Mylan (NSDQ:MYL) said last week that its manufacturing partner, Meridian Medical Technologies, expanded an EpiPen recall to include the U.S. and other markets. The move comes 1 week after Mylan recalled 81,000 EpiPen devices in countries outside the U.S. following 2 reports that the allergy auto-injector failed to work in emergency situations. “While the number of reported […]
Auto-injectors
Mylan recalls 81,000 EpiPens over reports of device failure
Mylan (NSDQ:MYL) recalled 81,000 EpiPen emergency allergy auto-injectors this week after receiving 2 reports that the device failed to work in emergencies. The recall affects devices in Australia, New Zealand, Europe and Japan, the company reported. Canonsburg, Penn.-based Mylan said that in both cases, patients received treatment using an alternate EpiPen. The drugmaker also said that it […]
Press Release: Nemera wins the “Editor’s choice” Exhibitor Award at Interphex with its autoinjector Safelia
(Press release) – International Pharmaceutical Expo (INTERPHEX), the premier event dedicated to pharmaceutical and biotechnology innovation, technology, and knowledge from development through commercialization and sponsored by the Parenteral Drug Association (PDA), has announced the winners for the INTERPHEX Exhibitor Awards for 2017. Nemera was recognized for the ‘Editor’s choice’ for Safelia. Safelia is an innovative […]
Report: Increase in allergy auto-injector scripts, with little guidance on optimal use
Prescriptions of emergency allergy auto-injectors have increased over the last decade, according to research published in the British Journal of General Practice, but there is little guidance for general practitioners on the optimal use of these devices. The most recent guidelines suggest that each child at risk of anaphylaxis should be given no more than 2 devices […]
Grassley questions Auvi-Q’s list price, while Trump shows support for Medicare drug-pricing reform
Although Mylan (NSDQ:MYL) has been under fire for its pricey EpiPen device since August last year, competitor Kaleo found itself garnering unwanted attention from politicians this week over the price of its epinephrine injection, Auvi-Q. Chairman of the Senate Judiciary Committee, Sen. Chuck Grassley (R-Iowa), wrote a letter to the Richmond, Virginia-based company asking CEO Spencer Williamson to explain […]
Demand for EpiPen alternatives jumps as states consider access legislation
Prescriptions for EpiPen alternatives such as Kaléo Inc.‘s Auvi-Q device have quadrupled since the beginning of this year, according to data from the Athenahealth Network. The demand for cheaper alternative devices is likely driven by revelations that Mylan (NSDQ:MYL) hiked the price of its EpiPen emergency allergy injector by 500% since it acquired the device in 2007. Generic […]
CMS nominee Verma: Mylan’s EpiPen case ‘disturbing’
Seema Verma, the nominee to head the Centers for Medicare & Medicaid, said at her confirmation hearing that she would like to review the way pharmaceutical companies classify products as generic or branded, citing the case of Mylan‘s (NSDQ:MYL) EpiPen emergency allergy device. Mylan faced criticism this year for classifying EpiPen as a generic and paying smaller rebates to Medicaid […]
Senators question Kaleo over pricey opioid overdose device
In a letter signed by 30 U.S. senators, Sen. Claire McCaskill (D-Missouri) asked Kaleo Pharmaceutical to explain the 550% price hike for its Evzio opioid overdose device. The company’s product, which Kaleo sold for $690 in 2014, is priced at $4,500. Evzio is a naloxone auto-injector designed to reverse the effects of an opioid overdose. It can […]
Mylan hit with antitrust lawsuit over EpiPen device
Mylan (NSDQ:MYL) said on Monday that it is undergoing an antitrust probe by the Federal Trade Commission into the company’s commercial practices regarding its EpiPen device. The Canonsburg, Pa.-based company reportedly responded to the allegations that it improperly fought off competition, saying “any suggestion that Mylan took any inappropriate or unlawful actions to prevent generic competition […]
Kaleo announces US availability, pricing of allergy auto-injector
Kaléo Inc. said yesterday that its Auvi-Q epinephrine auto-injector will be available by prescription in the U.S. beginning Feb. 14th. The Richmond, Virginia-based company’s emergency allergy treatment was pulled from the market in 2015 due to manufacturing issues. The Epipen competitor device will be sold at a list price of $4,500, but Kaléo said that as a […]