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 […]
BioCardia wins CE Mark renewal for Helix, Morph catheters
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 […]
Walmart brings One Drop wireless glucose meter kit to stores
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 […]
Haselmeier licenses Axis-D pen injector to Stevanato Group
Haselmeier said today that it entered into an exclusive agreement with Stevanato Group to license the Axis-D pen injector and intellectual property for the development, manufacturing and supply of the device for diabetes care. Haselmeier’s Axis-D auto-injector pen is approved for use by the European Medical Agency and the FDA, among other regulatory bodies. The […]
Intersect ENT’s Ascend study misses endpoint
Intersect ENT (NSDQ:XENT) shares plunged today after the company said it failed to meet the primary endpoint in a study of its Ascend investigational drug-coated sinus balloon. The 70-person, randomized, double-blind trial was designed to compared treatment with Intersect ENT’s DCB when randomized against an uncoated balloon control. The study missed the primary endpoint, frontal sinus […]
GSK seeks additional asthma indication for Trelegy Ellipta
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said yesterday that they filed a supplemental New Drug Application with the FDA, seeking an additional indication for GSK’s Trelegy Ellipta inhaler for the treatment of asthma in adults. The once-daily, single-inhaler triple-therapy device received FDA approval for the treatment of chronic obstructive pulmonary disease in September 2017. Trelegy Ellipta has not […]
Frequency Therapeutics prices $84m IPO
Frequency Therapeutics said yesterday that it priced its initial public offering at roughly $84 million. The 6-million-share offering priced at $14 per share and includes a 30-day underwriters option on another 900,000 shares that’s worth $12.6 million, the Woburn, Mass.-based company said. Frequency said it expected to begin trading the shares on the NASDAQ exchange […]
Boehringer Ingelheim touts Spiolto Respimat inhaler data
Boehringer Ingelheim said yesterday that results from a study of its Spiolto Respimat inhaler showed benefits including improving symptoms and lung function in treating chronic obstructive pulmonary disease. The Spiolto Respimat is a soft-mist inhaler designed for the treatment of airflow obstruction in patients with COPD. A pooled analysis exploring COPD treatment with the tiotropium-based […]
LifeScan inks deal to broker institutional sales for OneTouch Reveal Plus
LifeScan said yesterday that it entered into an agreement with Willis Towers Watson to expand the commercialization of its OneTouch Reveal Plus digital diabetes therapy system. The companies hope the collaboration will see LifeScan and Willis Towers Watson combine to support self-insured employers in helping their employees and dependents manage diabetes. The OneTouch Reveal Plus […]
Philips touts Stellarex balloon study
Royal Philips (NYSE:PHG) said today that third-party data from worldwide clinical trials for the Stellarex drug-coated balloon showed that there was no difference in mortality between patients treated with the device compared to uncoated percutaneous transluminal angioplasty. The primary analysis consisted of three-year patient-level data from the Illumenate pivotal trial and the Illumenate European randomized controlled […]
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