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Health Highlights: Oct. 31, 2014

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Ebola Concerns Overshadow Medical Meeting in New Orleans Ebola fears have triggered a conflict between Louisiana officials and a medical group holding its annual meeting in the state. The American Society of Tropical Medicine and Hygiene is meeting in New Orleans, starting this weekend, and thousands of doctors...

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Is Tau the 'How' Behind Alzheimer's?

Posted today in Medical

FRIDAY, Oct. 31, 2014 -- Malfunction of a key brain protein called tau is the likely culprit behind Alzheimer's disease and other forms of dementia, a new study in mice concludes. Neurons -- highly specialized nerve cells in the brain -- appear to die when tau malfunctions and fails to clear the cells of unwanted and toxic proteins, explained Charbel Moussa, head of the Laboratory for Dementia and Parkinsonism at...

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Child's Appendix More Likely to Rupture in Regions Short of Surgeons

Posted today in Medical

FRIDAY, Oct. 31, 2014 -- Children and teens with poor access to general surgeons are at increased risk of suffering a ruptured appendix, and the risk is particularly high among young children, a new study finds. If an infected appendix isn't removed quickly enough, it can burst or rupture, leading to a serious, sometimes fatal infection, according to background information from the study. Researchers analyzed data...

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Spinal Surgery Varies by Region in U.S.: Study

Posted today in Medical

FRIDAY, Oct. 31, 2014 -- Surgery for low back pain caused by spinal stenosis varies depending on where in the United States you live, a new report says. "Nearly 80 percent of Americans will experience low back pain at some point in their lives, and about 30 million people a year receive professional medical care for a spine problem," co-author Brook Martin, of the Dartmouth Institute of Health Policy & Clinical...

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Sleep Apnea May Steal Some of Your Memory: Study

Posted today in Medical

FRIDAY, Oct. 31, 2014 -- Sleep apnea may make it hard for you to remember simple things, such as where you parked your car or left your house keys, a small study suggests. Tests on 18 people with severe sleep apnea showed that this ability -- called spatial memory -- was impaired when sleep apnea disrupted rapid eye movement (REM) sleep, even when other stages of sleep weren't affected. REM sleep is the deepest...

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Monthly News Roundup - October 2014

Posted today 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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FDA Approves Xigduo XR (dapagliflozin and metformin hydrochloride) for Type 2 Diabetes

Posted today in New Drug Approvals

WILMINGTON, Del., October 30, 2014 -- AstraZeneca today announced that the U.S. Food and Drug Administration has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. Xigduo XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin (trade name in the U.S. Farxiga™), an inhibitor of...

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Phase 2 Objective Response Rate and Survival Data for Opdivo (nivolumab) in NSCLC to be Presented

Posted yesterday in New Drug Applications

PRINCETON, N.J., October 30, 2014 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from CheckMate -063, a Phase 2 single-arm, open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, administered as a single agent in patients with advanced squamous cell non-small cell lung cancer (NSCLC) who have progressed after at least two prior systemic...

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FDA Approves Trumenba - First Vaccine to Prevent Serogroup B Meningococcal Disease

Posted 2 days ago in New Drug Approvals

October 29, 2014 -- The U.S. Food and Drug Administration announced today the approval of Trumenba (meningococcal group B vaccine), the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis)...

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

Posted 2 days 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 3 days 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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Sarepta Therapeutics Announces Regulatory Update on Eteplirsen

Posted 3 days ago in New Drug Applications

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 27, 2014-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-based therapeutics, today provided an update on its discussions with the U.S. Food and Drug Administration (FDA) regarding its planned New Drug Application (NDA) submission for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy (DMD). In meeting minutes received last...

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Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII

Posted 3 days ago in New Drug Applications

October 27, 2014 -- Pfizer Inc. has notified Pain Therapeutics, Inc. that it has decided to discontinue its agreement to develop and commercialize Remoxy (oxycodone) Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory activities, to Pain Therapeutics, Inc. Pfizer has concluded an internal review...

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FDA Approves Obizur [Antihemophilic Factor (Recombinant)] for Acquired Hemophilia A

Posted 6 days ago in New Drug Approvals

October 24, 2014 -- The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency). Acquired hemophilia A is a rare, but potentially life threatening, bleeding disorder caused by the development of antibodies (immune system proteins) directed...

