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 […]
Novartis steps in to compete with Mylan’s Epipen
Adamis Pharmaceuticals (NSDQ:ADMP) said this week that it inked an exclusive deal with Novartis‘ (NYSE:NVS) Sandoz unit to distribute and commercialize its Symjepi emergency allergy treatment. The agreement puts Novartis in the position to compete directly with Mylan‘s (NSDQ:MYL) EpiPen auto-injector. The pharma giant has been under pressure in recent months thanks to manufacturing delays that have […]
Insys Therapeutics reports positive preliminary data for allergy nasal spray
Shares in Insys Therapeutics (NSDQ:INSY) jumped yesterday after the company reported positive data for its investigational epinephrine nasal spray designed as a needle-free treatment for anaphylaxis. In a 60-person pharmacokinetics study, early data show that the company’s intranasal formulation of epinephrine boasted similar bioavailability to epinephrine delivered via Mylan‘s (NSDQ:MYL) EpiPen auto-injector. “Because epinephrine is […]
Noble launches AdhereIT platform for self-injection training
Noble this week launched its connected device platform, AdhereIT, to provide people that use auto-injectors with real-time feedback regarding their injection. Users can attach the AdhereIT system to an auto-injector training device or a commercial product, Noble reported. The platform can detect when the auto-injector makes contact with a user’s skin and the time when an […]
Propeller Health touts investment from McKesson Ventures
Building on a $20 million funding round announced last month, Propeller Health said today that it landed an investment of an undisclosed amount from McKesson Ventures. The company is looking to expand its digital therapeutics business beyond devices that manage the treatment of chronic respiratory diseases. Propeller noted that it’s interested in exploring opportunities in […]
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