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The Lead

Facing Health Law Hikes, Consumers Mull Options

November 25, 2014 | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

Consumers across most of America will see their health insurance premiums go up next year for popular plans under President Barack Obama's health care law.                

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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 | News | 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.


Doctor Behind 'Free Radical' Aging Theory Dies

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


Italy's Ebola Patient Gets Experimental Treatment

November 25, 2014 11:35 am | News | 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.   


Cocrystal Pharma and RFS Pharma Merge to Create Antiviral Development Organization

November 25, 2014 11:10 am | News | 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.


Mylan Files Patent Challenge Relating to BREVIBLOC(R)

November 25, 2014 11:07 am | News | Comments

Mylan has confirmed that it and several subsidiaries have been sued by several Baxter subsidiaries in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Esmolol HCl in Sodium Chloride Injection.    


How Single-Use, Mini Bioreactors Could Revolutionize Bioprocess Scale-Up

November 25, 2014 10:53 am | by Mwai Ngibuini, ambr250 Product Manager, Sartorius Stedim Biotech | TAP Biosystems | Articles | Comments

With new mAb drugs such as Kadcyla costing over 100,000 Euros per year, the price per patient for these therapies is considerably more than small molecule drug treatments. One reason for this is that these therapies cost more to manufacture than small molecules. By using mini scale bioreactor models to determine optimum scale-up bioprocess parameters in fed-batch culture could speed up process development and reduce manufacturing costs.


Tablet Press External Lubrication System

November 25, 2014 10:10 am | Product Releases | Comments

The PharmaSpray is an external lubrication system that sprays dry lubricant continuously onto tablet press punch tips and die walls. It delivers a consistent, validatable amount of dry lubricant onto the tablet’s outer surface over time.

Dentists Warn About the Dangers of "Bleachorexia"

November 25, 2014 9:46 am | Videos | Comments

Using too many teeth whiteners may damage your smile.                                 


pH Meter

November 25, 2014 8:26 am | Product Releases | Comments

The Seven2Go portable meter is designed to provide fast quality data, single-handed operation, durability, and reliable pH measurement for laboratory, at-line, and outdoor environments.

FDA Approves Valeant’s ONEXTON Acne Gel

November 25, 2014 8:13 am | News | 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.  


Plague Outbreak Kills 40 People in Madagascar

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


New FDA Rules Will Put Calorie Counts on Menus

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


VA Ousts Hospital Chief in Phoenix Scandal

November 25, 2014 7:57 am | by MATTHEW DALY, Associated Press | News | 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.


FDA Grants Priority Review to Two Bayer Respiratory Meds

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


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

November 24, 2014 4:09 pm | News | 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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