Samsung Bioepis said it has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar for Stelara (ingredient: ustekinumab), for North America and Europe.Stelara was developed by multinational pharmaceutical company Janssen, the pharmaceutical arm of Johnson & Johnson (J
In a recent development regarding corporate trade secrets, Samsung Biologics has achieved a partial victory in its lawsuit against three former employees who moved to Lotte Biologics. The company accused the former employees of breaching trade secrets.According to Money Today, a local news outlet, t
After receiving preliminary listing approval from the Korea Exchange, Curocell has maintained that it will proceed with an initial public offering (IPO) this year.The Korea Exchange's Kosdaq market headquarters approved the preliminary listing review of Curocell on Thursday. That comes about four mo
CG Bio said Friday that it recently organized the "Meet the Korean Masters of Endoscopic Spine Surgery," an educational session on spine endoscopic surgery for overseas medical professionals.CG Bio and other companies have formed a consortium to provide the training session under the auspices of the
ABL Bio will likely be able to resume its U.S. phase 1 clinical trial of ABL301, a candidate for treating Parkinson's disease licensed out to Sanofi, the company said.ABL Bio said Wednesday it had confirmed the safety of ABL 301 in a nonclinical toxicity study to determine the feasibility of adminis
Celltrion announced its intention to construct a new drug product (DP) factory at its Songdo campus on Tuesday, to proactively address the rising demand.For the construction of the new facility, Celltrion will commit to a phased investment of about 126 billion won ($95.3 million). The facility has a
The Korea Health Industry Development Institute (KHIDI) said on Monday that a multidisciplinary Korean research team demonstrated the process of fibrosis of tau protein, which has been identified as the pathogenesis of Alzheimer's disease, and the mechanism of formation of neurotoxic substances.In p
Celltrion said it has received approval from the Therapeutic Goods Administration (TGA) of Australia for the sale of Vegzelma, its biosimilar referencing Avastin (ingredient: bevacizumab).Celltrion has secured the right to market Vegzelma in Australia for a range of indications approved for Avastin.
As the increasing demand for transplants cannot be filled with human-to-human organ transplants, this has shifted the focus to animal-to-human transplants, better known as xenotransplants.Accordingly, Optipharm CEO Kim Hyun-il revealed that his company is planning to fill this void and is currently
Celltrion said it has completed a marketing authorization application for CT-P43, a biosimilar referencing Stelara (ustekinumab) that treats autoimmune diseases, to Australia’s Therapeutic Goods Administration (TGA) on Thursday (local time).Celltrion filed a marketing authorization application in Au
HK inno.N said it has signed a contract manufacturing agreement (CMO) with Brexogen, a company specializing in exosome therapeutics, to produce cell lines for exosome therapeutics derived from stem cells.The agreement follows a memorandum of understanding signed between the two companies in April.Un
The Coalition for Epidemic Preparedness Innovations (CEPI) highlighted the importance of working on the preparedness stage, emphasizing the need to establish alternative clinical evidence to facilitate rapid vaccine development in alignment with the CEPI's 100-day mission.CEPI's 100-day mission refe
Shin Dong-kun, a dentist-turned-politician, criticized the Yoon Suk Yeol government’s recent decision to slash the research and development (R&D) budget for 2024, at an international bio conference in Seoul.Rep. Shin of the opposition Democratic Party is also the head of the National Assembly’s Heal
U.S. health authorities have announced the first group of drugs targeted for price cuts under its Inflation Reduction Act (IRA).Included among them are original biopharmaceutical products, including Stelara (ustekinumab) and Enbrel (etanercept), drawing the attention of Korean industry executives to
Liveome has received approval from the Australian Human Research Ethics Committee (HREC) for the phase 1 clinical trial of its microbiome drug LIV001 to treat inflammatory growth disorders.Liveome is an affiliate of Medytox, the Korean botulinum toxin maker. In September, Liveome plans to start a ph
Gencurix said Tuesday that its lung cancer companion diagnostic test has received marketing authorization from the Thai Food and Drug Administration. The approval was granted for Droplex EGFR Mutation Test v2, a liquid biopsy lung cancer companion diagnostic test.Companion diagnostic test is an esse
Pharos iBio, an AI-backed new drug developer based in Korea, said it would conduct a translational study with Johns Hopkins University School of Medicine to develop a combination therapy using its pipeline PHI-101 to treat relapsed or refractory acute myeloid leukemia (AML). A translational study in
Celltrion Group Chairman Seo Jung-jin said that after the merger between the Celltrion Group's three major affiliates is completed, he may look into an initial public offering (IPO) process for Celltrion Holdings controlling Celltrion, Celltrion Healthcare, and Celltrion Pharm.Speaking to about 3,20
Celltrion Healthcare said that more than 10 U.S. insurers have included its Avastin biosimilar Vegzelma (ingredient: bevacizumab), indicated for in their formulary listings.Vegzelma is indicated to treat six types of cancer -- metastatic colorectal cancer; recurrent or metastatic non-squamous non-sm
SK Biopharmaceuticals has transferred the commercialization rights for the Middle East and North Africa (MENA) region for the epilepsy drug cenobamate (brand name in the U.S.: Xcopri) for just 4 billion won ($2.98 million).The amount is unusually small for a licensing-out of a U.S. FDA-approved new