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 […]
Credence MedSystems raises $13m to support syringe systems
Credence MedSystems said today that it closed a $12.8 million Series B round to help support the commercialization of its Companion Syringe system. The company’s components combine with existing syringes to create a product that protects users against accidental needlestick injuries and creates a more user-friendly drug injector, according to Credence. “This investment comes at […]
PharmaJet, Mundipharma team up to boost access to needle-free drug-delivery systems
PharmaJet and Mundipharma have inked an exclusive partnership to market and distribute PharmaJet’s Tropis and Stratis needle-free drug-delivery devices to more than 120 markets around the world. The devices are designed for vaccine immunizations. PharmaJet, which has an ongoing deal to use its devices in the World Health Organization’s efforts to eradicate polio, touts that […]
- 1
- 2
- 3
- …
- 8
- Next Page »
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn