GlaxoSmithKline

Scope of Things covers a Graves’ disease trial, diagnostic tampon recruitment, Walgreens-BARDA partnership, AI aiding trial diversity, and exclusions in cancer studies.

Precision Medicine Group appoints Margaret Keegan as CEO, succeeding Mark Clein who becomes Executive Chairman. Co-founders Clein and Ethan Leder remain on the Board. Precision, founded in 2012, specializes in drug development and commercialization services.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.

The BIOSECURE Act aims to reduce US dependence on Chinese biopharma manufacturing, impacting supply chains and partnerships. The bill, passed by the House, restricts government contracts with Chinese 'biotechnology companies of concern,' affecting ~80% of US biopharma firms reliant on Chinese CDMOs. Industry responses include investment in biomanufacturing capacity and strategic partnerships, with new contracts with Chinese partners declining since the Act's introduction.

Dupixent, a drug by Sanofi and Regeneron, has received FDA approval for treating COPD, becoming the first biologic therapy for the condition. The drug targets type 2 inflammation driven by eosinophils, showing significant reductions in COPD exacerbations in Phase 3 trials. Dupixent has previously been approved for dermatitis and asthma, contributing to €10.7 billion in sales in 2023.

Immunomodulatory agents, monoclonal antibodies, bispecific antibodies, and CAR T-cell therapy have transformed multiple myeloma treatment. Despite improvements, MM remains incurable, prompting research into protein degradation and immune system activation. The triSpecific antibody JNJ-79635322 targets BCMA, GPRC5D, and CD3, showing promise in preclinical trials. Other approaches include BCMA-targeting ADCs like belantamab mafodotin and small molecule E3 ligase modulators like mezigdomide, aiming to enhance immunotherapies and prolong patient survival.

Immunotherapies are crucial for multiple myeloma (MM) but face resistance and relapse. Proteasome inhibitors (PIs) and targeted therapies like BCL2 and BRAF/MEK inhibitors offer alternatives. Clonal evolution and subclonal mutations drive disease progression. Combination therapies, including melphalan, increase mutational load. Resistance to lenalidomide and anti-CD38 antibodies is common, but combinations like carfilzomib, daratumumab, and dexamethasone improve progression-free survival (PFS). BCMA-targeted antibody-drug conjugates (ADCs) show promise. Targeted inhibitors for BCL2, BRAF/MEK, and NSD2 benefit refractory patients. Despite clinical promise, access to these therapies is limited, highlighting the need for cost-effective treatments and innovative approaches.

FDA approves Regeneron and Sanofi's Dupixent for COPD, making it the first biologic treatment for the condition. Dupixent, an interleukin-4 receptor alpha antagonist, showed reduced exacerbations and improved lung function in Phase III studies. The approval follows failures of GSK's Nucala and AstraZeneca's Fasenra in COPD trials.

Sanofi and Regeneron's Dupixent is the first biologic approved in the U.S. for COPD, potentially benefiting 300,000 adults with poorly controlled disease. Dupixent showed a 30-34% reduction in COPD exacerbations in Phase III studies and is consistent with existing safety profiles. The approval adds to Dupixent's list of FDA-approved indications, including asthma and eczema, with anticipated sales of $3.5 billion from the COPD approval. Competitors like GSK, AstraZeneca, and Amgen are also developing treatments for COPD.