BioSpace

Ladenburg, Germany–based Heidelberg Pharma AG is laying off 75% of its staff after the company failed to meet the conditions for a royalty payment. #layoffs #pharma #biospace https://hubs.li/Q03Ll-bg0

After Emma Walmsley steps down as GSK CEO in January, Vertex Pharmaceuticals’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again. #editorial #pharma #biospace https://hubs.li/Q03LlPhD0

Chief Commerical Officer Luke Miels will replace outgoing GSK CEO Emma Walmsley at the U.K. pharma next year. #csuite #pharma #biospace https://hubs.li/Q03Llkhz0

The AAV pullback comes amid Biogen's aggressive cost-cutting campaign, which put some 1,000 jobs on the chopping block with the goal of generating $1 billion in savings by 2025. #layoffs #pharma #biospace https://hubs.li/Q03LkhW-0

Applied Therapeutics, Inc. has yet to confirm whether the study, posted on Clinicaltrials on Thursday, means it has indeed aligned with the FDA on govorestat’s development. #rarediseases #clinicaltrials #biospace https://hubs.li/Q03LkhV_0

The centerpiece of the acquisition is petosemtamab, Merus’ bispecific antibody targeting EGFR and LGR5, which in May demonstrated best-in-class potential for head-and-neck cancer. #acquisition #cancer #biospace https://hubs.li/Q03LkhnS0

The FDA in September issued two rejections for spinal muscular atrophy therapies—both linked to manufacturing problems—and granted approvals in Barth syndrome and for a subcutaneous version of Merck’s Keytruda that could be key to the blockbuster’s future earnings. #rarediseases #pharma #biospace https://hubs.li/Q03Lklrm0

By publishing complete response letters as soon as they are issued to drug sponsors, the FDA is expanding transparency in a way that, while positioned as a public health measure, also grants investors greater visibility into regulatory decisions. Experts question whether this is the agency’s proper remit. #FDA #regulatory #investors #biospace https://hubs.li/Q03LjLN50

In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency authority, a judge ruled that the FDA does not have authority to regulate tests developed by clinical laboratories. #opinion #FDA #biospace https://hubs.li/Q03LjXbK0

🔔 BioSpace Senior Editor Annalee Armstrong will join the first session of The Briefing Room, produced by ENTENTE Network and Demy-Colton on 📅 October 1. Policy Pressure: Communicating at the Speed of Change Policy shifts are reshaping the landscape of science and innovation—drug pricing reforms, evolving regulatory expectations, and new funding realities are forcing communications teams to adapt faster than ever. In this first session of The Briefing Room, I’ll be joining a great panel of experts to explore how policy turbulence is transforming messaging, positioning, and public trust in life sciences. Don’t miss the conversation—register here: https://hubs.li/Q03LjSVv0 #TheBriefingRoom #Communications #BioPharma #Leadership #LifeSciences #Innovation