EMA Links Semaglutide to Rare Vision Loss Risk
Two-fold increased risk prompts label updates for blockbuster GLP-1 drugs.
Shajini
Owens & Minor Scraps $1.4B Rotech Deal Amid FTC Opposition
Medical distributor abandons home healthcare consolidation play.
Dupixent Shows Efficacy in Diverse Patient Population
Dupixent shows 76% efficacy in patients with darker skin tones.
Medtronic Issues Class I Recall for Tracheostomy Tubes
Medtronic recalls Shiley trach tubes over flange detachment causing airway complications.
J&J Faces $442M Treble Damages Over Catheter Monopoly
J&J’s $147M antitrust penalty tripled to $442M for monopolizing cardiac catheter market.
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.
Synopulse Weekly: Top Deals, FDA Moves & Pricing Insights
Top biopharma deals, FDA approvals, and market access news from the past week.
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