Sphere-9 Can Ablate VT in Europe While Its US Pivotal Is Still Enrolling
Medtronic can sell Sphere-9 into ventricular tachycardia in Europe while the trial meant to prove it works in the US is only now enrolling.
Regulatory
The FDA Approved Orzeyful and Handed the Approval Date to the DEA
FDA’s letter says the approval date is whenever the DEA publishes scheduling. Takeda holds a first-in-class approval it cannot sell yet.
The 340B Rebate Pilot Is Back at Under 5.5% of Sales, Rebuilt to Survive the Court That Killed It
HRSA restarted the 340B rebate pilot at under 5.5% of sales, wrapped in 21 pages of answers to the court that vacated the first one.
LifeScience Weekly Digest: Key Industry Updates (6th – 10th January)
In early 2025, significant developments across the biopharmaceutical and medical device sectors shaped the healthcare landscape. Stryker’s $4.9 billion acquisition of Inari Medical, Transcarent’s $621 million deal for Accolade, and several FDA designations for investigational treatments, such as Johnson & Johnson’s nipocalimab, highlight industry advancements. Medicare’s rescinding of coverage for certain cancer genetic tests and … Read more
Regulatory Roundup: Weekly Insights on Pharma and MedTech—Key Updates from Leading Agencies (December 30th to January 3rd)
Welcome to this week’s Regulatory Insights from Synopulse, featuring the latest updates from the FDA, EMA, and other global regulatory authorities. From groundbreaking drug approvals to critical recalls and new designations, we cover the most significant events driving the pharmaceutical sector. This comprehensive report offers a concise view of the regulatory milestones shaping the pharma, … Read more