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 […]
Auto-injectors
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 […]
Mylan settles EpiPen pricing probe with $465m
Mylan (NSDQ:MYL) last week agreed to pay $465 million to settle claims that it underpaid Medicaid for its EpiPen auto-injector by misclassifying the device as a generic. Last week, the Centers for Medicare & Medicaid Services said it spent $797 million on the emergency allergy treatment between 2011 and 2015, including rebates. The Canonsburg, Pa.-based company has […]
CMS finds Mylan overcharged Medicaid for EpiPens for years
The Centers for Medicare & Medicaid Services said this week that Mylan Pharmaceuticals (NSDQ:MYL) has been overcharging Medicaid for its EpiPen auto-injector for years, despite being warned that it should have paid bigger rebates. CMS said that between 2011 and 2015, Medicaid spent $797 million on the epinephrine auto-injector after deducting rebates, marking the 1st […]
Committee pens letter to Mylan demanding EpiPen price info
Members of the U.S. House Committee on Oversight & Government Reform penned a letter to Mylan (NSDQ:MYL) demanding a more complete look at the pricing of its EpiPen epinephrine auto-injector. At a Sept. 21 congressional hearing, Mylan CEO Heather Bresch testified that the company makes a $100 profit per 2-pack of EpiPens. Last week, Mylan […]
Analyst: Insulet’s drug-delivery biz a long-term growth driver
Insulet’s (NSDQ:PODD) drug-delivery business will be a long-term growth driver for the company by as much as 20% a year for the next few years, according to Leerink Partners analysts. Billerica, Mass.-based Insulet generates 86% of its revenue from its OmniPod insulin delivery device, according to Leerink. The OmniPod technology could be easily adapted to […]
Mylan clarifies $104 profit on $600 EpiPens
Mylan (NSDQ:MYL) acknowledged that the $104 profit it reported to Congress included taxes, after the Wall Street Journal reported that the company applied the statutory U.S. tax rate of 37.5% to calculate its profits for testimony before the Senate, according to Reuters. “Without the tax-related reduction, Mylan’s profits on the EpiPen 2-pack would be closer […]
