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Product Reviews & Approvals

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Approvals

Set Alert for Approvals

US FDA Vaccine Approvals Set Up CDC Votes On Merck’s Capvaxive, Moderna’s mResvia

Advisory Committee on Immunization Practices expected to vote 26-28 June on use of Merck’s 21-valent pneumococcal vaccine, Moderna’s mRNA vaccine for RSV, and an expanded age range for GlaxoSmithKline’s Arexvy RSV vaccine.

Approvals Vaccines

New EU Filings

Sepiapterin, PTC Therapeutics' treatment for hyperphenylalaninemia in adult and pediatric patients with phenylketonuria, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Drug Review Europe

First Drug Treatment For Myopia Among 14 New EU Filings

Vyluma’s eyedrop for treating myopia in children and Vertex’s next-generation triple combination treatment for cystic fibrosis are among the latest drugs that the European Medicines Agency has begun reviewing for potential EU marketing approval.

Europe Drug Review

EU Regulators Clarify How ‘Super-Grouping’ Under New Variations Rules Will Work

Feedback is being sought on revised guidelines that tell companies how they should make post-authorization changes to their drug approvals once new rules take effect in January 2025.

Post Market Regulation & Studies Europe

EU Launches New Mechanisms To Boost Quality Of Clinical Trial And Marketing Applications

As of today, drug developers can apply to take part in two pilot programs that will involve regulators across the EU strengthening their coordination when it comes to providing companies with advice on their applications for clinical trials and marketing authorization.

Europe Clinical Trials

A Success But Room For Improvement: Canada’s Conditional Approval Pathway

Ninety-two approvals, seven revocations and myriad standard-of-care treatments are all discussed in a first-of-its kind study examining the data and nuances of oncology submissions processed under Health Canada’s 26-year-old notice of compliance with conditions (NOC/c) pathway.

Canada Post Market Regulation & Studies

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Qalsody, Biogen's treatment for amyotrophic lateral sclerosis associated with a mutation in the superoxide dismutase 1 gene.

Europe Approvals

Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

International Europe

Swiss Pilot Allows Applicants To Discuss Preliminary Drug Approval Decisions

A new kind of meeting will allow companies to discuss any questions and obtain advice on how to respond to a preliminary approval decision by Swissmedic.

Europe Switzerland

EU CHMP Opinions And MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

Chikungunya Vaccine, Hemophilia B Gene Therapy Among 14 Products On Track For EU Approval

The EU is on track to get its first vaccine for preventing the disease caused by chikungunya virus. Thirteen other products have also been recommended for pan-EU approval. 

Europe Drug Review

DREAMM Comeback Prompts GSK To Seek Fast-Track EMA Review For Blenrep

The European Medicines Agency is this week deciding whether the planned EU filings for sipavibart, lifileucel and Blenrep – which was previously approved but withdrawn in the EU and the US – merit an accelerated assessment.

Review Pathway Approvals
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Drug Reviews

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Anti-Globalism Policy Cannot Stifle International Cooperation, US FDA’s Califf Says

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

DIA Supply Chain

Advisory Committees: US FDA Should Explain Divergent Decisions But Keep The Vote

Agency should be more proactive in issuing communications after advisory committee meetings, stakeholders advised; public interest group and industry representatives said the voting process is important for transparency and accountability.

Advisory Committees Drug Review

New EU Filings

Sepiapterin, PTC Therapeutics' treatment for hyperphenylalaninemia in adult and pediatric patients with phenylketonuria, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Drug Review Europe

PDUFA VIII: Continuous Fee Increases May Be Wearing On Sponsors

A Pfizer exec says that the old prescription drug user fee formulas that usually increase funding and staffing for many FDA programs no longer deliver the same return on investment.

User Fees Drug Review

First Drug Treatment For Myopia Among 14 New EU Filings

Vyluma’s eyedrop for treating myopia in children and Vertex’s next-generation triple combination treatment for cystic fibrosis are among the latest drugs that the European Medicines Agency has begun reviewing for potential EU marketing approval.

Europe Drug Review

US FDA User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike

With likely more fee-paying applications arriving at the agency, sponsors may be wondering whether user fees should have been increased as much as they were at the start of FY 2024.

User Fees Drug Review

Anti-Amyloid Class Labeling Could See Changes With Lilly’s Donanemab Approval

The US FDA is considering labeling that calls greater attention to the symptoms of amyloid-related imaging abnormalities to ensure proper treatment and avoid misclassification as ischemic stroke.

Advisory Committees Drug Review

Lilly’s Donanemab Set For Broad Indication, No Tau PET Imaging Condition Following US FDA Panel Nod

The advisory committee also hails the treatment-to-amyloid clearance approach used in the Phase III trial as innovative, but questions how it should apply in clinical practice.

