Product Reviews & Approvals
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Approvals
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Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy
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.
Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod
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.
New EU Filings
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.
Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug
The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.
No Korea-Originated New Drugs Approved Domestically In 2023
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.
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
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.
Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
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.
J&J’s Carvykti Claims Broadest CAR-T Label In Multiple Myeloma
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.
Abecma Approval In Earlier Myeloma Carries Caution On Early Death Data
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.
Keeping Track: Cardio-Renal Drugs At Heart Of US FDA’s March Approval Binge
Seven novel agents approved in March include one accelerated approval, two rare pediatric disease priority review vouchers, two breakthrough therapy designations and one regenerative medicine advance therapy designation.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Drug Reviews
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Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod
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.
Generic Or Innovator? Sandoz Sues CMS Over Potential Change In Rebate Classification
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.
New EU Filings
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.
Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug
The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.
EMA Releases Guidance On How & When Its RWE Generation Service Can Be Used
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.
Pink Sheet Podcast: US FDA Adcomm Open Public Hearings, Clinical Trial Diversity Plans, Stealth’s Elamipretide
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.
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.
Adcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur
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.
Stealth’s Elamipretide Gets US FDA Review, But Same Questions Linger
The Barth Syndrome candidate application will be reviewed by the FDA, but Stealth BioTherapeutics' CEO tells the Pink Sheet that the company still does not have clear guidance on how or whether it should gather additional clinical data.
Abecma Approval In Earlier Myeloma Carries Caution On Early Death Data
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.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Pink Sheet Podcast: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA
Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.
Advisory Committees
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Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity
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.
US FDA Expects Joint AdComm Briefing Document, Oncology Chief Says
The combined format is the new default for briefing advisory committee members, US FDA Oncology Center of Excellence Director Pazdur declared.
Minimal Residual Disease Gains Max US FDA AdComm Support For Myeloma Trials
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 Podcast: US FDA Adcomm Open Public Hearings, Clinical Trial Diversity Plans, Stealth’s Elamipretide
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.
Minimal Residual Disease Inches Closer To Supporting Myeloma Accelerated Approvals
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.
Want Simpler US Vaccine Recommendations? Bring Better Evidence, Price To CDC, ACIP Head Says
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.
Adcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur
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.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Pink Sheet Podcast: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA
Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.
Pazdur’s Big Moment: ‘Project Odyssey’ Webinar Gives Oncology Chief External Buy-In On His Ideas To Revamp ODAC
OCE Director Richard Pazdur is known for cultivating 'Pazdur moments' during advisory committees when he feels the conversation has gone off track. A recent webinar with ODAC members created a perfect opportunity to promote his agenda.
US FDA Envisions Advisory Committees For Allergy, Asthma Biomarkers With ‘Real Impact’
Expert panels may be used to help the FDA decide when and how a new biomarker could be leveraged for regulatory purposes. Participants at workshop on allergy and asthma biomarkers also discuss need for standardization of food allergy trials and new trial design approaches.
US CDC’s Adult RSV Vaccine Recommendations In Flux With Impending FDA Approvals
Moderna touts enriched Phase II/III population and severe RSV data as CDC advisory committee re-evaluates shared clinical decision-making and prepares for expected June votes on Moderna’s mRNA-1345 and expanded adult use of GSK’s Arexvy.
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