BD (NYSE:BDX) announced today that it will begin remediation for a 2020 Class I-level recall of its Alaris infusion system. Franklin Lakes, N.J.–based BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes, with pumps only going to health providers […]
Auto-injectors
Innovative Health Sciences wins CE mark for syringe infusion system
Innovative Health Sciences announced today that it received CE mark approval in Europe for its Insignis syringe infusion system. Chester, N.Y.–based Innovative Health Sciences designed the Insignis syringe infusion system to offer a combination of intravenous and subcutaneous non-electric infusion with a selectable rate flow controller — the IV Controller and the OneSett. According to […]
Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’
As we enter what may be the “new normal,” Dexcom’s CEO bets the company can pave the way in continuous glucose monitoring. Dexcom (NSDQ:DXCM), like any company seeking to innovate, remains in a state of perpetual forward motion. That’s the way chair, president & CEO Kevin Sayer views it, anyway. As the company looks toward […]
Pfizer agrees to pay $345M in EpiPen pricing lawsuit
Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices. Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices […]
Medtronic touts trial results for InPen smart insulin pen, extended infusion system
Medtronic (NYSE:MDT) today presented positive study results for its InPen smart insulin pen and its extended-wear infusion set. Fridley, Minn.-based Medtronic touted real-world clinical results comparing glycemic outcomes for 1,736 individuals before and after using the InPen smart insulin pen for 90 days with a continuous glucose monitor (CGM). According to a news release, data […]
Bigfoot Biomedical diabetes management program rolls out in some U.S. states
Bigfoot Biomedical announced today that made its Bigfoot Unity diabetes management program available in select U.S. markets. Milpitas, Calif.-based Bigfoot’s program is now available in California, Texas, Florida, Pennsylvania, Ohio, New York, New Jersey, Massachusetts and other New England states. The program is offered as a bundle of devices, supplies and services and delivered as […]
FDA accepts biologics license application for Genentech’s drug-eluting eye implant
Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery System (PDS) with ranibizumab. The PDS is a permanent, refillable eye implant that’s the approximate size of a grain of rice. It offers continuous delivery of a customized formulation of ranibizumab over a period of months to reduce the treatment […]
Kansas Distric Court rules in favor of Mylan in EpiPen class action
Viatris (NSDQ:VTRS) announced that the U.S. District Court for the District of Kansas ruled in favor of Mylan in an EpiPen class action. Mylan, which Pfizer combined with its Upjohn business to form Viatris in November 2020, received a favorable ruling in substantial part that dismissed all of the plaintiffs’ claims under the federal RICO […]
Soleo Health appoints new VP of business development, industry relations
Soleo Health announced today that it appointed Becky Rand as its VP of business development and industry relations. Rand’s responsibilities include initiating and maintaining relationships with pharmaceutical manufacturers and biotechnology companies while also looking to broaden the company’s portfolio of exclusive and limited drug distribution partnerships and other strategic initiatives. Frisco, Texas-based Soleo Health is […]
FDA classifies Novo Nordisk insulin pen recalls as Class I
In May, Novo Nordisk announced that it voluntarily recalled 1,468 product samples related to its Levemir, Tresiba, Fiasp, Novolog and Xultophy insulin lines. The products were held at sub-freezing temperatures, prompting the FDA to recently classify the recalls as Class I. FDA uses the Class I designation for situations where there is “a reasonable probability” […]