Regional Comparisons

Drug Sponsors Can Help Shape Agenda For FDA/EMA Pediatric ‘Cluster’ Calls

 
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Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

Early Support For EMA’s Trial Of US-Style Standards In Non-Clinical Reviews

 
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An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
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Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.


America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.

Infographic: Leqembi – A Geographical Comparison

 

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

UK And US Regulators In Sync On RWD External Control Arms

 
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The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.


EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

AstraZeneca Says Andexxa Will Not Convert To Full Approval, Quietly Reveals Complete Response

 

Whether the FDA will seek withdrawal of the anticoagulant-reversal agent or request additional confirmatory data is unclear.

How The UK, EU, Canada, Australia And Japan Are Tackling Diversity In Clinical Trials

 
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As efforts to improve diversity in clinical trials gain momentum globally, the Pink Sheet asked regulators in the UK, the EU, Canada, Australia and Japan about their efforts to support representative enrolment. 

EU Revokes Intercept/Advanz’s Ocaliva Approval As Moment Of Reckoning Nears in US

 
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The EU marketing authorization for the primary biliary cholangitis treatment has now been revoked. Meanwhile the drug's approval is in jeopardy in the US, where an advisory committee will opine on whether the accelerated approval drug has confirmed clinical benefit.


England Lags Behind Eight European Countries On Innovative Drug Availability

 

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

Decoding Regulatory Agency Decisions: The Case of Amylyx’s Relyvrio/Albrioza In The US And EU

 

Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.

Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU

 
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Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.

US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals

 

Comprehensive table comparing all the novel agents approved by either the US FDA or the European Commission over 2023 through April 2024.


Approval Geography: Novel Agent Landscape Across US And EU

 

Pink Sheet infographic shows how a large majority of novel drugs make it past the US FDA before receiving approval in the European Union. Lag times ranged from almost five years to less than two weeks.

New Oncologics Overwhelmingly Approved In US Before EU

 

Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.

Getting To Global Is A Hurdle For Cell And Gene Therapies

 

Only three of the 10 new therapies approved by the US FDA also have been approved in the European Union, while both of the EU gene therapy approvals followed FDA clearance, a Pink Sheet analysis shows.

Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

 

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.