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Firm Seeks FDA Approval to Release Genetically Modified Mosquitoes

January 26, 2015 11:43 am | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

The U.S. Food and Drug Administration is considering a proposal that would allow Oxitec to release millions of mosquitoes in an effort to fight the painful dengue and chikungunya viruses.           

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How to Stay Healthy During the Measles Outbreak

January 26, 2015 11:22 am | Videos | Comments

State officials are working to stem the spread of a measles outbreak that began in California. Vanderbilt University’s Dr. William Schaffner discusses ways to protect your health.            

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CHMP Issues Positive Opinion for Merck's Investigational Antibiotic SIVEXTRO®

January 26, 2015 11:00 am | News | Comments

Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO® for the treatment of acute bacterial skin and skin structure infections in adults.

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FDA Approves Symplmed's Prestalia® for Treatment of Hypertension

January 26, 2015 10:44 am | News | Comments

Symplmed Pharmaceuticals has announced that the FDA has approved Prestalia® (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension.         

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GSK Expands Its Asthma and COPD Portfolio in the US

January 26, 2015 10:36 am | News | Comments

GlaxoSmithKline has announced the simultaneous availability of two of its recently approved products for the treatment of asthma and COPD to retail pharmacies in the US. Over the past 15 months, GSK has launched four inhaled respiratory therapies in the US, all delivered in its Ellipta inhaler.

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FDA Approves Octapharma's Second Octagam® 10% Manufacturing Site

January 26, 2015 10:24 am | News | Comments

Octapharma announced that the FDA has approved the company’s manufacturing facility in Vienna, Austria for the production of Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation], which became available in the U.S. during October 2014.

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Debunking Flu Myths

January 26, 2015 9:09 am | Videos | Comments

Dr. Sanjay Gupta dismisses the idea that you can get the flu from the flu shot or from being outside in cold weather.                       

Dr. Fauci: It's a "Shame" Children Are Not Being Vaccinated for Measles

January 26, 2015 9:03 am | Videos | Comments

The measles outbreak with roots in Disneyland continues to spread, with at least 75 confirmed cases in six states. At least 54 of those cases have been traced back to the resort, and many of those infected were not vaccinated. National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci joins "CBS This Morning" to discuss the severity of the outbreak.

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Regeneron and Sanofi Announce Praluent BLA Accepted for Priority Review by FDA

January 26, 2015 8:56 am | News | Comments

Regeneron Pharmaceuticals and Sanofi today announced that the FDA has accepted for priority review the Biologics License Application (BLA) for  (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015.

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Added Protections for Consumer Information on Health Website

January 26, 2015 8:46 am | by RICARDO ALONSO-ZALDIVAR, Associated Press; JACK GILLUM, Associated Press | News | Comments

The Obama administration appears to be making broader changes to protect consumer information on the government's health insurance website, after objections from lawmakers and privacy advocates.          

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Bungled Ebola Response Prompts WHO to Adopt Reforms to Repair Reputation

January 26, 2015 8:43 am | by MARIA CHENG, AP Medical Writer | News | Comments

The World Health Organization has proposed reforms that could overhaul its structure after botching the response to the biggest-ever Ebola outbreak, a sluggish performance that experts say cost thousands of lives.       

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Doctors: Medical Pot Only OK for Sick Kids Failed by Other Drugs

January 26, 2015 8:40 am | by LINDSEY TANNER, AP Medical Writer | News | Comments

With virtually no hard proof that medical marijuana benefits sick children, and evidence that it may harm developing brains, the drug should only be used for severely ill kids who have no other treatment option, the nation's most influential pediatricians group says in a new policy.

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Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent

January 26, 2015 8:30 am | News | Comments

Gilead Sciences has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C.

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Insys Therapeutics Receives FDA Orphan Drug Designation for Ovarian Cancer Treatment

January 26, 2015 8:25 am | News | Comments

Insys Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer.      

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PwCReport: Regulatory Innovation Should Adapt to New Health Economy

January 26, 2015 8:19 am | News | Comments

Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the Food and Drug Administration (FDA).  Increased pressures for speedy access to breakthrough drugs and medical devices, and a focus on value in addition to medical benefit, are driving these changes.

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