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EU Pharma Strategy Offers Window For Regulatory Optimization

‘Very Significant’ Reforms Offer A Chance To Build On Pandemic Experiences

 
• By Dave Wallace

Attendees to Medicines for Europe’s Regulatory Affairs and Pharmacovigilance virtual conference heard that a window of opportunity to optimize the region’s regulatory landscape is now “wide open” with the advent of the new EU Pharmaceutical Strategy.

Optimization key keyboard computer
Optimizing the regulatory environment in Europe is key for the off-patent industry • Source: Shutterstock

The new EU Pharmaceutical Strategy has opened a window of opportunity “wide open” for the optimization of Europe’s regulatory environment, according to off-patent industry association Medicines for Europe.

Attendees to the association’s Regulatory Affairs and Pharmacovigilance virtual conference in late January heard that this opportunity went well beyond...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

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• By Eleanor Malone

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Is Towa’s Guidance For 2024 ‘Somewhat Mediocre?’

 
• By Dean Rudge

Bringing in sales that translated to nearly $1.5bn last year, Japan’s Towa was feeling upbeat after a challenging few years, both for itself and the broader Japanese generics market. However, its financial guide for the next 12 months has left investors feeling cold.

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• By Generics Bulletin Team

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Aurobindo Expects Lannett Acquisition To Pass FTC Scrutiny; Q1 US Revenue Falls

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will pass US FTC scrutiny after an attempt to acquire Sandoz assets was called off in 2020 post a delay in approval. The deal could widen Aurobindo’s US manufacturing presence at a time when its US Q1 revenue saw a year-on-year decline.

‘Concrete Solutions, Not Big Words’ – Samsung Bioepis Suggests European Improvements For Biosimilars

 
• By Dave Wallace

While biosimilars have seen success in Europe, there are still plenty of areas in which policy improvements could solve problems for the market, according to a new Samsung Bioepis white paper. Adam Levysohn, the firm’s local head of commercial strategy, talks about the proposals.

Polpharma Biologics And Fresenius Kabi Team Up On Entyvio Biosimilar

 
• By Urtė Fultinavičiūtė

Fresenius Kabi has picked up commercialization rights to Polpharma Biologics’ vedolizumab biosimilars in almost all markets. Still, the originator Takeda stands solid with no competition expected until at least 2032.