The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled yesterday that the claims of United Therapeutics‘s (NSDQ:UTHR) patent, which covers Remodulin, are unpatenable due to obviousness. SteadyMed (NSDQ:STDY) challenged the patent in October last year. The patent, No. 8,497,393, relates to the process to purify prostacyclin derivatives, including treprostinil, which is […]
Regulatory/Compliance
Reva Medical wins CE Mark for Fantom bioresorbable scaffold
Reva Medical (ASX:RVA) said yesterday that it won CE Mark approval in the European Union for its Fantom sirolimus-eluting bioresorbable coronary scaffold. The Fantom scaffold is the San Diego, Calif.-based company’s 1st commercial product. Reva said it plans to begin selling the product in Europe this quarter. “CE Mark approval for Fantom is a major milestone for […]
Russian technical file requirements for medical devices and IVDs clarified by regulators
By Stewart Eisenhart, Emergo Group The Russian Ministry of Health has issued a new regulation to explain longstanding but unofficial technical file and instructions for use requirements for medical device and IVD registrants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Medtech stories we missed this week: March 31, 2017
This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press release that robot-assisted […]
RenovoRx wins label expansion for RenovoCath device
RenovoRx said yesterday that it won label expansion for the RenovoCath dual-balloon infusion catheter to include the delivery of chemotherapeutics. The device isolates segments of the peripheral vasculature, allowing doctors to deliver therapeutics in a more targeted fashion, according to the Los Altos, Calif.-based company. “This additional FDA indication marks yet another milestone for RenovoRx as […]
Samsung Biologics slides on South Korean regulatory probe
News that Samsung Biologics (KRX:207940) is facing a probe by South Korean regulators over its valuation ahead of an initial public offering last year sent its share price down this week in Seoul. South Korea’s Financial Supervisory Service is running a special audit of the drugs contract manufacturer, prompted by a Korean Institute of Certified Public Accountants review that […]
Aura Biosciences wins fast track designation for light-activated nanoparticle therapy
Aura Biosciences said today that it enrolled and dosed the 1st patient in the Phase Ib trial of its light-activated AU-011 viral nanoparticle conjugate therapy for the treatment of ocular melanoma. The company also said that the FDA granted fast track designation to its targeted treatment, which will give priority review for the company’s New Drug […]
Acorda plans NDA for inhaled Parkinson’s drug after touting long-term safety data
Acorda Therapeutics (NSDQ:ACOR) touted data from 2 ongoing, long-term safety studies of its inhaled Parkinson’s therapy. The trials showed no difference in pulmonary function between the group receiving CVT-301, the inhaled formulation of Parkinson’s drug levodopa, and the control group. The investigational drug is being studied as a therapy for people with Parkinson’s disease experiencing “off” […]
Mylan shares down -3% after FDA rejects Advair generic
Shares in Mylan (NSDQ:MYL) dropped -3% to $40.46 apiece today after the FDA rejected its Abbreviated New Drug Application for the generic version of GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus. The Canonsburg, Penn.-based company said it is “in the process of reviewing this response and will provide an update on its application as soon as practicable once it has […]
Trump FDA pick to recuse himself from agency decisions involving 20 companies
Donald Trump’s nominee to head the FDA, Dr. Scott Gottlieb, reportedly told ethics officials at the Office of Government Ethics he plans to recuse himself for 1 year from agency decisions on more than 20 companies, including GlaxoSmithKline (NYSE:GSK) and Bristol-Myers Squibb (NYSE:BMY). Gottlieb has received millions of dollars for his roles as advisor, paid speaker […]
