Pharmaceutical Regulatory Affairs | Compliance| Pink Sheet

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Pink Sheet

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

By Derrick Gingery 14 Aug 2019

Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.

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The Stakes Are High So Get It Right: CHMP Oral Explanations & FDA AdComs

By Neena Brizmohun 09 Aug 2019

The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. How they perform is critical. Consultant Kate Dion has a raft of helpful tips for companies facing this daunting situation. Neena Brizmohun reports.

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FTC Wades Into ‘Rebate Walls’ And Biosimilar Access With Remicade Investigation

By Cathy Kelly 09 Aug 2019

Investigation may help define when rebate arrangements seeking to protect a brand against biosimilar competition are anticompetitive.

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Canada: National Pharmacare Or 'Fill The Gaps'?

By Francesca Bruce 29 Jul 2019

A national pharmacare program in Canada could make it harder to access higher cost drugs.

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Medicare Price Inflation Rebates, Part D ‘Redesign’ Proposed In Senate Finance Bill

By Cathy Kelly 26 Jul 2019

Price inflation rebates are expected to generate $50bn in savings over 10 years, according to the Congressional Budget Office.

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The Drug Pricing Article Pack

15 Jul 2019

Get expert insights into the events driving drug pricing polices around the world. This Article Pack covers drug pricing issues for: The EU - Vital developments for Norway, Denmark, and other EU countries, including the UK The US – Essential drug pricing info from a country where the issue has taken center stage Australia – Developments surrounding drug pricing issues in Australia

Pink Sheet

The Drug Pricing Debate Article Pack

15 Jul 2019

Get expert insights into the events driving drug pricing polices around the world. This article pack covers drug pricing issues for: The EU - Vital developments for Norway, Denmark, and other EU countries, including the UK The US – Essential drug pricing info from a country where the issue has taken center stage Australia – Developments surrounding drug pricing issues in Australia

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Lessons From Mercosur Multi-Country Pricing Negotiations

By Francesca Bruce 05 Jul 2019

Latin American joint price negotiations have proved successful and other countries are taking note.

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Romosozumab Among Latest Drugs Up For CHMP Opinion

By Vibha Sharma 04 Jul 2019

Four drugs are up for an opinion this week on whether they should be granted EU-wide approval, including Amgen/UCB's osteoporosis drug romosozumab.

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Will US Government Pursue Fewer False Claims Act Cases In 2019

By Brenda Sandburg 03 Jul 2019

Fallout from Supreme Court's Escobar decision and Department of Justice memos could impact types of healthcare fraud complaints in which the government intervenes.

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US Initiative To End HIV Epidemic Will Boost PrEP Access

By Brenda Sandburg 03 Jul 2019

'Number of different initiatives' coming in next several months to make drugs more affordable, including for PrEP prophylaxis, HHS Assistant Secretary for Health Giroir says. Multi-agency approach is key strategy.

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The Tricky Task Of Bringing Smaller EU Countries Into The Fold

By Maureen Kenny 03 Jul 2019

Clusters of excellence, competition as well as co-operation, Brexit, and aiming high. Danish Medicines Agency head Thomas Senderovitz talks national agencies and engagement in an interview with the Pink Sheet.

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Shutdown Will Drug Reviews Become Emergencies When User Fee Money Runs Out

By Sue Sutter 02 Jul 2019

Exhaustion of US FDA's PDUFA funds before partial federal government shutdown ends could lead sponsors or agency to assert that reviews for certain types of drugs should continue under an exception to the Anti-Deficiency Act, former FDA officials say.

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Sharpless Calls For A Nimble, Flexible, More Efficient US FDA

By Derrick Gingery 02 Jul 2019

In his first speech to an outside group, Sharpless strikes a collaborative tone, saying he expects to listen to the advice of the FDA bar, as well as his own experts.