The medical technology (medtech) market is forecasted to grow at 4.4 percent per year between 2011 and 2018, to reach $440 billion, according to a new report from EvaluatePharma, the EvaluateMedTech World Preview 2018. This growth will outpace the global pharmaceutical Industry, which has long over shadowed the medtech sector. This report finds that medtech is expected to grow 2.5 percent per year between 2011 and 2018.
From The Corner Lab - Blog Posts
In honor of Breast Cancer Awareness Month, we pay tribute to Evelyn H. Lauder, daughter-in-law of Estee Lauder, whose fight for a cure founded the Breast Cancer Awareness Campaign (BCA Campaign) and co-created the iconic pink ribbon. A decade later, the campaign has raised more than $35 Million to fund grants for medical research. To learn more about the BCA Campaign, visit http://www.bcacampaign.com.
Topics: Breast Cancer Awarness
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).
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 The study, a new review of peer-reviewed journals finds the percentage of studies withdrawn because of fraud or suspected fraud has zoomed.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.
A review of 483's and Warning Letters issued by the FDA, shows ongoing enforcement for USP method verification. Since the issuance of USP <1226>, the FDA has interpreted the term “under actual conditions of use” to be specific to each sample matrix. All USP compendial methods must have verification performed to demonstrate competency in running the method. In other words, you are mandated to prove you can successfully preform the USP method, similarly as you would in a method transfer. If USP tests are outsourced, you should have the CRO perform verification on your specific matrix.
In May 2012 Quantex Laboratories was recognized as the leading analytical CRO in the areas of productivity and regulatory compliance – receiving The CRO Leadership Award. Based upon over 40,000 pharmaceutical and biopharmaceutical executives who were invited to participate in the survey of the CRO industry, Only CROs scoring in the top quartile in each category qualified as CRO Leaders. Quantex was selected by them as a CRO Leader in those categories –beating out every other CRO.