Category Archives: Safety
First Orphan Launch a Challenge for AstraZeneca
Four months after AstraZeneca received FDA approval for vandetanib, a treatment for inoperable medullary thyroid cancer, the company announced the drug’s trade name: Caprelsa. FDA said other proposed names – Zactima, for example – too closely resembled other currently marketed proprietary names.
Getting FDA approval on a brand name for vandetanib, AstraZeneca’s very first orphan drug, isn’t [...]
Also posted in FDA, Marketing, Strategy, patient education Tagged AstraZeneca, Cancer, Launch, Orphan Drugs, Sales, Ultra Orphan Leave a comment
FDA Finding Fuels Indian Crackdown on Sub-standard Drugs
By Mangesh Sai, Asia Correspondent.
A routine monthly inspection carried out by the Food and Drugs Administration (FDA) authorities in the state of Maharashtra, India, last month noted an increase in the number of sub-standard drug samples raising apprehensions about the availability of safe and genuine drugs in the state.
Officials pointed out that 26 drug samples [...]
Also posted in Anti-counterfeiting, Global, Guest Blog, IP Tagged Emerging Markets, EU, FDA, india, sub-standard drugs Leave a comment
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

Accelerated Approvals Could Raise Risks for Patients