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Health Highlights: Sept. 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: Doctor Admits to Fraudulent Cancer Treatment A Michigan cancer doctor who admitted putting patients through unnecessary chemotherapy treatments and bilking health insurers pleaded guilty to fraud Tuesday. U.S. Attorney Barbara McQuade said she would seek life in prison for Dr. Farid Fata, 49, who pleaded guilty...

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College Women Can Use Food Strategies, Study Finds

Posted today in Medical

SUNDAY, Sept. 21, 2014 -- Young women starting college understand the benefits of a healthy diet and know which foods they should eat. But they aren't confident they can follow through on these wise nutritional choices, according to a new study. The study involved 268 female college freshmen enrolled in the University of Illinois's Peer Education Exercising and Eating Right program. The students answered...

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Get a Flu Shot During Checkup, Doctor Says

Posted yesterday in Medical

SATURDAY, Sept. 20, 2014 -- As flu season approaches, the best way to stay healthy and avoid infection is to get a flu shot and a checkup, according to an infectious disease specialist. A primary care doctor can vaccinate people against the flu, and also address other health concerns or issues patients may have. Retail stores may provide flu shots for their customers, but they can't dole out medical advice, said...

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Avian Flu In Harbor Seals Could Infect People

Posted 2 days ago in Medical

FRIDAY, Sept. 19, 2014 -- The avian flu that killed 160 harbor seals in New England in 2011 could be spread through respiratory drops and therefore poses a potential threat to humans, according to a new study. Although no human illnesses have been linked to the harbor seal virus, researchers at St. Jude Children's Research hospital have discovered natural mutations to the avian H3N8 seal virus that might allow it...

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Trulicity Approved for Type 2 Diabetes

Posted 2 days ago in Medical

FRIDAY, Sept. 19, 2014 -- Trulicity (dulaglutide) has been approved by the U.S. Food and Drug Administration to treat type 2 diabetes, which accounts for 90 percent of diabetes cases in the United States. The drug contains a hormone that helps stabilize blood sugar at normal levels, the agency said in a news release. Trulicity's safety and effectiveness were evaluated in clinical trials involving 3,342 people with...

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FDA Approves Trulicity (dulaglutide) for Type 2 Diabetes

Posted 3 days ago in New Drug Approvals

September 18, 2014 -- The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes. Type 2 diabetes affects about 26 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar...

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FDA Approves Movantik (naloxegol) for Opioid-Induced Constipation

Posted 5 days ago in New Drug Approvals

September 16, 2014 -- The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain. Opioids are a class of drugs that are used to treat and manage pain. A common side effect associated with the use of these drugs are that they reduce the gastrointestinal tract’s motility, making bowel movements difficult and...

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

Posted 9 days 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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FDA Approves Contrave (bupropion/naltrexone) for Weight Management

Posted 11 days ago in New Drug Approvals

September 10, 2014 -- The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater...

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FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas

Posted 12 days ago in Pharma Industry News

September 9, 2014 -- The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or...

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Keryx Biopharmaceuticals Receives FDA Approval of Ferric Citrate for Dialysis Patients With Hyperphosphatemia

Posted 12 days ago in New Drug Approvals

NEW YORK, Sept. 5, 2014 -- Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. "We are thrilled with the FDA's decision to approve Ferric Citrate, and look forward to bringing it to market in the U.S. within the next...

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FDA allows marketing of the first test to assess risk of developing acute kidney injury

Posted 2 weeks ago in Pharma Industry News

September 5, 2014 -- Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient...

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U.S. Marshals seize drug products from Flawless Beauty

Posted 2 weeks ago in Pharma Industry News

September 4, 2014 -- Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey. These products, including injectable drug products, were marketed, sold and distributed...

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FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma

Posted 2 weeks ago in New Drug Approvals

September 4, 2014 -- The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Melanoma, which accounts for approximately 5 percent of all new cancers in the United States, occurs when cancer cells form in skin cells that make the pigment responsible for color in...

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

Posted 2 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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Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

Posted 2 weeks ago in New Drug Applications

DUBLIN, Sept. 2, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D). Actavis' NDA for eluxadoline has been granted priority review...

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Monthly News Roundup - August 2014

Posted 2 weeks ago in Pharma Industry News

Belsomra: Merck’s First-in-Class Insomnia Treatment Approved The U.S. Food and Drug Administration (FDA) approved the long-awaited Belsomra (suvorexant) tablets for difficulty in falling and staying asleep (insomnia). Belsomra, in a new class called orexin receptor antagonists, blocks the action of orexin, a chemical involved in the sleep-wake cycle in the brain. The FDA has approved Belsomra in various 5 to 20...

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Amgen Submits BLA For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab

Posted 3 weeks ago in New Drug Applications

THOUSAND OAKS, Calif., Aug. 28, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for evolocumab seeking approval 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...

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FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure

Posted 3 weeks ago in New Drug Applications

THOUSAND OAKS, Calif., Aug. 27, 2014 /PRNewswire/ -- Amgen today announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.1 Ivabradine works to slow the heart rate without negative effects on...

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FDA takes action against Georgia dietary supplement manufacturer

Posted 3 weeks ago in Pharma Industry News

MONDAY August 25, 2014 -- A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and...

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Merck Announces Data from Phase 3 Study for Odanacatib for Treatment of Osteoporosis

Posted 5 days ago in Clinical Trials

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Monday, September 15, 2014 -- Merck, known as MSD outside the United States and Canada, today announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial (LOFT), odanacatib met its primary...

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Analysis of Phase III Trials Examines the Impact of Nintedanib on Lung Function Decline

Posted 11 days ago in Clinical Trials

Ridgefield, Conn., September 9, 2014 – A pre-specified, pooled subgroup sensitivity analysis from the two identically designed Phase III INPULSIS™ trials, presented today at the European Respiratory Society International Congress (ERS) evaluated the impact of the investigational drug nintedanib on reducing the decline in lung function, as measured by annual rate of decline in forced vital capacity (FVC), in...

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NEJM and ERS publish positive results from GSK phase III studies of mepolizumab

Posted 12 days ago in Clinical Trials

London UK ,08 September 2014 -- Results published today in the New England Journal of Medicine (NEJM) and presented at the European Respiratory Society (ERS) congress provide further data from the two pivotal Phase III asthma studies of mepolizumab, an investigational IL-5 antagonist monoclonal antibody: MENSA - MEpolizumab as adjunctive therapy iN patients with Severe Asthma SIRIUS – The SteroId ReductIon with...

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Merck’s Beta-lactamase Inhibitor Relebactam Granted QIDP and Fast Track Designations by FDA

Posted 2 weeks ago in Clinical Trials

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Thursday, September 4, 2014 --Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has designated relebactam (previously known as MK-7655), the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. The QIDP and Fast Track...

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MEI Pharma Completes Enrollment In Randomized Phase II Clinical Trial Of Pracinostat In Front Line Myelodysplastic Syndrome

Posted 2 weeks ago in Clinical Trials

SAN DIEGO, Sept. 2, 2014 PRNewswire -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that it has completed enrollment in a randomized Phase II clinical trial of its lead investigational drug candidate Pracinostat in combination with azacitidine in patients with previously untreated intermediate-2 or high-risk myelodysplastic...

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