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Sean Whooley

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

Haselmeier licenses Axis-D pen injector to Stevanato Group

October 7, 2019 By Sean Whooley

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 […]

Filed Under: Auto-injectors, Diabetes, Featured, Mergers & Acquisitions Tagged With: haselmeier, Stevanato Group

Intersect ENT’s Ascend study misses endpoint

October 7, 2019 By Sean Whooley

Intersect ENT updated

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Otolaryngology Ear, Nose & Throat Tagged With: Intersect ENT Inc., SVB Leerink

GSK seeks additional asthma indication for Trelegy Ellipta

October 3, 2019 By Sean Whooley

GlaxoSmithKline, Innoviva, 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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: GlaxoSmithKline plc, Innoviva

Frequency Therapeutics prices $84m IPO

October 3, 2019 By Sean Whooley

Frequency Therapeutics updated logo

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 […]

Filed Under: Featured, Funding Roundup, Initial Public Offering (IPO), Otolaryngology Ear, Nose & Throat, Wall Street Beat Tagged With: Frequency Therapeutics

Boehringer Ingelheim touts Spiolto Respimat inhaler data

October 2, 2019 By Sean Whooley

Boehringer Ingelheim

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 […]

Filed Under: Clinical Trials, Respiratory Tagged With: Boehringer Ingelheim Pharmaceuticals

LifeScan inks deal to broker institutional sales for OneTouch Reveal Plus

October 2, 2019 By Sean Whooley

LifeScan OneTouch app

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 […]

Filed Under: Diabetes, Featured, Mergers & Acquisitions, Patient Monitoring Tagged With: lifescan, welldoc

Philips touts Stellarex balloon study

October 1, 2019 By Sean Whooley

philips-stellarex-low-dose-drug-coated-balloon

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured Tagged With: Royal Philips

Convexity Scientific raises $4m Series B for Flyp nebulizer

September 27, 2019 By Sean Whooley

Flyp

Convexity Scientific said yesterday that it closed a Series B financing round worth nearly $4 million ahead of the launch of its Flyp nebulizer. Fairfield, Conn.-based Convexity’s funding was led by HighCape Capital with participation from Connecticut Innovations, Benslie International and Stonehenge Capital, according to a news release. The company said the funding is earmarked […]

Filed Under: Drug-Device Combinations, Funding Roundup, Respiratory Tagged With: convexityscientific

Nemaura, Sparsha ink drug-delivery deal

September 27, 2019 By Sean Whooley

Nemaura Pharma said today that it entered into a strategic collaboration with Sparsha Pharma USA for the development and manufacturing of transdermal drug delivery systems. The terms of the agreement state that Loughborough, England-based Nemaura will develop transdermal therapeutic systems at its facilities in the U.K., up to pilot clinical manufacture, for both global pharmaceutical […]

Filed Under: Drug-Device Combinations, Featured, Mergers & Acquisitions Tagged With: Nemaura Pharma, Sparsha Pharma

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