With peptides, oligos and peptide conjugates continuing to attract drug developer interest and industry capacity in short supply, WuXi AppTec last week reported its Changzhou site has been approved by Japan’s PMDA [Pharmaceuticals and Medical Devices Agency}. The 3-day inspection was passed without any major findings and follows on from the continuing expansion plans announced late last month during DCAT.  The new investments cover several large sites, including the 169-a

Eisai Co., Ltd. announced today that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan. The injection formulation of Fycompa received manufacturing and marketing approval on January 18, 2024 and was included in the Japan’s National Health Insurance (NHI) Drug Price List today. Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories

Immutep Limited, a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (1L NSCLC). Immutep SVP, Regulatory & Strate

PureTech Health plc, a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF). LYT-100 is a deuterated form of pirfenidone, which is one of the two standard-of-care treatments, along with nintedanib, approved to treat IPF. Both pirfenidone and ninte

Actinogen Medical Limited announces that the first patient has been randomized and treated in the XanaMIA phase 2b clinical trial in patients with biomarker-positive mild to moderate Alzheimer's disease. This represents the culmination of the site and screening setup phase of the trial when patient pre-screening for elevated levels of the pTau blood biomarker commenced at multiple clinical sites. The XanaMIA trial is a double-blind placebo-controlled randomized trial design whic

Pulmocide Ltd., a late-stage biopharmaceutical company developing novel inhaled therapies for patients suffering from serious acute and chronic respiratory diseases, today announced topline results from the OPERA-S study: a Phase 2 safety and tolerability study in lung transplant patients receiving inhaled opelconazole monotherapy as prophylaxis against pulmonary aspergillosis. Opelconazole is an investigational inhaled triazole antifungal being developed to prevent and treat pulmonary asperg

Enliven Therapeutics, Inc., a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced positive proof of concept data from the Phase 1 clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377). ELVN-001 is a potent, highly selective, potentially best-in-class sm

ViGeneron GmbH, a next-generation clinical-stage gene therapy company, today announced that the first patient has been dosed in its Phase Ib clinical trial evaluating intravitreal injection of VG901 to treat retinitis pigmentosa (RP) caused by mutations in the CNGA1 gene. This milestone marks an important advance as the company continues to leverage its next-generation technology platforms to develop groundbreaking gene therapies addressing critical unmet medical needs. “By de