J&J Faces $442M Treble Damages Over Catheter Monopoly
J&J’s $147M antitrust penalty tripled to $442M for monopolizing cardiac catheter market.
News
UnitedHealth, Humana Back Medicare Home Visit Reforms
Major insurers endorse billing limits on controversial home-based risk assessments.
RedETSA Convenes 38 HTA Institutions for Americas Summit
Regional HTA network addresses equity, economic evaluation, and adaptation frameworks.
Simplify Healthcare Captures 30% Medicare Advantage Market Share
Platform achieves 30% market dominance in Medicare Advantage bid submissions.
Innovent’s IBI363 Gains Second China BTD for Resistant Lung Cancer
China’s National Medical Products Administration has granted a second Breakthrough Therapy Designation to Innovent Biologics’ IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, for treating immunotherapy-resistant squamous non-small cell lung cancer (sqNSCLC). The designation applies to unresectable, locally advanced, or metastatic sqNSCLC that has progressed following anti-PD-(L)1 immunotherapy and platinum-based chemotherapy. This marks IBI363’s fourth … Read more
NICE Endorses Linzagolix for NHS Endometriosis Care
The National Institute for Health and Care Excellence (NICE) has approved linzagolix combined with hormonal add-back therapy for endometriosis treatment within the NHS, expanding therapeutic options for an estimated 1.5 million women in the UK affected by this chronic condition. Clinical trials have substantiated that linzagolix effectively reduces both dysmenorrhea and non-menstrual pelvic pain in … Read more
CAT-os Tool Addresses Global Orthopedic Surgery Gap
A validated capacity assessment tool designed to strengthen orthopedic surgery capabilities in low- and middle-income countries (LMICs) has demonstrated excellent reliability and practical utility in pilot testing, addressing a critical healthcare disparity that affects millions globally. The Capacity Assessment Tool for Orthopedic Surgery (CAT-os) provides systematic evaluation frameworks for surgical outreach programs targeting regions where … Read more
Randox Gains FDA De Novo Clearance for Hemophilia CDx
Randox Laboratories has secured FDA de novo clearance for its ConcizuTrace ELISA companion diagnostic, designed to quantify plasma concentrations of Novo Nordisk’s recently approved hemophilia treatment Alhemo (concizumab-mtci). The regulatory milestone comes just weeks after Alhemo received FDA approval in December 2024 as a once-daily prophylactic injection for adults and pediatric patients 12 years and … Read more
Medicare Expands Signatera Genome MRD Assay Coverage
Medicare has approved coverage for Natera’s genome-based Signatera molecular residual disease (MRD) assay under LCD L38779, extending access to beneficiaries across six cancer indications. The coverage applies to colorectal, breast, bladder, ovarian, and lung cancers, as well as pan-cancer immunotherapy monitoring, aligning with the scope of Natera’s original Signatera test. This regulatory milestone positions the … Read more
CND’s Syn-One Test Shows 75% Detection in Sleep Disorder
CND Life Sciences reported baseline results from its NIH-sponsored Syn-Sleep Study, demonstrating the Syn-One Test’s ability to detect phosphorylated alpha-synuclein (P-SYN) in 75% of patients with idiopathic REM sleep behavior disorder (iRBD). The 24-month longitudinal study enrolled 80 participants across 11 US sites, representing a critical validation step for cutaneous biomarker detection in prodromal neurodegenerative … Read more