GlaxoSmithKline

FDA revoked EUA for sotrovimab on GSK's request due to expired lots and nonsusceptible SARS-CoV-2 variants.

The ZEST trial, evaluating niraparib for breast cancer recurrence prevention, was terminated early due to low ctDNA detection post-treatment. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients for future trials.

iTeos Therapeutics has deprioritized inupadenant for non-small cell lung cancer due to disappointing mid-stage data, focusing instead on TIGIT therapies. The Phase II A2A-0005 trial showed inupadenant met safety but not efficacy endpoints, with an objective response rate similar to standard treatments.

Mintz advised Relation on a $15 million equity investment from GSK, involving two strategic collaborations for novel therapeutics development in fibrotic diseases and osteoarthritis. Relation received an upfront $45 million, with potential success-based payments and royalties. The Mintz team was led by Lewis Geffen and Sarah Palmer.

The global Duchenne muscular dystrophy market was valued at US$2.2 billion in 2023 and is projected to grow at a CAGR of 11.7% to reach US$7.4 billion by 2034, driven by advancements in gene therapy, novel treatment approvals, and increased awareness.

Momelotinib showed improved overall survival vs best available therapy in ruxolitinib-pretreated myelofibrosis patients, with median OS benefits in both overall and anemic subgroups, according to a matching-adjusted indirect comparison analysis presented at the 2024 ASH Annual Meeting & Exposition.

Ionis Pharmaceuticals awaits FDA decision on olezarsen by Dec. 19, a therapy for familial chylomicronemia syndrome with potential for broader use. CEO Brett Monia shifted strategy to develop drugs independently, aiming to maximize value for both company and patients.

Study MET59 evaluated meningococcal antibody persistence 3–6 years after priming with MenACYW-TT or MCV4-CRM vaccines in adolescents, and immune response post-booster with MenACYW-TT. Results showed immune response persistence and robust booster response, supporting ACIP's recommended priming at 11–12 years and booster at 16 years.

ASH 2024 highlights include GSK's Blenrep Phase 3 data supporting re-market, J&J's Darzalex Faspro delaying progression in smoldering multiple myeloma, Arcellx's anito-cel showing comparable safety to Carvykti, and J&J/Legend's Carvykti improving survival outcomes. Kura Oncology's ziftomenib showed high response rates in leukemia, Eli Lilly's Jaypirca reduced disease progression risk, and Merck's zilovertamab vedotin achieved high complete response rates in lymphoma. Beam Therapeutics' BEAM-101 showed durable effects in sickle cell disease, Novo Nordisk's etavopivat reduced crises, and Bristol Myers Squibb's arlo-cel demonstrated durable responses in multiple myeloma. Galapagos' GLPG5101 showed encouraging cell therapy results, Orca Bio's Orca-T improved survival in blood cancers, and Sanofi's rilzabrutinib improved platelet response in thrombocytopenia. Regeneron's drug combo showed better disease control than Ultomiris in PNH.

JAK2 inhibitors pacritinib and momelotinib improved anemia and transfusion requirements in myelofibrosis patients, with favorable hematologic responses, though long-term follow-up is needed.