Mylan, Momenta take aim at Regeneron’s Eylea with biosimilar

From Medical Design & Outsourcing

• Malaysian regulators extend moratorium to summer 2018 for qualifying medical device registrants
  By Stewart Eisenhart, Emergo Group The Medical Device Authority (MDA), Malaysia’s medical device regulator, will extend a moratorium for companies that have registered for market access but not yet received approval so that they may continue selling in the country as their premarket reviews proceed. Get the full story here at the Emergo Group’s blog. […]
• Medical device companies need to worry more about liability: Here’s why
  Mike Drues has a piece of advice he likes to repeat to clients of his medical device regulatory consulting business: Don’t fear FDA; fear the product liability attorneys. “You should fear the product liability attorneys because they could impose a heck of a lot more damage on a company than the FDA ever could. And by […]
• Why innovation isn’t the key for treating stroke
  Technology and innovation are not the most important things we can do for stroke, according to Stacey Pugh, VP and general manager of the neurovascular unit at Medtronic. The most important thing that could happen for stroke is passing proper legislation about taking patients in emergency situations to comprehensive stroke centers for proper treatment, Pugh […]
• These lab-grown blood vessel replacements could benefit dialysis patients
  University of Minnesota researchers have developed a blood vessel replacement made of biological materials in a lab. The lab-grown vessels have no living cells at implantation and could be used as a graft for kidney dialysis patients. The lab-engineered blood vessel replacement is the first non synthetic, decellularized graft that is repopulated with cells using […]
• Medical Device Excise Tax set to return early this year
  By Stewart Eisenhart, Emergo Group Despite multi-year efforts to fully repeal the Medical Device Excise Tax (MDET) on device sales in the US, the tax appears set to come back into force in early 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
• Webinar: The top medtech stories of 2017 – Jan. 30
  Tuesday, January 30, 2018 2:00pm ET / 11:00 PT     The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. MDO’s managing editor Chris Newmarker will […]
• Report slams European Union’s high-risk medical device approvals rate
  A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. The authors looked at 1,376 health technology assessment (HTA) reports filed between 2010 and 2015. […]
• Victrex opens $13 million Polymer Innovation Center
  Victrex recently announced that it has opened its new $13 million Polymer Innovation Center in Thornton Cleveleys, U.K. to help accelerate innovation. Victrex currently makes high-performance polyaryletherketone (PAEK) as well as selected parts for gears and dental discs. In hopes of developing next-generation thermoplastic solutions, the new facility is fully-operational and is dedicated to research […]
• Medical device startups: Here’s how you successfully plan
  The development of the product development plan is an evolutionary effort that continues through the life of the medical device project. Bill Betten, Betten Systems Solutions, and Tom Waddell, Waddell Group This is the second in a series of articles that will discuss the design of innovative products in the highly regulated medical environment.  The […]
• FDA refines least burdensome guidance for medical device oversight
  Stewart Eisenhart, Emergo Group Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market 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 do not necessarily reflect those of MedicalDesignandOutsourcing.com […]
• The medical device tax is back in effect
  The ringing in of the new year also rang in the return of the medical device tax, a 2.3% levy on medtech sales that went back into effect after a two-year pause. The U.S. Congress closed out 2017 without taking action to delay or repeal the medtech tax, despite broad support from both sides of the […]