Category Archives: Op-Ed

Pharma Battered in 2012, But Signs of Hope for 2013

This year has been marked by flat to declining growth rates, but there are hopeful signs for 2013, writes Andrew Forman. The long-awaited patent cliff that has loomed over the pharma industry for years has arrived in earnest in 2012, with more than $40 billion in 2011 brand sales facing loss of exclusivity (LOE). Although [...]
Also posted in Guest Blog | Leave a comment

Whistleblower Case Highlights FDA Confidentiality Concerns

By David L. Rosen New stories earlier this year (1) reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.
Also posted in FDA, Guest Blog, Legal, Regulatory | Tagged , , , , | Leave a comment

Compounded Drug Crisis Spotlights Regulatory Confusion

Compounded drug crisis spotlights regulatory confusion The call for stiffer FDA regulation of compounded drugs has been reignited by a national fungal meningitis outbreak. Last week, the Centers for Disease Control and Prevention (CDC) reported 7 deaths linked to contaminated vials of steroid injectables from a Massachusetts compounding operation. 91 people have been taken ill, with [...]
Also posted in FDA, Safety | Tagged , , , , | Leave a comment

Is the Worst of the Patent Cliff Behind Us?

By Amy Ritter. In a bit of good news for pharma, Moody’s Investors Service has upgraded its outlook for the global pharmaceutical industry to stable. The Moody’s rating reflects expectations for fundamental business conditions in the industry over the next 12 to 18 months, and until now, the industry had been limping along under a negative [...]
Posted in Op-Ed | Tagged , , , | 1 Comment

Monsanto's Rat Tumor Scare: A Wake-Up Call for the Pharma Industry?

ARE Monsanto’s RAT-TUMOUR SCARES A WAKE-UP CALL TO THE PHARMA INDUSTRY? By Reflector, Brussels correspondent. The furore that burst across Brussels in late September over reported findings of tumors in rats fed with genetically modified maize may seem only tangentially related to the concerns of European pharmaceutical executives — but the significance of the debate it has [...]
Also posted in Biotech, Europe, Gene therapy, Guest Blog, Safety, Technology | Tagged , , , , , , | 2 Comments