Alere Reader, a point-of-care influenza diagnostic, gains 510(k) clearance
WALTHAM, Mass. – Alere on Tuesday announced that its Alere Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings, has received 510(k) marketing clearance from the U.S. Food and Drug Administration.
“The Alere BinaxNOW Influenza A & B Card 2 test with the Alere Reader, improves what is already a leading rapid testing solution for influenza diagnosis in two key ways – by eliminating operator subjectivity and by connecting test results with information management systems,” stated Avi Pelossof, Alere Global president of infectious disease. “The Alere Reader platform, paired with Alere’s market-leading lateral flow portfolio, will ensure that over time this novel technology will be accessible for use with a wide variety of diseases and conditions across numerous clinical settings.”
With the Alere Reader, physicians, lab technicians and other healthcare personnel insert test cards into the platform, which detects, identifies and analyzes the completed lateral flow assay. Results are displayed on an intuitive touch screen, can immediately be linked to patient electronic medical records and back-end information systems, or can be printed. Further, the Alere Reader provides the user additional confidence in the results with an automated function that ensures quality controls have been tested.
This announcement represents the introduction into the U.S. market of the Alere Reader, a diagnostic platform with objective result interpretation and connectivity capabilities. This follows a successful release of the Alere Reader into Europe and select Asian markets.
Diplomat appoints new CFO
FLINT, Mich. — Diplomat Pharmacy on Tuesday named Atul Kavthekar as its CFO and treasurer, effective May 1. Kavthekar will head up Diplomat’s financial operations and investor relations, as well as managing the company’s liquidity, balance sheet risk and capital market transactions, reporting directly to CEO and chairman Phil Hagerman.
“I couldn’t be more excited to welcome Atul to the Diplomat team,” Hagerman said. “He is highly qualified to lead our finance and accounting teams. In addition to his previous CFO experience, Atul has a deep background in financial management, operational improvement, and company leadership, as well as strategic corporate and business development.”
Kavthekar has more than 20 years of experience in finance, most recently serving as CFO at e-retailer LivingSocial from June 2015 to December 2016, where he was responsible for the company’s overall financial and operational business improvement. He also has worked at Walgreens and Sears Holdings’ health and wellness division (which includes Kmart pharmacy) in executive roles. He has experience as an investment banker, as well as in mergers and acquisitions.
“I have long been an admirer of the company and look forward to adding to the company’s strong reputation as a leader in the specialty pharmacy industry,” Mr. Kavthekar said. “As the leading independent specialty pharmacy, Diplomat has tremendous opportunity, and I look forward to contributing to its success.
Amneal Pharmaceuticals launches its first product in spray form
BRIDGEWATER, N.J. — Amneal Pharmaceuticals launched mometasone furoate nasal spray, the company's first pharmaceutical product in spray form.
Mometasone furoate, available in 50 mcg/spray strength, is an AB-rated therapeutic equivalent to Nasonex. Amneal's generic comes packaged in a white, high-density, polyethylene bottle fitted with a white, metered-dose, manual spray pump and turquoise cap. Each 17-gram bottle delivers 120 sprays.
"This launch marks a new milestone for us," said Jim Luce, Amneal’s EVP Sales and Marketing. "As the first nasal spray product from Amneal, it stands as yet another example of how we continue to expand into new and more complex dosage forms. Metered dose inhalers, transdermal patches and chewable tablets are just a few of those in the pipeline that we are excited to bring to market, significantly expanding our product offering."
Annual U.S. sales of brand and generic Nasonex were $653 million according to December 2016 IMS market data.