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Successfully navigate the complex worlds of compliance, legislation, policy regulation, and industry developments with the expertise of our worldwide network of expert analysts and journalists.
Our team of global contributors helps you to anticipate challenges, minimize risks and maximize opportunities. Pink Sheet is the biopharma industry’s go-to source for business-critical insights and policy and regulatory intelligence.
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Pink Sheet gives you the power to go behind the regulatory and compliance headlines to understand the implications of worldwide industry developments on your business.
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With a network of journalists and analysts crisscrossing the globe, our industry experts and thought leaders track product progress from submission to approval. We also draw on the strength and expertise of the rest of the Pharma Intelligence family of analytical and market intelligence tools.
Analysis and opinion covers key topic areas such as:
Pink Sheet
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.
Topic FDA Company analysis
Pink Sheet
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.
Topic Drug approval
Pink Sheet
By Cathy Kelly 09 Aug 2019
Investigation may help define when rebate arrangements seeking to protect a brand against biosimilar competition are anticompetitive.
Topic Policy and regulation
Pink Sheet
By Francesca Bruce 29 Jul 2019
A national pharmacare program in Canada could make it harder to access higher cost drugs.
Topic Policy and regulation
Pink Sheet
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.
Pink Sheet
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
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
Topic Policy and regulation Drug development landscape Deal trends
Pink Sheet
By Francesca Bruce 05 Jul 2019
Latin American joint price negotiations have proved successful and other countries are taking note.
Pink Sheet
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.
Pink Sheet
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.
Topic Drug approval Strategy
Pink Sheet
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.
Pink Sheet
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.
Pink Sheet
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.
Topic US Shutdown FDA
Pink Sheet
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.
Topic FDA
Pink Sheet
By Francesca Bruce 02 Jul 2019
Regulatory harmonization is gathering pace in Latin America, which is good news for pharmaceutical companies.
Topic Policy and regulation
Pink Sheet
23 Aug 2019
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23 Aug 2019
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23 Aug 2019
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23 Aug 2019
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23 Aug 2019
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23 Aug 2019
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23 Aug 2019
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23 Aug 2019
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23 Aug 2019
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22 Aug 2019
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22 Aug 2019
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22 Aug 2019
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22 Aug 2019
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21 Aug 2019
Pink Sheet
21 Aug 2019
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