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BD supports higher flu test standards from FDA

BY Alaric DeArment

FRANKLIN LAKES, N.J. — At least one company making rapid influenza tests agrees with proposed new standards from the Food and Drug Administration.

BD said Monday that it would support the FDA’s proposal to reclassify rapid influenza tests as Class II devices. They are currently considered Class I, and the new classification would hold them to higher performance standards in order to give healthcare providers criteria for evaluating the tests they use.

The proposal would increase performance requirements for the tests to attain a sensitivity of at least 90% for influenza A and 80% for influenza B; any test not meeting those requirements would have to be withdrawn form the market one year after the rule is finalized. BD makes the Veritor System Flu A+B Test, which it launched two years ago.

"This proposal is a step in the right direction as physicians and hospitals routinely rely on rapid diagnostic influenza tests to help manage patients that are suspected of having influenza," BD Diagnostics president for diagnostic systems Tom Polen said. "Raising the standards of rapid influenza tests will provide healthcare providers the right information to guide patient diagnosis and treatment without requiring repeat testing."

 

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Sears Holdings’ Shop Your Way Link offers reward points for shopping at partnering retailers

BY Alaric DeArment

HOFFMAN ESTATES, Ill. — Members of Sears Holdings Corp.’s loyalty program can increase their reward points by linking certain credit and debit cards to their accounts, the retailer said Monday.

The company said members of the Sears and Kmart Shop Your Way program could link up to three eligible Visa cards to their account and use it at any number of Reward Partner merchants, such as Burger King, Popeyes, Louisiana Kitchen, Picture People, Public Storage and 1-800-Flowers.com.

"As students and parents head back to school, they are looking for extra savings and more ways to earn rewards," Sears Holdings EVP and president for marketing, online, pricing and financial services Imran Jooma said. "Shop Your Way Link allows our members to earn points on everyday purchases made with popular restaurants, retailers and service providers, and enjoy a more personalized and rewarding shopping experience with Sears and Kmart."

Sears Holdings has also hired Adam Levine and Nicki Minaj on ShopYourWay.com to offer exclusive messages, photos and videos, as well as insider tips and entertainment and lifestyle news.

Cards not eligible for the program include prepaid Visa Buxx, Flexible Spending Account Visa cards, Eletronic Benefits Transfer Visa cards, gift cards and others that are not processed through the Visa U.S.A. payment system.

 

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Amgen to buy Onyx Pharmaceuticals for $10.4 billion

BY Alaric DeArment

THOUSAND OAKS, Calif. — Biotech company Amgen is buying Onyx Pharmaceuticals, the companies said Sunday.

Onyx, based in South San Francisco, Calif., has a portfolio of cancer drugs, including the injected multiple myeloma drug Kyprolis (carfilzomib), as well as Nexavar (sorafenib) tablets, developed with Bayer HealthCare Pharmaceuticals; Stivarga (regorafenib) tablets, developed by Bayer; and palbociclib, developed by Pfizer.

The $10.4 billion deal, a $125 per share tender offer, is expected to close in the fourth quarter. Amgen will acquire global rights to Onyx’s cancer portfolio and pipeline.

"We believe that Amgen is ideally suited to realize the full potential of Onyx’s portfolio and pipeline for the benefit of physicians and patients," Amgen CEO and chairman Robert Bradway said. "Our acquisition of Onyx follows a thorough due-diligence process and is fully consistent with our strategy of advancing innovative medicines that address serious, unmet medical needs."

 

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