BIO Notebook: A Post-Mortem On The CNPV
The third day of BIO featured a debate over the origins and future of the CNPV, reflections on dealmaking strategies, and how neuroinflammation is a growing path for Alzheimer's research.
Scrip - June 25, 2026

BrightHeart Wins CE Mark For AI Prenatal Heart Defect Detection Tool
BrightHeart announced it received the CE mark for its AI-driven prenatal ultrasound technology, which follows several FDA clearances.
Medtech Insight - June 24, 2026

HepQuant SHUNT Wins FDA Premarket Approval For Variceal Screening In Compensated Cirrhosis
The FDA has granted premarket approval to HepQuant SHUNT, a blood-based liver function test that quantifies the risk of large esophageal varices in compensated cirrhosis patients, potentially reducing unnecessary endoscopies.
Medtech Insight - June 24, 2026

India Reopens Consultation On Medical Device Import Exemption List
India is reviewing which medical devices should remain exempt from domestic procurement requirements — and the gap between domestic manufacturers who want the list cut and importers who warn against restricting patient access is wider than the consultation process might suggest.
Medtech Insight - June 24, 2026

Alzheimer’s Experts At BIO 2026 Said Biomarkers Are The Biggest Barrier And Opportunity
A panel of venture philanthropists, VC, pharma exec and biotech leader discussed diversifying investments and pipeline to accelerate progress in Alzheimer’s agreed that the biggest bottleneck today is biomarkers.
Medtech Insight - June 24, 2026

FDA-Cleared Digital Health Tools Pass 1,900, With AI Driving Almost All The Growth
FDA-cleared digital health tools have passed 1,900, with AI-enabled devices accounting for 73 of the 87 net additions this quarter as the agency signals it will begin tracking foundation models and large language models (LLMs).
Medtech Insight - June 24, 2026

Prime Note For Amazon Missing From US FDA’s Unapproved Drug Warnings To Other Firms
Unapproved Drugs and Labeling Compliance and Compliance offices in FDA’s CDER reached firms from a Delaware startup to businesses from Canada to South Africa, India to Albania and the UK to Hong Kong in recent warning letters about unapproved drugs.
HBW Insight - June 25, 2026

Vermont: Non-Compliance With EPR Program Could Result In Stop-Sales Action
The Vermont Department of Environmental Conservation encourages beauty firms to check whether their products must comply with its EPR program and if so, register before they potentially face stop-sales enforcement.
HBW Insight - June 25, 2026

FTC Warns Stelara Ruling Could Weaken Pharma Antitrust
The US FTC believes CareFirst need not prove J&J specifically intended to harm biosimilar competition in its Stelara monopoly case, warning the lower court’s standard could blunt pharma antitrust enforcement.
Generics Bulletin - June 24, 2026

‘It’s A Question Of How This New Game Will Be Played’ – Adapting To The EU Pharma Package
While the new EU pharma legislation package has been broadly well-received by industry, it remains to be seen how certain elements will be implemented in practice. Panelists shared their views at Medicines for Europe’s legal affairs conference in Athens earlier this month.
Generics Bulletin - June 24, 2026

India’s Generics Giants Could Ease US Cancer Shortage
The FDA is seeking potential Indian suppliers of ifosfamide after a US supply disruption hit availability of the cancer drug, with the IDMA saying India has the capacity to help if companies meet US quality requirements.
Generics Bulletin - June 24, 2026

Rising Leaders: Jared Kelly’s Path From Lawyer To Leader
A decade spent in corporate law gave Jared Kelly, CEO at Oncolytics Biotech, a unique perspective to step into a position of leadership.
In Vivo - June 25, 2026