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AirFluSal’s Decentralized Approach to EU Shields Seretide From Exposure

 
• By Faraz Kermani

Sandoz’ AirFluSal Forspiro has been approved in Germany, but the company’s decentralized route into Europe means that GSK’s Seretide is somewhat shielded from all-out competition.

GlaxoSmithKline PLC is not about to panic over the authorization of Novartis AG subsidiary Sandoz International GMBH’s AirFluSal Forspiro for asthma and COPD in Germany and Sweden on Jan. 13. As a generic version of GSK’s best-selling drug Seretide (fluticasone and salmeterol) it will doubtless raise eyebrows amongst payers and reimbursement authorities, but so far authorization has been restricted to only a handful of European countries.

The latest authorization in Europe contrasts with repeated claims by GSK – and indeed its CEO Sir Andrew Witty –...

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More from Europe

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

 
• By Francesca Bruce

A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
• By Francesca Bruce

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

More from Geography

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.