Tags : Regulatory

Insights+ Exclusive: Key Takeaways from the DIA India Medical Devices

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

ViewPoints Interview: Views of Dr. Upendra Kaul and Dr. Anish

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

DIA India Medical Devices Conference from 21-22 February 2020 I

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

Novartis Announces Acceptance of its Novel Siponimod (BAF312) by the

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

Coherus Biosciences’ Udenyca (Pegfilgrastim Biosimilar) Receives EU Marketing Approval for

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