Advisory Committees Neurology

EU Launches New Mechanisms To Boost Quality Of Clinical Trial And Marketing Applications

As of today, drug developers can apply to take part in two pilot programs that will involve regulators across the EU strengthening their coordination when it comes to providing companies with advice on their applications for clinical trials and marketing authorization.

Europe Clinical Trials

Project Orbis, 'Cluster' Calls Validate Global Regulators’ Drug Application Concerns

Regulators from the US, Canada, European Union, Switzerland and Japan talk about the benefits of global collaboration, and reasons why they might reach different decisions on the same drug, at the American Society of Clinical Oncology annual meeting.

Drug Review Regional Comparisons

Lykos’ MDMA Trial Conduct Allegations Influence US FDA Advisory Committee

Safety concerns related to MDMA patient suggestibility and impairment troubled the panel reviewing psychedelic therapy for PTSD, although the FDA advised that therapist misconduct is outside its control.

Advisory Committees Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

Advisory Committees Drug Review
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Advisory Committees

Set Alert for Advisory Committees

US FDA Vaccine Approvals Set Up CDC Votes On Merck’s Capvaxive, Moderna’s mResvia

Advisory Committee on Immunization Practices expected to vote 26-28 June on use of Merck’s 21-valent pneumococcal vaccine, Moderna’s mRNA vaccine for RSV, and an expanded age range for GlaxoSmithKline’s Arexvy RSV vaccine.

Approvals Vaccines

Advisory Committees: US FDA Should Explain Divergent Decisions But Keep The Vote

Agency should be more proactive in issuing communications after advisory committee meetings, stakeholders advised; public interest group and industry representatives said the voting process is important for transparency and accountability.

Advisory Committees Drug Review

Advisory Committee Consumer Reps Often Fail To Represent Consumer Interests, Groups Tell US FDA

Many positions are vacant or filled by individuals with ties to academia, industry or patient groups, representatives from public interest and consumer groups say during an FDA listening session on advisory committee reforms.

Advisory Committees FDA

Anti-Amyloid Class Labeling Could See Changes With Lilly’s Donanemab Approval

The US FDA is considering labeling that calls greater attention to the symptoms of amyloid-related imaging abnormalities to ensure proper treatment and avoid misclassification as ischemic stroke.

Advisory Committees Drug Review

Lilly’s Donanemab Set For Broad Indication, No Tau PET Imaging Condition Following US FDA Panel Nod

The advisory committee also hails the treatment-to-amyloid clearance approach used in the Phase III trial as innovative, but questions how it should apply in clinical practice.

Advisory Committees Neurology

Lykos’ MDMA Trial Conduct Allegations Influence US FDA Advisory Committee

Safety concerns related to MDMA patient suggestibility and impairment troubled the panel reviewing psychedelic therapy for PTSD, although the FDA advised that therapist misconduct is outside its control.

Advisory Committees Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

Advisory Committees Drug Review

Lilly’s Donanemab: US FDA's Questions Focus On Patient Selection, Dose Cessation

Given the frequent occurrence of ARIA and an imbalance of deaths in the pivotal TRAILBLAZER-ALZ 2 study, the agency also will ask the Peripheral and Central Nervous System Drugs Advisory Committee whether there are patient subgroups where the benefit-risk is more or less favorable.

Advisory Committees Drug Review

COVID-19 Vaccines: Novavax Gets Reprieve With US FDA Panel Supporting JN.1 Formulation

Advisory committee members said having Novavax’s protein-based vaccine available in the fall was important, but would not have been possible if a different variant strain were used. They also worried separate recommendations by vaccine type would cause confusion.

Advisory Committees Vaccines

Therapy Component Trips Up Lykos’ MDMA At US FDA AdComm For PTSD

Functional unblinding and vague psychotherapy guidance lead to two negative votes for Lykos’ pioneering psychotherapy-assisted psychedelic therapy at the US FDA’s Psychopharmacologic Drugs Advisory Committee.

Advisory Committees Drug Review

COVID Vaccines: US FDA Seeks Panel Vote On New Formulation Targeting JN.1 Variant

But agency wants discussion on considerations for the selection of a specific JN.1 lineage strain, such as the KP.2 subvariant, for the 2024-2025 formulation. Although JN.1 sublineages were predominant in the spring, KP.2 is now the most prevalent circulating strain in the US.

Advisory Committees Vaccines

Lykos’ MDMA Heads To AdComm With US FDA Concerns About Adverse Event Reporting

‘Short-term effects of midomafetamine were not captured’ in the clinical program for post-traumatic stress disorder, FDA notes. Proposed REMS for the psychedelic therapy to be discussed at 4 June would limit dispensing setting, restrict post-treatment driving.

Advisory Committees Drug Safety
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