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FDA Approves Edenbridge Pharmaceuticals' Generic Stromectol (Ivermectin Tablets 3mg)

Posted 7 days ago in Pharma Industry News

Parsippany, New Jersey, October 24, 2014 -- Edenbridge Pharmaceuticals, LLC today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Merck & Co., Inc.'s Stromectol (ivermectin tablets 3 mg). Prior to today, there have been no FDA approved generic versions of Stromectol and Edenbridge intends to begin shipping...

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Arbor Pharmaceuticals Announces FDA Approval of Sotylize

Posted 7 days ago in New Drug Approvals

Atlanta, GA — October 23,2014 -- Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Sotylize (sotalol hydrochloride) oral solution. Sotylize is the first and only sotalol oral solution indicated for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with...

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Relypsa Submits NDA for Patiromer for Oral Suspension to Treat Hyperkalemia

Posted 8 days ago in New Drug Applications

REDWOOD CITY, Calif., Oct. 22, 2014 (GLOBE NEWSWIRE) -- Relypsa, Inc. (Nasdaq:RLYP), today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood. The NDA is...

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U.S. FDA Accepts Filing Of NDA for Empagliflozin/Metformin Fixed-Dose Combination

Posted 9 days ago in New Drug Applications

RIDGEFIELD, Conn. and INDIANAPOLIS, Oct. 21, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes (T2D). Empagliflozin plus metformin is part of the Boehringer Ingelheim...

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GSK update on current development status of the GSK/NIH Ebola vaccine candidate

Posted 12 days ago in Pharma Industry News

London UK -- 18 October 2014 -- With the Ebola crisis in west Africa continuing, GSK is working closely with the World Health Organization (WHO), regulators and other partners to respond to the outbreak, to accelerate development of our investigational Ebola vaccine and to ramp up production as quickly as possible. Development of the vaccine candidate is progressing at an unprecedented rate, with first phase 1...

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FDA Approves Labeling with Abuse-Deterrent Features for Embeda (morphine/naltrexone)

Posted 2 weeks ago in New Drug Approvals

October 17, 2014 -- The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an 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. Embeda is the third ER opioid analgesic to be approved with labeling...

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GeoVax Presents HIV Vaccine Clinical Trial Data

Posted yesterday in Clinical Trials

October 29, 2014 -- GeoVax Labs, Inc., a biotechnology company developing innovative human vaccines using its novel DNA/MVA platform technology, today announced that its Chief Scientific Officer, Harriet L. Robinson, Ph.D., gave an oral presentation entitled Elicitation of Immune Responses by a DNA/MVA Vaccine in ART Treated Patients in a Treatment Interruption Trial. Dr. Robinson delivered the presentation at the...

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Ultragenyx Granted Orphan Drug Designation for Triheptanoin for Glucose Transporter Type-1 Deficiency Syndrome

Posted 3 days ago in Clinical Trials

NOVATO, CA – October 27, 2014 – Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that the FDA Office of Orphan Products Development has granted orphan drug designation for triheptanoin (UX007) for the treatment of glucose transporter type-1 deficiency syndrome (Glut1 DS). Glut1 DS, also known as De...

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Synergy Pharmaceuticals Presents Positive Phase 2b Study Results for Plecanatide in IBS with Constipation

Posted 10 days ago in Clinical Trials

NEW YORK--October 21, 2014 -- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the presentation of results from a phase 2b dose-ranging study assessing plecanatide’s safety and efficacy in 424 adult patients (mITT population= 423) with irritable bowel syndrome with constipation (IBS-C). Data presented at ACG demonstrate that plecanatide, once-daily oral tablet, significantly improved complete spontaneous...

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CytRx Announces Publication of Phase 1b/2 Aldoxorubicin Clinical Data

Posted 10 days ago in Clinical Trials

LOS ANGELES, Oct. 20, 2014 /PRNewswire/ -- CytRx Corporation (CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that a paper, titled "A Phase 1b/2 Study of Aldoxorubicin in Patients With Soft Tissue Sarcoma," has been published online in Cancer, the prestigious, peer-reviewed journal of the American Cancer Society. The paper discusses results from CytRx's...

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Sanofi And Regeneron Announce Start Of Phase 3 Study Of Dupilumab in Patients With Atopic Dermatitis

Posted 10 days ago in Clinical Trials

TARRYTOWN, N.Y. and PARIS, October 20, 2014 – Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the...

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