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 […]
Kaleo partners with Walgreens to offer epinephrine auto-injector
Kaleo said this week that its epinephrine auto-injector, Auvi-Q, is available at Walgreens locations across the U.S. The partnership comes as the country is dealing with a shortage of the emergency allergy therapies – a number of epinephrine auto-injector manufacturers have reported supply issues to the FDA. In August, Kaleo confirmed that despite ongoing manufacturing delays […]
FDA extends expiration date for swath of Mylan’s Epipens amid shortage
In an attempt to mitigate an ongoing shortage of Epipen auto-injectors, the FDA today extended the expiration date of specific lots of 0.3-mg devices by four months. The move to extend the expiration dates beyond the approved 20-month shelf-life is based on stability data provided by Mylan (NSDQ:MYL) to the FDA, the U.S. regulatory agency reported. “Many […]
In midst of Epipen shortage, Kaleo confirms ‘sufficient supply’ of Auvi-Q auto-injectors
Kaleo said today that despite ongoing manufacturing delays reported by epinephrine auto-injector manufacturers, Kaleo’s Auvi-Q device is available via prescription and that the privately-held company has ‘sufficient supply to meet any anticipated demand.’ Kaleo’s epinephrine auto-injector features voice instructions that guide users through the drug-delivery process and an auto-retractable needle system, according to the company. […]
Mylan lowers outlook after Q2 earnings, sales miss estimates
Shares in Mylan (NSDQ:MYL) fell today after the pharmaceutical company missed expectations on Wall Street with its second-quarter financial results. The Canonsburg, Penn.-based company posted profits of $37.5 million, or 7¢ per share, on sales of $2.8 billion for the three months ended June 30, representing a bottom-line loss of -87.4% on a sales loss of […]
- 1
- 2
- 3
- …
- 8
- Next Page »
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn