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Sean Whooley

Novartis unit spikes Pear Therapeutics deal

October 17, 2019 By Sean Whooley

Pear Therapeutics

Novartis (NYSE:NVS) unit Sandoz said this week that Pear Therapeutics will take sole responsibility for the commercialization of their prescription digital therapeutics program for treating substance and opioid use disorders. In April 2018, Pear announced that it agreed to deal commercialization rights of its digital therapeutics to Sandoz. The companies did not disclose financial details, but […]

Filed Under: Business/Financial News, Featured, Pharmaceuticals Tagged With: Novartis, peartherapeutics, sandoz

NIH study: Tandem Diabetes artificial pancreas bests other treatments

October 17, 2019 By Sean Whooley

Tandem Diabetes Care - updated logo

A pivotal trial funded by the National Institutes of Health found that an artificial pancreas system from Tandem Diabetes Care (NSDQ:TNDM) was more effective than existing treatments for people with Type 1 diabetes. The Tandem system combines its t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology with a continuous glucose monitor made by DXCM, […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured Tagged With: National Institutes of Health, Tandem Diabetes Care

Gates Foundation backs Credence MedSystem’s drug-delivery device

October 17, 2019 By Sean Whooley

Credence MedSystems said yesterday that it won a grant from the Bill & Melinda Gates Foundation for the development of its Companion dual-chamber reconstitution syringe for use in developing nations. The development project is meant to advance the safety of the Companion device for drug and vaccine products, which include storing drugs in dried form […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured Tagged With: Credence MedSystems

Senseonics touts Eversense reimbursement win

October 16, 2019 By Sean Whooley

eversense-logo

Senseonics (NYSE:SENS) said this week that Health Care Service Corporation – Blue Cross Blue Shield is providing coverage for the Eversense continuous glucose monitoring system, effective as of yesterday. HCSC – Blue Cross Blue Shield is the fourth-largest health insurer in the U.S. and serves more than 16 million members, according to a news release. Last […]

Filed Under: Business/Financial News, Diabetes, Featured Tagged With: Reimbursement, Senseonics

FDA approves Philips’ low-dose Stellarex balloons

October 15, 2019 By Sean Whooley

philips-logo

Royal Philips (NYSE:PHG) said today that two of the company’s new Stellarex drug-coated balloons received FDA approval for the treatment of upper leg artery blockages. The approval was for both de novo and restenotic lesions in upper leg arteries. The Amsterdam-based company said the new low-dose (200 mm and 150 mm) balloons will be added to […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA, Royal Philips

Intarcia Therapeutics takes another run at FDA approval

October 15, 2019 By Sean Whooley

Intarcia Therapeutics

Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants Tagged With: FDA, Intarcia Therapeutics

Abbott inks inks diabetes tech partnerships with Tandem Diabetes, Omada Health

October 15, 2019 By Sean Whooley

Abbott logo updated

Abbott (NYSE:ABT) said today that it has entered into an agreement with Tandem Diabetes Care (NSDQ:TNDM) to combine the former’s glucose-sensing technology with the latter’s insulin delivery systems. The news comes one day after Abbott announced a partnership with Omada Health to pair Abbott’s FreeStyle Libre continuous glucose monitoring system with Omada’s digital care program. Tandem designed its […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured Tagged With: abbott, Omada Health, Tandem Diabetes Care

OcuMedic, Gelest ink drug-delivering contact lens deal

October 9, 2019 By Sean Whooley

OcuMedic said today that it entered into an exclusive supply agreement and picked up a strategic investment from Gelest for its proprietary drug-eluting soft contact lens of an undisclosed amount. Under the terms of the agreement, Morrisville, Pa.-based Gelest is set to manufacture and supply OcuMedic’s key chemistry components used in the controlled release of […]

Filed Under: Drug-Device Combinations, Featured, Funding Roundup, Optical/Ophthalmic Tagged With: Gelest, OcuMedic

BioCardia wins CE Mark renewal for Helix, Morph catheters

October 9, 2019 By Sean Whooley

BioCardia

BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]

Filed Under: Cardiovascular, Featured, Regenerative Medicine, Regulatory/Compliance Tagged With: BioCardia

Walmart brings One Drop wireless glucose meter kit to stores

October 9, 2019 By Sean Whooley

One Drop

One Drop said yesterday that its wireless glucose meter kit and supplies are now available at hundreds of Walmart stores in the U.S. The kits for sale at the retail store include a Bluetooth glucose meter, lancing device, carry case, test strips and lancets, along with a year of free access to One Drop’s certified […]

Filed Under: Business/Financial News, Diabetes, Featured Tagged With: One Drop

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