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R&D In Brief: Imaging Agent Approvals, EULAR Updates, Post-ASCO Cancer Data

 
• By Lisa LaMotta and Jessica Merrill

FDA approves new oncology imaging agents and a long-acting hemophilia drug; Sanofi/Regeneron present positive Phase III on RA drug sarilumab; biosimilar infliximab shows no meaningful differences to Remicade; Imbruvica response rates improved with umblituximab; Cyramza fails survival endpoint in liver cancer.

FDA approved new indications for two imaging agents that help physicians identify certain types of tumors. Bayer HealthCare LLC’s magnetic resonance contrast agent Gadavist (gadobutrol) was cleared June 11 to be used with MRI to identify malignant breast tissue. The approval was based on two Phase III studies, GEMMA-1 and GEMMA-2, which included 787 patients and showed that the Gadavist-enhanced MRI improved identification of breast cancer over MRI alone. Gadavist was initially approved in March 2011 to detect disrupted blood brain barrier or abnormal vascularity of the central nervous system Also see "Gadavist Dosing Complexities To Be Handled With Packaging, Not REMS" - Pink Sheet, 15 March, 2011..

On June 13, FDA approved Navidea Biopharmaceuticals Inc.’s radioactive diagnostic imaging agent Lymphoseek (technetium 99m tilmanocept) to identify sentinel lymph nodes in patients with head and neck cancer; the...

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More from United States

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

More from North America

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.