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Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Keeping Track Feature image

The US FDA’s high-profile approval of a broad, breakthrough-designated heart failure indication for Eli Lilly and Company/Boehringer Ingelheim GmbH’s Jardiance was a ray of sunshine in a week dominated by bad news, from complete response letters for Mallinckrodt plc’s terlipressin and Reata Pharmaceuticals, Inc.’s bardoxolone to a refuse-to-file letter for Allarity Therapeutics A/S’s dovitinib and delays in the FDA reviews of United Therapeutics Corporation/MannKind Corporation’s Tyvaso DPI and Rhythm Pharmaceuticals, Inc.’s Imcivree.

Provention Bio, Inc., however, looked to the future in disclosing its plans, in agreement with FDA, for the resubmission of teplizumab after a June 2021 CRL. New indications were...

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Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
• By Neena Brizmohun

The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.