...

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FDA Accepts Amgen's BLA For LDL Cholesterol-Lowering Medication Evolocumab

Posted 2 weeks ago in New Drug Applications

THOUSAND OAKS, Calif., Nov. 10, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's Biologics License Application (BLA) for evolocumab for the treatment of high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces...

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Novartis to present first IL-17A Phase III data for AIN457 (secukinumab) in Psoriatic Arthritis and Ankylosing Spondylitis

Posted 2 weeks ago in New Drug Applications

EAST HANOVER, N.J., Nov. 10, 2014 Novartis announced today that data from two pivotal Phase III studies (FUTURE 1 and FUTURE 2) in psoriatic arthritis (PsA) patients and two pivotal Phase III studies (MEASURE 1 and MEASURE 2) in patients with ankylosing spondylitis (AS) will be presented at the American College of Rheumatology (ACR) Congress, November 14-19, in Boston. The four oral presentations and four posters...

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Avanir Pharmaceuticals Announces Preliminary Feedback from the FDA on AVP-825 for the Acute Treatment of Migraine

Posted 2 weeks ago in New Drug Applications

ALISO VIEJO, Calif., Nov. 7, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has issued preliminary written feedback to its New Drug Application (NDA) for AVP-825. AVP-825 is a drug-device combination product consisting of low-dose sumatriptan powder, delivered intranasally utilizing a novel Breath Powered delivery technology. The FDA...

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Monthly News Roundup - October 2014

Posted 4 weeks ago in Pharma Industry News

AstraZenenca’s Xigduo XR Approved for Type 2 Diabetes Type 2 diabetes is estimated to affect 29.1 million people in America. The U.S. Food and Drug Administration (FDA) has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a combination drug of two agents that work together to lower blood sugar. Dapagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2),...

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Pfizer’s Pristiq Demonstrates Low Potential For Sexual Dysfunction in Adults with Major Depressive Disorder

Posted 4 weeks ago in Pharma Industry News

October 29, 2014 - Pfizer Inc. today announced the publication of a clinical study in the Journal of Clinical Psychiatry showing comparable sexual function in adult patients diagnosed with major depressive disorder (MDD) treated daily with Pristiq (desvenlafaxine) Extended Release Tablets 50mg and 100mg doses versus placebo. Sexual dysfunction is often an issue for patients treated with antidepressants, and Pfizer...

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Merck Receives FDA Breakthrough Therapy Designation for Keytruda in Advanced Non-Small Cell Lung Cancer

Posted 4 weeks ago in Pharma Industry News

WHITEHOUSE STATION, N.J.-- October 27, 2014 --Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK)...

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Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab

Posted 2 days ago in Clinical Trials

THOUSAND OAKS, Calif. and LONDON, Nov. 25, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and AstraZeneca (NYSE: AZN) today announced that AMAGINE-2TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. Brodalumab 210 mg given every two...

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Avaxia Biologics Receives FDA Orphan Drug Designation for AVX-470 for Pediatric Ulcerative Colitis

Posted 3 days ago in Clinical Trials

LEXINGTON, Mass. – November 21, 2014 – Avaxia Biologics, Inc., a clinical stage biopharmaceutical company developing gut-targeted antibody therapeutics for gastrointestinal diseases, announced today that the US Food and Drug Administration (FDA) granted Orphan Drug Designation to AVX-470 for the treatment of pediatric ulcerative colitis. AVX-470 is a gut-targeted anti-TNF antibody, which earlier this year...

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Amgen Announces Termination Of All Amgen-Sponsored Clinical Studies Of Rilotumumab In Advanced Gastric Cancer

Posted 3 days ago in Clinical Trials

THOUSAND OAKS, Calif., Nov. 24, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the termination of all Amgen-sponsored clinical studies of rilotumumab in advanced gastric cancer, including the Phase 3 RILOMET-1 and RILOMET-2 studies. Amgen's decision is based on a planned safety review by the RILOMET-1 independent data monitoring committee that found an increase in the number of deaths in the rilotumumab...

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Merck and NewLink Genetics Enter Into Licensing and Collaboration Agreement for Investigational Ebola Vaccine

Posted 3 days ago in Clinical Trials

WHITEHOUSE STATION, N.J. & AMES, IA, November 24, 2014 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ:NLNK), announced today that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate. The vaccine candidate, originally...

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OncoMed Presents New Clinical and Biomarker Data From Its Tarextumab and Demcizumab Clinical Trials

Posted 6 days ago in Clinical Trials

BARCELONA, Spain and REDWOOD CITY, Calif., Nov. 21, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, presented data in two posters highlighting the company's translational research and biomarker efforts for its tarextumab (anti-Notch2/3, OMP-59R5) and demcizumab (anti-DLL4,...

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