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Health Highlights: Dec. 19, 2014

Posted 2 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Many Doctors Hit With Medicare Payment Cuts Hundreds of thousands of American doctors will have their Medicare payments cut next year because they haven't met specified goals, federal officials say. More than 257,000 doctors will have their payments reduced by one percent because they didn't meet federal goals...

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Health Tip: Warning Signs of Sleep Apnea

Posted today in Medical

-- Sleep apnea causes brief disruptions in breathing as you sleep. It can lead to any of the dangers of sleep deprivation, such as daytime fatigue. The U.S. National Heart Lung and Blood Institute says warning signs of sleep apnea include: Loud, persistent snoring, including gasping or choking sounds. Daytime sleepiness. Morning headaches. Difficulty concentrating, learning or remembering. Feeling moody, irritable...

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Mother's Depression Tied to Later Delinquency in Kids

Posted today in Medical

MONDAY, Dec. 22, 2014 -- Teens are more likely to smoke, drink and use marijuana -- and to do so at an earlier age -- if their mothers were depressed when the kids were in grade school, a new study says. These same teens are also more likely to engage in violence and other delinquent behaviors, according to the study, published online Dec. 22 in Pediatrics. The researchers expected that teens of mothers who were...

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Health Tip: Finding Time for Fitness

Posted today in Medical

-- Struggling to fit in 30 minutes of daily exercise? The American Heart Association recommends you: Go for a walk. Take the dog or child, or head to the mall and do laps while you window shop. Get together a group of friends for a team sport or exercise. Walk while you're talking on the phone. Park further from the door at work or while running an errand. Skip the elevator in favor of the stairs. Throw an...

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Vaccine for Deer Against 'Mad Cow'-Like Illness Shows Promise

Posted today in Medical

SUNDAY, Dec. 21, 2014 -- A new vaccine created to fight an illness similar to "mad cow disease" in deer might also protect livestock and even humans from similar brain infections, researchers report. The vaccine appears to help prevent deer from becoming infected by the incurable brain disorder known as chronic wasting disease, according to the report in the Dec. 21 online edition of the journal Vaccine. Chronic...

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FDA Approves Zerbaxa (ceftolozane/tazobactam) for Complicated Intra-Abdominal/Urinary Tract Infections

Posted 2 days ago in New Drug Approvals

December 19, 2014 -- The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa is used to...

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FDA approves pathogen reduction system to treat platelets

Posted 2 days ago in Pharma Industry News

December 19, 2014 -- The U.S. Food and Drug Administration yesterday approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets. The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections. On...

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Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze

Posted 2 days ago in New Drug Approvals

DUBLIN, Dec. 19, 2014 /PRNewswire/ -- Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved the intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi). Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E....

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FDA Approves Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) to Treat Hepatitis C

Posted 2 days ago in New Drug Approvals

December 19, 2014 -- The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced...

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FDA Approves Lynparza (olaparib) to Treat Advanced Ovarian Cancer

Posted 2 days ago in New Drug Approvals

December 19, 2014 -- The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test. Ovarian cancer forms in the ovary, one of a pair of female reproductive glands where ova, or eggs, are formed. The National Cancer Institute estimates that 21,980...

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Teva Announces FDA Approval of QNASL for Children with Seasonal and Perennial Allergic Rhinitis

Posted 2 days ago in New Drug Approvals

JERUSALEM--(BUSINESS WIRE)--Dec. 19, 2014-- Teva Pharmaceutical Industries Ltd., announced today that the U.S. Food and Drug Administration (FDA) approved QNASL (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis (AR) in children 4-11 years of age. QNASL 40 mcg is a lower dose formulation of QNASL Nasal Aerosol (80 mcg), a waterless (non-aqueous) intranasal...

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Pozen’s Yosprala Receives Complete Response Letter from the FDA

Posted 4 days ago in New Drug Applications

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Dec. 17, 2014-- Pozen Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that their investigational drug candidates Yosprala 81/40 and 325/40 (aspirin / omeprazole delayed release tablets) have received a second complete response letter (CRL) from the U.S. Food and Drug Administration (FDA). A CRL is issued by...

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FDA approves first pathogen reduction system to treat plasma

Posted 5 days ago in Pharma Industry News

December 16, 2014 -- The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI). “The approval of devices like the Intercept Blood System allows blood establishments to prepare plasma that carries a lower risk of...

