prestige biopharma fda
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Bio & Pharma
HLB’s Rivoceranib, Hengrui's Camrelizumab approved as combination therapy in China
South Korea's HLB Co. announced on Thursday that the combination therapy of its drug candidate rivoceranib and Jiangsu Hengrui Pharmaceuticals Co., ...
Feb 09, 2023 (Gmt+09:00)
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Bio & Pharma
Prestige Bio's Herceptin biosimilar proves equivalence in clinical trials
Prestige Biopharma, a South Korean biopharmaceutical developer, said on Tuesday that the final analysis of phase 3 clinical trial on the anti-cancer...
Feb 08, 2023 (Gmt+09:00)
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Bio & Pharma
Korean biopharma, biotech companies scale up as sales balloon
South Korea’s biotech and biopharmaceutical companies are growing big with their sales rising above 1 trillion won ($796 million) last year on...
Feb 07, 2023 (Gmt+09:00)
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Bio & Pharma
Prestige Biopharma submits clinical trial plan in Australia
Prestige Biopharma, a Singapore-based biopharmaceutical company with operations in South Korea and the US, has applied to the Australian clini...
Feb 03, 2023 (Gmt+09:00)
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Bio & Pharma
GC Cell's AB-101 NK therapy achieves FDA fast-track status
South Korea's bio firm GC Cell announced on Wednesday that its US affiliate Artiva Biotherapeutics has received fast-track designation from the US F...
Feb 02, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma's Sanfilippo treatment eligible for FDA priority review
GC Biopharma Corp. said on Wednesday that its Sanfilippo type A treatment, which is under joint development with Novel Pharma, a bio-venture special...
Jan 18, 2023 (Gmt+09:00)
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Bio & Pharma
MedPacto's anti-cancer substance designated as US FDA fast-track item
South Korean biotech company MedPacto Inc. ’s Vactosertib monotherapy for osteosarcoma patients has been designated as a fast-track developmen...
Jan 18, 2023 (Gmt+09:00)
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Bio & Pharma
SK Inc. eyes significant growth in bio business from 2024
SAN FRANCISCO – SK Inc., the investment and holding company of South Korea’s SK Group, expects significant growth in its biopharma...
Jan 13, 2023 (Gmt+09:00)
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Bio & Pharma
Prestige Biopharma attains patent for solid cancer treatment antibody
Prestige Biopharma Korea said on Tuesday that it has obtained a domestic patent for the CTHRC1 neutralizing antibody of the drug candidate PBP1710. ...
Jan 12, 2023 (Gmt+09:00)
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Bio & Pharma
CJ applies to FDA for trials of immuno-anticancer drug candidate
CJ Bioscience, an independent red bio (pharmaceutical and healthcare) subsidiary of CJ CheilJedang Corp., said on Monday it has submitted a phase 1 ...
Dec 26, 2022 (Gmt+09:00)
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Bio & Pharma
Celltrion applies for FDA approval for Remsima SC
Celltrion Ltd. said on Friday it had applied the previous day for permission from the US Food and Drug Administration (FDA) for Remsima SC, an autoi...
Dec 23, 2022 (Gmt+09:00)
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Bio & Pharma
GC Biopharma confirms safety of flu vaccine in phase 1 trial
South Korea's leading pharmaceutical company GC Biopharma Corp. said on Thursday that it has confirmed the safety and immunogenicity of the patch-ty...
Dec 15, 2022 (Gmt+09:00)
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Bio & Pharma
Celltrion to seek FDA approval for sale of Remsima SC by year-end
Celltrion Inc. said it has confirmed the effectiveness and safety of Remsima SC in its third-phase global clinical trials, conducted on 438 patients...
Nov 28, 2022 (Gmt+09:00)
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Bio & Pharma
Mezzion Pharma to try again for US FDA approval of drug
South Korea's Mezzion Pharma will seek to get the oral medicine Udenafil to treat side effects from heart surgery, planning to clinical trials in th...
Nov 23, 2022 (Gmt+09:00)
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Bio & Pharma
SK Biopharma's epilepsy treatment posts impressive growth in US
South Korean SK Biopharmaceuticals' epilepsy treatment Cenobamate has seen rapid growth on the US market.The company on Thursday said the medic...
