- Company
- Will 'Bylvay' be listed in the second half the year?
- by Eo, Yun-Ho Sep 18, 2025 06:04am
- Attention has been drawn to whether Bylvay, the first drug in the Concurrent Approval-Evaluation-Negotiation Pilot Program, will be approved for the reimbursement listing. Ipsen Korea is currently in negotiations with the National Health Insurance Service (NHIS) over the drug price for Bylvay (odevixibat), a treatment for pruritus in pati
- Company
- Rewriting the Medical Field with AI: KHF 2025
- by Hwang, byoung woo Sep 18, 2025 06:03am
- “Artificial intelligence (AI) technology is no longer just being applied to clinical settings; it is reshaping daily life.” Korea’s largest healthcare exhibition, the Korea-Hospital and Health Tech Fair (KHF2025), kicked off on the 17th at COEX in Seoul for three days. Experts and stakeholders at the venue remarked that the medica
- Company
- Alteogen secures EU authorization for Eylea biosimilar
- by Cha, Jihyun Sep 18, 2025 06:03am
- [Bio platform company Alteogen (CEO Soon-jae Park) announced on the 17th that it has obtained marketing authorization from the European Commission (EC) for ‘Eyluxvi (project name ALT-L9),’ an Eylea biosimilar it had jointly developed with Alteogen Biologics. Eyluxvi is Alteogen’s second biosimilar product to receive approval, following
- Policy
- MFDS, "Increase in fees will expedite biosimilar approval"
- by Lee, Tak-Sun Sep 18, 2025 06:02am
- The Ministry of Food and Drug Safety (MFDS) has announced that it will expedite biosimilar approvals in relation to a recent "increase in approval fees." The MFDS plans to establish a dedicated review team to provide approval and review services commensurate with the new fees. The MFDS issued an administrative announcement on September
- Policy
- Reimb listing a hurdle for Dutasteride + Tadalafil combos
- by Jung, Heung-Jun Sep 18, 2025 06:02am
- The dutasteride-tadalafil combination was approved in January for the treatment of benign prostatic hyperplasia (BPH), but has failed to clear the reimbursement hurdle, which is delaying the drug’s market launch. Four companies &8211; Dongkook Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, and Shinpoong Pharm - are reportedly discussin
- Company
- Samjin Pharm and Sanofi collide in the influenza vaccine mkt
- by Hwang, byoung woo Sep 17, 2025 06:12am
- With the influenza (flu) vaccination season approaching, competition in the vaccine market for adults aged 65 and over is anticipated. The government has switched the National Immunization Program (NIP) vaccine to a three-valent vaccine and lowered the procurement price. The introduction of the four-valent vaccine in the non-reimbursed medic
- Company
- Jemperli nears final hurdle for reimb in endometrial cancer
- by Eo, Yun-Ho Sep 17, 2025 06:11am
- The immunotherapy Jemperli is on the verge of securing expanded reimbursement coverage for endometrial cancer in Korea. According to industry sources, GSK Korea has recently finalized drug price negotiations with the National Health Insurance Service (NHIS) for the PD-1 inhibitor Jemperli (dostarlimab). The only step remaining is review
- Company
- Vivozon "Joint sales of Unafra with Daiichi Sankyo"
- by Kim, Jin-Gu Sep 17, 2025 06:10am
- Vivozon has chosen Daiichi Sankyo Korea as its co-promotion partner for Unafra Inj (opiranserin). The pharmaceutical industry points to two key reasons for this partnership: a synergy in sales and marketing for postoperative patient care, and the potential for Daiichi Sankyo Korea to play a positive role in Unafra's global market entry. s
- Company
- Did companies pre-stock inventories in the U.S.?
- by Kim, Jin-Gu Sep 17, 2025 06:10am
- The surge in Korean pharmaceutical exports to the United States&8212;driven by concerns over possible tariffs&8212;returned to normal levels within 2 months. Industry observers suggest that companies may have frontloaded shipments to secure inventories in the U.S. market. While exports have declined, some note that since tariff risks remain
- Policy
- Bill bans remote narcotics and hair loss drug prescriptions
- by Lee, Jeong-Hwan Sep 17, 2025 06:10am
- A partial amendment to the Medical Service Act was introduced in the National Assembly on the 16th, mandating that physicians check the Drug Utilization Review (DUR) system when prescribing via telemedicine. The rule applies to high-risk drugs such as narcotics, psychotropics, anti-obesity drugs like Wegovy, hair loss treatments, and isotret
