EU Medical Devices Regulation Upcoming Release November 18, 2016 EU Commission finalizes medical device regulation. Read More
Teva Earmarks $520 Million to Resolve Overseas Bribery Charges November 18, 2016 Advanced discussions prompted the company to set aside the funds to resolve claims. Read More
Seattle Genetics Nabs FDA Breakthrough Therapy Designation for Adcetris November 17, 2016 The decision was based on data from the Phase III Alcanza clinical trial. Read More
Genedrive Gains CE-IVD Certification for Human Genotyping Test November 17, 2016 The device performs a 50-minute test with an inner-cheek swab sample. Read More
CHMP Gives Nod to 9 Drugs November 16, 2016 Among the drugs earning CHMP’s recommendation are two diabetes therapies. Read More
Ignyta Gains EAP Designation and CE Marking for its Trailblaze Pharos Assay November 15, 2016 The assay is used as an aid in selecting patients with solid tumors that harbor certain gene rearrangements. Read More
HHS Issues IG Agenda for Fiscal 2017 November 15, 2016 The office will continue its examination of industry compliance with the Drug Supply Chain Security Act. Read More
InspireMD Gains Commercialization Approval in Russia for CGuard November 14, 2016 The device is designed to prevent peri-procedural and late embolization. Read More
Innocoll Says Diabetes Infection Treatment Missed Endpoints November 14, 2016 Drug candidate did not confer sufficient additional clinical benefit over the placebo. Read More
Concert Medical Issues Recall Due to Galeo Pro Guidewire Coating Malfunctions November 11, 2016 The coating separation could lead to blood clots. Read More
Amendments Made to Citizen’s Petitions to Fight ANDA Delays November 11, 2016 All submitters of a petition or (stay of action) should include with their submission a verbatim certification statement. Read More
Health Canada Issues New Guide on Device Recalls; No Substantive Changes November 10, 2016 The revised guide has improved the graphic display of information it contains. Read More