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Importation, Pricing Policies Raised Concerns For US FDA's Project Orbis

 
• By Derrick Gingery

Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.

Global strategy solution concept - earth jigsaw puzzle
Singapore and Switzerland could join Project Orbis soon. • Source: Shutterstock

Richard Pazdur worried that his program allowing simultaneous submission and assessment of drug applications in the US and other countries would be improperly linked to, and potentially damaged by, White House plans to allow drug importation from Canada.

The director of the US Food and Drug Administration's Oncology Center of Excellence also was concerned that ex-US drug pricing...

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Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
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‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 
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Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

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Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates

 
• By Neena Brizmohun

Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.

Argentina Speeds Up Market Access Process

 
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Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

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