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Health Highlights: Oct. 24, 2014

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Surgeons Transplant First Non-Beating Heart Surgeons in Australia say they successfully transplanted a heart that had stopped beating for up to 20 minutes. Until now, heart transplants have only been able to use still-beating hearts from brain-dead donors. But a surgical team at St. Vincent's Hospital in Sydney...

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New York, New Jersey to Quarantine All Travelers With Ebola Contacts

Posted today in Medical

SATURDAY, Oct. 25, 2014 -- On Friday, the governors of New York and New Jersey announced strict new quarantine measures for anyone returning via Kennedy and Newark Liberty airports who may have had contacts with Ebola patients in Guinea, Liberia or Sierra Leona. The measures, which exceed current federal guidelines, mean that people who had such contacts would be tested and kept in quarantine for 21 days, the...

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Tips for Safe Trick-or-Treating

Posted today in Medical

SATURDAY, Oct. 25, 2014 -- Arriving home safe and sound is one of the best Halloween treats of all. To that end, be sure that costumes and goody bags have reflective strips that improve visibility to drivers, said Dr. Sampson Davis, an emergency medicine doctor at Meadowlands Hospital Medical Center in Secaucus, N.J. Trick-or-treaters should also carry a flashlight, and costumes should be flame-resistant, Davis...

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

Posted yesterday in New Drug Approvals

DEERFIELD, Ill., October 24, 2014 - Baxter International Inc. today announced that the United States Food and Drug Administration (FDA) has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), a very rare and potentially life-threatening acute bleeding disorder. Obizur was granted orphan-drug status by the FDA and...

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Dark Days Here for Folks With Seasonal Depression

Posted yesterday in Medical

FRIDAY, Oct. 24, 2014 -- October's shorter, darker days can trigger a type of depression, known as seasonal affective disorder, according to an expert. People affected by seasonal affective disorder, also called SAD, may feel overly tired, lack motivation and even have trouble getting out of bed. In extreme cases, SAD can lead to suicide, said Dr. Angelos Halaris, a professor in the department of psychiatry and...

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Knowing Genetic Risk for Cancer May Not Change Behavior

Posted yesterday in Medical

FRIDAY, Oct. 24, 2014 -- As more genetic tests are developed that spot increased risks for certain cancers, one might think that high-risk people would be more proactive about getting screened. But a new study suggests that, at least with colon cancer, knowledge does not change behavior: People who found out their genes doubled their risk of colon cancer were no more likely than people with average risk to get...

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Arbor Pharmaceuticals Announces FDA Approval of Sotylize

Posted 2 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 3 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 4 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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FDA Advisory Committee Recommends Approval of Secukinumab for Plaque Psoriasis

Posted 5 days ago in New Drug Applications

EAST HANOVER, N.J., Oct. 20, 2014 Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA) today voted 7 to 0 to support the approval of AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy (a drug that is absorbed...

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

Posted 7 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 8 days 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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Joan Rivers Died from Complications Under Propofol, Coroner Rules

Posted 9 days ago in Pharma Industry News

THURSDAY, Oct. 16, 2014 -- Joan Rivers has died of "therapeutic complications" while undergoing a procedure to evaluate vocal and gastrointestinal issues, according to the New York medical examiner. The death was caused by a lack of oxygen to the brain during a laryngoscopy, a procedure to view the vocal chords, and an upper gastrointestinal endoscopy. She was sedated with the drug propofol, the medical examiner...

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U.S. FDA Grants Priority Review Status to NDA for Anticancer Agent Lenvatinib

Posted 10 days ago in New Drug Applications

Tokyo -- October 15, 2014 -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) submitted by its U.S. subsidiary Eisai Inc. for its novel in-house developed anticancer agent lenvatinib mesylate (lenvatinib) as a treatment for progressive radioiodine-refractory differentiated...

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FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

Posted 10 days ago in New Drug Approvals

October 15, 2014 -- The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF...

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FDA Approves Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis

Posted 10 days ago in New Drug Approvals

October 15, 2014 -- The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for...

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Pfizer Announces FDA Acceptance Of Palbociclib New Drug Application With Priority Review

Posted 12 days ago in New Drug Applications

Monday, October 13, 2014 - Pfizer Inc. today announced the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA). This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor...

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FDA Approves Lutonix 035 DCB - First Drug-Coated Angioplasty Balloon Catheter to Treat Vascular Disease

Posted 2 weeks ago in Pharma Industry News

October 10, 2014 -- The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD). PAD occurs when fatty material...

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Rescheduling of Hydrocodone Combo Prescriptions: As of Today, Refills Become More Difficult

Posted 2 weeks ago in Pharma Industry News

October 6, 2014 -- Today the final DEA rule on switching hydrocodone combination products like Lortab and Vicodin from schedule III to schedule II comes into effect. This rule has been put into place to help curb abuse and encourage patients and prescribers to consider alternative ways to deal with pain. What does this mean? Until now, hydrocodone combination products were regulated as schedule III drugs. These...

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Re-scheduling prescription hydrocodone combination drug products: An important step toward controlling misuse and abuse

Posted 2 weeks ago in Pharma Industry News

October 6, 2014 -- Hydrocodone is the most prescribed opioid in the United States, including 137 million prescriptions in 2013. While it is useful in the treatment of pain, it has also contributed significantly to the very serious problem of opioid misuse and abuse in the United States. With the aim of curbing this misuse and abuse, new prescribing requirements go into effect today for hydrocodone combination...

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

Posted 4 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 5 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 5 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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US FDA Accepts for Review a BLA for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine

Posted 5 days ago in Clinical Trials

WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa.--(BUSINESS WIRE) October 20, 2014 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN and NYSE:SNY), announced today that the Biologics License Application (BLA) filed for the companies’ investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review...

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Bristol-Myers Squibb Statement about Asunaprevir in the U.S

Posted 2 weeks ago in Clinical Trials

PRINCETON, N.J., October 7, 2014 --(BUSINESS WIRE)--Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb (NYSE:BMY) has decided that it will not pursue U.S. Food and Drug Administration (FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application...

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