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Pfizer Contraceptive Pill Packaging Error Leads to Recall
February 9th 2012Following a packaging error affecting birth-control pills, Pfizer has issued a one-million pack recall and warned women in the US who have been taking the medication during the last several months to consult with their physicians.
EMA to Implement Pharmacovigilance
February 9th 2012The European Medicines Agency (EMA) has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk–benefit monitoring of drugs. The new legislation will represent the biggest change in the legal framework of the industry since EMA was first established in 1995.
FDA Commissioner Testifies for PDUFA Reauthorization
February 8th 2012Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to support the fifth authorization of the Prescription Drug User Fee Act, also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V.
PhRMA Transitions Management of its Benefit–Risk Action Team
February 2nd 2012PhRMA announced that it will transition the management of its benefit–risk action team to the Centre for Innovation in Regulatory Science (CIRS). CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters.
FDA Files Consent Decree Against Ranbaxy
February 2nd 2012The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The decree was filed on Jan. 25, 2012, and is subject to court approval.
Pharma Targets Tropical Diseases
February 2nd 2012Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom, and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization, and several other global health entities.
Call for Funding to End Animal Experiments
January 26th 2012As the EU debates how best to spend billions of euros worth of research funding, the Humane Society International/Europe has issued a call to develop in vitro and computational techniques that can replace the use of animals in medical experiments.
European Outsourcing Revenue to Grow by 50%
January 26th 2012According to a report from Frost & Sullivan, the European pharmaceutical contract manufacturing market could earn revenues of up to $20.75 billion in 2018, almost double that of 2011's revenue when the market earned $10.02 billion. Over the same period, the European market for biotechnology outsourcing is forecast to grow from $1.21 billion to $2.67 billion.
Genzyme Plant Approved to Begin Manufacture of Drug in Critically Short Supply
January 26th 2012Sanofi's subsidiary Genzyme has received FDA's approval for the production of Fabrazyme (agalsidase beta), used in the treatment of Fabry's disease, at its manufacturing facility in Framingham, Massachusetts. Shortages of Fabrazyme have been ongoing for the past two years.
FDA Recommends Three Drug User Fee Programs
January 19th 2012On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act and programs for human generic drugs and biosimilar biological products.
Global Market Boom for Generic Drugs
January 19th 2012The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.
