Vectura said this week that it has settled a U.S. patent infringement litigation with GlaxoSmithKline and was awarded $89.7 million in damages. Following a jury trial in the U.S. District Court for the District of Delaware, Ventura was awarded damages for the period from August 2016 through December 2018 for an infringement on Vectura’s U.S. […]
Dance Biopharm Holdings raises $20.5M in private investment financing round
Privately-held Dance Biopharm said yesterday that it has completed a private equity financing round to secure about $20.5 million in gross proceeds. The financing round was insider-only with a number of institutional and individual accredited investors participating. Molex Ventures made a substantial equity investment in Dance Biopharm, according to the company. Molex has been involved in […]
Regulatory updates from Brazil ANVISA
By Stewart Eisenhart, Emergo Group Brazilian medical device regulators are currently working to streamline and modernize market access via initiatives such as a new notification pathway for lower-risk devices, ongoing participation in the Medical Device Single Audit Program (MDSAP) and implementation of Unique Device Identification (UDI) requirements. Below, we’ve compiled several important Brazilian market and […]
Insulet cuts ribbon on new global headquarters
Insulet (NSDQ:PODD) hosted a ribbon cutting ceremony today to open its new global headquarters and manufacturing facility in Acton, Mass. The new facility is part of a $200 million investment in Massachusetts and is located on 26 acres of land. The site’s groundbreaking ceremony took place a year and a half ago and the investment has created […]
Latest Brexit extension raises more questions for U.K. and European medical device industries
By Stewart Eisenhart, Emergo Group The British government has asked for – and the EU Member States unanimously agreed to– a further extension of the article 50 procedure, by which a Member State can leave the EU in two years’ time. The previous date had been set at March 29th, then it was extended until […]
Japan regulators extend MDSAP participation
By Stewart Eisenhart, Emergo Group The Japanese Ministry of Health, Labour and Welfare (MHLW) is extending the country’s participation in the Medical Device Single Audit Program through early 2020. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
New MDCG guidance on timelines and legacy device in Eudamed
By Ronald Boumans, Emergo Group New guidance from European regulators addresses data entry timelines for the Eudamed medical device database, as well as how to develop and assign Unique Device Identification (UDI) data for “legacy devices.” Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Satsuma raises $62 million for nasal drug delivery tech
Satsuma Pharmaceuticals has raised $62 million in a Series B preferred stock financing, led by Wellington Management. Other investors included RA Capital Management, TPG Biotech and Shin Nippon Biomedical. Osage University Partners, CAM Capital, Surveyor, Eventide Asset Management, Cormorant, Lumira Ventures and SBI Investment were new investors. Satsuma is working on a nasal powder version […]
Orchestra BioMed receives FDA Breakthrough Device designation for Virtue Sirolimus-Eluting Balloon
Orchestra BioMed recently announced that its Virtue Sirolimus-Eluting Balloon has received Breakthrough Device destination from the FDA. The Breakthrough Designation is granted to medical devices and device-led combination products that can provide a more effective treatment of life-threatening or other debilitating diseases. It allows for medical devices to be expedited in their development, assessment and […]
Alvogen recalls fentanyl patches over 3M labeling error
Alvogen announced that it is voluntarily recalling two of its Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level because of a labeling issue. The company says that a small number of cartons that were labeled as 12 mcg/h Fentanyl Transdermal System patches actually had 50 mcg/h patches. The 50 mcg/h patches in […]