After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec). Re-examination of the file led to a happier outcome for another drug that has attracted considerable controversy, Eli Lilly and Co. Inc.’s Kisunla (donanemab) for treating the early stages of Alzheimer’s disease.

Roche Holding AG received CE mark for its Elecsys pTau181 test to help rule out Alzheimer’s disease. The minimally invasive blood test, developed in collaboration with Eli Lilly and Co., measures phosphorylated Tau 181 protein, a biomarker indicative of amyloid pathology, a hallmark of Alzheimer’s.

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.