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 […]
Regulatory/Compliance
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 […]
New clinical guidelines for medical devices from Australian TGA
By Stewart Eisenhart, Emergo Group Medical device regulators at the Australian Therapeutic Goods Administration (TGA) have published new guidelines explaining what constitutes acceptable clinical evidence for medical device and IVD manufacturers. 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 […]
New medical device rules change India’s Authorized Agent role
By Stewart Eisenhart, Emergo Group The role of in-country representatives for medical device manufacturers registered in India will change substantially under the country’s new Medical Device Rules published earlier in 2017. 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 […]
EU regulators: We should suspend drugs at suspect Indian facility
This week, the European Medicines Agency recommended the suspension of more than 300 generic drug approvals and applications, after they uncovered “unreliable” tests conducted by Micro Therapeutic Research Labs. The India-based contract research firm is part of the country’s drug-testing industry, which has faced problems with international regulators in recent years. European officials have reportedly […]
CMS updates on criteria for Dexcom G5 coverage
Shares in DexCom Inc. (NSDQ:DXCM) jumped 9% today after the Centers for Medicare & Medicaid Services updated the criteria for coverage of the company’s G5 Mobile continuous glucose monitor. The device is the only therapeutic CGM classified as durable medical equipment under Medicare Part B. Patients covered by Medicare who have Type I or II diabetes and […]
