- Company
- AprilBio licenses out novel drug to a U.S. firm
- by Son, Hyung-Min Jun 21, 2024 05:47am
- AprilBio, a company developing biopharmaceuticals, announced on June 20th that it has licensed out 'APB-R3,' an autoimmune diseases candidate, to the U.S.-based novel drug developer Evommune. It has been contracted for up to US$475 million (approximately KRW 655 billion), including a non-refundable upfront fee of US$15 million (KRW 20.7 bi
- Policy
- DLBCL treatment Epkinly is approved in Korea
- by Lee, Hye-Kyung Jun 21, 2024 05:47am
- The Ministry of Food and Drug Safety(Minister: Yu-Kyoung Oh) announced that it had approved the orphan drug 'Epkinly (epcoritamab)' that is being imported by Abbvie Korea on the 20th. Epkinly is a&160;bispecific monoclonal antibody that binds to both the CD3 on the surface of T-cells and CD20 on the surface of B-cells and is indicated fo
- Company
- JW Pharmaceutical’s new drugs enter clinical trials
- by Son, Hyung-Min Jun 21, 2024 05:46am
- JW Pharmaceutical is accelerating the development of innovative first-in-class drugs. Recently, the company's STAT3-targeted anticancer drug candidate entered Phase I clinical trials. In addition to targeted anticancer drugs, the company also owns first-in-class drug candidates in the fields of atopic dermatitis, hair loss, and blood cancer.
- Opinion
- [Reporter’s View] Reliability Verification Review Committee
- by Lee, Hye-Kyung Jun 20, 2024 05:48am
- The Ministry of Food and Drug Safety has formed a Reliability Verification Review Committee. In the 'Guideline for Drug Manufacturing, Sales, and Import Marketing Authorizations and Labeling Change Authorizations,' which was revised by the MFDS on the 17th, a procedure was added for the Reliability Verification Review Committee to verify the
- Company
- ‘Treatment access improved for Lysosomal Storage Diseases'
- by Son, Hyung-Min Jun 20, 2024 05:48am
- "Lysosomal storage diseases show various symptoms throughout the body, making it difficult to diagnose the disease based on clinical manifestation alone. Therefore, it is important to diagnose it early and prevent the progression of symptoms with enzyme replacement therapy." On September 19, Sanofi held a press conference at the Lotte Hot
- Policy
- When will 'Paxlovid' become reimbursable?
- by Lee, Tak-Sun Jun 20, 2024 05:48am
- The review of 'Paxlovid (nirmatrelvir&8231;ritonavir, Pfizer),' a COVID-19 drug, for reimbursement has been prolonged. It has been over eight months since the submission of the reimbursement application last October, yet it has not been considered for the Drug Reimbursement Evaluation Committee (DREC) review. Because the Paxlovid free-o
- Company
- ‘Long-term treatment for osteoporosis is now possible'
- by Son, Hyung-Min Jun 20, 2024 05:48am
- The improved reimbursement standards for osteoporosis drugs have created a treatment environment that promotes fracture prevention. Healthcare professionals have pointed out that the treatment continuation rate of osteoporosis patients has been low stressing the importance of continuous treatment to minimize the risk of fracture. On Sep
- Policy
- 'Approvals-Reimbursement Reviews-Price Negotiations' pilot
- by Lee, Hye-Kyung Jun 20, 2024 05:48am
- The government is preparing to commence “The 2nd Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations” The pilot system is intended to concurrently process applications to the Ministry of Food and Drug Safety (MFDS), reimbursement assessment, and drug price negotiations. Following t
- Company
- HK inno.N and others license out jointly developed candidate
- by Kim, Jin-Gu Jun 20, 2024 05:48am
- 'IMB-101(OXTIMA),' a dual-antibody candidate jointly developed by HK inno. N, IMBiologics, and Y-Biologics, was licensed out to a U.S. biotech company specializing in new drug development. The contract amounts to US$940 million (approximately KRW 1.3 trillion), including an up-front payment of US$20 million (KRW 27.6 billion). HK inn
- Company
- K-pharma speeds up Keytruda biosimilar development...
- by Kim, Jin-Gu Jun 19, 2024 05:46am
- Biopharmaceutical companies in South Korea are fast-developing biosimilars referencing 'Keytruda (pembrolizumab),' which has ranked no.1 in global sales. Samsung Bioepis and Celltrion have initiated global phase 3 trials. Due to Keytruda’s leading position in global sales, competition is expected among the companies mentioned above, as
