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Latest Pharma Insights



UK Government Unconditionally Backs Ambitious MHRA AI Regulation Plans
MHRA will update its definition of “medical device” when it sets out implementation plans for a new AI regulatory framework in spring 2027.
Medtech Insight - October 6, 2026
Orion And Qilu Add To Pembrolizumab Line-Up In Europe
The latest deal for a Keytruda biosimilar has fallen into place, with Finland’s Orion Corporation reaching an agreement with China’s Qilu Pharma for the latter’s pembrolizumab candidate in Europe.
Generics Bulletin - October 6, 2026
Strategic Intent: Using Agentic AI To Create ‘The Self-Driving Clinical Trial, Kind Of Like The Car’
In this Strategic Intent episode, In Vivo speaks with Ken Getz, executive director of the Tufts CSDD and research professor at the Tufts University School of Medicine, and Pamela Tanaerts, CMO and CSO at Medable, to discuss promising data from an AI Clinical Monitoring Agent. 
In Vivo - October 6, 2026
Pipeline Watch: AbbVie and Mirum Score Back-to-Back FDA Wins With Juvmo and Atebrioz
Johnson & Johnson’s Tecvayli plus Darzalex Faspro improves overall survival in new analyses of the Phase III MajesTEC-3 in multiple myeloma, while Rafael Holdings’ Trappsol Cyclo missed its primary endpoint in a Phase III Niemann-Pick type C trial.
Scrip - October 6, 2026
Sanofi And Regeneron Show Alliances Are Never Finished, Only Renegotiated
Two decades, five approved drugs and four restructurings later, Sanofi and Regeneron are reopening the alliance that produced Dupixent.
In Vivo - October 6, 2026
The People Behind The Pipeline: How The Global Race For Talent Is Reshaping Pharma
The biopharma industry is accustomed to competing for capital, technology and promising assets. Increasingly, however, one of its most important constraints is human: securing the scientists, researchers and technical specialists capable of turning complex science into viable medicines.
In Vivo - October 6, 2026
US FDA Principal Deputy COO Melissa Shea Departs For NIH
Shea joined the agency in April 2025 and helped oversee the consolidation of HR, IT and other functions into the Office of Operations.
HBW Insight - October 6, 2026
AI Already Common Across US FDA, Consumer Health Industry With Plenty Still To Learn
FDA officials’ comments at recent CHPA conference describe a perception that much remains to be mastered about using AI even as it already is established a common tool across regulatory and business operations.
HBW Insight - October 6, 2026

Pipeline Watch: AbbVie and Mirum Score Back-to-Back FDA Wins With Juvmo and Atebrioz
Johnson & Johnson’s Tecvayli plus Darzalex Faspro improves overall survival in new analyses of the Phase III MajesTEC-3 in multiple myeloma, while Rafael Holdings’ Trappsol Cyclo missed its primary endpoint in a Phase III Niemann-Pick type C trial.
Scrip - October 6, 2026

UK Government Unconditionally Backs Ambitious MHRA AI Regulation Plans
MHRA will update its definition of “medical device” when it sets out implementation plans for a new AI regulatory framework in spring 2027.
Medtech Insight - October 6, 2026

US FDA Principal Deputy COO Melissa Shea Departs For NIH
Shea joined the agency in April 2025 and helped oversee the consolidation of HR, IT and other functions into the Office of Operations.
HBW Insight - October 6, 2026
AI Already Common Across US FDA, Consumer Health Industry With Plenty Still To Learn
FDA officials’ comments at recent CHPA conference describe a perception that much remains to be mastered about using AI even as it already is established a common tool across regulatory and business operations.
HBW Insight - October 6, 2026

Orion And Qilu Add To Pembrolizumab Line-Up In Europe
The latest deal for a Keytruda biosimilar has fallen into place, with Finland’s Orion Corporation reaching an agreement with China’s Qilu Pharma for the latter’s pembrolizumab candidate in Europe.
Generics Bulletin - October 6, 2026

Strategic Intent: Using Agentic AI To Create ‘The Self-Driving Clinical Trial, Kind Of Like The Car’
In this Strategic Intent episode, In Vivo speaks with Ken Getz, executive director of the Tufts CSDD and research professor at the Tufts University School of Medicine, and Pamela Tanaerts, CMO and CSO at Medable, to discuss promising data from an AI Clinical Monitoring Agent. 
In Vivo - October 6, 2026
Sanofi And Regeneron Show Alliances Are Never Finished, Only Renegotiated
Two decades, five approved drugs and four restructurings later, Sanofi and Regeneron are reopening the alliance that produced Dupixent.
In Vivo - October 6, 2026
The People Behind The Pipeline: How The Global Race For Talent Is Reshaping Pharma
The biopharma industry is accustomed to competing for capital, technology and promising assets. Increasingly, however, one of its most important constraints is human: securing the scientists, researchers and technical specialists capable of turning complex science into viable medicines.
In Vivo - October 6, 2026