Research & Development

FDA clears MSD’s Keytruda combo plus Welireg for ccRCC treatment

Merck & Co (MSD) has received approval from the US Food and Drug Administration (FDA) for both Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Welireg (belzutifan), as adjuvant treatment for adults with renal cell carcinoma with a clear cell component (ccRCC).

China’s NMPA approves Akeso’s gumokimab for plaque psoriasis

Akeso has received approval from China’s National Medical Products Administration (NMPA) for gumokimab (AK111), an anti-Interleukin-17 (IL-17) monoclonal antibody, to treat adults with moderate-to-severe plaque psoriasis.

XtalPi enters $400m partnership for small molecule therapy for GPCR target

XtalPi has entered a strategic partnership valued at more than $400m with an international biopharmaceutical company to develop oral small-molecule therapeutics targeting a G protein-coupled receptor (GPCR).

Aditxt and Ignite announce merger plans with strategic partner

Health innovation platform developer Aditxt and its fully owned subsidiary Ignite Proteomics have announced their plans for a business combination with a strategic partner that values the latter at an implied equity value of nearly $150m.

MHRA to roll out new AI sandbox for medicines development

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to launch a new AI sandbox to expedite the development of medicines and improve safety.

J&J to acquire Firefly Bio for $1bn to enhance oncology pipeline

Johnson & Johnson (J&J) has agreed to purchase Firefly Bio for $1bn in cash, aiming to strengthen its oncology pipeline with Firefly Bio’s proprietary Firelink degrader-antibody conjugate (DAC) platform.

Sanofi and Owkin partner to develop next-generation biopharma AI agents

Sanofi has entered a multi-year agreement with France-based agentic AI company Owkin to co-develop next-generation AI-driven biopharma agents.

Pfizer signs licence agreement with Chai for AI drug discovery

Pfizer and Chai Discovery have agreed on a licensing deal enabling the former to incorporate Chai’s AI platform into its drug discovery operations.

Cellares and TScan to assess automated manufacturing of TSC-101 therapy

Cellares and TScan Therapeutics have entered an agreement to examine the use of automated manufacturing for TScan’s TSC-101 therapy in patients with acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS).