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Health Highlights: July 22, 2014

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Judge Says FDA Can't Use Panel's Report on Menthols A 2011 expert advisory panel's report on menthol cigarettes can't be used by the U.S. Food and Drug Administration because some panel members have conflicts of interest, a federal judge ruled on Monday. The FDA conducted an independent review of the impact on...

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Technique Used in Some Hysterectomies May Help Spread Cancer: Study

Posted today in Medical

TUESDAY, July 22, 2014 -- Removing the uterus with a minimally invasive procedure known as morcellation carries a risk of spreading undetected cancer, and now a new study pinpoints the likelihood more clearly. Twenty-seven of every 10,000 women who had the technique had undetected uterine cancer at the time of the procedure, researchers found, with the odds being highest for patients over the age of 65. Surgeons...

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Obamacare Dealt Setback by Federal Appeals Court

Posted today in Medical

TUESDAY, July 22, 2014 -- In a bombshell ruling that could potentially play havoc with Obamacare, a federal appeals court said Tuesday that the financial subsidies provided to millions of Americans who bought health insurance though the federal HealthCare.gov website exchange are illegal. In a 2-1 ruling, the federal appeals court for the District of Columbia said that as the law is written, the subsidies may only...

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Gene Discoveries Could Shed New Light on Schizophrenia

Posted today in Medical

TUESDAY, July 22, 2014 -- One of the largest studies ever conducted into the genetic origins of a psychiatric disorder has uncovered 83 new sites on chromosomes that harbor inherited genes tied to schizophrenia. The findings, made by an international team of researchers, now bring the total number of common gene variants linked to the disorder to 108. Although these schizophrenia-associated genes aren't specific...

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Sleepless Nights After Divorce May Be Tied to Blood Pressure Rise

Posted today in Medical

TUESDAY, July 22, 2014 -- People who suffer long-term sleep problems after a divorce are at risk for a rise in blood pressure, a new study suggests. Previous research has linked divorce to major health problems and even early death, but few studies have examined the reasons for this link. Sleep trouble may be one of the causes, according to the University of Arizona investigators. Their study included 138 people who...

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Medicines360 and Actavis Announce FDA Acceptance for Filing of NDA for Levosert IUD

Posted today in New Drug Applications

San Francisco, CA and Dublin, Ireland, – June 21, 2014 - Medicines360, a non-profit women’s health pharmaceutical company, and Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360’s New Drug Application (NDA) for Levosert™ (levonorgestrel), a hormonal intrauterine contraceptive (IUC)...

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Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs

Posted 3 days ago in Pharma Industry News

July 17, 2014 -- The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act. Agents from FDA’s Office of...

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FDA Approves Ruconest for Hereditary Angioedema

Posted 4 days ago in New Drug Approvals

July 17, 2014 -- The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Hereditary angioedema, which is caused by having insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the United...

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InterMune Receives FDA Breakthrough Therapy Designation for Pirfenidone, an Investigational Treatment for IPF

Posted 5 days ago in New Drug Applications

BRISBANE, Calif., July 17, 2014 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial...

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Popping Pills in America: Can the DEA Fix This?

Posted 7 days ago in Pharma Industry News

There's no doubt about it - the U.S. is a big consumer of prescription painkillers. In fact, in 2010 enough prescription painkillers were prescribed to medicate each American adult every four hours for an entire month. A report released in March 2014 from the U.S. National Safety Council shows that prescription drug overdoses – more than car accidents – are the leading cause of accidental death among...

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FDA Approves Rasuvo (methotrexate) Injection

Posted 7 days ago in New Drug Approvals

Chicago, IL, July 14, 2014 -- Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced that the U.S. Food and Drug Administration (FDA) has approved Rasuvo, a subcutaneous injectable methotrexate (MTX) therapy delivered in an auto-injector for rheumatoid arthritis (RA), polyarticular-course juvenile...

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DEA: Placement of Tramadol Into Schedule IV

Posted 11 days ago in Pharma Industry News

July 11, 2014 -- The U.S. Drug Enforcement Administration (DEA) has announced tramadol has been placed into schedule IV of the Controlled Substances Act (CSA) effective August 18, 2014. The new scheduling applies to all tramadol salts, isomers, and salts of isomers. This action imposes the regulatory controls applicable to schedule IV controlled substances on persons who handle or propose to handle...

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Astellas Submits NDA for Isavuconazole Invasive Aspergillosis and Invasive Mucormycosis

Posted 13 days ago in New Drug Applications

NORTHBROOK, Ill., July 9, 2014 /PRNewswire/ -- Astellas today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients. "This NDA submission is a...

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Mylan Launches Generic Micardis Tablets

Posted 13 days ago in Pharma Industry News

PITTSBURGH, July 8, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Telmisartan Tablets USP, 20 mg, 40 mg and 80 mg, the generic version of Boehringer Ingelheim's Micardis® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of hypertension, to...

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FDA Approves Kerydin (tavaborole) Topical Solution for Onychomycosis of the Toenails

Posted 13 days ago in New Drug Approvals

PALO ALTO, Calif. July 8, 2014--(BUSINESS WIRE)-- Anacor Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Kerydin (tavaborole) topical solution, 5%, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails. Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35...

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FDA Accepts Sanofi's New Drug Application for Basal Insulin Toujeo

Posted 2 weeks ago in New Drug Applications

PARIS, July 8, 2014 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European...

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Human Anti-human PD-1 Monoclonal Antibody Opdivo Approved in Japan for Unresectable Melanoma

Posted 2 weeks ago in Pharma Industry News

July 4, 2014 -- Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director and CEO, Gyo Sagara; “ONO”) announced that ONO has today received manufacturing and marketing approval for the human anti-human PD-1 monoclonal antibody Opdivo® Intravenous Infusion 20 mg/100 mg(Opdivo) for the treatment of unresectable melanoma. Melanoma is considered to be a form of tumor characterized by the...

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FDA Approves Beleodaq (belinostat) for Peripheral T-Cell Lymphoma

Posted 2 weeks ago in New Drug Approvals

July 3, 2014 -- The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program. PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous. In 2014, the National Cancer...

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U.S. FDA Accepts NDA Filing for Boehringer Ingelheim’s Nintedanib for Idiopathic Pulmonary Fibrosis

Posted 2 weeks ago in New Drug Applications

Ridgefield, Conn., July 2, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the U.S. Food & Drug Administration (FDA) and granted Priority Review designation. The application for nintedanib is currently under review for the treatment of people with idiopathic pulmonary fibrosis...

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Flamel Technologies Announces FDA Approval of Vazculep

Posted 3 weeks ago in New Drug Approvals

LYON, FRANCE--(Marketwired - Jun 30, 2014) - Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Vazculep (phenylephrine hydrochloride). Vazculep Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the...

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Titan Pharmaceuticals Announces First Patient Enrollment In Clinical Study Of Probuphine for Opioid Dependence

Posted today in Clinical Trials

South San Francisco, CA - July 21, 2014 - Titan Pharmaceuticals, Inc. (TTNP.OB) today announced enrollment of the first patients in the Phase 3 clinical study to support resubmission of the New Drug Application (NDA) for Probuphine, the company’s investigational subdermal implant for the maintenance treatment of opioid dependence. The study, which is expected to be completed by the middle of 2015, is designed to...

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Rexahn Pharmaceuticals Provides Update on Phase I Supinoxin Trial in Cancer Patients with Solid Tumors

Posted 3 days ago in Clinical Trials

ROCKVILLE, Md.--July 18, 2014 -- (BUSINESS WIRE)-- Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced an update in its Phase I multi-center dose-escalation study to evaluate the safety, tolerability, dose-limiting toxicities and maximum tolerated dose (MTD) of Supinoxin™ (RX-5902) in cancer...

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Cynapsus Therapeutics Commences Phase 2 Clinical Trials in the United States

Posted 4 days ago in Clinical Trials

TORONTO, CANADA – (Marketwired) – July 17, 2014 - Cynapsus Therapeutics Inc. (CTH: TSX-V) (CYNAF: OTCQX), a specialty pharmaceutical company focused on Parkinson’s disease, today announced that following communication from the United States Food and Drug Administration (“the FDA”) on July 16, 2014, Phase 2 clinical studies for APL-130277 will commence immediately. Specifically, clinical study CTH-105 will...

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Alkermes Announces Initiation of Phase 1 Clinical Study of ALKS 8700 for Treatment of Multiple Sclerosis

Posted 5 days ago in Clinical Trials

DUBLIN--(BUSINESS WIRE)--Jul. 17, 2014-- Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 1 clinical study of ALKS 8700, a novel monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS). The randomized, double-blind study will evaluate the safety, tolerability and pharmacokinetics of several oral formulations of ALKS 8700 compared to both placebo and active...

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Dipexium Pharmaceuticals Initiates Pivotal Phase 3 Clinical Trial of Locilex

Posted 5 days ago in Clinical Trials

NEW YORK, July 17, 2014 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) today announced it has initiated patient enrollment in the first of two pivotal Phase 3 clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex (pexiganan cream 0.8%), the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild...

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