Category Archives: Manufacturing

The Patent Black Label: Six Side-Effects of India's Novartis Glivec Ruling

By William Looney | Published: April 3, 2013
Monday’s decision by India’s Supreme Court to deny a patent for the top-selling oncologic drug Glivec took nearly a decade of litigation to resolve – but the implications in and beyond India are both immediate and lasting.  Here’s a list of six that Pharm Exec thinks are most important:
Also posted in Emerging Markets, Global, IP, Legal, Market Access, Strategy, pricing | Tagged , , , , , , , , | 6 Comments

For Becton Dickinson, Medication Errors are a Business Opportunity

By Ben Comer | Published: April 1, 2013
Over the next few years, med tech company Becton Dickinson will launch up to 30 generic, pre-filled syringes in an attempt to lower medication errors and raise company revenues, according to BD Rx president Mark Sebree. One man’s goof is another man’s growth, potentially.
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Congress, FDA Should Consider Tech Solutions for Safer Compounding

By Guest Blogger | Published: March 14, 2013
By Niels Erik Hansen Last fall’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risk of errors inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened nearly 700 people in [...]
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IOM: Curb Fake Meds through Track-and-Trace, but Forget "Counterfeits"

By Jill Wechsler | Published: February 19, 2013
A new report from the Institute of Medicine (IOM) has drawn a lot of attention to the public health dangers of falsified and substandard medicines around the world. The aim is to build support for a range of activities that can limit the spread of fake medicines in the U.S. and help developing nations strengthen [...]
Also posted in Anti-counterfeiting, Events, FDA, R&D, Regulatory, Safety, Strategy, Supply Chain, compliance | Tagged , , , , , | Leave a comment

The Sunshine Act: Cloudier Still?

By Clark Herman | Published: February 7, 2013
With the recent release of the Patient Protection Sunshine Act (PPSA), the Center for Medicare and Medicaid Services (CMS) has established reporting requirements to ensure that drug manufacturers properly disclose payments to physicians in areas of research, continuing medical education, etc. However a key uncertainty is the issue of state pre-emption. While state and local [...]
Also posted in Legal, Medical Education, Meetings, Regulatory, compliance | Tagged , , | 1 Comment