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Sean Whooley

Enable Injections inks deal with Genentech

August 22, 2019 By Sean Whooley

Enable Injections

Enable Injections said yesterday that it entered a developmental partnership with Genentech for the Enable enFuse device. Cincinnati-based Enable’s enFuse is an on-body drug delivery platform containing a drug transfer system compatible with syringes and vial containers. Currently, the enFuse is being developed for subcutaneous delivery of large volumes potentially rising to 50 mL. The […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Enable Injections, Genentech

FDA wants more on new manufacturing process from Clearside Biomedical

August 22, 2019 By Sean Whooley

Clearside Biomedical logo - updated

Clearside Biomedical (NSDQ:CLSD) said today that the FDA ordered the company to provide stability data on its new manufacturing process for triamcinolone acetonide suspension, pushing the timeline on the agency’s decision into next year. Alpharetta, Ga.-based Clearside’s Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. Clearside said […]

Filed Under: Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Clearside Biomedical

Baxter foundation, Direct Relief ink diabetes pact

August 21, 2019 By Sean Whooley

Baxter

Baxter (NYSE:BAX) and Direct Relief announced today that they are launching a three-year program awarding funding to health centers and free and charitable clinics that are working to improve diabetes outcomes for patients. The program, Transformative Innovation Awards for Community Health: Incorporating Nutrition to Improve Diabetes Health Outcomes, will award $750,000 to the centers and […]

Filed Under: Diabetes, Featured Tagged With: Baxter International, Direct Relief

Adherium inks digital health deal with Summatix

August 21, 2019 By Sean Whooley

adherium

Adherium (ASX:ADR) announced a data-based initiative with Summatix to allow clinicians to improve care of patients with asthma and chronic obstructive pulmonary disease across the world. New Zealand-based Adherium and Australia-based Summatix plan to build upon an existing relationship, as the former will gain access to Summatix’s platform to release data from its Hailie sensors […]

Filed Under: Featured, Mergers & Acquisitions, mHealth (Mobile Health), Respiratory Tagged With: Adherium, Summatix

Teva launches generic EpiPen Jr.

August 20, 2019 By Sean Whooley

Teva Pharmaceutical logo - updated

Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available in the U.S. The device wholesales to most retail pharmacies in packs of two for $300, or $150 per pen. Teva’s product is less than half the cost of Mylan’s non-generic EpiPen Jr., which lists at $643.89 per two-pack at Drugs.com. ”We’re […]

Filed Under: Auto-injectors, Featured, Pediatrics, Pharmaceuticals Tagged With: Mylan, Teva Pharmaceuticals

Medtronic wins FDA approval for new extended-wear infusion set

August 16, 2019 By Sean Whooley

Medtronic logo updated

Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set. The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more than twice the amount of time any infusion set can currently […]

Filed Under: Clinical Trials, Diabetes, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Medtronic

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