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Find out solutions to mitigate the impact from clinicalsupply chain risk and discover how to improve dynamic drug supply forecasting strategies. Join this webinar to learn how supply forecasting and interactive response technology can help biotech companies improve supply planning and distribution while reducing cost and risk.
AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinicaldevelopment of ATX01. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia. Source link.
Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinicaldevelopment. In July 2020, the U.S. subsidiary MorphoSys US Inc.,
Drug developer companies across the pharma industry report notable reductions in drug development timelines where 10 to 12 months, from lead monoclonal antibody (mAb) identification to IND application, is the new norm and in which earlier Tox material generation has been a critical component for shortening IND timelines.
The varying groups that generate or summarize the information that comprises the MPD over the course of development are called the sending unit , and the group that utilizes the information to manufacture the drug substance or drug product is call the receiving unit.
VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. Pfizer is collaborating with Vivet on the clinicalsupply of VTX-801 for the Phase 1/2 clinical trial.
Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to treat a variety of acute and chronic diseases.
Keeping ahead of schedule will help to maintain manufacturing efficiencies, ensure adequate supply and product quality, and meet development timelines. I am fortunate to have a great Tech Ops team at Lifordi who is on top of managing all the moving parts across the globe for making tox and clinicalsupply for us.
Under the agreement, during the option period, Molecular Partners will conduct Phase 1 clinical trials for MP0420, expected to begin in November 2020, and perform all remaining preclinical work for MP0423 and Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of these trials.
Critical focus areas to fast-track your clinical trials In the race to bring therapies to market faster, sponsors can gain a competitive edge by addressing three critical areas in their clinicaldevelopment strategy: artificial intelligence (AI), integrated solutions, and site feasibility, selection and support.
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