The FDA has approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. Teva, Eli Lilly, and Amgen/Novartis already have calcitonin gene-related peptide (CGRP) class migraine drugs on the market, but…
Eye scan device to identify autism developed
The non-invasive eye scan utilises the device to find a pattern of subtle electrical signals in the retina that are different in children on the autism spectrum, which are directly linked to differences in their brain development. The scan was…
Can flexible batteries revolutionise power in medical devices?
Ian Bolland asks EJ Shin, Jenax and Andy Baker, HP1 Technologies, about the effect flexible batteries could have on medical devices. This interview followed a webinar on how flexible batteries can be used in the manufacturing process, ‘creating product innovation…
Blood test that detects all cancers to launch in UK
A non-invasive blood test which can detect all cancers at every stage with high accuracy is to launch in the UK. Cancer diagnostics, treatment and prevention experts RMDM has developed PanTum Detect. It can detect any cancer at any stage…
FDA Accepts BioMarin’s Submission for Valrox, a Gene Therapy for Hemophilia A
The U.S. Food and Drug Administration (FDA) agreed to review BioMarin Pharmaceutical’s Biologics License Application (BLA) for valoctocogene roxaparvovec (valrox) for adults with hemophilia A. It was accepted for Priority Review. The target action date is August 21, 2020. Valrox…
Baudax Bio Wins FDA Approval for Anjeso, a Non-Opioid Pain Treatment
Shares of Pennsylvania-based Baudax Bio are up more than 40% in premarket trading after the company announced its pain medication Anjeso was greenlit by the U.S. Food and Drug Administration. Late Thursday, the company said the FDA approved its New…
IBM Watson Health Launches Study Design and Authoring Tool
IBM announced its data-driven tool, IBM Study Advance that optimizes clinical trial protocol design by providing access to real-world patient population data, a collaborative workplace and standardizing protocol template guidance. – IBM Study Advance’s collaborative workspace is designed to allow near…
Audentes to Build $109 Million Gene Therapy Factory in North Carolina
Audentes Therapeutics, an Astellas company, announced it is building a gene therapy manufacturing plant in Sanford, North Carolina. The company is investing $109 million in a new 135,000-square-feet facility, with the initial phase to take place over about 18 months.…
FDA Rejects Merck’s 6-Week Dosing Schedule for Keytruda
It doesn’t happen that often, but Merck’s checkpoint inhibitor Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration (FDA). Six all at once, as a matter of fact. The company had submitted six supplemental Biologics License Applications…
Medtronic insulin pump recall tied to 1 death, more than 2K injuries, FDA says
Dive Brief: A Medtronic insulin pump hardware malfunction that prompted the company to alert certain MiniMed customers late last year has been linked to 26,421 complaints, 2,175 injuries and one death, FDA said in a noticeissued Wednesday. Medtronic warned customers Nov.…
