- Company
- 1st patient enrolled in Phase 2 FDA trial of 'Nugel' in KOR
- by Lee, Seok-Jun Jun 9, 2025 05:51am
- Shaperon announced on June 5 that a Phase 2 Part 2 U.S. Food and Drug Administration (FDA) clinical trial for its atopic dermatitis drug 'Nugel' has enrolled the first patient for clinical trials being conducted in South Korea. This trial is a multinational clinical trial evaluating Nugel's safety and efficacy in 177 patients across 12 cli
- Company
- GC’s US affiliate Curevo extends shingles vaccine trial
- by Cha, Jihyun Jun 9, 2025 05:50am
- GC Biopharma (CEO Eun-Chul Huh) announced on the 4th that its U.S. affiliate Curevo Vaccine has completed the enrollment of its first patient in the Phase 2 extension study of its shingles vaccine amezosvatein. This clinical trial was designed based on the results of the previously conducted Phase II trial. The extension trial will serve
- Company
- 'Vonjo' for myelofibrosis expected to be marketed in KOR
- by Eo, Yun-Ho Jun 5, 2025 06:11am
- The oral myelofibrosis treatment 'Vonjo' is expected to be commercialized in Korea. According to industry sources, the Ministry of Food and Drug Safety is conducting an approval review of Vonjo (pacritinib). This drug obtained orphan drug designation (ODD) in September of last year. Vonjo is indicated for 'treatment of intermediate-ri
- Company
- Global pharmas race to introduce bispecific antibodies
- by Son, Hyung Min Jun 5, 2025 06:10am
- Major global pharmaceutical companies are challenging the throne held by the immunotherapy Keytruda with their respective bispecific antibodies. Recently, BMS signed a partnership agreement with Germany's BioNTech to develop a new bispecific antibody, while Pfizer successfully introduced a bispecific antibody from China's 3SBio last month. MSD a
- Company
- "Effect of Camzyos confirmed in Korean patients with oHCM"
- by Son, Hyung Min Jun 5, 2025 06:09am
- "After Camzyos was introduced to Korea, patients with obstructive hypertrophic cardiomyopathy (oHCM) and doctors have high treatment satisfaction. Notably, realworld data showed that Camzyos administration had a comparable effect to confirmatory clinical trial." During a recent meeting with Daily Pharm, Hyung-Kwan Kim, Professor of Seoul
- Company
- K-Bios eye US’s reintroduction of the Biosecure Act
- by Cha, Jihyun Jun 4, 2025 06:21am
- The U.S. is pushing ahead with its Biosecure Act that restricts transactions with Chinese biotech companies. According to the Korea Biotechnology Industry Organization (KoreaBIO) on the 2nd, U.S. Democrat Senator Gary Peters recently announced at a Brookings Institution event that he would soon reintroduce the Biosecure Act, which restri
- Company
- More treatment options for PNH…entry of 'Piasky' imminent
- by Eo, Yun-Ho Jun 4, 2025 06:19am
- The entry 'Piasky,' a new PNH drug, into the Korean market is imminent. According to industry sources, Roche Korea's Piasky (crovalimab), a treatment for paroxysmal nocturnal hemoglobinuria (PNH), is undergoing final review for approval by the Ministry of Food and Drug Safety (MFDS). It is expected to be officially approved in the second
- Company
- UCB Korea launches psoriasis drug Bimzelx with reimb
- by Whang, byung-woo Jun 4, 2025 06:18am
- On June 2, UCB Korea (CEO Sujin Hwang) announced that its psoriasis treatment Bimzelx (bimekizumab) was launched on June 1 with reimbursement coverage under the national health insurance system. In line with the Ministry of Health and Welfare (MOHW) notification, Bimzelx is reimbursed as a treatment for moderate-to-severe plaque psoriasis
- Company
- "U.S. MFN drug policy will impact KOR's new drug companies"
- by Kim, Jin-Gu Jun 4, 2025 06:17am
- Analysis suggests that the Korean pharmaceutical and biotech industry may be significantly impacted if the U.S. government institutes a 'most-favored-nation (MFN)' policy on drug prices. Sejin Lee, CEO of Acadia Pharmaceuticals, presented the potential impact of U.S. drug price policy changes on the Korean pharmaceutical industry during the '
- Company
- Multiple myeloma drug Elrexfio seeks reimb again in KOR
- by Eo, Yun-Ho Jun 2, 2025 05:51am
- The new multiple myeloma drug Elrexfio is again seeking insurance reimbursement coverage in Korea. Pfizer Korea recently submitted a reimbursement application for Elrexfio (elranatamab) and is aiming to receive the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee review. Following its rejection by
