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Biosimilar Regulatory Updates - February 2024 | Goodwin

On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. CT-P47 references...

Ustekinumab-biosimilar , Seika-pharma , Thomas-nusbickel , Klinge-biopharma-gmb , Aflibercept-biosimilar , Stefan-glombitza , Fresenius-kabi , Tocilizumab-biosimilar , European-medicines-agency , Intas-pharmaceuticals , Accord-biopharma-inc , Donga-socio-holdings

Accord's ABLA For Proposed Biosimilar DMB-3115 Accepted By FDA - Life Sciences, Biotechnology & Nanotechnology

According to a January 2024 press release from Accord BioPharma, Inc. ("Accord"), the FDA accepted Accord's abbreviated Biologics License Application (aBLA)...

United-states , A-johnson , Seika-pharma , April-breyer-menon , Accord-biopharma-inc , Donga-socio-holdings , Intas-pharmaceuticals , Accord-biopharma , Biologics-license , Janssen-biotech , Meiji-seika-pharma , Mondaq

Accord's aBLA for Proposed Biosimilar DMB-3115 Accepted by FDA | Venable LLP

According to a January 2024 press release from Accord BioPharma, Inc. (“Accord”), the FDA accepted Accord’s abbreviated Biologics License Application (aBLA) for DMB-3115 (ustekinumab),...

United-states , A-johnson , April-breyer-menon , Seika-pharma , Accord-biopharma-inc , Donga-socio-holdings , Intas-pharmaceuticals , Accord-biopharma , Biologics-license-application , Janssen-biotech , Meiji-seika-pharma ,

FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara (Ustekinumab)

FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara (Ustekinumab)
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

Canada , United-kingdom , United-states , Seika-pharma , Intas-pharmaceuticals , Drug-administration , Accord-biopharma-inc , Janssen-biotech-inc , Intas-pharmaceuticals-ltd , Donga-socio-holdings , Accord-healthcare-ltd , Accord-biopharma

BTS agency likely to face tougher disclosure rules

Hybe, the K-pop powerhouse behind the mega success of bands such as BTS and New Jeans, could be obliged to disclose its corporate information if the total assets of the firm and its affiliates continue to surpass 5 trillion won ($3.7 billion) by the end of this year. The combined total assets of Hybe and its 16 affiliates stood at 5.37 trillion won as of end-June, a report by corporate data research institute CEO Sco...

Donga-socio-holdings , Fair-trade-commission , Weverse-company , Hyundai , Lotte-energy-materials , Iljin-holdings , New-jeans , Monopoly-regulation , Fair-trade-act , Big-hit-music , Pledis-entertainment

Dong-A ST eyes Europe market with Stelara biosimilar

Dong-A ST, the pharmaceutical unit of South Korean giant Dong-A Socio Holdings, has submitted a Marketing Authorization Application to the European Medicines Agency for its Stelara biosimilar DMB-3115, the company announced Wednesday. DMB-3115 is a biosimilar to ustekinumab, also dubbed Stelara, a monoclonal antibody for the treatment of autoimmune and inflammatory diseases including Crohn’s disease, plaque pso...

Canada , Japan , Meiji , Hokkaido , South-korea , United-kingdom , Japanese , South-korean , Paul-tredwell , Seika-pharma , European-medicines-agency , Donga-socio-holdings

Analysis of the Global AI in Clinical Trials Industry, 2023 to 2035 - Product/Technology Utilization and Integration Agreements Lead the Way in Partnerships

/PRNewswire/ -- The "Global AI in Clinical Trials Market: Trends and Forecasts 2023-2035" report has been added to ResearchAndMarkets.com's offering. The...

United-states , Iowa , Herefordshire , United-kingdom , Alexandria , Al-iskandariyah , Egypt , France , Gloucestershire , India , Australia , Charterhouse

Global AI in Clinical Trials Market Overview 2023-2035: AI

Dublin, Aug. 18, 2023 (GLOBE NEWSWIRE) -- The "AI in Clinical Trials Market: Software and Service Providers - Distribution by Trial Phase, Target...

Northpond , New-york , United-states , Worcestershire , United-kingdom , Menlo , Iowa , Memorial-sloan-kettering-cancer-center , Ohio , Springrock , California , Charterhouse

South Korean President grants special pardons to boost economy

SEOUL (ANN/THE KOREA HERALD) – South Korean President Yoon Suk Yeol granted a series of special presidential pardons on Monday, encompassing 2,176 individuals which included 12 notable business magnates. The presidential pardons are part of preparations for the upcoming Liberation Day on August 15 and the primary motivation behind the move is to stimulate the […]

Kumho , Cholla-namdo , South-korea , Japan , Seoul , Soult-ukpyolsi , South-korean , Korea , Japanese , Lee-joong-keun , Yoon-suk-yeol , Rhee-jang-han

President Yoon pardons 12 business tycoons to spur 'economic recovery'

President Yoon pardons 12 business tycoons to spur 'economic recovery' Asia News Network (ANN) is the leading regional alliance of news titles striving to bring the region closer, through an active sharing of editorial content on happenings in the region.

Seoul , Soult-ukpyolsi , South-korea , Japan , Kumho , Cholla-namdo , Japanese , Korea , Ahn-jong-beom , Yoon-suk-yeol , Rhee-jang-han , Kang-jung-seok