The EMA has started a review of Amgen Inc.’s Tavneos (avacopan) after questions were raised about the integrity of the data in the Advocate study that the agency assessed when granting approval of the vasculitis treatment in January 2022.

Medtronic plc acted on the increase in M&A and expansion of its investment ecosystem touted at the J.P. Morgan Healthcare Conference earlier this month with a $90 million infusion into Brisbane, Australia-based Anteris Technologies Global Corp. The investment had been contingent on a public offering of stock by Anteris, which it completed on Jan. 22. Together, the new funds for the biomimetic heart valve company totaled $320 million.

Zylox-Tonbridge Medical Technology Co. Ltd. plans to expand globally with M&As, company chairman and CEO Jonathon Zhong Zhao told BioWorld, starting with a stepwise acquisition of Optimed Holding GmbH and its subsidiaries, including Optimed Medizinische Instrumente GmbH.

Following a clinical hold last October of Intellia Therapeutics Inc.’s Magnitude and Magnitude-2 phase III trials of CRISPR/Cas9 gene editing therapy nexiguran ziclumeran (nex-z) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN), respectively, the U.S. FDA lifted the hold on Magnitude-2, pushing the company’s shares up by 22% in early trading Jan. 27.

Acute inflammation is a physiological and host defense response to cardiac injury after suffering myocardial infarction (MI), which programmes cardiac repair and wound healing. Leukocyte-mediated innate inflammatory response is crucial to clear ischemic injury during MI; whilst macrophages produce specialized pro-resolving mediators such as maresin 1, the therapeutic potential of exogenous maresin 1 in cardiac repair is not clear.

Highlife SAS secured CE mark for its transcatheter mitral valve replacement (TMVR) system, bringing a much needed treatment option for patients with limited alternatives. The Highlife TMVR system is indicated for individuals with symptomatic moderate-severe or severe mitral valve regurgitation who are unsuitable for surgical repair or replacement and transcatheter edge-to-edge repair.

The FDA’s Center for Devices and Radiological Health posted two important guidances just in the first week of the new year. The agency seems determined to sustain that pace with a new draft guidance for cuffless blood pressure monitors, apparently in response to sales of unauthorized over-the-counter devices for this indication.

Scientists from the Smidt Heart Institute, Cedars-Sinai Medical Center (Los Angeles, CA, USA) recently explored adeno-associated virus (AAV) vectors carrying the T-box transcription factor 18 (TBX18) transgene to produce a physiologically responsive biological pacemaker activity for the treatment of bradycardia.

Lexicon Pharmaceuticals Inc. announced that it received no objections from the U.S. FDA to move pilavapadin, its non-opioid candidate for diabetic peripheral neuropathic pain, into phase III study, pushing company shares up near 20% on the day.