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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.

Europe United States Drug Approval Standards

EMA Explores Optimizing Vaccine Development In Immunocompromised Patients

The European Medicines Agency has issued draft recommendations on how vaccine developers can generate efficacy data to enable their product’s safe use in immunocompromised individuals.

Europe Guidance Documents Regulation

EMA Sticks With JN.1 Variant For COVID-19 Vaccines, Despite US FDA's Choice of KP.2

Targeting the JN.1 subvariant of the SARS-CoV-2 virus will facilitate timely vaccination campaigns in Europe to help reduce the burden of disease associated with COVID-19, according to the EU regulator.

Europe Coronavirus COVID-19 Vaccines

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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

FDA Leadership Changes Tune On Pediatric Priority Review Voucher Benefit

As the reauthorization deadline nears, CDER and CBER leaders stressed that sunsetting the program would hurt pediatric rare disease development, while endorsing a new Democrat-proposed stick for rare disease research. 

Rare Diseases Legislation

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
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

Product-Specific or Class-Specific Biosimilar Guidances? US FDA Wants Feedback

The FDA’s experience with product-specific guidances for generic drugs may impact biosimilar industry decision-making, but the program has improved in recent years.

Biosimilars Guidance Documents

FDA Leadership Changes Tune On Pediatric Priority Review Voucher Benefit

As the reauthorization deadline nears, CDER and CBER leaders stressed that sunsetting the program would hurt pediatric rare disease development, while endorsing a new Democrat-proposed stick for rare disease research. 

Rare Diseases Legislation

Brand-Backed ASBM Pushes Back On Biosimilar Reforms

The Alliance for Safe Biologic Medicines urged restraint when considering FDA findings suggesting switching studies may not be as vital to support interchangeability.

Biosimilars Review Pathway

Cancer Trials: US FDA Debuts Framework For Patient-Reported Tolerability Assessments

The agency wants sponsors to start with three core symptoms common across cancer therapeutics and then add more treatment-related adverse events from item libraries based on a drug’s mechanism of action and other factors.

Clinical Trials ImmunoOncology

PBM Execs Stay On Message Amid Growing US Congressional Frustration At Hearing

The House Oversight Committee held its third hearing on pharmacy benefit manager reforms in 10 months, but could not elicit an admission from executives that they are responsible for increasing drug prices.

Reimbursement Legislation

US FDA Sending AZ, Other Cancer Sponsors Trial Design Message With Imfinzi AdComm

The Oncologic Drugs Advisory Committee will vote on a product agnostic question related to perioperative trial designs during a 25 July meeting after discussing whether AstraZeneca needs an additional trial for its Imfinzi perioperative regimen in non-small cell lung cancer.

Advisory Committees ImmunoOncology

Shuren Steps Down As US FDA Device Center Director

Shuren is retiring after 15 years as head of the FDA Center for Devices and Radiological Health.

FDA Leadership

Environmental Risk Assessments To Loom Larger In EU Drug Reviews

In this final article in a series on the ongoing amendments to the pharmaceutical reform package, the Pink Sheet looks at the tougher environmental risk assessment requirements that pharma companies are likely to face in the not-too-distant future.

Europe EU Legislative Reform

EMA Proposes Guidance On Oligonucleotide Drugs Amid Growing Role In Personalized Medicine

The draft guidance addresses specific requirements for oligonucleotide-based medicines that are not answered in existing guidance documents, and has been two years in the making.

BioPharmaceutical Clinical Trials

Challenges Persist in EU Clinical Trials Regulation Rollout

EU regulators say they have tackled many of the concerns raised by study sponsors in two surveys regarding the implementation of the EU Clinical Trials Regulation and are now focused on addressing the five “most critical remaining challenges.”

Europe Clinical Trials

EU Moment Of Truth For Lecanemab & 14 Other Drugs

Eisai/Biogen could this week learn whether the European Medicines Agency will give the thumbs up to market lecanemab across the EU for early Alzheimer’s disease.

Europe Drug Review

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
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