Shots: The P-I dose-escalation study will assess the safety, tolerability, and preliminary efficacy of DS-1055 in adult patients with r/r advanced or metastatic head and neck, gastric and esophageal cancers, and other tumor types The focus of the study is to determine the maximum tolerated dose and recommended dose of DS-1055 for further study and […]Read More
The DIA India Medical Devices Conference 2020 is the first effort of DIA India to bring together leaders from the medical devices industry, regulatory and academia from India in New Delhi to discuss the current landscape and regulatory updates of the medical devices industry. New upcoming medical devices regulations, changing landscapes and the evolution of […]Read More
The Medical Devices Conference will be hosted by DIA India on 21st and 22nd February in collaboration with Medical Technology Association of India (MTaI), AIC-AMTZ Medivalley Incubation Council and mDI Europa, is one of the largest gatherings of medical devices professionals in the region. The conference will be focusing on giving better insights into the […]Read More
The Medical Devices Conference hosted by DIA India on 21st and 22nd February in collaboration with Medical Technology Association of India (MTaI), AIC-AMTZ Medivalley Incubation Council and mDI Europa, is one of the largest gatherings of medical devices professionals in the region. This initiative is a first for DIA in India and holds promise to […]Read More
Shots: The approval is based on two P-III studies assessing Orilissa 150 mg qd and 200 mg bid vs PBO enrolling 1,700 women with moderate to severe endometriosis pain P-III studies Results: showed reduction in daily menstrual pain and non-menstrual pelvic pain @6mos.; reduction in numeric rating scale (NRS) scores @3mos.; reduction in pain during […]Read More
Shots: The NDA and MAA Acceptance of Siponimod is based on P-III EXPAND study, assessing Siponimod vs PBO in adults with Secondary Progression Multiple Sclerosis (SPMS) evaluating its safety and efficacy P-III EXPAND study results: reduction in risk confirmed disability progression @3mos 21% & @6mos. 26%. Additionally, P-II BOLD study was conducted to evaluate Siponimod […]Read More
Shots: The Notice of Compliance (NOC) authorization is based on the clinical trial assessing Radicava (edaravone), demonstrating its positive 1EP measured by using the ALSFRS-R Edaravone is a IV medication, received the US FDA PR designation to treat ALS and marketed as Radicava in the US and as Radicut in Japan (IV 30mg) to treat […]Read More
Shots: The approval is based on the results of P-II EMPOWER-CSCC-1 study and P-I study 1423 (two advanced CSCC expansion cohorts) assessing Libtayo in patients with mCSCC, locally advanced CSCC or Combined CSCC enrolling ≥163 candidates P-II EMPOWER-CSCC-1 study & P-I study 1423 Results: ORR (47%, 49%, 47%); CRR (5%, 0%, 4%); PRR (41%, 49%, […]Read More
Shots: Emgality’s approval is based on two P-III trials (N=425) (EVOLVE-1 and EVOLVE-2) and one P-III REGAIN trial (N=450) administering once monthly PBO vs Emgality 120 mg after an initial dose of 240 mg, or Emgality 240 mg, evaluating its safety and efficacy P-III EVOLVE-1 & EVOLVE-2 Results: mean change from baseline days (4.7 vs […]Read More
Shots: Udenyca’s (Pegfilgrastim biosimilar) EU approval is based on the data demonstrating its PK and PD, for reducing the chances of infection by febrile neutropenia This biosimilar is currently under the US FDA inspection and has provided a PDUFA date 3 Nov, 2018. Udenyca is currently not available for commercial sale Udenyca (pegfilgrastim-cbqv/CHS-1701), is a […]Read More
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