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European Notebook: Data Transparency And Adaptive Licensing Move Forward

 
• By Sten Stovall, Faraz Kermani, and John Davis

More clinical trials move to Denmark, Sanofi’s Viehbacher moves to Boston, and analysts suggest thwarted Pfizer’s next strategic move may be to use contingent value rights in a future attempt for AstraZeneca, plus more in this month’s notebook.

Pfizer Inc. has walked away from AstraZeneca PLC – for now – but the world’s biggest drug maker can make another offer later this year under U.K. takeover laws, which prohibit any re-engagement for three months from May 26. What happens after that will depend on how AstraZeneca's drug research fares in the meantime ([A#14140526001]).

The British pure pharma needs to give investors a reason to believe it deserves to go it alone. It used...

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More from Europe

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, one of which is Rezdiffra, Madrigal Pharmaceuticals’s treatment for metabolic dysfunction-associated steatohepatitis.

MHRA Backs Global AI Framework For Pharmacovigilance Over UK-Specific Guidance

 
• By Vibha Sharma

The UK’s medicines regulator wants to ensure that guidance on the use of artificial intelligence in pharmacovigilance processes remains fit for the future.

Cosmo Wins Over EMA With Risk Minimizing Measures And Expert Advice For Winlevi

 
• By Neena Brizmohun

The European Medicines Agency says that Winlevi should be approved in the EU for treating acne, having previously turned the drug down.

Navigating Rare Disease Submissions: Minoryx Stresses Early EMA Engagement

 
• By Manas Mishra

Minoryx explained to Pink Sheet why it believes its resubmission for leriglitazone stands a stronger chance of approval, and highlighted the value of early dialogue with the regulators when it comes to rare diseases, where the understanding of the natural history and outcomes is often limited.

More from Geography

US FDA’s ARIA Analysis Adds Earlier Scan To Biogen/Eisai Leqembi Label

 
• By Bridget Silverman

Six deaths early in treatment inspired a new safety requirement for Biogen/Eisai’s Leqembi to promote early identification of patients affected by the well-known risk of amyloid-related imaging abnormalities with edema (ARIA-E).

COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad

 
• By Sue Sutter

The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.

New US FDA AI Councils Will Focus On Internal, External Policy

 
• By Sarah Karlin-Smith

The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.