- Policy
- Approval of abortion drugs at a halt in KOR
- by Lee, Jeong-Hwan Jul 31, 2024 05:52am
- The Ministry of Food and Drug Safety has gained attention for stating that the Criminal Code and the Mother and Child Health Act must be amended before the approval of abortion drugs in Korea. The process of gaining marketing authorization for abortion drugs that the pharmaceutical companies applied for has been at a halt for 4 years, as
- Company
- Competition rises in 1st-line urothelial cell carcinoma mkt
- by Eo, Yun-Ho Jul 31, 2024 05:51am
- The battle for the first-line treatment market for urothelial cell carcinoma (bladder cancer) is heating up amongst anticancer drugs. In addition to the PD-L1 immuno-oncology drug Bavencio (avelumab), which is already being reimbursed in Korea, the PD-1 immuno-oncology drug Opdivo (nivolumab) in combination with cisplatin and gemcitabine,
- Company
- Clinical trials for K-pharma's new lung fibrosis drugs
- by Son, Hyung-Min Jul 31, 2024 05:51am
- Pharmaceutical and biotech companies in South Korea are developing new drugs for Idiopathic pulmonary fibrosis (IPF). BridgeBio's Bersiporocin has progressed to Phase 2 trials, and the company has recently completed registering patients for Phase 2 trials. Nextgen Bioscience received Phase 1 investigational new drug (IND) approval from the Minis
- Company
- Samsung Bioepis launches Stelara biosimilar Pyzchiva in EU
- by Hwang, Byung-woo Jul 30, 2024 05:52am
- Samsung Bioepis has launched Pyzchiva, its biosimilar version of Stelara (ustekinumab), in the European market. Pyzchiva was approved in Europe and Korea in April and was launched into the Korean market as Epyztek. The drug was approved in the U.S. in June. The company’s marketing partner, Sandoz, will take charge of its sales in Europ
- Opinion
- [Reporter's View] Insight into reimb of high-priced drugs
- by Eo, Yun-Ho Jul 30, 2024 05:52am
- How should we consider the reimbursement coverage of 'preventive' drugs that are not used to treat disease or improve symptoms? This is not a new concept. Individuals have taken medicines for 'management' rather than treatment for chronic diseases. Medicines such as coagulants are primarily preventive care. However, it has become an issue
- Company
- First patient dosing with Pluvicto imminent in Korea
- by Moon, sunh-ho Jul 30, 2024 05:52am
- Novartis Korea's prostate cancer drug Pluvicto, which has been in the spotlight since its approval by the Ministry of Food and Drug Safety, is gaining further attention as the company prepares to administer the first dose to patients in Korea. Pluvicto is a blockbuster drug that generated more than KRW 1 trillion in global sales last year and
- Opinion
- [Reporter's View] Pharmas rethink bio venture investments
- by Lee, Seok-Jun Jul 30, 2024 05:51am
- Multiple pharmaceutical companies have made significant investments in promising bio ventures, spending a substantial amount to acquire shares. Some have become the largest shareholder, and those holding over 5% of the share are involved in the management. Through the investment, companies anticipate sharing R&D results in the future. How
- Policy
- GSK receives administrative disposition in KOR
- by Lee, Hye-Kyung Jul 30, 2024 05:51am
- The global pharmaceutical company GlaxoSmithKline (GSK) has received administrative dispositions for failing to report changes to the specifications of the main ingredient of its active pharmaceutical ingredient and for issues relating to the drug containers. The Ministry of Food and Drug Safety recently imposed a fine of KRW 52.2 million
- Company
- Pfizer's MM drug Elerexfio seeks reimb in KOR
- by Eo, Yun-Ho Jul 29, 2024 05:48am
- Pfizer is attempting reimbursement listing of its new multiple myeloma drug ‘Elerexfio’ in Korea. According to industry sources, Pfizer Korea recently submitted a reimbursement application for its relapsed-refractory multiple myeloma (RRMM) treatment q (elranatamab). The company promptly started its listing process after receiving
- Company
- Eylea biosimilar 'Afilivu' will be prescribed
- by Eo, Yun-Ho Jul 29, 2024 05:48am
- Samsung Bioepis' Eylea biosimilar 'Afilivu' is becoming available for prescription at general hospitals. Industry sources said that Afilivu (aflibercept), a macular degeneration treatment, has passed the drug committees (DC) of medical centers, including Seoul National University Hospital and Seoul National University Bundang Hospital.
