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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 the American Society of Clinical Oncology annual meeting to highlight...

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More from Europe

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.