Merck, Inc.

Formycon AG successfully completed patient enrollment for its Dahlia pharmacokinetic study with 96 participants, comparing biosimilar candidate FYB206 to Keytruda in melanoma patients.

BioInvent successfully developed a population model to characterize BI-1910 pharmacokinetics and pharmacodynamics across a broad dose range, supporting optimal dose selection for upcoming Phase 2a studies.

• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer. • Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy. • Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.

• The schizophrenia market is expected to grow significantly, driven by the launch of novel therapies and increased diagnosis rates. • Long-acting injectables (LAIs) are gaining traction despite higher costs, offering an alternative to oral antipsychotics. • The US dominates the schizophrenia market due to a large patient population and high drug costs. • Emerging treatments like Cobenfy, evenamide, Ingrezza, and iclepertin aim to address unmet needs in managing both positive and negative symptoms.

Long-term follow-up of the KEYNOTE-671 trial demonstrates that perioperative pembrolizumab plus chemotherapy continues to improve event-free survival (EFS) and overall survival (OS).

The Phase III LEAP-001 trial evaluated lenvatinib plus pembrolizumab versus chemotherapy as a first-line treatment for advanced or recurrent endometrial cancer.

Lupin secured tentative FDA approval for its generic version of Raltegravir 600mg tablets, a treatment for HIV-1 infection.

A phase II study (OLIE) found that adding lenvatinib to ifosfamide/etoposide did not significantly improve progression-free survival (PFS) in pediatric and young adult patients with relapsed osteosarcoma.

• Atezolizumab and nivolumab-based regimens failed to meet primary endpoints in improving disease-free survival (DFS) for resected renal cell carcinoma (RCC). • Pembrolizumab demonstrated a significant improvement in both DFS and overall survival (OS) as adjuvant therapy for patients with resected RCC at increased recurrence risk. • Ongoing trials are evaluating durvalumab, and the combination of belzutifan plus pembrolizumab, to further improve survival outcomes in this patient population. • Pembrolizumab is currently the only immunotherapy agent that has demonstrated improved outcomes and should not be substituted with other ICIs.

A phase 3 trial (ENGOT-en11/GOG-3053/KEYNOTE-B21) showed that adding pembrolizumab to adjuvant chemotherapy did not improve disease-free survival (DFS) in high-risk endometrial cancer patients.