Shares in Novo Nordisk (NYSE:NVO) were up 2% this morning after the European Medicines Agency’s Committee for Medicinal Products for Human Use backed the company’s application for a label update to its Tresiba insulin injection. The company submitted an application in November to add data from 2 studies to the medication’s label. The final ruling is expected […]
Regulatory/Compliance
Abbott divests 60% of its stake in Mylan
Abbott (NYSE:ABT) divested 60% of its remaining stake in Mylan (NSDQ:MYL) this week, according to regulatory filings, disposing of 44 million shares at $41.60 apiece. The trade was valued at $1.7 billion. In 2014, Mylan bought Abbott’s generics business outside the U.S. in a deal that rang in at nearly $5.3 billion. The deal allowed Canonsburg, Penn.-based Mylan […]
Gamida Cell wins additional EMA orphan drug designation for NiCord
Gamida Cell said today that the European Medicines Agency granted its NiCord cell graft an additional orphan drug designation as a treatment for hematopoietic stem cell transplantation, or bone marrow transplantation. The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the […]
Mylan recalls 81,000 EpiPens over reports of device failure
Mylan (NSDQ:MYL) recalled 81,000 EpiPen emergency allergy auto-injectors this week after receiving 2 reports that the device failed to work in emergencies. The recall affects devices in Australia, New Zealand, Europe and Japan, the company reported. Canonsburg, Penn.-based Mylan said that in both cases, patients received treatment using an alternate EpiPen. The drugmaker also said that it […]
Medical device firms have little understanding of European MDR, IVDR
By Stewart Eisenhart, Emergo Group Many medical device companies have yet to fully absorb the ramifications of the new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) for their compliance efforts, according to Emergo’s 2017 Global Medical Device Industry Outlook. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
Malaysia plans to ratify ASEAN Medical Device Directive
By Stewart Eisenhart, Emergo Group Malaysia’s medical device market regulatory agency has provided updates on various fronts at a recent seminar attended by Emergo consultants. 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 DrugDeliveryBusiness.com or […]
Opthea gets positive feedback from European regulatory groups for wet AMD injection
Opthea (ASX:OPT) said today that it received positive feedback from meetings with the U.K.’s Medicines and Healthcare Products Regulatory Agency and Sweden’s Medical Products Agency over its OPT-302 therapy for the treatment of wet age-related macular degeneration. The Australia-based company’s OPT-302 therapy consists of a soluble form of vascular endothelial growth factor receptor 3 that […]
FDA proposes exempting 337 Class II devices from 510(k) requirements
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016. Get the full story here at the Emergo Group’s blog. The […]
No management support is common QMS audit problem
By Stewart Eisenhart, Emergo Group Undergoing an audit from a third party or conducting your own inspection of your medical device quality management system (QMS) can be a complex process with many moving parts—any of which can go wrong if not carefully monitored. Over a series of blog posts, we’ll discuss various common problems that […]
Study: Streamlined regulatory pathway has not shortened approval times for drugs
A study published by the Tufts Center for the Study of Drug Development found that the streamlined 505(b)(2) approval process for new drug applications in the U.S. has not led to shorter approval times. The 505(b)(2) pathway allows drug developers to seek FDA approval using safety and effectiveness data that was previously collected for a […]
