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 […]
Convexity Scientific raises $4m Series B for Flyp nebulizer
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 […]
Nemaura, Sparsha ink drug-delivery deal
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 […]
Cook Regentec spinout Sexton Biotechnologies raises $5m
Cook Regentec spinout Sexton Biotechnologies said today that it raised $5 million for the cell and gene therapy bioproduction tools it’s developing. The company is Cook’s first to pick up outside investment capital and spin out as an independent biotechnology company, according to a news release. Sexton is made up of a 17-person team from Cook […]
FDA clears Insulet’s OmniPod Dash as insulin pump alternative
Insulet (NSDQ:PODD) said today that it won FDA clearance to market its Omnipod Dash alternate controller-enabled (ACE) infusion pump as an integrated insulin pump. The Acton, Mass.-based company received FDA 510(k) clearance for the Omnipod Dash in June 2018 and launched the device earlier this year. The latest indication states that the pump can reliably and […]
