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Health Highlights: Oct. 1, 2014

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Doctors, Hospitals Received Billions From Drug and Medical Device Companies About 546,000 doctors and 1,360 teaching hospitals in the United States received billions of dollars from drug and medical device makers in the second half of 2013, according to data released Tuesday by the Centers for Medicare and...

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Healthy Lifestyle Before Pregnancy May Cut Gestational Diabetes Risk

Posted today in Medical

WEDNESDAY, Oct. 1, 2014 -- Healthy lifestyle habits could prevent about half of all diabetes cases that develop during pregnancy, a new study finds. Researchers looked at data from more than 14,000 American women. They found that the strongest risk factor for diabetes during pregnancy ("gestational diabetes") was being overweight or obese during pregnancy. Women who were obese before pregnancy had more than a four...

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Preterm Birth, Pneumonia Leading Causes of Death for Children Under 5

Posted today in Medical

WEDNESDAY, Oct. 1, 2014 -- Nearly 2 million children younger than 5 died worldwide in 2013 of complications from premature birth and pneumonia, a new study shows. In all, 6.3 million children under 5 died in 2013, said researchers who examined the leading causes of death. They were complications from premature birth, resulting in 965,000 deaths; pneumonia, which caused 935,000 deaths, and childbirth complications,...

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Health Tip: Plan Ahead for Healthy Dinners

Posted today in Medical

-- It can be difficult to find the time, energy and motivation to put together a healthy family dinner every night of the week. The Academy of Nutrition and Dietetics offers these suggestions: Create a menu of five-to-seven family-approved meals. Strive for easy, crowd-pleasing dishes, and be sure to include fruit, vegetables and a grain. Pack your pantry with non-perishable staples such as beans, pasta, rice and...

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Health Tip: Help Prevent Acne Scars

Posted today in Medical

-- Proper skin care can minimize acne and help prevent scarring. The Womenshealth.gov website offers these suggestions: Wash skin carefully twice per day, and after heavy sweating. Wash your face with a gentle cleanser, from the hairline to below the jawline. Rinse thoroughly and avoid harsh scrubbing. Wash your hair daily, and more frequently if your hair is oily. Never pick or squeeze acne blemishes, which can...

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CDC and Texas Health Department Confirm First Ebola Case Diagnosed in the U.S.

Posted today in Pharma Industry News

September 30, 2014 -- The Centers for Disease Control and Prevention (CDC) confirmed today, through laboratory tests, the first case of Ebola to be diagnosed in the United States in a person who had traveled to Dallas, Texas from Liberia. The patient did not have symptoms when leaving West Africa, but developed symptoms approximately four days after arriving in the U.S. on Sept. 20. The person fell ill on Sept....

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Monthly News Roundup - September 2014

Posted yesterday in Pharma Industry News

Orexigen’s Combo Drug Contrave Approved for Weight Loss The U.S. Food and Drug Administration has approved Contrave (bupropion HCl/naltrexone HCl) for chronic weight management in addition to diet and physical activity. Contrave is an extended-release form of two previously approved drugs, naltrexone (ReVia, Vivitrol) and bupropion (Wellbutrin, Zyban). Naltrexone is approved to treat alcohol or opioid...

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FDA Approves Revised Indication for Ozurdex for the Treatment of Diabetic Macular Edema

Posted yesterday in New Drug Approvals

IRVINE, Calif.-September 29, 2014 - Allergan, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME). Ozurdex was originally approved in June as a treatment for DME in adult patients who have an artificial lens implant (pseudophakic) or...

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FDA Approves Iluvien for Diabetic Macular Edema

Posted 4 days ago in New Drug Approvals

WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Iluvien for the treatment of diabetic macular edema (DME). It is indicated for patients who have been previously treated with a course of corticosteroids and did not have a clinically...

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FDA Approves Tybost (cobicistat) for use in the treatment of HIV-1 Infection

Posted 5 days ago in New Drug Approvals

September 24, 2014 -- The U.S. Food and Drug Administration (FDA) has approved Tybost (cobicistat), a CYP3A inhibitor used in combination with atazanavir or darunavir for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Cobicistat is a pharmacokinetic enhancer that works by inhibiting the enzyme (CYP3A) that metabolizes atazanavir and darunavir. It increases the systemic exposure of these...

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FDA Approves Vitekta (elvitegravir) for HIV-1 Infection

Posted 5 days ago in New Drug Approvals

September 24, 2014 -- The U.S. Food and Drug Administration (FDA) has approved Vitekta (elvitegravir), an integrase strand transfer inhibitor for the combination treatment of human immunodeficiency virus type 1 (HIV-1) infection in treatment-experienced adults. Elvitegravir is an HIV integrase strand transfer inhibitor that works by interfering with one of the enzymes that HIV needs to multiply. It is indicated in...

