HITTING THE HEADLINES
FDA Approvals Increased in 2012
FDA approved 39 new molecular entities and new biologic licenses in 2012, up from 30 in 2011. December is typically an active
month for FDA approvals and December 2012 was no exception, with FDA approving seven new drugs.
EMA Reveals Work Program for 2013
The management board of EMA has endorsed the agency's work program for 2013, as well as several activities relating to implementing
Europe's new pharmacovigilance legislation. EMA says it expects approximately 100 applications for human medicines in 2013.
AbbVie Celebrates Official Launch
AbbVie, a specialty biopharmaceutical company recently spun off from Abbott, was officially launched in January. The new company
will employ approximately 21,000 people in more than 40 countries.
Partnership Targets Malaria Vaccine R&D
The PATH Malaria Vaccine Initiative and Inovio Pharmaceuticals will be collaborating to advance the development of malaria
vaccines using a new vaccine delivery technology that combines genetically engineered DNA with electroporation.
• A three-year agreement will see Janssen Pharmaceuticals and GlycoVaxyn working together on a multivalent bacterial vaccine.
• Almac and TTP Labtech's alliance will give customers of either party access to a range of biological applications coupled
with microplate-reader technology.
• Mobile technology will be used to vaccinate children in Africa against common infectious diseases as part of a collaboration
between GlaxoSmithKline and Vodafone.
• OPKO and Bristol-Myers Squibb have expanded their collaboration to identify biomarkers predictive of drug response in several
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ON THE BLOG
"From 2013 onwards, we can expect to see more bolt-on acquisitions, more divestitures, and more offshore deals. "
"According to a recently conducted global survey, the overall reputation of the pharma industry declined more in 2012."
"With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step
closer to clarifying its thinking on acceptable formulations for this product class. "