BioSpace

Unable to align with the FDA on a potential registrational clinical trial of immunoproteasome inhibitor zetomipzomib in patients with autoimmune hepatitis (AIH), Kezar Life Sciences will lay off employees. Learn more in our layoff tracker. #layoffs #biopharma #biospace https://hubs.li/Q03P7yk_0

CMS Administrator Mehmet Oz clarified that a deal has not yet been sealed with the manufacturer of semaglutide, Novo Nordisk or any other GLP-1 drugmaker. #GLP1 #drugpricing #biospace https://hubs.li/Q03P7lXf0

Roche will gain worldwide rights outside of the Greater China region to Hansoh’s HS-20110, an antibody-drug conjugate in early-stage development for colorectal cancer. #ADC #biospace https://hubs.li/Q03P5Pbq0

The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting domestic manufacturing and lowering drug prices—with faster reviews and more frequent interactions with the FDA. #regulatory #FDA #vouchers #biospace https://hubs.li/Q03P5PL20

With more than $1.5 billion on the line, Gilead Sciences looks to bolster its CAR T portfolio. #celltherapy #biospace https://hubs.li/Q03P5z_x0

EMD Serono will offer its fertility treatments on TrumpRx at a steep discount, and Roche’s direct-to-consumer offering will cover its flu pill Xofluza. #drugpricing #biospace https://hubs.li/Q03P5yL10

As part of its restructuring that includes cutting about 9,000 employees globally, Novo Nordisk is reportedly laying off U.S. employees this week and continuing into next week. Learn more in our layoff tracker. #layoffs #biopharma #biospace https://hubs.ly/Q03NXgjf0

Due largely to CSL, Merck and Novo Nordisk's reorganizations that could total about 19,350 people, Q3 cuts rose significantly year over year and quarter over quarter, based on BioSpace tallies. #layoffs #biopharma #biospace https://hubs.ly/Q03NX8540

The partners have yet to disclose what their priority indications are, though EVOQ’s NanoDisc technology aims to enable the development of potentially curative treatments for autoimmune conditions such as celiac disease and type 1 diabetes. #autoimmune #disease #biospace https://hubs.li/Q03NVRC70

An unnamed source clarified that Sandra Retzky has not been fired from the FDA, but it remains unclear where she was reassigned. #FDA #government #biospace https://hubs.li/Q03NVWQy0