A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

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.

The US FDA approved Day One’s pediatric brain cancer drug Ojemda, ImmunityBio’s bladder cancer immunotherapy Anktiva, an uncomplicated UTI claim for Utility Therapeutics’ Pivya, which has a long history in Europe, and Pfizer’s hemophilia B gene therapy Beqvez.

The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.

Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.

Notable new drug approvals in South Korea last year included Pfizer’s Tukysa, Genentech’s Columvi and BeiGene’s Tevimbra, but the tally did not include any domestically-originated products. Alzheimer’s disease therapy lecanemab may be on the horizon this year.

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.

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

The second-line indication comes with safety labeling recently approved for BCMA-targeted CAR-T competitor Abecma, particularly around increased early mortality and secondary malignancies.

Labeling describes early death imbalance that delayed approval of Bristol Myers Squibb’s CAR-T therapy for more than three months after its user fee goal, but does not add to boxed warning; J&J’s Carvykti is due for imminent US FDA action on its own early-stage myeloma bid.

The Swiss agency says the aim of the agreement is to bring “high-quality, life-saving medicines to patients as quickly as possible.”

The FDA’s drug center has all but stopped holding meetings at this point, which begs the question: why do they want advice on how to make them better?

The MHRA’s regulatory strategy on AI outlines key areas where this technology could be used to improve the agency’s own processes, and says that the use of AI to develop drugs will not change the questions it asks companies.

The agency seeks feedback at a 13 June virtual hearing on three general topics related to advisory committees: panel composition, barriers to service for Special Government Employees, and public perception and understanding of the adcomm process.

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.

The EU and Korean authorities say the agreement will allow them to further develop moves towards mutual recognition and regulatory harmonization.

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

The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.

Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.

Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.

New EU guidance outlines the process through which scientific committees, national competent authorities and other relevant decision-makers can request real-world evidence studies for regulatory purposes.

The CDC’s Melinda Wharton discusses how the ACIP handled COVID-19 and how the pandemic will shape the committee’s work in the future. 

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort, the agency’s efforts to help clinical trial modeling and simulation, and the UK’s MHRA plan to use artificial intelligence to assist in drug reviews.

The FDA’s drug center has all but stopped holding meetings at this point, which begs the question: why do they want advice on how to make them better?

The agency seeks feedback at a 13 June virtual hearing on three general topics related to advisory committees: panel composition, barriers to service for Special Government Employees, and public perception and understanding of the adcomm process.

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

The Centers for Disease Control and Prevention’s ACIP is not able to take on all vaccine-like preventative medicines and still has to grapple with how to handle therapeutic vaccines. 

The combined format is the new default for briefing advisory committee members, US FDA Oncology Center of Excellence Director Pazdur declared.

The US FDA’s Oncologic Drugs Advisory Committee unanimously agreed that accelerated approvals should be enabled by multiple myeloma trials using MRD as a surrogate endpoint.

Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings, agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans, and the pending review of Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide.

US FDA’s oncology advisory committee will discuss two meta-analyses supporting use of MRD as a surrogate endpoint to support accelerated approval in multiple myeloma trials.

As sponsors complain about difficult-to-implement ACIP recommendations hampering uptake, the government says developers share some of the blame, but adds that it is working to ensure recommendations can be operationalized. 

Oncology Center of Excellence Director Richard Pazdur says he would like to see more diverse views during the OPH session, not just individuals curated by the sponsor to present ‘a very positive picture’ of the drug. An upcoming ODAC meeting will have everyone in-person except the OPH speakers, public and press.