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Sotio Biotech

July 2025 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions

by Jakub Jarolím, Business Intelligence Department

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Market

Trump demands pharmas provide “most favored nation pricing” for Medicaid drugs

The FDA's top vaccine official, Vinay Prasad, has left the agency after just three months as Director of CBER. President Trump demands pharmas provide “most favored nation” pricing for Medicaid drugs, prices that are lower than those in other developed countries. NBI added 5 % during July.

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Antibody-Drug Conjugates

Blenrep combinations approved in EU for treatment of R/R multiple myeloma

Pfizer announced that FDA has approved the supplemental BLA for Adcetris in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.

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Interleukin-15 and Interleukin-2

UK MHRA approved Anktiva plus BCG for BCG-unresponsive NMIBC in situ

ImmunityBio announced that the UK’s MHRA has granted marketing authorization for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with BCG for the treatment of certain bladder cancer patients.

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Cell Therapies

Turnstone Biologics entered into agreement to be acquired by XOMA

Cellecta, a company active in functional genomics and immune profiling technologies, announced the launch of its new DriverMap Single-Cell Adaptive Immune Receptor (scAIR) TCR-BCR assay product line, a groundbreaking solution for delivering chain-pairing information from full-length T-cell and B-cell receptor chains, without the need for specialized instrumentation or complex workflows.

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Other Innovative Treatment Areas

FDA received complete response letter from FDA for Columvi in DLBCL

Genentech announced that FDA issued a Complete Response Letter (CRL) for Genentech’s supplemental BLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant.

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DISCLAIMER / SOTIO

Legal Notice 7/25

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