News: Market Boom for Generics - Pharmaceutical Technology

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PharmTech Europe

News: Market Boom for Generics

Pharmaceutical Technology Europe
Volume 24, Issue 3

News bites

Pharmacovigilance update

The EMA has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July. The legislation will improve the safety and risk–benefit monitoring of drugs and represents the biggest change in the EMA's legal framework.

Fighting tropical diseases

Pfizer, Sanofi, GlaxoSmithKline and other major companies and global healthcare organisations have joined forces and pledged to defeat 10 neglected tropical diseases by 2020. The companies will donate an average of 1.4 billion treatments each year, while new collaborative R&D is expected to lead to new treatment options.

Jobs axed at AstraZeneca

AstraZeneca has announced restructuring initiatives that could lead to 7300 job losses. Positions affected include those in selling, general and administrative areas, as well as operations and neuroscience R&D. The restructuring is expected to deliver around $1.6 billion in annual benefits by the end of 2014.

FDA's Heparin guidance

The FDA has released a draft guidance for API manufacturers that provides recommendations for procedures to ensure that crude heparin does not contain oversulfated chondroitin sulphates or nonporcine origin material. The guidance is titled Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.


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Building a sustainable pipeline of products
Attracting a skilled workforce
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Regulatory compliance
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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology Europe,
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