Enable Injections said yesterday that it entered a developmental partnership with Genentech for the Enable enFuse device. Cincinnati-based Enable’s enFuse is an on-body drug delivery platform containing a drug transfer system compatible with syringes and vial containers. Currently, the enFuse is being developed for subcutaneous delivery of large volumes potentially rising to 50 mL. The […]
Teva launches generic EpiPen Jr.
Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available in the U.S. The device wholesales to most retail pharmacies in packs of two for $300, or $150 per pen. Teva’s product is less than half the cost of Mylan’s non-generic EpiPen Jr., which lists at $643.89 per two-pack at Drugs.com. ”We’re […]
Windgap Medical inks deal with Denmark’s ALK for epinephrine auto-injector
Windgap Medical last week announced a strategic partnership with ALK-Abelló to commercialize its epinephrine auto-injector to treat anaphylactic shock. ALK will have exclusive, worldwide sales and distribution rights for the Windgap epinephrine auto-injector through the deal in exchange for technical and sales milestone payments and tiered royalties on net sales in the U.S. The companies […]
Mylan agrees to settle SEC EpiPen probe for $30 million
Mylan (NSDQ:MYL) is nearing a $30 million settlement with the Securities and Exchange Commission (SEC) over an investigation involving the company’s EpiPen auto-injector and the Medicaid drug rebate program. The SEC probe was announced in 2016, shortly after Mylan agreed to pay $465 million to the U.S. Department of Justice to settle claims that it […]
ARS Pharmaceuticals wins fast track status for epinephrine nasal spray
ARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1. The San Diego, Calif.-based company’s device is designed to be an easy-to-use treatment for people suffering from severe allergic reactions to food, drugs and insect bites. ARS Pharmaceuticals reported that the ARS-1 aqueous intranasal […]
Teva aims for 25% of U.S. EpiPen market by 2020
Teva (NYSE:TEVA) expects its generic EpiPen auto-injector to claim 25% of the U.S. market by the end of this year, according to a report from Seeking Alpha. For years, Mylan‘s (NSDQ:MYL) brand-name emergency allergy device has dominated the markets. But the company faced widespread criticism in 2016 when reports revealed that Mylan hiked the price of the […]
FDA approves J&J’s Tremfya self-injection pen for psoriasis
FDA has approved Johnson & Johnson’s patient-controlled injector for Tremfya, a treatment for adults with moderate to severe plaque psoriasis. The self-injection approval may help Tremfya compete with AbbVie’s (NYSE:ABBV) Humira pen, which was previously approved for self-injection by psoriasis patients. Made by J&J subsidiary Janssen Pharmaceuticals (Horsham, Penn.), Tremfya is a biologic therapy that selectively […]
FDA takes big step toward over-the-counter naloxone
In a first for the agency, the FDA has developed and tested a consumer-friendly Drug Facts label to support the development of an over-the-counter version of naloxone, an emergency opioid overdose treatment. A DFL is required for OTC drug products and the FDA has never before proactively developed and tested one. But in this case, […]
Sandoz launches PFS alternative to epinephrine auto-injector
Novartis (NYSE:NVS) division Sandoz said today that it launched its Symjepi epinephrine pre-filled syringe in the U.S. The company’s product is designed as an alternative to epinephrine auto-injectors to treat emergency allergic reactions. Sandoz described Symjepi as an “affordable” alternative to EpiPens but did not disclose the product’s price. “The Symjepi device is small in size and […]
Philips’ HealthSuite will track Ypsomed’s connected self-medication devices
Philips and Ypsomed said today that they will jointly develop a solution for Ypsomed’s new self-medication adherence monitoring services based on Philips’ HealthSuite digital platform. The combination of Ypsomed’s connected devices and Philips’ (NYSE:PHG) cloud-based digital platform will allow Ypsomed’s pharmaceutical customers to deliver value-added services aimed at improving patient outcomes, the companies said in […]
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