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The FDA has released a draft guidance for API manufacturers that provides recommendations for procedures to ensure that crude heparin does not contain oversulfated chondroitin sulphates or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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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
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology Europe,
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