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Japanese Pharmaceutical Market & Registration Strategies- Part 2 Deepak Hegde
November 12, 2024
The second article in the series focuses on strategies for success in registering products on the Japanese market.
Japanese Pharmaceutical Market & Registration Strategies – Part 1 Deepak Hegde
November 12, 2024
The article provides an outline of characteristics、Regulatory bodies、 Pricing、Reimbursement、the process of registering an innovative drug and generic drugs in Japan.
South Africa Ups Registration of New Pharmaceutical Products SHEM OIRERE
March 13, 2023
SAHPRA has recently announced completion of a review of 16,000 applications for new products and variations nearly four years after it took over from the former regulator, the Medicines Control Council.
Electronic Drug Registration and Listing (eDRLS) Lin Zhang
December 02, 2021
Last month (October 13, 2021), the Food and Drug Administration (FDA) held a conference that is part of the CDER Small Business & Industry Assistance (SBIA) Regulatory Education for Industry (REdI) series.
Australia Therapeutic Goods Administration (TGA) Grants Provisional Registration for Novavax COVID-19 Vaccine prnasia
January 20, 2022
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Australia's Therapeutic Goods Administration...
CStone announced two key phase 3 registrational clinical trials of sugemalimab completed patient enrollment prnasia
January 18, 2022
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines...
CStone announces the clinical data from registrational study of Sugemalimab in stage III non-small cell lung cancer published in The Lancet Oncology prnasia
January 17, 2022
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines...
IND Application for Phase 3 Registration Study of KN046 in Combination with Chemotherapy for the Treatment of Pancreatic Cancer was Approved by CDE prnasia
November 24, 2021
Alphamab Oncology (stock code: 9966.HK) announced that the IND application for phase 3 registration study (KN046-303) of the PD-L1/CTLA-4 bispecific antibody KN046 plus nab-paclitaxel/gemcitabine...
Electronic Drug Registration and Listing Instructions FDA
November 10, 2021
There are three steps, or submissions, that are needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates...
CStone presents updated data from registrational clinical study of sugemalimab in patients with stage IV NSCLC in an oral presentation at IASLC 2021 WCLC prnasia
September 28, 2021
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focus on researching, developing and commercializing innovative immuno-oncology therapies and precision medicines...