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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 UK Network Targets Speed And Inclusion For Commercial Clinical Trials

 
• By Vibha Sharma

The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.

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.

More from Geography

Vanda Slams US FDA ‘Generic Bias,’ Again Seeks To Undo Hetlioz ANDA Approvals

 
• By Dave Wallace

In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.

Pink Sheet Podcast: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

Project Orbis: 2025 Shaping Up To Be A Strong Year For Canadian Approvals

 
• By Eliza Slawther

Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.