GSK CEO Emma Walmsley steps down
Emma Walmsley will leave her CEO role in December, but will remain with the company through her contractual notice period until September 2026. Her replacement will be Luke Miels, who is currently the company’s chief commercial officer. He will take on the CEO role as of January 1.
Walmsley became GSK’s chief executive in 2017, making her the first woman to lead a major global pharmaceutical company. During her time at the helm, she oversaw a period of significant restructuring, including the demerger of GSK’s consumer health business into Haleon, and a renewed focus on vaccines and specialty medicines. Prior to joining GSK in 2010, she spent 17 years at L’Oréal.
In a statement, Walmsley said: “2026 is a pivotal year for GSK to define its path for the decade ahead, and I believe the right moment for new leadership. As CEO, you hope to leave the company you love stronger than you found it and prepare for seamless succession. I’m proud to have done both - and to have created Haleon, a new world-leader in consumer health. Today, GSK is a biopharma innovator, with far stronger momentum and prospects than nine years ago. Most importantly, the inspiring people in our labs, factories, and markets worldwide are delivering innovation that matters to get ahead of disease. I know Luke will lead them brilliantly to even greater impact for patients. I look forward to supporting this transition and to cheering GSK’s future success as I begin my own new adventures.”
AstraZeneca and Cellectis face gene editing lawsuit
Factor Bioscience has filed a complaint in the US District Court for the District of Delaware against Cellectis and AstraZeneca, alleging infringement of gene editing patents. According to a statement, Factor alleges that Cellectis “transformed its research program after learning about Factor's patented mRNA TALENs technology in 2013 and proceeded to illegally exploit that technology, including in its partnership with AstraZeneca, by infringing Factor's patents.”
The lawsuit focuses on the infringement of Factor’s 10,662,410, 10,829,738, and 10,982,229 US patents.
Verismo teams up with Miltenyi
Verismo Therapeutics has agreed a partnership with Miltenyi Biotec to support the advancement of its clinical programs. Under the agreement, Miltenyi’s CDMO, Miltenyi Bioindustry, will provide lentiviral vector for Verismo’s STAR-101 clinical trial. Verismo confirmed that it has already manufactured its first clinical cell therapy product (SynKIR-110) using vector supplied by Miltenyi. The therapy is based on Verismo’s proprietary KIR-CAR platform and designed to target mesothelin, a protein expressed in a range of solid tumors.
Amgen invests in Puerto Rico
Amgen says it will invest $650 million to increase drug production and implement advanced technologies at its biologics facility in Juncos, Puerto Rico. The investment is part of a broader strategy to expand US production capabilities. Approximately 750 jobs will be created, including both construction-related roles and long-term positions in manufacturing. “This expansion underscores Amgen's commitment to U.S. biomanufacturing and to strengthening the resilience of our global supply chain,” said Amgen CEO Robert A. Bradway. “By growing our capacity to deliver innovative medicines with cutting edge technology in our manufacturing plants, we will not only better serve patients but also create high-quality jobs that reinforce America's leadership in biotechnology.”
Capricor provides update on previously rejected therapy
Capricor Therapeutics has issued an update on the regulatory status of its investigational Duchenne muscular dystrophy (DMD) cell therapy, deramiocel. The company met with the FDA in a Type A meeting after its previous attempt to seek approval for the therapy was rejected earlier in 2025. At that time, the FDA determined that existing clinical data were not sufficient to support a biologics license application.
Capricor says the FDA has now provided a clearer path forward and that the HOPE-3 pivotal trial will fulfill the “additional study” requested in the agency’s Complete Response Letter.
“We are encouraged by the outcome of our discussions with the FDA, which provided clarity on our regulatory strategy and reinforced the opportunity to deliver HOPE-3 data as the basis for approval, should it meet regulatory requirements,” said Linda Marbán, CEO of Capricor. “The results from the HOPE-2 and HOPE-2-OLE studies have already demonstrated clinically meaningful and statistically significant benefits in both cardiac and skeletal muscle function, and HOPE-3 is designed to further validate these findings in an adequate and well-controlled study. With HOPE-3 completed and data expected later this year, we remain confident in our ability to advance Deramiocel toward potential approval.”
PHC Corporation receives 2025 R&D award
PHC Corporation’s Biomedical Division has been named a winner of the 2025 R&D 100 Awards for its live cell metabolic pathway analyzer, LiCellMo. The awards, established in 1963, highlight 100 technologies each year that represent significant contributions to science and innovation. By tracking key indicators such as glucose and lactate levels, the device allows researchers to observe cell state transitions without the risks associated with conventional sampling methods. The analyzer integrates directly into compatible CO₂ incubators, making it possible to study cellular activity without disrupting culture conditions.
Chikara Takauo, Director of PHC Corporation and Head of the Biomedical Division, said: “We are deeply honored that LiCellMo has been recognized with an R&D 100 Award. This innovation empowers researchers with new insights into cell metabolism, particularly in cancer immunology and stem cell research, and supports the advancement of manufacturing processes for next generation therapies.”
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