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U.S. Marshals Seize Botanical Substance Kratom from Southern California Facility

Posted 5 days ago in Pharma Industry News

September 25, 2014 -- U.S. Marshals at the request of the U.S. Food and Drug Administration today seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California. Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Kratom is promoted on numerous...

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NIH and FDA Win Top Award for Intellectual Property Licensing of Meningitis Vaccine

Posted 5 days ago in Pharma Industry News

September 25, 2014 -- The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal, for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The 2014 Deals of Distinction Award will be presented to the two federal agencies and their collaborators by the...

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FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease

Posted 5 days ago in New Drug Approvals

NORTH CHICAGO, Ill., Sept. 25, 2014 /PRNewswire/ -- AbbVie announced today that the U.S. Food and Drug Administration (FDA) has approved Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough. This FDA approval represents the eighth indication for...

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Tekmira Establishes Regulatory Framework for Emergency Use of TKM-Ebola

Posted 8 days ago in Pharma Industry News

VANCOUVER, British Columbia, Sept. 22, 2014 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference (RNAi) therapeutics, today announced that the FDA has authorized Tekmira to provide TKM-Ebola for treatment under expanded access protocols to subjects with confirmed or suspected Ebola virus infections. "Tekmira is reporting that an appropriate regulatory and clinical...

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Amgen Submits BLA for Investigational BiTE® Immunotherapy Blinatumomab

Posted 8 days ago in New Drug Applications

THOUSAND OAKS, Calif., Sept. 22, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for its investigational bispecific T cell engager (BiTE®) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute...

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FDA accepts Tuzistra XR (CCP-01) NDA for full review

Posted 2 weeks ago in New Drug Applications

15 September 2014 -- Vernalis plc and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for Tuzistra XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30...

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FDA Advisory Committee Votes 14-1 in Favor of Saxenda (liraglutide) for Obesity

Posted 2 weeks ago in New Drug Applications

WASHINGTON, Sept. 11, 2014 /PRNewswire/ – Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Application (NDA) for Saxenda, the intended brand name for liraglutide 3 mg, a once-daily human GLP-1 analogue for the treatment of obesity. Based on the data contained in the NDA...

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BioCryst Announces Rapivab (peramivir injection) Trial Results for the Treatment of Influenza

Posted 2 weeks ago in New Drug Applications

RESEARCH TRIANGLE PARK, N.C., Sept. 6, 2014 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. today announced trial results related to Rapivab (peramivir injection), a neuraminidase inhibitor (NAI) for the treatment of influenza at the Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC) in Washington, D.C., September 5-9, 2014. "Based on clinical trial data, peramivir is the first...

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Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab

Posted 4 weeks ago in New Drug Applications

WHITEHOUSE STATION, N.J. Sept. 2, 2014 --(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from ongoing clinical trials evaluating the anti-tumor activity of pembrolizumab, the company’s investigational anti-PD-1 antibody, at the European Society of Medical Oncology (ESMO) 2014 in Madrid, Spain, September 26 – 30. Data on pembrolizumab...

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Catalyst Pharmaceuticals Announces Positive Top-Line Phase 3 Data From Pivotal Firdapse Clinical Trial

Posted yesterday in Clinical Trials

CORAL GABLES, Fla., Sept. 29, 2014 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc., (Catalyst Pharmaceuticals), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced positive top-line results from the pivotal Phase 3 clinical trial of Firdapse™ (amifampridine phosphate tablets equivalent to 10 mg...

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FDA Approves NeuroGenetic Pharmaceuticals Application To Begin Clinical Trials for NGP 555

Posted yesterday in Clinical Trials

SAN DIEGO, Sept. 29, 2014 – The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application from NeuroGenetic Pharmaceuticals, Inc. (NGP) to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer’s disease (AD). The approval follows successful completion of all preclinical phases under a fast-track grant from the National Institute of Neurologic...

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Gilead’s Investigational Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Meets 48-Week Primary Objective in Two Phase 3 Studies

Posted 6 days ago in Clinical Trials

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2014-- Gilead Sciences, Inc. today announced that two Phase 3 clinical trials (Studies 104 and 111) evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives. The studies demonstrated that the single tablet regimen comprising...

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MediciNova Provides Update on Phase 2b Trial of MN-166 (ibudilast) in Progressive MS

Posted 8 days ago in Clinical Trials

LA JOLLA, Calif., Sept. 23, 2014 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that, as of September 15, 2014, the ongoing Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis (MS) had enrolled 150 of the 250 subjects planned to be enrolled. ...

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Acceleron Provides Update on Clinical Trial of Dalantercept Monotherapy in Ovarian Cancer

Posted 8 days ago in Clinical Trials

CAMBRIDGE, Mass.- September 23, 2014 -- Acceleron Pharma Inc., a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases, today announced results from an interim report for a two-part clinical study sponsored by the Gynecology Oncology Group evaluating dalantercept as monotherapy in patients with recurrent or...

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