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The Lead

VA Ousts Hospital Chief in Phoenix Scandal

November 25, 2014 | by MATTHEW DALY, Associated Press | Comments

The head of the troubled Phoenix veterans' hospital was fired Monday as the Veterans Affairs Department continued its crackdown on wrongdoing in the wake of a nationwide scandal over long wait times for veterans seeking medical care and falsified records covering up the delays.

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Spark Therapeutics Appoints Former Chief of FDA’s Gene Therapy Branch as Head of Regulatory Affairs

November 25, 2014 2:06 pm | Comments

Spark Therapeutics has announced today appointment of Daniel M. Takefman, Ph.D., as head of regulatory affairs. Dr. Takefman previously served as chief of the gene therapy branch of the Center for Biologics Evaluation and Research at the FDA, a position he held since 2006.

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Doctor Behind 'Free Radical' Aging Theory Dies

November 25, 2014 1:24 pm | by JOSH FUNK, Associated Press | Comments

The scientist who developed the most widely accepted theory on aging that's used to study cancer and other diseases has died in Nebraska. Dr. Denham Harman developed the "Free Radical Theory of Aging" in 1954, though it took years for additional research to prove its importance.

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Italy's Ebola Patient Gets Experimental Treatment

November 25, 2014 11:35 am | Comments

An Italian doctor who contracted Ebola while working in Sierra Leone has arrived back in Italy and is being treated with the same experimental drugs used in the U.S. and other European countries to treat people infected with the virus.   

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Cocrystal Pharma and RFS Pharma Merge to Create Antiviral Development Organization

November 25, 2014 11:10 am | Comments

Cocrystal Pharma, a biotechnology company developing novel antiviral therapeutics for human diseases, today announced the closing of its merger with RFS Pharma, a privately owned biotech company founded by renowned drug developer, Dr. Raymond Schinazi.

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Isis Pharmaceuticals Initiates Phase 3 Study of ISIS-SMN Rx in Children with Spinal Muscular Atrophy

November 25, 2014 10:58 am | Comments

Isis Pharmaceuticals, has announced the initiation of a pivotal Phase 3 study evaluating ISIS-SMNRx in approximately 120 non-ambulatory children with spinal muscular atrophy (SMA).  SMA is a severe and rare genetic neuromuscular disease characterized by muscle atrophy and weakness. 

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FDA Approves Valeant’s ONEXTON Acne Gel

November 25, 2014 8:13 am | Comments

Valeant Pharmaceuticals has received approval from the FDA for ONEXTON Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older.  

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Plague Outbreak Kills 40 People in Madagascar

November 25, 2014 8:05 am | by LYNSEY CHUTEL, Associated Press | Comments

WHO said a national task force has been set up to manage the outbreak, with the cost of the project reaching $200,000. The international health organization said it is working with the Red Cross and Madagascan health authorities to control the disease.

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New FDA Rules Will Put Calorie Counts on Menus

November 25, 2014 8:01 am | by MARY CLARE JALONICK, Associated Press | Comments

Whether they want to or not, consumers will soon know how many calories they are eating when ordering off the menu at chain restaurants, picking up prepared foods at supermarkets and even eating a tub of popcorn at the movie theater.    

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FDA Grants Priority Review to Two Bayer Respiratory Meds

November 25, 2014 7:51 am | by The Associated Press | Comments

Two medicines Bayer HealthCare Pharmaceuticals Inc. is testing for respiratory disorders will get priority review by U.S. regulators and other benefits under a 2012 program to boost development of new antibiotics.      

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BMS and Five Prime Therapeutics to Evaluate Investigational Immunotherapies Opdivo and FPA008 in Six Tumor Types

November 24, 2014 4:09 pm | Comments

Bristol-Myers Squibb Company and Five Prime Therapeutics have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo, Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, with FPA008, Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor.

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Aurobindo Pharma Recalls Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules

November 24, 2014 3:04 pm | Comments

Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.         

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Amgen Ends Studies of Gastric Cancer Drug

November 24, 2014 2:45 pm | Comments

Amgen is ending late-stage trials of its gastric cancer treatment rilotumumab because patients who took the drug were more likely to die. Amgen said more patients died after treatment with rilotumumab and chemotherapy than with chemotherapy alone.

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FDA Issues Additional Guidance for Outsourcing Facilities That Compound Sterile Human Drugs

November 24, 2014 1:18 pm | Comments

The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the DQSA, which was enacted in November 2013.

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FDA Strengthens Warning on Device Linked to Cancer

November 24, 2014 11:50 am | by LINDA A. JOHNSON, AP Business Writer | Comments

The FDA is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.

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INTERPHEX Announces Launch of New INTERPHEX Exhibitor Awards for 2015

November 24, 2014 11:13 am | Comments

Recognizing Cutting-Edge Technology and the Outstanding Efforts of Companies that Support Pharmaceutical and Biopharmaceutical Development and Manufacturing                 

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