Today's Top Stories
Product enhancements and reformulations, opportunities in niche markets and better planning for competition as patents expire are tactics Pfizer is adopting at its 2-year-old Established Products business unit. The manufacturing operation in Portage, MI, works to grow sales of products that face competition from generics.
The most recent investment in the plant--the company's largest manufacturing operation--involves a $100-million modular sterile packaging and freeze-drying facility. It took three years to install and ramp up, will provide automated filling and formulation, and promises to keep a cap on operating costs while product yields remain high.
Pfizer had $10 billion in worldwide sales of off-patent products last year, according to a local press report. The company says it expects the global market for such products to grow to $500 billion by 2015, nearly double the 2006 figure.
Among such products produced in Portage are anti-inflammatory medicine Solu-Medrol, antibacterial treatment Zyvox and cancer treatment Camptosar.
-see the article
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Daiichi Sankyo's increasing involvement in the regulatory matters of Ranbaxy, its 2008 acquisition, are kindling hope that the Indian generics maker may soon see an end to the FDA's import ban on 30 of its products. Press reports indicate that Ranbaxy may offer to pay a one-time penalty to settle with the regulator and reset their relationship.
Reports also indicate that an FDA inspection of the company's plants at Dewas and Paonta Sahib, where the troubles began, would follow before matters are resolved. The first inspection would be at the Dewas facility, "because the issue is less complicated there," Moneycontrol reports.
The ban stretches back to 2008 when GMP violations lingered at the two Indian facilities. And in early 2009, the FDA halted review of drug applications from Paonta Sahib, alleging Ranbaxy had falsified data.
- here's a Dow Jones report
- see more here
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Scientists have recommended to President Obama that fill/finish, potency assays and sterility testing are three areas that can be improved to speed the production of pandemic vaccine. The President's Council of Advisors on Science and Technology has submitted a 65-page document, Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza, outlining what the government can do to speed up production.
The council advises that pandemic vaccine production time could be halved in three years. One recommendation: government incentives to drive development of the equipment used in fill/finish operations, "a major rate-limiting step" in production. Advisors suggest that a comprehensive six-month review of fill/finish technology is a first step. One focus of the review would be facilities, with an eye toward evaluating the capabilities of existing plants against the promise of new plants.
The advisors also suggest that effort be devoted to improving potency assays, work that should be driven by the FDA and contractors. The council projects that a four- to eight-week time savings may be available in this area.
Similarly, the council suggests that changes to sterility testing could test time in half.
- see this article
- here's the report
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Packaging is paving the way for improved patient compliance with drug regimens. The so-called Pill Timer that is being introduced by the Henry Ford Health System promises to improve treatment outcomes through better medication management by patients.
The solution comes from an alliance between the healthcare provider, prescription-vial maker Rexam and medication management solution provider Med Time. Pharmacists will give patients free programmable timers with Rexam prescription vials; the vials will provide audio and visual alerts at prescribed intervals.
Henry Ford Continued Care will use the enhanced packaging for chronically ill patients. The system meets USP safety requirements, according to an announcement.
- see the Henry Ford release
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A study funded by the European Union finds that, with the notable exception of drugs, counterfeiting is an overblown concern. In fact, it may be good for the brands being copied. However, brand-holders and law enforcement are rejecting the report's conclusions.
The quality of many of the fake goods has "improved greatly," the report says. That's as true for drugs as for any other brand-name product, consumer or otherwise. "We should be focusing on the trade in counterfeit drugs, dodgy aircraft parts and other stuff that really causes public harm," says study co-author David Wall, a University of Durham professor, in a U.K. press report.
The British Journal of Criminology study, co-written by Wall and a U.K. Home Office adviser, calculates that the cost to industry might be a fraction of commonly accepted estimates and says it should be up to the industry--and not police--to halt the trade. That thought appears to have occurred some time ago to Pfizer, the maker of Viagra, which is one of the most copied drugs. The drug giant employs its own counterfeits investigative staff to work with government officials. It has found "a massive black market economy generated by counterfeit medicines," and estimates that as much as 90 percent of medicines bought online are fake or contain too little or none of the active ingredient.
- see the article about the EU report
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