Coherus Biosciences has announced its acquisition of Surface Oncology for up to $65m, which is expected to close in Q3 2023. The deal will see Surface shareholders receive Coherus Biosciences stock as consideration. This move is significant for Coherus, which is launching biosimilar Yusimry in July and currently markets biosimilars of Neulasta and Lucentis. The acquisition will provide Coherus a..
Merck has announced that its blockbuster drug Keytruda met one of its primary endpoints in a Phase III trial for patients with esophageal cancer. The results are an important step toward full approval of the drug for this indication. Merck is now working with the FDA to update the current indication for Keytruda "to those patients whose tumors are PD-L1 positive" following positive results from ..
The FDA advisory committee has given unanimous approval for Eisai and Biogen’s Alzheimer’s drug Leqembi to receive traditional approval. However, concerns remain about the safety of the drug in certain subgroups such as people with two copies of the ApoE ε4 allele, a known genetic risk factor in the development of Alzheimer’s disease. The FDA is expected to make a decision on full approval by Ju..
Molecular Templates, a clinical-stage biopharmaceutical company focused on developing targeted biologic therapeutics for cancer, has announced a restructuring agreement with K2 HealthVentures to fully discharge and satisfy outstanding debt obligations. The agreement also includes the granting of contingent value rights and warrants. Molecular Templates will reduce its current workforce by approx..
Hoth Therapeutics has received approval from the University of Texas MD Anderson Cancer Center Institutional Review Board (IRB) to proceed with its First-in-Human Phase 2a clinical trial of HT-001. This milestone marks multiple sites hosting the trial, as Washington University of St Louis previously approved it as well. The randomized, placebo-controlled, parallel Phase 2a dose-ranging study aim..
Amneal Pharmaceuticals has received 505(b)(2) New Drug Application (NDA) approval from the US Food and Drug Administration for PEMRYDI RTU, a ready-to-use presentation of pemetrexed for injection. The treatment is indicated in combination with pembrolizumab and platinum chemotherapy for initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK geno..
Clinical stage AI drug discovery company, MindRank, has announced the start of its first-in-human (FIH) Phase 1 study of MDR-001 in China. The proprietary glucagon-like peptide 1 receptor agonist (GLP-1 RA), which is an oral small-molecule designed to treat obesity and type 2 diabetes mellitus (T2DM), was discovered using MindRank's Molecule Pro AI platform. The FIH Phase 1 trial will evaluate t..
IO Biotech, a clinical-stage biopharmaceutical company focused on developing immune-modulating cancer vaccines, has achieved a significant milestone in its global Phase 3 clinical trial for IO102-IO103. The company has randomized 225 patients with advanced melanoma in combination with pembrolizumab. The trial protocol calls for an interim analysis of overall response rate one year after the enro..
A Vermont mother shares her experience of how a common cough led to the diagnosis of her baby's rare, incurable, and deadly disease. Christian Leduc was diagnosed with hypomyelination with atrophy of the basal ganglia and cerebellum (H-ABC), which is a severe form of TUBB4A leukodystrophy - a rare, debilitating and life-threatening genetic disease that mainly affects babies and children. The dis..