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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

EMA Official Clarifies Benefits & Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

More from Geography

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.