Nov 11, 2022 (Gmt+09:00)
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Mergers & Acquisitions
Korea's LG Chem buys Nasdaq-listed biotech firm AVEO for $566 mn
South Korea’s chemicals giant LG Chem Ltd. announced on Oct. 18 that it will acquire AVEO Pharmaceuticals Inc., a Nasdaq-listed US biotech fir...
Oct 18, 2022 (Gmt+09:00)
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Bio & Pharma
Samsung Biologics opens the world's largest CDMO factory
South Korea’s Samsung Biologics Co.’s new biopharmaceuticals plant launched operations on Tuesday, a move expected to widen the gap betw...
Oct 11, 2022 (Gmt+09:00)
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Bio & Pharma
Biden’s move to beef up US bio industry poses threat to Korean firms
President Joe Biden’s plan to support the US biomanufacturing infrastructure aimed at containing China’s clout is posing a threat to Sou...
Sep 14, 2022 (Gmt+09:00)
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Bio & Pharma
Hanmi’s anti-cancer drug Rolontis gets FDA approval; US sale via Spectrum
South Korea’s Hanmi Pharmaceutical Co. said on Tuesday that Rolontis, an anti-cancer drug it has jointly developed with its US partner, has ob...
Sep 13, 2022 (Gmt+09:00)
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Bio & Pharma
Korean bio firms look to pills, patches for people who fear needles
Getting shots of a drug or vaccine over a long period is not easy for many people.That's probably why global biopharmaceutical companies and biotech...
Aug 24, 2022 (Gmt+09:00)
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Bio & Pharma
LG Chem receives FDA nod for CUE-102 cancer treatment phase 1 trials
LG Chem Life Sciences, the biopharmaceutical unit of LG Chem Ltd., has received the US Food and Drug Administration’s approval for phase 1 cli...
May 13, 2022 (Gmt+09:00)
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Bio & Pharma
Medytox-Hugel dispute over botox strain intensifies with ITC probe
A legal dispute over a botox strain between South Korean pharmaceutical company Medytox Inc. and its crosstown rival Hugel Inc. has intensified with...
May 03, 2022 (Gmt+09:00)
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Bio & Pharma
FutureChem seeks FDA nod for prostate cancer radiopharma trials
FutureChem Co., a South Korean radiopharmaceutical company, is seeking the US Food and Drug Administration’s approval for clinical tests of it...
Apr 20, 2022 (Gmt+09:00)
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Bio & Pharma
FDA to review Hanmi Pharmaceutical’s Rolontis for marketing approval
The US Food and Drug Administration has begun reviewing a medicine developed by South Korea’s Hanmi Pharmaceutical Co. for marketing authoriza...
Apr 13, 2022 (Gmt+09:00)
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Bio & Pharma
Korea Hanmi to launch blockbuster hypertension drug in China
South Korea’s Hanmi Pharmaceutical Co. is set to launch its blockbuster high blood pressure drug Amosartan in China, the world’s largest...
Mar 11, 2022 (Gmt+09:00)
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COVID-19
Celltrion wins COVID-19 treatment approval from Europe
South Korea’s pharmaceutical giant Celltrion Inc. has won final approval for its COVID-19 treatment Regkirona from the European Commission, a ...
Nov 15, 2021 (Gmt+09:00)
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Bio
Sartorius to invest $300 mn in bio material, equipment plant in Korea
Sartorius AG, German laboratory equipment and raw material maker, is slated to invest $300 million in the next three years to build a plant in South...
Nov 03, 2021 (Gmt+09:00)
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COVID-19
Samsung Biologics-made Moderna vaccine available to Koreans this week
Moderna Inc.’s COVID-19 vaccine first produced by Samsung Biologics Co. under a contract manufacturing organization (CMO) service will be avai...
Oct 27, 2021 (Gmt+09:00)
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Biosimilars
Samsung Bioepis gets FDA approval for Lucentis biosimilar Byooviz
Samsung Bioepis Co., a leading South Korean biopharmaceutical company, has received approval from the US Food and Drug Administration for its Byoovi...
Sep 23, 2021 (Gmt+09:00)
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IPOs
World’s top COVID-19 test kit maker draws $28 bn in IPO subscriptions
The IPO of SD Biosensor Inc., which has sold the most COVID-19 test kits in the world -- selling more than 700 million kits from February 2020 to Ma...
Jul 09, 2021 (Gmt+09:00)