Global Regulatory & Consumer Insights (GR-CIS) a leading Regulatory service provider announced that it has been selected as the strategic partner by Bioplus Life Sciences, a global biopharmaceutical company, to provide clinical development and regulatory services worldwide. GR-CIS will work…
Phillips-Medisize to manufacture drug and device combination wearable
The product is stated to be in post-phase three development-stage and combines two-day, single use, disposable technology for subcutaneous drug delivery. The wearable needs to be replaced every two days and can be worn using an adhesive patch or near…
Medtech player to commercialise device for mental health illnesses
Australian medtech company NeuralDx is set to progress the commercialisation of its EVestG device, which supports clinical diagnosis of psychiatric and neurological disorders. The EVestG device enables clinicians to diagnose such disorders via digital biomarkers – a quick, painless, convenient…
Fresenius gets breakthrough tag for clot-preventing dialysis device
Dive Brief: Fresenius Medical Care received FDA’s breakthrough device designation for a new hemodialysis system, the company said Thursday. The system features a polymer called Endexo designed to cut the risk of clotting, thereby reducing the need for physicians to…
Medtronic developing fully implanted LVAD with FDA breakthrough support
Dive Brief: Medtronic received FDA’s breakthrough device designation for a new implantable heart pump it is developing to treat patients with advanced heart failure, the company announced Tuesday. The left ventricular assist device (LVAD) in development would be fully implanted without…
FDA puts J&J’s Ethicon surgical stapler recall in top risk category
Dive Brief: FDA has categorized Johnson & Johnson unit Ethicon’s recall of its Echelon Flex Endopath staplers as a Class I event, the agency saidWednesday. The agency put the recall of 8,256 devices in its highest-risk category after concluding the fault…
The Roivant-Sumitomo Deal: $3 Billion, 5 Companies, $550 Million in Loans and an Option on 6 More Companies
In September, Roivant Sciences, Vivek Ramaswamy’s umbrella biotech company, agreed to sell ownership of five of its Vant companies to Japan’s Sumitomo Dainippon Pharma for $3 billion. Sumitomo Dainippon also was buying an equity stake of more than 10% of…
TrialScope Acquires Clinical Trial Connect
TrialScope has acquired Clinical Trial Connect, a platform used by disease foundations and advocacy groups that connects their community members to relevant clinical trials. As part of the acquisition, founder Mike Wenger will share his technological expertise as part of…
Oracle Health Sciences and Phlexglobal Collaborate
Oracle Health Sciences, Clinical technology provider and Phlexglobal, provider of Trial Master File (TMF) technology and services for the global life sciences industry, have announced enhanced integrations designed to speed and accuracy of regulatory compliance and inspection readiness in clinical…
Veeva Survey Finds CROs Undergoing Major Changes
Contract research organizations (CROs) are making significant progress in advancing the industrywide move to improve clinical trial performance, according to the Veeva 2019 Unified Clinical Operations Survey: Annual CRO Report. The findings from Veeva Systems reveal that CROs are eliminating…
