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Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
Job Trends
Merck, known as MSD outside the United States and Canada, will hold its fourth-quarter and full-year 2021 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EST on Thursday, Feb. 3. During the call, company executives will provide an overview of Merck’s performance for the quarter and outlook.
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After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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The startup launches with $50 million to improve its Chemilogics platform, which is designed to speed up the identification and development of small molecule drug candidates.
Here are the top biotech companies in California hiring now on BioSpace’s life sciences–focused job board.
FDA
The FDA has approved Jardiance and Synjardy as the first SGLT-2 inhibitors to treat pediatric Type 2 diabetes, providing a new class of oral medicines.
Following an FDA warning in May, Novo Nordisk has filed several lawsuits against spas, clinics and pharmacies selling compounded version of semaglutide.
An International Chamber of Commerce arbitration tribunal has dismissed Boehringer’s attempt to seek indemnification from Sanofi for the ongoing Zantac lawsuits faced by the companies.
Biopharma executives suggested that some companies might seek to bypass the U.S. government’s national health insurance program altogether, among other sweeping changes to drug development.
The latest round of layoffs comes just two months after Thermo Fisher announced plans to close three sites in San Diego, bringing the total to nearly 600 jobs cut in 2023.
The study participant who died was apparently ineligible for the treatment according to the trial protocol, Arcellx announced Monday. The company has since retrained the study’s clinical sites.
Eli Lilly stands to gain access to DICE Therapeutics’ DELSCAPE platform, which enables the design of orally available molecules for autoimmune and inflammatory diseases.
FDA
Following the FDA’s approval in March, India-based Lupin is launching its generic thiamine hydrochloride injection USP in the U.S. for treating vitamin B1 deficiency.