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Category Archives: Safety
CDER Addresses 'Challenges of Globalization' With a New Office
In recognition of the difficulties presented by a rapidly expanding global drug market, FDA’s Center for Drug Evaluation and Research (CDER) has created a new office “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain,” according to memo sent by CDER director Janet Woodcock.
The new “Office of Drug Security, Integrity [...]
Also posted in FDA, Global, Regulatory, Supply Chain Tagged CDER, FDA, Janet Woodcock Leave a comment
Is Sanofi Right to Bank on MS Drug?
Newswires have long been waiting for Sanofi-Aventis to officially announce its acquisition of US biotech company Genzyme, but what few analysts were expecting is just how much the transaction would hedge on one potentially controversial product. As the focus of Sanofi’s contingent value rights (CVR) approach, Genzyme’s multiple sclerosis treatment Lemtrada (also sold as Campath [...]
Also posted in Strategy, pricing Tagged Deals, Genzyme, Lemtrada, MS, Multiple Sclerosis, Sanofi-Aventis 1 Comment
Fighting Cancer — A Checklist of Change
Payer and regulatory pressures are likely to take some steam off of heady projections of market growth in this sensitive therapeutic area.
Against a backdrop of new figures detailing the mounting cost of fighting cancer, Pharm Exec’s sister CBI conference unit held its annual meeting — co-chaired by Alison Ayers of Pfizer and Ben Steinmetz of [...]
Also posted in FDA, Global, Meetings, Regulatory, healthcare 1 Comment
Pharma Is Over the Social Media Hump. Now What?
So, pharma is — arguably — “over the social media hump.” Everyone now “wants to do it”. But how does pharma do it? How can companies successfully use social media to market their messages and their products? That’s the question addressed in Pharm Exec’s new episode of Pharma Faceoff, chaired by Barbara Ryan of Deutsche [...]
Also posted in E-Media, FDA, Medical Education, R&D, Regulatory, Strategy, patient education, social media Leave a comment
FDA Finding Fuels Indian Crackdown on Sub-standard Drugs