Teva Pharmaceuticals is pulling its generic version of Wellbutrin XL. After extended testing, the FDA has determined that Teva's generic isn't equivalent to the branded drug. And now, the FDA is requiring other generics companies to test whether their own versions of Wellbutrin XL are acceptable (read Bloomberg story).
From The Corner Lab - Blog Posts
Fraud in biomedical and life-science research papers has become a growing issue in recent years as more studies are retracted all the time. Speaking to the Associated Press (here’s the AP story), the lead study author Arturo Casadevall, a professor of microbiology at the Albert Einstein College of Medicine in New York., said “Fraud in life sciences research is still minuscule and committed by only a few dozen scientific scofflaws. However, it causes big problems.” The study, a new review of peer-reviewed journals finds the percentage of studies withdrawn because of fraud or suspected fraud has zoomed. In 1976, there were fewer than 10 fraud retractions for every 1 million studies published, compared with 96 retractions per million in 2007.
The U.S. Food and Drug Administration is creating an internal task force to help it develop and revise guidance on antibacterial drug development and address the growing crisis of antibiotic resistance.
Are you are concerned about the level of arsenic, cadmium, lead or mercury that may slip through manufacturing processes and find their way into pharmaceuticals? Well, the US Pharmacopeia is working to ease any worries. The non-profit, which sets standards for the identity, strength, quality, and purity of medicines, is working on two new ‘chapters’ that would help drugmakers upgrade their testing for so-called heavy metals. The new guidance becomes official on December 1, although implementation will not be required until May 1, 2014. Why? We spoke with Kahkashan Zaidi, a senior scientific liaison at USP, about these new chapters and the implications…
As more and more R&D and analytical testing is outsourced by pharmaceutical companies, a study released by the global consulting firm Booz & Company provides new insight into how to structure the relevant relationships for success.
In a revised draft for General Chapter <621>, major changes have been proposed in the Pharmacopeial Forum:
A revision of General Chapter <621> on Chromatography is proposed in the Pharmacopeial Forum (volume 38, edition 2). This new chapter has a major impact on HPLC system suitability tests (SST).
In the current USP 35, adjustments in the mobile phase in gradient conditions are not recommended. Now, adjustments should be possible but as they may cause changes in selectivity, they should be made with caution.
The revised USP chapter now defines for each variable of the SST whether this variable applies for isocratic separations only or for gradient separations, too. In the future, the following parameters of the SST will be possible for gradient separations:
• pH of the mobile phase (+/-0,2)
• Concentration of salts in buffer (+/- 10 %)
• Injection volumes
• Column temperature (+/-10%)
Different length, internal diameter, and/or particle size in the stationary phase in gradient separations are not allowed.
Also the formula for calculating the flow rate will be modified. A new table will also be created to show the interaction between the variables length, internal diameter, particle size, and flow rates for a few significant column configurations. The objective of this is to maintain the performance of the separation system when modifying the SST parameter.
Finally, changes in the chemical characteristics of the stationary phase will be considered a modification to the method and will require full validation.
Recent news articles and industry analysts have discussed what’s wrong with and how to fix pharmaceutical industry R&D. It's no secret the industry has suffered, and continues to do so, and that innovation appears to have stalled with new drug approvals having slowed considerably. Add to this that the stock prices of the large pharmaceutical companies are down and large numbers of jobs have been lost in the last ten years. ,/span>