Policy
Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.
FEATURED STORIES
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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The FDA has granted a rolling review to CRISPR Therapeutics and Vertex’s exa-cel, a potential one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
The U.S. Equal Employment Opportunity Commission filed a lawsuit Monday against Eli Lilly and Co. alleging the company refused to hire older workers for sales representative positions.
In the ongoing proxy battle between London-based Mereo BioPharma Group and Rubric Capital Management, Mereo outlined the outcome of the most recent negotiations, which Rubric rejected.
Daiichi Sankyo won approval in Japan for Ezharmia, making it the first dual inhibitor of EZH1 and EZH2 to receive regulatory approval for ATL.
In an 8-4 vote, the FDA’s Oncologic Drugs Advisory Committee Roster voted against the benefit-risk profile of Secura Bio’s P13K inhibitor Copiktra (duvelisib).
The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-2 against Oncopeptides’ Pepaxto, a drug that has been on the market since 2021 for multiple myeloma under accelerated approval.
The FDA will meet Friday to discuss the future of Secura Bio’s Copiktra (duvelisib), which has been approved as a third-line treatment for relapsed or refractory CLL/SLL.
Merck announced positive results on its patent infringement case against Viatris, while Amgen faces political headwinds from the White House.
The U.S. FDA had a busy week with a range of drug approvals, advisory committee meetings and classification announcements.