- Policy
- AZ's bispecific ab 'Rilvegostomig' vs Keytruda trial
- by Lee, Hye-Kyung Sep 20, 2024 05:51am
- A Phase 3 trial comparing a combination therapy containing 'Rilvegostomig (Trial name: AZD2936),' AstraZeneca's bispecific antibody gathering attention as the next-generation medicine, to 'Keytruda (pembrolizumab),' a type of immunotherapy drug used to treat cancer, will be conducted in South Korea. The Ministry of Food and Drug Safety (M
- Company
- Peter Trang will head Business Operations at Takeda Korea
- by Whang, byung-woo Sep 20, 2024 05:51am
- On the 19th, Takeda Korea announced that it appointed Peter Trang from Australia as the new Head of Business Operations. The new head joined Takeda Pharmaceuticals Australia in 2016 as Business Insights Manager, then moved on and became the Strategy Lead of the Growth & Emerging Markets Business Unit (BU), which oversaw operations in more
- Company
- Ipsen Korea appoints Yang mi-sun as new CEO
- by Eo, Yun-Ho Sep 20, 2024 05:51am
- Ipsen Korea has appointed Yang Mi-sun, AstraZeneca Korea’s former Business Unit Director, as the new Chief Executive Officer (CEO). Sources said that Ipsen Korea has appointed its new CEO, replacing former CEO Audrey Schweitzer after the end of her term. Audrey Schweitzer has been in charge of Ipsen Korea since 2021. Yang is an indust
- Company
- Inventage Lab to codevelop a long-acting injectable with BI
- by Lee, Seok-Jun Sep 20, 2024 05:51am
- Inventage Lab (CEO Ju-Hee Kim) announced on the 19th that it has signed an agreement with Boehringer Ingelheim, a German multinational pharmaceutical company, to co-develop a long-acting injectable formulation for a new peptide drug. Inventage Lab will develop a long-acting injectable formulation based on Boehringer Ingelheim's drug cand
- Policy
- Cushing’s syndrome drug Isturisa is approved in Korea
- by Lee, Hye-Kyung Sep 20, 2024 05:51am
- Various doses of ‘Isturisa’ (osilodrostat), a treatment for Cushing's syndrome, are expected to be approved in Korea soon. According to industry sources on the 19th, the Ministry of Food and Drug Safety concluded the safety and efficacy review of Recordati Korea's Isturisa Film Coated Tab 1mg earlier this month and recently completed th
- Company
- Samsung Bioepis recruits Lina Choi as new global head
- by Nho, Byung Chul Sep 19, 2024 05:48am
- Samsung Bioepis garners attention as the company recruits specialists to strengthen its global entry capacity. Sources said that Samsung Bioepis has recruited Linda Choi, Vice President, as the Head of Global Commercial in August. Choi studied pharmacy at Ohio State University College of Pharmacy and has 28 years of experience in mult
- Opinion
- [Reporter’s View] The new drug approval fee hike
- by Lee, Hye-Kyung Sep 19, 2024 05:48am
- The Ministry of Food and Drug Safety has announced an amendment to the “Fee Regulations for the Approval of Drugs, etc.” that will significantly increase the fee for new drug approvals from KRW 8.83 million to KRW 410 million. This is the first time in 4 years that the government has decided to increase the new drug approval fee, which is
- Policy
- MFDS approves Hemgenix for Hemophilia B in Korea
- by Lee, Hye-Kyung Sep 19, 2024 05:48am
- The Ministry of Food and Drug Safety (MFDS) announced on the 13th that it has approved the orphan drug ‘Hemgenix Inj (etranacogene dezaparvovec)’ imported by CSL Behring Korea. Hemgenix is used to treat moderate-to-severe hemophilia B (congenital blood clotting factor IX deficiency) in adults without a history of Factor IX inhibitors. T
- Company
- Will Columvi be reviewed for reimb by CDDC in OCT?
- by Eo, Yun-Ho Sep 19, 2024 05:48am
- Demand is rising for the reimbursement of ‘Columvi,’ the first bispecific antibody treatment option for lymphoma, in Korea. The Korea Leukemia Patients Organization has requested the CD20-CD3 bispecific antibody for diffuse large B-cell lymphoma (DLBCL) Columvi (glofitamab) be redeliberated at the Health Insurance Review and Assessment
- Company
- Reimb for orphan drug 'Welireg' for cancer has been denied
- by Eo, Yun-Ho Sep 19, 2024 05:48am
- An orphan drug, 'Welireg,' for cancer still faces challenges in entering insurance reimbursement coverage. Sources said that MSD Korea is preparing to reapply for reimbursement review of its oral hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, Welireg (belzutifan), after failing to pass the Cancer Disease Review Committee (CDRC) rev
