PHARMACY

NanoInk to direct workshop on reducing counterfeiting and illegal diversion of pharmaceuticals

BY Allison Cerra

SKOKIE, Ill. NanoInk’s vice president of business development will be leading an interactive discussion at the Third Annual Global Pharma Manufacturing Summit later this week, the company said.

Jim Whittle will be representing NanoInk as a guest speaker for a workshop called “Protect the Patient, Not the Package”, to convey the dangers of not shielding unit dosage for patients’ medications from possible counterfeit.

“I will show how unit dosage protection can be vital to providing the highest level of patient safety and why it should be utilized as part of a multilayered approach to fighting anti-counterfeiting and illegal diversion,” Whittle said.

The FDA estimates that nearly 15 percent of all pharmaceuticals imported to the U.S. contain contaminants, wrong ingredients, or incorrect amounts or insufficient quantities of active ingredients. As this problem grows, the company said, the need for on-product brand protection is becoming increasingly urgent, not only for pharmaceutical companies but also for the safety of consumers. From this situation, NanoInk’s developed Nanoencryption technology, which provides the only true forensic level track and trace brand protection at the unit level.

The Global Pharma Manufacturing Summit brings together pharmaceutical professionals to discuss the current state of affairs and guidelines in the industry and discusses new way that manufacturing and packaging processes can be improved. 

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PHARMACY

Evista gets FDA approval for new use to reduce breast cancer risk

BY Drew Buono

INDIANAPOLIS The Food and Drug Administration has approved a new application for Eli Lilly’s osteoporosis drug Evista. The drug is now indicated as a way to reduce the risk of invasive breast cancer.

The drug’s new use is designed for postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. “The FDA’s decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns—osteoporosis and invasive breast cancer,” said Gwen Krivi, vice president of Lilly Research Laboratories.

The approval comes less than a year after the application was submitted to the FDA and also carries a recommendation of the Oncologics Drug Advisory Committee.

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Cubist to ask for patent reissue for Cubicin

BY Drew Buono

LEXINGTON, Mass. Cubist Pharmaceuticals is planning on asking U.S. regulators to reissue a patent on the drug Cubicin to block generic competition.

Cubicin is used as a treatment for skin infections and is set to lose its patent in 2016.  Cubist is going to ask the U.S. Patent and Trademark Office to correct and reissue a patent regarding the purity level of the compound daptomycin, which is the key ingredient in Cubicin.

On Wednesday, generic manufacturers were allowed to seek approval from the Food and Drug Administration to sell generic versions of the drug.  Now, with Cubist seeing corrections from the patent office, the original patent will be removed from the FDA’s registry of information on approved drugs until the mater is handled.

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