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 […]
Auto-injectors
SMC acquires UK auto-injector developer Oval Medical Technologies
SMC Ltd., said today that it acquired auto-injector developer Oval Medical Technologies for an undisclosed amount. Cambridge, UK-based Oval Medical Technologies develops auto-injectors for a 2-step administration of non-viscous and viscous drugs using cyclic olefin plastic and glass primary drug containers. Somerset, Wisconsin-based SMC is a global contract manufacturer of single-use devices for pharmaceutical, medical […]
Mylan’s Q3 misses on $465 million Medicaid settlement
Shares in Mylan (NDSQ:MYL) rose slightly today after the pharmaceutical giant missed expectations on Wall Street with its 3rd-quarter results. The Canonsburg, Pa.-based company posted a net loss of -$119.8 million, or -23¢ per share, on sales of $3.06 billion for the 3 months ended Sept. 30, for a bottom-line slide of -3% on sales growth of 14.2% […]
Mylan, Teva crash on report that Justice Dept. could file charges in generic pricing probes
The U.S. Justice Dept. could reportedly file charges in its generic-drug pricing probe into companies including Mylan Pharmaceuticals (NSDQ:MYL) and Teva Pharmaceuticals (NYSE:TEVA) by the end of year. The department is examining whether the generic drug makers colluded on drug pricing, Bloomberg reported yesterday. The news source said that Mylan and Teva have disclosed subpoenas and are cooperating […]
West Virginia wants Justice Dept. to nix Mylan settlement
(Reuters) – West Virginia Attorney General Patrick Morrisey on Wednesday blasted a pending $465 million settlement between Mylan NV (NSDQ:MYL) and the U.S. Justice Dept. over the misclassification of the EpiPen, saying it was “woefully deficient.” In a Nov. 2 letter to Attorney General Loretta Lynch, Morrisey said the amount likely fell short of how […]
Kaleo plans 2017 U.S. relaunch for EpiPen competitor Auvi-Q
Kaléo Inc. said today that it plans to relaunch its Auvi-Q injector for emergency allergy treatment in the U.S. during the 1st half of 2017, according to Reuters. The Richmond, Va.-based company’s device was recalled last year after concerns about the accuracy of delivered dose. Sanofi (NYSE:SNY) made and licensed the Auvi-Q device from Kaléo, but returned rights to […]
UCB’s Cimzia AutoClicks pen hits the U.K. market
UCB (EBR:UCB) said today that its Cimzia AutoClicks pre-filled pen is available in the U.K., after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the device for all approved indications, including rheumatoid arthritis and axial spondyloarthritis. The Belgian company partnered with OXO to develop the pen, based on technology licensed from Bespak. The AutoClicks […]
Physics-modeling software solves drug-delivery engineering problem
Software that models the laws of physics is usually used by theoretical physicists. But a multi-physics program based on “1st principles” can be used in real-world applications, as evidenced by a problem that cropped up for Eli Lilly (NYSE:LLY) while developing needle-based drug-delivery systems. Bernard McGarvey, a senior engineering advisor for the US pharma giant, said the […]
Consort Medical’s Bespak inks Syrina auto-injector development deal
Consort Medical (LON:CSRT) subsidiary Bespak said today that it inked a development agreement with an undisclosed biopharmaceutical company for its Syrina auto-injector. The deal makes Bespak responsible for early-stage development of the auto-injector. If the undisclosed partner agrees to commercialize the developed product, both parties will enter into a full commercial supply agreement, the company said. Rather […]
SEC launches probe, investors file suit against Mylan over EpiPen pricing
Despite a $465 million settlement with the U.S. Justice Dept., Mylan (NSDQ:MYL) is still under fire for misclassifying its EpiPen auto-injector with the Centers for Medicare & Medicaid Services. Last week, the Securities & Exchange Commission’s enforcement division launched an investigation into the Canonsburg, Pa.-based company’s history with CMS; yesterday investors filed a purported class […]
