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Featured Stories



US FDA Not Ready For Sponsors Citing Others’ Platforms Yet, Marks Says

Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.

Platform Technologies Review Pathway Regulation

Agenus Needs Phase III For BOT/BAL, Another Example Of Shifting Accelerated Approval Climate

The US FDA surprised some observers when it advised Agenus against filing for accelerated approval of the CTLA-4/PD-1 combination, but the agency has been cracking down on confirmatory trial requirements recently to better ensure the studies will be finished.

Cancer Review Pathway Regulation

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies and secure the supply of generics and biosimilars.

Generic Drugs Supply Chain Regulation

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Pink Sheet Podcast

Performance Trackers

US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer

June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.

US FDA Performance Tracker Drug Review Drug Approval Standards

Global Pharma Guidance Tracker – June 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation International


Multimedia

Coming Attractions: Novel Agents In Line For US FDA Decisions By Year-End

Interactive table from the Pink Sheet breaks down the 40 novel drugs and biologics have user fee goal dates before the new year.

Approvals Drug Review

Steady On For US FDA’s Novel Approvals At Mid-Year, But Another 2023 Is Unlikely

US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.

US FDA Performance Tracker Approvals

Medicare Negotiation Round Two Will Be Dominated By Oral Cancer Drugs, Researchers Predict

A number of diabetes drugs are also expected to be targeted in the next cycle of the price negotiation program, led by Novo Nordisk’s Ozempic.

Medicare Reimbursement

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.

Regional Comparisons Approvals
Regional Comparisons

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

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.

Regional Comparisons Approvals

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.

Regional Comparisons Approvals

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.

Regional Comparisons Approvals

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.

Regional Comparisons Approvals
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Recent Stories

EU Pharma Reform, SPCs, Compulsory Licensing Among Parliament’s ‘Unfinished Business’

A number of legislative proposals will be coming under scrutiny at the newly constituted European Parliament in the coming months, including the pharma reform package and draft legislation on EU-level compulsory licensing and “unitary” supplementary protection certificates.

Europe Legislation

EMA Backs New Method For Measuring Alzheimer’s Disease In Trials

Evidence generated through an EU public-private funding initiative has resulted in a new biomarker method for measuring the level of Alzheimer’s disease in a person’s brain, which drug developers can use during clinical trials.

Europe EU

Parexel Execs On Regulatory Harmonization, AI Impact, RWE Challenges

From the US FDA’s ISTAND Program to EU’s Melloddy Initiative, and from the global challenges of real-world data to the opportunities in India, Parexel’s EVP for Clinical Data and Digital Services, chief strategy officer and India head speak on a range of topics in this interview with the Pink Sheet.

Research & Development Clinical Trials

Top FDA Staff Are Pushing Review Teams To Be Comfortable With Regulatory Flexibility

Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.

Drug Approval Standards Rare Diseases

First Four Members Of US FDA’s Newest Advisory Committee Are Mostly Rookies

Most of the new Genetic Metabolic Diseases Advisory Committee members have little FDA or advisory committee experience, except the new industry representative, with six more voting slots still to fill before its first meeting.

Rare Diseases Advisory Committees

Clinical Trial Diversity Action Plans Will Take 100 Hours To Prepare, US FDA Predicts

The agency’s Center for Drug Evaluation and Research expects to receive 200 plans annually, with 40 plans expected to go to the biologics center.

Clinical Trials Diversity & Inclusion

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

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.

Regional Comparisons Approvals

UK Regulatory Changes ‘Seldom’ Reduce The Burden For Rare Diseases

Establishing multi-site network centers for rare diseases can help advance clinical research, but “onerous” regulatory compliance issues are a barrier that must be overcome, a clinical academic says.

BioPharmaceutical Europe

EU Commission Sets Out Plans For New Life Sciences Strategy

As well as planning action to improve the EU’s competitiveness in the life science sector, the European Commission has confirmed that it will propose new legislation to reduce the bloc’s reliance on overseas suppliers of medicines as a way of tackling drug shortages.

Europe Artificial Intelligence

World’s Largest Commercial Human Challenge Trials Unit Launched To Keep Up With Growing Demand

A UK-based CRO specializing in human challenge trials says there is a big shift in industry sentiment towards such studies. Companies targeting infectious diseases are now actively accommodating challenge trials in their development plans instead of needing persuasion.

Clinical Trials United Kingdom

RWE-Only To Support A US FDA-Approved Indication? ‘Yes, Potentially’

CDER real world evidence policy head John Concato said the FDA could approve a new labeled use based only on real-world evidence, but made clear the approach is challenging. 

Real-World Evidence Drug Approval Standards

Vertex Opens New Front In Patient Assistance Conflict Between Pharma, HHS Inspector General

Vertex’s fertility preservation assistance program would provide up to $70,000 in financial support for in vitro fertilization and other services to patients prescribed Casgevy.

Gene Therapy Legal Issues
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