New guidance by the Medical Device Coordination Group spells out many of the routine aspects of compliance with the In Vitro Diagnostic Regulation, but test developers should remain aware of the tripwires in connection with modifications to both the test and the test’s performance studies.
Abivax SA is positioning to change the treatment landscape in ulcerative colitis after delivering positive results and a favorable safety profile in two phase III trials of its orally available miRNA-124 enhancer, obefazimod. Abivax stock rocketed in Europe and the U.S. on news of the data. Shares (Paris:ABVX) rose €45.40, or 510%, to close at €54.30 July 23. In the U.S., shares (NASDAQ:ABVX) leapt 586%, or $58.60, to close at $68.60.
Plexāā Ltd. recently raised $4.5 million to support the upcoming U.S. launch of Bloom43, its wearable device that helps patients prepare for breast cancer surgery and reconstruction by using a technique called supraphysiological preconditioning.
The U.K. Medicines and Healthcare Products Regulatory Agency unveiled another round of measures designed to promote access to the latest medical technology, which includes a move to jettison domestic device markings in favor of unique device identifiers.
Respiratory vaccines specialist Vicebio Ltd. is to be acquired by Sanofi SA in a $1.6 billion deal, of which $1.15 billion will be paid up front. The acquisition rests on an ongoing phase I trial of the lead asset, VXB-241, a bivalent vaccine that is intended to provide protection against both respiratory syncytial virus and metapneumovirus. The interim analysis of the study showed a favorable safety and tolerability profile in adults, ages 60 and older, and validated the underlying vaccine technology, which is applicable to a wide range of respiratory viruses.
Directsens GmbH recently signed a collaboration agreement with Metage, an Austrian research consortium, to advance a test for the early detection of type 2 diabetes. The focus of the partnership will be on validating Directsens’ Xpressgt assay, which measures 2-hydroxybutyrate levels in venous blood, and could be used by clinicians to inform patients they are at risk of developing type 2 diabetes.
After two decades of research elucidating the basic science, Tafalgie Therapeutics SA has delivered the first clinical data for its non-opioid analgesic.
The pharmaceutical industry in Europe has taken the lead in pulling together a coalition of 17 industry groups, academics and clinicians to call for the urgent implementation of the EU Life Science Strategy published earlier this month, in order to rescue the clinical trial ecosystem from “a perilous situation.”
Uromems SAS received investigational device exemption (IDE) approval from the U.S. FDA, and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM), to begin a pivotal trial of its Uroactive smart implant.
The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.
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