News and Trends 9 Jan 2023 Selecta and Astellas sign LOPD treatment agreement Selecta Biosciences, Inc. and Astellas Pharma Inc. have announced an exclusive licensing and development agreement for IdeXork (Xork). Xork is being studied as a potential next generation immunoglobulin G (IgG) protease that will be developed by Astellas for use with AT845, an investigational, adeno-associated virus (AAV)-based treatment for late-onset Pompe disease (LOPD) in adults. Pompe […] January 9, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 9 Jan 2023 Rani Therapeutics provides pipeline update Rani Therapeutics Holdings, Inc. has completed a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) with respect to RT-102, the RaniPill GO containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis, and provided a corporate update. Following feedback from the meeting with […] January 9, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 9 Jan 2023 Alentis reports positive results from fibrosis study Alentis Therapeutics has announced positive results from a single ascending dose phase 1 study of its lead program, ALE.F02, currently in development for the treatment of advanced kidney, lung and liver fibrosis. The study found ALE.F02 to be well tolerated in healthy volunteers at all doses with a good safety profile and demonstrated initial evidence […] January 9, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 6 Jan 2023 Transgene approved for IV oncolytic virus trial Transgene has received clinical trial application (CTA) approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a phase I clinical trial of TG6050. TG6050 is a novel oncolytic virus (OV) that will be administered intravenously in patients with advanced non-small cell lung cancer (NSCLC). Transgene is […] January 6, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 4 Jan 2023 Actimed Therapeutics raises £10M for cancer cachexia treatment Actimed Therapeutics Ltd has completed its second and final £5 million ($6 million) tranche of seed financing. The round was closed with an investment by Indian pharmaceutical company, Mankind Pharma, marking Mankind’s first overseas investment of this type. Actimed Therapeutics is a U.K. based clinical stage specialty pharmaceutical company focused on bringing innovation to the […] January 4, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Jan 2023 Janssen looks for talquetamab marketing approval The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug […] January 3, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Jan 2023 Legend Biotech new drug application approved in China Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its new drug application (NDA) for ciltacabtagene autoleucel (cilta-cel). This submission is based on data from the confirmatory phase 2 clinical study CARTIFAN-1, conducted in China, which evaluated the efficacy and safety of cilta-cel in adult patients with relapsed or […] January 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Jan 2023 Newron announces interim results from treatment-resistant schizophrenia trial Newron Pharmaceuticals S.p.A. has announced what it says are “very compelling new results” from the first 100 enrolled patients to have reached the six-month timepoint in its international study of evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS), who were not responding to their current […] January 3, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Jan 2023 Sensorion announces first patient enrolled in cisplatin-induced ototoxicity trial Sensorion has announced that the first patient has been enrolled in its phase 2a proof of concept clinical trial of SENS-401 (Arazasetron) in patients suffering from cisplatin-induced ototoxicity. Cisplatin and other platinum-based compounds are essential chemotherapeutic agents for many cancers. A serious side effect of these therapies is ototoxicity, or permanent and irreversible hearing loss, […] January 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 22 Dec 2022 First CAR-T technology trial for patients with T-cell leukemia subtype authorized The Spanish Agency of Medicines and Medical Products (AEMPS) has approved the CARxALL clinical trial led by the company OneChain Immunotherapeutics (OCI). It will be the world’s first trial with CAR-T technology for patients with a subtype of T-cell leukemia. The CARxALL trial will evaluate, for the first time, the CAR-T CD1a (OC-1) therapy. This […] December 22, 2022 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 22 Dec 2022 Positive Dupixent eosinophilic esophagitis phase 3 results The New England Journal of Medicine has published results from a positive phase 3 trial showing adults and adolescents treated with Dupixent (dupilumab) 300 mg weekly experienced significant improvements in signs and symptoms of eosinophilic esophagitis (EoE), which were sustained for up to one year. EoE is a chronic, progressive inflammatory disease that damages the […] December 22, 2022 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 21 Dec 2022 Watch: Mauritius – clinical trials and emerging biotech hub The Economic Development Board (EDB) in Mauritius commenced its operations as a statutory body in 2018 following the merger between the Board of Investment, Enterprise Mauritius and the Financial Services Promotion Agency. The overarching objective of the EDB is to ensure greater coherence and effectiveness in implementing policies and draw the vision for the economic […] December 21, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email