Test that identifies Strep A within eight minutes cleared by FDA
WALTHAM, Mass. – Alere on Thursday announced that its Alere i Strep A test has received marketing clearance from the Food and Drug Administration. Alere i Strep A is the first molecular test that detects Group A Streptococcus (GAS) bacteria in throat swab specimens in 8 minutes or less.
Upon receipt of this clearance from the FDA, Alere submitted an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere i Strep A test. Other assays currently in development on the Alere i platform include respiratory syncytial virus (RSV), C. difficile and Chlamydia/Gonorrhoea.
"This FDA clearance brings the power of our Alere i molecular platform to the detection of Strep A," stated Avi Pelossof, global president infectious diseases at Alere. "The speed and accuracy of the Alere i Strep A test empower healthcare professionals to initiate the right treatment in an actionable timeframe, which is a critical step in reducing unnecessary prescription of antibiotics and enhancing operational efficiency."
The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014. In January 2015, Alere i Influenza A & B became the first-ever molecular test to receive CLIA waiver, which allows for broad use by healthcare providers, ranging from hospitals and physician offices to clinics and other healthcare settings. Expanding the menu on the Alere i platform to include Strep A and potentially other assays increases the utility of the platform for a wider range of users. Furthermore, given the less seasonal nature of Strep A, its addition enhances the value of the platform for users on a year-round basis.
With BioRx deal closed, Diplomat becomes one of nation’s largest specialty infusion providers
FLINT, Mich. – Diplomat Pharmacy announced Wednesday it has completed the acquisition of BioRx, a highly specialized pharmacy and infusion services company that provides treatments for patients with ultra-orphan and rare, chronic diseases. With the close of this acquisition, the combined resources and capabilities will make Diplomat one of the nation's largest specialty infusion providers.
Diplomat and BioRx are dedicated to personalized medication therapies for patients with chronic and complex therapies. "The combined resources of both companies will better serve our patients with broader access to limited distribution drugs as Diplomat and BioRx manage a strong therapy mix," stated Phil Hagerman, Diplomat chairman and CEO. "The combination furthers our capabilities to roll out services to a larger national geographic footprint which will strengthen our ties with pharmaceutical manufactures by satisfying their demand for multi-channel reach."
"For payor partners, our expanded offering improves our ability to take care of patients regardless of benefits," said Phil Reilly, co-founder of BioRx.
Both BioRx co-founders, Rielly and Eric Hill, have made multi-year commitments to help lead the combined infusion services organization going forward.
Under the terms of the agreement, Diplomat is paying BioRx $210 million cash and approximately 4.05 million shares of Diplomat common stock. In 2014, BioRx generated approximately $227 million in revenue.
Sam’s Club expands $4/$10 program with five free generics
BENTONVILLE, Ark. — Sam’s Club on Thursday expanded its prescription savings program to offer five generic prescriptions for free in 35 states, including donepezil, vitamin D 50,000 IU, pioglitazone, finasteride and escitalopram. This new benefit is part of Sam’s Club Extra Value Drug List, through which Sam’s Club Plus and Business Plus members also receive 10%-30% savings on select brand name medications.
Sam's Club will begin a marketing campaign in support of the new prescription savings program "FreeRx" this spring.
"The reason we picked these five drugs is because these are some of the disease states that affect our members most," Jill Turner-Mitchael, SVP Sam's Club Health and wellness, told Drug Store News. These medications are indicated for treatment of Alzheimer’s, diabetes, enlargement of the prostate gland and generalized anxiety disorder, she said, and are "not your typical drugs that you see most people give away for free."
In those states where these medicines cannot be offered free of charge, they will be available at a discounted cost of $4.
“Sam’s Club is always looking for ways to help improve the health of our communities and provide exceptional value to our members,” Turner-Mitchael said. “That’s why we created an extensive list of prescriptions to offer at substantial savings to our Plus and Business Plus members, especially those who are under or uninsured. It’s part of our ongoing commitment to making health care more accessible and affordable.”
Sam's Club has also added a significant number of medications to its $4/$10 program, Turner-Mitchael said. "There are over 200 drugs that'll be on [the $4] program as well as a little over 400 drugs that will be on the $10 program, making both of those [programs] a lot more robust."
Members with an active Plus membership can use the prescription discount benefit by presenting their Plus membership card along with a valid prescription at participating Sam’s Club pharmacies. Many other health and wellness benefits are available to Plus members, including up to 40% savings on certain generic prescriptions and up to 8% on name brand prescriptions that are not part of the EVDL program when paying without insurance, $50 off frames with the purchase of a year’s supply of contact lenses and 8% off pet medications.
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