News and Trends 12 Jan 2023 Breast cancer most studied disease area in 2022 Phesi, a global provider of patient-centric data analytics, has released the results of its global analysis of all clinical trials conducted in 2022. The report, which analyzed 80,917 trial records, reveals that breast cancer retained its position as the most-studied disease area, followed by COVID-19. Three of the top five most-studied disease areas fell within oncology, […] January 12, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 11 Jan 2023 Renexxion goes to FDA with cystic fibrosis drug Renexxion Ireland Limited has opened an investigational new drug (IND) application with the U.S Food and Drug Administration (FDA) for naronapride for the treatment of GI motility disorders in patients with cystic fibrosis (CF). This is a first step towards conducting clinical trials of the drug candidate in CF patients. Naronapride, post approval, could be […] January 11, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 11 Jan 2023 What the new year holds for clinical research Catherine Gregor is the chief clinical trial officer at Florence Healthcare. The company’s clinical trial software is used in more than 12,000 research sites in 45 countries for management of documents, data, and workflows. We asked Gregor about the clinical trial technology landscape in 2023. Why is remote clinical research connectivity so important? Remote connectivity […] January 11, 2023 - 6 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 11 Jan 2023 Clinical trends for 2023 By Richard Staines, account director, Optimum Strategic Communications Few would deny that the decade has had a turbulent start, but after the tragedies of the COVID-19 pandemic and the Ukraine war, there’s hope that 2023 will see a new wave of clinical research. Exciting new technologies such as gene editing, gene therapy and a next […] January 11, 2023 - 8 minutesmins - By External Contributor Share WhatsApp Twitter Linkedin Email
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