Celltrion Healthcare (Formerly Known As Celltrion)
1000 Marina Boulevard
About Celltrion Healthcare (Formerly Known As Celltrion)Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.
CEO: Jung Jini
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95 articles with Celltrion Healthcare (Formerly Known As Celltrion)
Celltrion Healthcare Presents Efficacy and Safety Data From Global Phase III LIBERTY Trial, at the 18th ECCO Congress
Celltrion Healthcare presented new data demonstrating the efficacy and safety of subcutaneous infliximab in patients with inflammatory bowel disease.
Celltrion Healthcare announces Canadian approval of Vegzelma (bevacizumab for injection) for the treatment of five types of cancer
Vegzelma ® , a bevacizumab biosimilar of Avastin ® , is now approved by Health Canada Vegzelma ® offers Canadian patients living with one of five types of cancer a new treatment option Celltrion Healthcare Canada Limited is committed to providing a patient centric approach, to ensure access to innovative, high quality, and affordable biologics in Canada.
Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to U.S. Food and Drug Administration
Celltrion USA announced the submission of a Biologics License Application under the 351 pathway of the Public Health Service Act for lead product candidate, CT-P13 SC, which is the subcutaneous formulation of infliximab to the U.S. Food and Drug Administration.
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
Celltrion USA Receives U.S. FDA Approval for its Oncology Biosimilar Vegzelma® (bevacizumab-adcd) for the Treatment of Six Types of Cancer
Celltrion USA announced that the U.S. Food and Drug Administration has approved Vegzelma®, a biosimilar to Avastin®, for the treatment of six types of cancer.
Celltrion agreed Wednesday to jointly develop Abpro’s cancer molecule ABP-102 in a deal that could net as much as $1.75 billion. See inside for more cancer collaborations.
It was a busy, busy week for clinical trial news and updates, largely driven by the annual ASCO meeting taking place June 3-7 in Chicago.
Celltrion Submits Investigational New Drug (IND) Application to Initiate a Global Phase III Clinical Trial Evaluating an Inhaled COVID-19 Antibody Cocktail Therapy
Celltrion Group announced it has submitted an Investigational New Drug application to conduct a global Phase III clinical trial evaluating the efficacy and safety of an inhaled COVID-19 antibody cocktail therapy for patients with mild-to-moderate symptoms of COVID-19; the trial is expected to enrol 2,200 patients globally.
Celltrion announces positive results for its cocktail therapy candidates including neutralisation data against Omicron variant
Celltrion Group announced results for its cocktail therapy candidates including neutralisation data against the Omicron variant.
Low-income countries still struggle to get first jabs into arms. Researchers and pharma companies continue to push for low-cost vaccines and drugs worldwide.
The Pfizer-BioNTech vaccine (now Comirnaty®) was fully approved by the U.S. Food and Drug Administration (FDA) on August 23 and boosters of this shot are now available to the most vulnerable Americans.
Clinical Catch-Up: October 4-8
10/11/2021Another busy week for clinical trial news. Here’s a look.
Celltrion Healthcare and 180 Life Sciences Enter Into Memorandum of Understanding for a Supply Agreement for the Ongoing Supply of Drug for Anti-TNF Product Trials for Novel Indications
180 Life Sciences Corp. announced that they have entered into a Memorandum of Understanding, with Celltrion Healthcare, a leading biopharmaceutical company, for the supply of anti-TNF biosimilar drug used in the ongoing development of anti-TNF products for new indications with significant unmet medical needs.
Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) becomes the first authorized COVID-19 treatment approved from the Korean Ministry of Food and Drug Safety (MFDS)
Celltrion Group announced that the Korean Ministry of Food and Drug Safety approved regdanvimab, a monoclonal antibody treatment for COVID-19 for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19.
Continuing studies and news about COVID-19 around the world keeps coming in. Here’s a look.
Celltrion Healthcare launches Remsima™ SC, the world's first subcutaneous formulation of infliximab in Canada, for the treatment of people with rheumatoid arthritis
Celltrion Healthcare Canada Limited announced the launch of Remsima™ SC, the world's first subcutaneous formulation of infliximab in Canada for the treatment of adult patients with rheumatoid arthritis.
Celltrion Receives FDA Emergency Use Authorization for Point of Care Antigen Rapid Test Kit – DiaTrust™ COVID-19 Ag Rapid Test
DiaTrust™ received the U.S. Food and Drug Administration Emergency Use Authorization approval for their COVID-19 Point of Care antigen rapid test kit, DiaTrust™.
Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59
CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over
Celltrion Submits Application for Conditional Marketing Authorisation of Its COVID-19 Treatment Candidate CT-P59 to the Korean MFDS
Celltrion submitted today an application for Conditional Marketing Authorisation of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate to the Korean Ministry of Food and Drug Safety (MFDS) Celltrion plans to submit Emergency Use Authorisation (EUA) to the U.S. FDA and Conditional Marketing Authorisation (CMA) to theEuropean Medicines Agency (EMA) for CT-P59 in the coming months
As if attempting to steal hard-won research wasn’t bad enough, hackers are now hitting people where it really hurts – with e-documents containing malicious code embedded in false offers of employment.