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 The agency seems determined to sustain that pace with a new draft guidance for cuffless blood pressure monitors, apparently in response to sales of unauthorized over-the-counter devices for this indication.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.
The economic and societal implications of the underfunding of women’s health finally reached the agenda of the World Economic Forum (WEF), with the launch at the 2026 annual meeting in Davos, Switzerland, this week of the inaugural Women’s Health Investment Outlook. The neglect of women’s health is not only a public health issue, but also “a market inefficiency on a global scale,” the WEF report said.
Abbott Laboratories reported fourth quarter sales below expectations before the market opened on Jan. 22, sending the stock down nearly 12% from the prior day's closing. The biggest hits came from contraction in the nutrition group along with continued disruption in the diagnostics unit from volume-based procurement in China. Medical devices suffered from market share loss in electrophysiology and slower than expected uptake of continuous glucose monitors. The pharma group performed as anticipated, posting 7% growth.
The good news is that the U.S. Congress is on track to pass a slate of fiscal 2026 spending bills before the current continuing resolution expires Jan. 30. So, barring any last-minute disputes or legislative hostage-taking, there should be no repeat of last year’s 43-day shutdown that impacted NIH grants and activities.
Microsurgery is performed to connect small human vessels, but the technical difficulty required to conduct this type of surgery is quite specialized and limits the number of surgeons who can perform microsurgery.