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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88 articles with Celltrion Healthcare (Formerly Known As Celltrion)
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.
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.
Further sharpens Takeda’s focus on ‘fast tracking’ patient access to highly innovative medicines for complex and rare diseases in Asia Pacific and the Emerging Markets
Celltrion Completes Acquisition of Primary Care (PC) Product Assets for Asia Pacific Markets from Takeda Pharmaceutical Company Limited
USD 278 million deal signed to secure 18 small molecule pharmaceutical product brand patents, trademarks, permits and sales rights in 9 Asia Pacific countries including South Korea
11/9/2020It was relatively quiet in terms of COVID-19-related clinical trials, but there was still quite a bit of news for trials involving other indications. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 26, 2020.
Celltrion Launches Human Clinical Trial of Potential COVID-19 Antiviral Antibody Treatment Following Positive Pre-Clinical Results
Celltrion Group announced the launch of its Phase I human clinical trial investigating a potential antiviral antibody treatment for patients with COVID-19.
Celltrion Healthcare Receives Positive CHMP Opinion for an Additional Five Indications for Remsima® SC Including for Use in Inflammatory Bowel Disease and Ankylosing Spondylitis
Celltrion Healthcare announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended expanding the existing marketing authorisation for the subcutaneous formulation of Remsima® in an additional five indications: for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.
Celltrion Announces Positive Pre-clinical Results for COVID- 19 Antiviral Antibody Treatment, Showing Improvement in Recovery Time
Pre-clinical data for Celltrion’s antiviral antibody treatment candidate demonstrate a 100-fold reduction in viral load of SARS-CoV-2 (COVID-19), as well as improvement in lung lesions