Roche Upbeat On Fenebrutinib Filing Prospects Despite Safety Questions
The company’s chief medical officer said he saw no ‘stumbling blocks’ for the potential first-in-class BTK inhibitor in multiple sclerosis, although safety questions will likely persist.
Scrip - April 22, 2026

INBRAIN Concludes Enrollment Of First In-Human-Trial Using Graphene Neural Interface
Brain-computer interface company INBRAIN said early results of its first-in-human study enrolling eight patients showed no device-related adverse events. Final results are expected this fall.
Medtech Insight - April 21, 2026

With Commitment Letter In View, FDA Takes MDUFA VI To Stakeholders
With an FDA-industry framework for MDUFA VI on the books, the agency turned to patient and medical stakeholder groups on March 24. Newly posted minutes show 15 attendees from 13 organizations pressing for detail on aspects of MDUFA — and pushing to be seated alongside industry in future talks.
Medtech Insight - April 21, 2026

STORM-PE 90-Day Data: CAVT Patients Walk 111 Meters Further Than Anticoagulation Alone
A quarter of pulmonary embolism patients treated with anticoagulation alone still had measurable functional limitations at 90 days. STORM-PE's follow-up data puts a number on a clinical problem that has largely gone unquantified.
Medtech Insight - April 21, 2026

Study Reveals How People Talk To AI About Health
New research from Microsoft analyzes Copilot conversations to understand what kinds of health questions users ask AI and how this could affect response design.
Medtech Insight - April 21, 2026

AI Medtech Regulation In Limbo After EU Rules Simplification
The EU’s Digital Omnibus legislation delegates some AI medtech regulation to MDR – a role it is not necessarily built for.
Medtech Insight - April 21, 2026

Blind Trust In Artificial Intelligence For Drug Production Misreads US FDA Compliance Chart
Recent warning letter explains that AI use in manufacturing drugs isn’t a violation on its own, but failing to review and validate its work is noncompliant with FD&C Act GMP regulations in place long before computer-based information analysis and generation platforms emerged.
HBW Insight - April 21, 2026

ACNU’s Simultaneous OTC/Rx Access Requirement Criticized By CHPA, PhRMA, Supported By AAM
Groups noted simultaneous OTC/Rx availability required for OTC switches approved through “additional conditions for nonprescription use” pathway in comments submitted in advance of meeting Duke-Margolis Institute for Health Policy conducts for FDA on April 23.
HBW Insight - April 21, 2026

Canada’s Jamp Deepens Immunology Biosimilars Push
Jamp Pharma has secured Health Canada approval for Upgolyv, a golimumab biosimilar to Simponi, expanding its Canadian immunology portfolio, strengthening its BioJamp division and advancing its strategy in high-growth specialty medicines.
Generics Bulletin - April 21, 2026

Graph Intelligence In Clinical Trials: Explainability Will Make Or Break It
In the first of an ongoing series of deep dives into biopharma-relevant AI topics, Norstella experts argue graph intelligence can untangle clinical trial fragmentation, if the results are explainable and GxP-compliant implementation discipline follows.
In Vivo - April 21, 2026