Hyundai Bioscience said Monday that it received positive reviews on the first round of phase 2 clinical trial of its CP-COV03, the first general-purpose Covid-19 treatment worldwide, from the Data & Safety Monitoring Board (DSMB).The DSMB is organized on a per-clinical basis, in which independent ex
Humasis, a company specializing in rapid on-site inspection, said it had obtained the Canadian Personal CE certification for its Covid-19 self-test kits.The company’s Covid-19 Ag Home Test was also certified and officially approved in Korea. Amid reviving demand for personal inspection kits due to t
The World Health Organization’s training program to turn Korea into a global hub to cultivate a bio workforce has begun in earnest.GC Biopharma said it conducted the ‘2022 Introductory Course for Biologics Development and Manufacturing’ under the auspices of the International Vaccine Institute (IVI)
Bristol Myers Squibb (BMS) Korea said it has appointed Lee He-young, the country manager of Viatris Korea, as its new CEO.According to industry sources, the current BMS Korea CEO, Kim Jin-young, has recently been appointed as the head of BMS’ global compliance organization and decided to recruit Lee
MSD said Friday it expects the expanded indication of anti-PD-1 therapy Keytuda (pembrolizumab) as neoadjuvant therapy for triple-negative breast cancer (TNBC) to resolve unmet needs and help patients return to normal life early.The company added that it won expanded indication to be used as neoadju
Bukwang Pharmaceutical said its local phase 3 clinical trial of lurasidone successfully treated schizophrenia and bipolar disorder, drawing attention from the pharmaceutical industry.In a public filing on Thursday, Bukwang disclosed the topline results of the local phase 3 study.The company said the
Moderna, a leading biotech company pioneering mRNA therapeutics and vaccines, said it would cooperate with International Vaccine Institute (IVI) to tackle viruses threatening global public health.Moderna signed a memorandum of understanding with IVI for vaccine R&D cooperation at the institute’s hea
Yuyu Pharmaceutical’s phase 2 clinical trial of YP-P10, a xerophthalmia treatment, is proceeding smoothly in the U.S. by completing its first patient registration, the company said Thursday.The clinical trial, which received approval from the U.S. Food and Drug Administration in April, is to evaluat
Physicians are increasingly emphasizing the importance of managing heart failure (HF), the final complication of cardiovascular disease, and Bayer’s new treatment Verquvo (vericiguat), is drawing attention from the medical community.According to the Korea Heart Failure Fact Sheet released by the Kor
Matica Biotechnology, CHA Biotech’s U.S. offshoot, said Thursday that it aims to achieve annual sales of 1 trillion won ($762 million) in 2030, emerging as one of the big-five cell and gene therapy CDMOs worldwide."The cell and gene therapy (CGT)’s contract development, and manufacturing organizatio
The Ministry of Food and Drug Safety (MFDS) said Wednesday that it has begun the preliminary review of the non-clinical and clinical trials results of Moderna’s Spikevax-2 mRNA Covid-19 vaccine submitted by Moderna Korea.Moderna’s Spikevax-2 is a multi-vaccine containing mRNA that expresses the anti
Ildong Pharmaceutical’s shares plunged to the lower limits on Thursday, as the Japanese regulator delayed giving emergency use approval (EUA) for Xocova, an oral Covid-19 treatment co-developed by Ildong and its Japanese partner, Shionogi Pharmaceutical.As of noon, Ildong’s shares stood at 37,400 wo
HLB's targeted anticancer drug, rivoceranib, has proven excellent efficacy, with 85 percent of patients showing cancer disappearance and more than 30 percent reduction in adenocarcinoma treatment for local progressive esophageal squamous cell cancer (ESCC).Following the recent successful clinical re
The ongoing strength of the U.S. dollar will likely result in mixed fortunes for Korean biopharmaceutical and biotech companies in the second quarter, according to industry analysts on Wednesday.According to the Korea International Trade Association, the Korean currency ended Wednesday’s trading at
In 2021, Korean biotech firm Bixink Therapeutics introduced Nerlynx Tab. (neratinib), a HER2 inhibiting breast cancer treatment developed by Puma Biotechnology and approved by the FDA in July 2017. The arrival of the drug drew much attention from the medical community.In Korea, Nerlynx obtained appr
Daewoong Pharmaceutical said it has completed preparations for speeding up its entry into the contract development and manufacturing organization (CDMO) business.The company said Wednesday that it received approval for an advanced regenerative medicine cell processing facility from the Ministry of F
Takeda’s oral drug Exkivity (mobocertinib) won the regulatory nod to treat non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (Ex20ins) mutation in Korea.The approval will prompt its competition against Janssen’s Rybrevant (amivantamab), an injection th
Chong Kun Dang Pharmaceutical said it would tap the 350 billion won ($267.4 million) local gastritis market with its new natural product-based treatment.On Monday, the drugmaker won regulatory approval for G-Tec (ingredient: cinnamon bark dried extract) to treat acute and chronic gastritis.Chong Kun
Samsung Biologics said Tuesday that it signed a contract with the Incheon Free Economic Zone (IFEZ) to purchase industrial facility land in the high-tech industrial cluster of Songdo International City’s 11th block.Samsung Biologics plans to become the "world's No. 1 CDMO company" by building four p
As the Omicron subvariants wreak havoc globally, Moderna’s top medical officer stressed the need to receive booster shots now instead of waiting for a revised vaccine that works better against Omicron mutations.Last week, Moderna released a study result, which showed that mRNA-1273.214, its revised