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Pfizer Announces Palbociclib PALOMA-1 Data Published in The Lancet Oncology

Posted 6 days ago in New Drug Applications

Monday, December 15, 2014 - Pfizer Inc. (NYSE:PFE) today announced the publication of the detailed results from PALOMA-1, a randomized Phase 2 study of palbociclib in combination with letrozole versus letrozole alone, in The Lancet Oncology. As previously disclosed, PALOMA-1 achieved its primary endpoint with the combination of palbociclib and letrozole significantly prolonging progression-free survival (PFS)...

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Collegium Pharmaceutical Submits NDA for Xtampza ER (oxycodone) Abuse-Deterrent Analgesic

Posted 6 days ago in New Drug Applications

Canton, MA – December 15, 2014 – Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain, today announced that it has filed a New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) seeking authorization to market Xtampza™ ER, its oxycodone extended-release (ER), abuse-deterrent analgesic utilizing the...

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Relypsa Announces FDA Acceptance of New Drug Application for Patiromer for Oral Suspension to Treat Hyperkalemia

Posted 6 days ago in New Drug Applications

REDWOOD CITY, Calif., Dec. 15, 2014 (GLOBE NEWSWIRE) -- Relypsa, Inc. (Nasdaq:RLYP), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood. Relypsa expects written notification of NDA...

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FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency

Posted 6 days ago in Pharma Industry News

December 15, 2014 -- The U.S. Food and Drug Administration today allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns. According to the Centers for Disease Control and Prevention, approximately 40 to 100 new cases of SCID are identified in newborns in the United States each year. SCID is a group of...

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FDA clears test that helps predict the risk of coronary heart disease

Posted 6 days ago in Pharma Industry News

December 15, 2014 -- The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks. FDA cleared the test for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black...

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FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis

Posted 6 days ago in Pharma Industry News

December 15, 2014 -- The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings. According to the U.S. Centers for Disease Control and Prevention (CDC), about 55,000 people in the United States are...

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Genentech Submits NDA to FDA for Investigational Cobimetinib Used in Combination with Zelboraf (vemurafenib) in Advanced Melanoma

Posted 7 days ago in New Drug Applications

South San Francisco, Calif. -- December 14, 2014 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the company has submitted a New Drug Application (NDA) for cobimetinib to the U.S. Food and Drug Administration (FDA) for treatment, in combination with Zelboraf® (vemurafenib), for people with BRAF V600 mutation-positive advanced melanoma. The submission is based on results of...

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Tetraphase Announces Positive Top-line Results from Phase 3 IGNITE 1 Clinical Trial of Eravacycline in Complicated Intra-abdominal Infections

Posted 4 days ago in Clinical Trials

WATERTOWN, Mass., December 17, 2014--(BUSINESS WIRE)-- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced positive top-line results from IGNITE 1, the Company's Phase 3 clinical trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI)...

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Zafgen Announces Initiation of Phase 2b Trial of Beloranib in Severe Obesity

Posted 6 days ago in Clinical Trials

BOSTON, Dec. 15, 2014 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that the Company has initiated a Phase 2b clinical trial with its lead product candidate, beloranib, in the treatment of patients with both severe obesity and type 2...

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Karyopharm Initiates Third Registration-Directed Clinical Trial of Oral Selinexor (KPT-330)

Posted 10 days ago in Clinical Trials

NEWTON, Mass., Dec. 11, 2014 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced the initiation of the SADAL study, (Selinexor and Dexamethasone in Aggressive Lymphoma), a registration-directed, Phase 2b study of Selinexor (KPT-330), in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This randomized, multi-center study of...

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Lakewood-Amedex Submits Investigational New Drug Application for Bisphosphocin™ Nu-3 for the Treatment of Diabetic Foot Infections

Posted 10 days ago in Clinical Trials

SARASOTA, Fla., Dec. 11, 2014 /PRNewswire/ -- Lakewood-Amedex Inc., a leading developer of novel anti-infective pharmaceuticals, announced that the Company has submitted an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to conduct a Phase 1/2a study of Nu-3 as a topical antimicrobial treatment for diabetic foot infections. Pending the FDA's acceptance, the Phase 1/2a is...

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Immuno-Oncology Clinical Collaboration Studying Opdivo (nivolumab) and Mogamulizumab in Advanced Solid Tumors Announced

Posted 11 days ago in Clinical Trials

TOKYO & OSAKA, Japan & NEW YORK, December 10, 2014--(BUSINESS WIRE)--Ono Pharmaceutical Co.,Ltd. (Tokyo: 4528), Bristol-Myers Squibb Company (NYSE:BMY) and Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151,“Kyowa Hakko Kirin”) announced today the companies have entered into a clinical trial collaboration agreement to conduct a Phase 1 combination study with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor,...

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