ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 27, 2012 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 27, 2012
News
Amgen Settles False Claims Act Allegations
By Amy Ritter
Amgen has agreed to pay $762 million to resolve criminal liability and false claims act allegations.
FDA Issues Final Guidance on Limiting the Use of Certain Phthalates as Excipients
By Patricia Van Arnum
The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.
FDA Approves First Anthrax Antitoxin
By Amy Ritter
Anthrax antitoxin is the first monoclonal antibody approved under FDA's Animal Efficacy Rule, and the first product from BARDA's Project Bioshield to receive FDA approval.
First Commercially-Available Mycoplasma Detection Test Accepted by FDA
By Adeline Siew, PhD
Roche's MycoTOOL, which offers rapid detection of mycoplasms based on a polymerase chain reaction (PCR) test, has received FDA acceptance.
University of Connecticut Studies Drug-Carrying Nanoparticles
By Jennifer Markarian
A University of Connecticut chemical engineering professor received a National Science Foundation grant to study how nanoparticles flow in the bloodstream, which is crucial for their use in drug delivery.
Week of December 24, 2012: AAIPharma Expands Parenteral Drug Capacity; Novartis Buys Dendreon Plant; and More
AAIPharma Expands Parenteral Drug Capacity; Novartis Buys Dendreon Plant; and More.

ADVERTISEMENT

LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Click here