Shots: The company reported that the COVID-19 vaccine is safe, well-tolerated & immunogenic in the P-I/II study & plans to initiate P-III clinical trial in ~30000 volunteers upon receiving necessary approvals The P-II study of ZyCoV-D had been conducted in ~1000 healthy adult volunteers as part of the adaptive P-I/II dose-escalation study The trial has […]Read More
Shots: Alligator reports that it has submitted a CTA application to the relevant regulatory authorities to start a P-II efficacy study of its CD40 targeting antibody mitazalimab Upcoming P-II OPTIMIZE-1 study is assessing mitazalimab + CT (mFolfirinox) in patients with metastatic pancreatic cancer and will be performed at several clinics in Europe involve up to […]Read More
Shots: The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma […]Read More
Shots: The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21 The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of […]Read More
Shots: The MAA submitted to the EMA and the NDA to the US is based on P-III FIDELIO-DKD study assessing finerenone (10/20mg, qd) + SOC vs PBO in ~5,700 patients with CKD and T2D Result: reduction in the combined risk of time to kidney failure; a decrease of eGFR (≥ 40%) from baseline @4wks. or […]Read More
Shots: Sorrento has reported that its EUA is under review at the US FDA for its COVI-TRACK in vitro diagnostic test kit for the detection of IgG and IgM Abs in sera of patients exposed to the SARS-CoV-2 virus Following the issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical […]Read More
Shots: The company submitted report for the FDA’s guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products clarifying the clinical immunogenicity study for the approval of certain proposed biosimilars and interchangeable insulin products The guidance suggests recommendations as when and whether comparative clinical immunogenicity study will be needed for insulins to support the […]Read More
Shots: The NDA filing is based on P-III SUNBEAM & RADIANCE studies assessing Ozanimod vs Avonex in 1,346 & 1,320 patients with RMS across 21 countries for 12 & 24 mos. respectively In H1’19 Celegene has also filed MAA to EMA for relapsing-remitting multiple sclerosis in adults and plans to develop new therapies for RMS […]Read More
Shots: The MAA submission is based on P-III ARAMIS study assessing Darolutamide + ADT vs PBO + ADT in 1,509 men with non-metastatic castration-resistant prostate cancer (nmCRPC) in ratio 2:1 The P-III ARAMIS study demonstrated improvement in metastasis-free survival (mFS), presented at ASCO GU in San Francisco with NDA filing & application for marketing in […]Read More
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