SEOUL, Jan. 14 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Friday its COVID-19 antibody treatment has won temporary approval from Swedish authorities. Swissmedic granted Temporary Authorization of Rekirona for adult COVID-19 patients who do not require supplementary oxygen treatment and are at high risk of developing into severe cases. The approval will [...]
SEOUL, Jan. 6 (Korea Bizwire) — South Korean biopharmaceutical company Celltrion Inc. said Thursday that its self-diagnostic kit for COVID-19 is available for purchase on global retailer Amazon. Celltrion DiaTrust COVID-19 Ag Home Test, co-developed by local health care business Humasis, received the U.S. Food and Drug Administration’s Emergency Use Authorization approval last year. The [...]
SEOUL, Jan. 3 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Monday that its antibody treatment candidate against COVID-19 has shown safety in its clinical trial. Celltrion said it has enrolled 24 healthy volunteers in its global phase one clinical trial and confirmed the safety, tolerability and pharmacokinetics of CT-P63. Separately, Celltrion said [...]
SEOUL, Dec. 30 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Thursday its new biosimilar of the arthritis drug Humira has won approval from Canadian authorities. Yuflyma, an adalimumab biosimilar with a high concentration, is used to treat patients with rheumatoid arthritis, psoriasis and inflammatory diseases. Yuflyma requires only half the solution administered [...]
SEOUL, Dec. 7 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Tuesday its COVID-19 antibody treatment has won emergency approval from Australian authorities. The Therapeutic Goods Administration (TGA) granted provisional approval of Rekirona for the intravenous treatment of mild-to-moderate COVID-19 in adult patients. It is the fifth COVID-19 treatment to receive regulatory approval [...]
SEOUL, Nov. 30 (Korea Bizwire) — Celltrion Healthcare Co., an affiliate of South Korean biopharmaceutical giant Celltrion Inc., said Tuesday it has inked a series of deals to supply its COVID-19 antibody treatment to nine European countries. Under the agreement, Celltrion Healthcare — which handles overseas business operations for Celltrion Inc. — will deliver 150,000 [...]
SEOUL, Nov. 12 (Korea Bizwire) — The European Union’s drug agency has recommended the approval of a COVID-19 antibody treatment by Celltrion Inc., paving the way for its sales in the region, the South Korean pharmaceutical giant said Friday. The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency recommended the [...]
SEOUL, Oct. 25 (Korea Bizwire) — South Korean biopharmaceutical company Celltrion Inc. said Monday that its self-diagnostic kit for the novel coronavirus has won emergency approval from U.S. drug authorities. Celltrion DiaTrust COVID-19 Ag Home Test, co-developed by local healthcare business Humasis, received the U.S. Food and Drug Administration’s Emergency Use Authorization approval. The product [...]
SEOUL, June 14 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Monday that its COVID-19 antibody treatment has sharply reduced recovery time and the chance of a severe case. Celltrion announced top-line results from a global phase three clinical study of Rekirona, a pivotal part of the study to obtain more comprehensive safety [...]
SEOUL, May 10 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. has begun the global supply of its COVID-19 antibody treatment starting with Pakistan, according to the company’s affiliate on Monday. Celltrion Healthcare, which handles Celltrion’s overseas business, said it has signed a contract with a Pakistan state-run company to export 100,000 tablets of [...]