The clinical trials system is “broken,” according to the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock. The system needs new clinical trial networks and the adoption of master protocols – protocols for trials that focus on multiple therapies for a single disease or a single treatment that could apply to […]
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5 DeviceTalks Boston exhibitors you should know
DeviceTalks Boston is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies. The event is hosted by MassDevice. Those who attend the event can expect to network with other medtech enthusiasts, attend in-depth interviews with leaders in the industry and panel discussions about medical devices and […]
Delcath deal with investors raises $500k, clears path for reverse split
Delcath Systems (NSDQ:DCTH) and a group of investors made an end run around the company’s shareholders with a deal that paves the way for the reverse split that stockowners have twice shot down. “Together with our Board of Directors, we are taking these actions in the best interests of all shareholders. Regaining access to equity capital […]
Nestle plans to slash headcount at Galderma R&D center
(Reuters) – Nestle plans to cut up to 450 jobs at a Galderma research and development center in southern France, the Swiss company said on Thursday, as it seeks to make the underperforming skin health business more efficient. Galderma, which Nestle took over from its joint venture partner L’Oreal in 2014, will cut as many as […]
Steroid inhalers linked with hard-to-treat infections in COPD, asthma patients
A study that included more than 400,ooo people with COPD or asthma found that older people who use steroid inhalers for their condition are more likely to suffer lung infections caused by nontuberculous mycobacteria. The study was published in the European Respiratory Journal. “These infections are not particularly common but they are chronic and difficult to […]
Nemaura Medical touts interim data from next-gen SugarBeat trials
Nemaura Medical touted interim data today from the European clinical trial program evaluating its wireless, adhesive skin-patch for use as a non-invasive and needle-free glucose monitoring system. The clinical trial program enrolled 75 patients, who continuously wore the 2nd-gen SugarBeat device for up to 14 hours per day over the course of seven days in […]
Convenience, compliance & control: How Insulet is changing insulin delivery tech
Shacey Petrovic spent nearly a decade trying to convince her diabetic father to switch to an insulin pump, rather than inject himself multiple times each day. But he was wary of the tubing and other challenges that come with constantly wearing a pump. So when Petrovic was tapped to serve as chief commercial officer at Insulet (NSDQ:PODD) in […]
Graybug Vision launches trial for injectable, depot formulation of wet AMD drug
Graybug Vision said yesterday that it launched the first clinical trial of its lead product, GB-102, in patients with wet age-related macular degeneration. The two-part study is slated to evaluate patients being treated with available intravitreal anti-VEGF agents who are later switched over to just GB-102. The first part of the study will evaluate up […]
OptiNose registers $100m IPO
OptiNose has registered a $100 million initial public offering with the SEC to list its common stock on the Nasdaq market, according to a regulatory filing. The Yardley, Penn.-based company posted a net loss of -$16.3 million in the six months ended June 30, 2017 – down from a $34.3 million net profit during the […]
DarioHealth joins Philips-backed accelerator for development of diabetes management tech
DarioHealth (NSDQ:DRIO) said today that it inked a strategic collaboration with Philips (NYSE:PHG)-backed accelerator, HighTechXL. The Netherlands-based program chose DarioHealth “because of its strong management team, innovative business model and smart solutions for diabetes management,” the company said. The three-month program is designed to accelerate startups into the next stage of development. Collaborating with HighTechXL could help […]