PureTech subsidiary Gelesis today touted results from a pivotal weight-loss study of its obesity drug, Gelesis100. The study met one of its two primary endpoints, with 58% of adults in the treatment arm experiencing clinically-meaningful weight loss of 5% or more. Nearly twice as many adults lost 10% or more of the body weight in the […]
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Keeping a patient’s lungs clean & expanded after surgery: a Drug Delivery Business News podcast
Every year, more than 1 million patients in the U.S. find themselves suffering from respiratory complications following surgery, according to Hill-Rom (NYSE:HRC). These complications come at a cost – to both the patient and the hospital. A respiratory problem can increase a patient’s time in the hospital by as much as 89%. More people die each […]
Medtech stories we missed this week: Sept. 22, 2017
From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, […]
Grifols wins FDA nod for liquid formulation of replacement therapy for rare genetic disorder
Grifols (NSDQ:GRFS) said today that it won FDA approval for a liquid formulation of its alpha-1 antitrypsin, Prolastin-C Liquid, as a replacement therapy to treat alpha-1 antitrypsin deficiency. Prior to this approval, the company only offered Prolastin-C in a lyophilized format. The new formulation requires less preparation time and volume for infusion, according to Barcelona-based […]
DeviceTalks Boston: Here’s what you need to know
DeviceTalks Boston on Oct 2. will give attendees the chance to see some of the best minds in medtech live. There will be learning and networking opportunities galore. Read on and meet some of the top medical device leaders and experts who will be speaking – and discover other highlights from the upcoming show. Next>> (See […]
Clinical trials system is ‘broken’, FDA’s Woodcock says
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 […]
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 […]