Category Archives: Safety

Accelerated Approvals Could Raise Risks for Patients

By Guest Blogger | Published: November 10, 2011
By Erik Greb. FDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s lower [...]
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First Orphan Launch a Challenge for AstraZeneca

By Ben Comer | Published: August 2, 2011
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 [...]
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FDA Finding Fuels Indian Crackdown on Sub-standard Drugs

By Guest Blogger | Published: July 27, 2011
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 [...]
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CDER Addresses 'Challenges of Globalization' With a New Office

By Ben Comer | Published: June 8, 2011
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 [...]
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Is Sanofi Right to Bank on MS Drug?

By Julian Upton | Published: February 23, 2011
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 [...]
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