Common Sensing said today that it has enlisted design company Flex to help redesign its Gocap insulin pen device. Flex is tasked with finding materials to help extend the product’s battery life, as well as boost measurement accuracy and prepare for high volume manufacturing. Common Sensing’s Gocap device is designed to attach to existing injector pens and […]
Auto-injectors
Manufacturing delays lead to Epipen shortage in U.S.
At least 400 people across the U.S. have had trouble getting their hands on an Epipen in recent weeks, according to a survey from the advocacy group Food Allergy Research & Education. Mylan (NSDQ:MYL), which makes the emergency allergy auto-injector, reportedly told the FDA months ago that manufacturing delays were straining its Epipen supply. Some patients […]
Common Sensing, Haselmeier ink deal to develop connected injection pen
Swiss-based manufacturer Haselmeier inked a deal with Common Sensing to develop a smart, connected drug-delivery device for people who use injectable medications. The companies plan to combine Haselmeier’s subcutaneous injection technology with Common Sensing’s Gocap injector monitor. The product, which will be sold by Haselmeier, will record the time and dose of every injection and […]
Drug delivery needs better human factors
Adopting neuroscience-based human factors methods could yield better outcomes for patients, improved communication design and engineering teams, and maybe even help companies build IP. The methods behind assessing human factors in medtech are outdated—and they’re due for an upgrade, said Charles Mauro CHFP, of Mauro Usability Science. “The type of research employed to determine if […]
Meet the insulin-makers and device companies developing smart insulin pens
The global market for connected insulin pens could be worth up to $123 million by 2023, according to a report published this year by Research & Markets. Insulin pens, designed for people who control their diabetes with multiple daily injections instead of a pump or wearable patch, are portable devices that were first introduced in 1985 with […]
Mylan: Generic competition pushes EpiPen sales down
Mylan (NSDQ:MYL) revealed in its annual report yesterday that EpiPen sales in the U.S. were down $655.4 million last year compared to 2016. The company, which faces continued backlash over the price of its emergency allergy treatment, cited the launch of a generic version of its device, higher governmental rebates and increased competition as reasons for […]
EpiPen shortage in Canada to last until March
Pfizer Canada (NYSE:PFE) has warned Health Canada that there is a shortage of 0.3 mg EpiPen auto-injectors due to a manufacturing disruption. The company, which licenses the emergency allergy treatment from Mylan (NSDQ:MYL), reported that the problem should be resolved by March 2. There are no alternative auto-injectors available on the market in Canada for patients at […]
FDA approves Kaleo’s allergy auto-injector designed for infants
The FDA has approved Kaleo‘s Auvi-Q epinephrine auto-injector designed to treat life-threatening allergic reactions in infants and small children, according to the privately-held biopharma company. The device, which Kaleo touts as the first of its kind, was given priority review by the FDA. The 0.1 mg Auvi-Q auto-injector has a shorter needle and a lower […]
Amgen launches Enbrel Mini single-dose cartridges with reusable auto-injector
Amgen (NSDQ:AMGN) announced today the U.S. launch of its Enbrel Mini single-dose prefilled cartridges, which are delivered using a reusable AutoTouch auto-injector. The drug-device combination was designed with a needle that stays hidden during injection and a sensor to detect placement on the skin. Amgen’s latest product uses a new drug formulation of Enbrel, an injectable […]
EMD Serono wins FDA nod for redesigned pen injector
Merck KGaA‘s biopharma biz, EMD Serono, said today that it won FDA approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector. The device, which was first approved in 2013, is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women. The newly-designed pen was evaluated in a simulated-use study involving […]