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2025-07-02 23:52
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Polycythemia vera drug 'Besremi' nearing end of reimb review
by
Eo, Yun-Ho
Jun 10, 2025 06:04am
The polycythemia vera (PV) treatment 'Besremi' has entered the final stage of an insurance reimbursement review process. The Ministry of Health and Welfare (MOHW) has recently ordered the National Health Insurance Service (NHIS) to initiate drug price negotiation for PharmaEssentia Korea's Besremi (ropeginterferon alfa-2b). If the company
Company
Celltrion¡¯s Stelara biosimilar Qoyvolma gains EU approval
by
Kim, Jin-Gu
Jun 10, 2025 06:03am
Celltrion announced on the 9th that ¡®Qoyvolma,¡¯ its biosimilar version of the autoimmune disease treatment Stelara (ustekinumab) has received marketing authorization from the European Commission (EC). Qoyvolma has been approved with the addition of ¡ã'ulcerative colitis (UC)' to the existing indications of ¡®Steqeyma,' another Stelara bi
Company
Next-gen oral breast cancer drugs near commercialization
by
Son, Hyung Min
Jun 9, 2025 05:53am
The arrival of next-generation oral selective estrogen receptor degraders (SERDs) is imminent. At the American Society of Clinical Oncology (ASCO) Annual Meeting 2025&160;which was held in Chicago, USA, from the 30th of last month to the 4th, multinational pharmaceutical companies simultaneously disclosed the results of their Phase III clin
Company
K-Bio unveils new cancer drug outcomes at the ASCO meeting
by
Son, Hyung Min
Jun 9, 2025 05:53am
The Korean pharmaceutical and biotech industry has unveiled additional clinical outcomes of drug candidates, such as immunotherapy for cancer, targeted anticancer agents, and bispecific antibodies, under development. Major Korean companies, including Daewha Pharmaceutical, LG Chem, Onconic Therapeutics, ImmuneOncia, and Tium Bio, unveiled th
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
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