The medical device industry and the role of CDRH

Dr. Nigel A.S. Hernandez A current pacemaker. Future devices are getting smaller and more complex. The public trust manufacturers of medical products to develop and commercialize ...

The Future of Convergent Technologies

Dr. Nigel A.S. Hernandez BIOMEDevice Forum 2009 (Report from BIOMEDevice 2009 Executive Forum) I took time off to finalize my doctoral thesis draft and research bleeding edge companies ...

Talkback: Response to Article in Nature, A To-Do List for the New FDA Commissioner, by Susan Okie, M.D.

Dr. Nigel A.S. Hernandez FDA Centennial-1906-2006 ARTICLE: http://content.nejm.org/cgi/content/full/360/14/1373 The article in Nature by Dr. Susan Okie titled, A To-Do List for ...

Safety watchdog flags GLP-1 drugs for pancreatitis reports to FDA

Tracy Staton Two months ago, a study published in the Journal of the American Medical Association raised some new questions about cancer risks linked with some big diabetes drugs. ...

Report: Antibiotics pipeline lackluster as resistance surges

Emily Mullin As antibiotic resistance grows in the U.S. with the rise in increasingly deadly bacteria, nicknamed "nightmare bacteria," a new report has identified that only ...

The Chasmic Shift in Disruptive Business Climates

Dr. Nigel A.S. Hernandez The Chasmic Shift in Disruptive Business Climates It has been a few months since I have had an opportunity to write for pleasure. After completing my doctoral ...

New GlaxoSmithKline lung drug nabs thumbs-up from FDA experts

Tracy Staton An FDA advisory panel gave an approval stamp to GlaxoSmithKline's ($ GSK) new lung drug, Breo. The agency advisers weren't unanimous in backing GSK's follow-up ...

Epizyme hits the biotech IPO queue with rapid R&D plan for cancer drugs

Ryan McBride Epizyme wants to go public as the company plans on taking the fast lane to develop small molecules for genetically defined cancers. The Cambridge, MA-based biotech company ...

Saving lives is worth celebrating, CDC Reports Sharp Decline in Foodborne Illnesses

Dr. Nigel A.S. Hernandez Saving lives is worth celebrating…. Foodborne illnesses are defined as the illnesses caused by pathogens that enter the human body where food is the ...

Hikma decides injectables drug business a prize to hold onto

Eric Palmer When Mylan agreed to pay $ 1.6 billion to nab Strides Arcolab's sterile injectables drug business, the competitors it bested were thought to be sniffing around elsewhere ...

Johnson & Johnson cashes out on Elan shares after failed Alzheimer’s trials

Ryan McBride Johnson & Johnson ($ JNJ) has sold 82 million Elan shares ($ ELN) for $ 11.25 per share as part of Elan's $ 1 billion stock buyback plan, providing J&J's ...

Influenza Antiviral Drugs – An Overview

Dr. Nigel A.S. Hernandez The Influenza Virus is Winters Worst Nightmare The winter season has been in full swing all around the USA. Winter, with the snow is a beautiful season, albeit ...
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