PTSM: Pharmaceutical Technology Sourcing and Management, Jan 8, 2014 - Pharmaceutical Technology

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PTSM: Pharmaceutical Technology Sourcing and Management, Jan 8, 2014
Outsourcing Outlook
Climate Change Drives New Opportunities in Outsourcing
By Jim Miller
Ongoing changes create new opportunities for CROs and CMOs.
API Synthesis & Manufacturing
Deficiencies Discovered in API Inspections Suggest Strategies for Improvement
By Carmelo Rosa , Alicia Mozzachio , Paula R. Katz
PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
Manufacturing
GDUFA Off to Good Start, But Storm Clouds on the Horizon
By John DiLoreto
GDUFA is off to a good start from a facility inspection perspective, but there are storm clouds on the horizon.
CSR and Sustainability Forum
Janssen Announces Drug Donation Program for HIV Treatment-Experienced Children
By Melanie Sena
Janssen's donation program will improve access to the company's approved HIV medicines for children and adolescents in sub-Saharan Africa.
Jimmy Carter and Pfizer Mark 15-Year Effort To Help End Blinding Trachoma
By Melanie Sena
Former US President Jimmy Carter and Pfizer commemorate the 15th anniversary of the International Trachoma Initiative to end blinding trachoma by the year 2020.
BMS Grants Support Mental Health Needs of US Military Veterans
By Melanie Sena
The Bristol-Myers Squibb Foundation is awarding 10 grants to fund programs for veterans and their families.
Business
Bridgepoint Development Capital Acquires Quotient Clinical
By Melanie Sena
Bridgepoint Development Capital acquires Quotient for an undisclosed sum.
New Dynamics in Drug Pricing and Prescribing
By Rita Peters
Generics, market dynamics, and global demand are changing drug-spending patterns.
Metrics Appoints New Vice-President
By Melanie Sena
Metrics appoints a new vice-president to manage and expand its fee-for-service operations.
Cambrex Completes FDA Inspection
By Melanie Sena
FDA completes an inspection of Cambrex's API manufacturing facility in Charles City, Iowa.
Pall Corporation to Acquire ATMI's LifeSciences Business for $185 million
Pall Corporation, a solutions provider in filtration, separation and purification, has signed a definitive agreement with ATMI to acquire ATMI's LifeSciences business unit for $185 million.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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