Category Archives: Safety

Government-Funded Research: Is It That Different?

By Guest Blogger | Published: February 2, 2012
In December 2011, the President’s Bioethics Commission released its “Moral Science: Protecting Participants in Human Subjects Research.” The report was ordered by President Obama following an October 2010 revelation that the US Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases [...]
Also posted in Guest Blog, R&D, Regulatory | Tagged , , , | Leave a comment

Pharma: Get Ready for the New Supply Chains

By Guest Blogger | Published: January 30, 2012
New pharma supply chains, where chill control and traceability challenges will be far more critical, will emerge over the next decade, So it’s time, argues Julian Mosquera, for the industry to upgrade its capabilities. The pharmaceuticals industry is undergoing major disruption and every comparative benchmark indicates that the sector needs to make a step change in [...]
Also posted in Global, Guest Blog, Supply Chain | Tagged , , | 1 Comment

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 [...]
Also posted in Guest Blog, Regulatory | Tagged , , , , | Leave a comment

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 [...]
Also posted in FDA, Marketing, Strategy, patient education | Tagged , , , , , | Leave a comment

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 [...]
Also posted in Anti-counterfeiting, Global, Guest Blog, IP | Tagged , , , , | Leave a comment