- Company
- nAMD tx Vabysmo can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 15, 2023 05:33am
- Vabysmo, a treatment for macular degeneration, can be prescribed at general hospitals. According to related industries, Vabysmo, Roche Korea's first bispecific antibody treatment for eye diseases, passed the drug committee of medical institutions such as Konyang University Hospital, Kim Eye Clinic, Nune Eye Clinic, Inje University Busan P
- Company
- Gilead Sciences Korea appoints Jae-Yeon Choi as new head
- by Eo, Yun-Ho Sep 15, 2023 05:33am
- Gilead Sciences Korea announced it has appointed Jae-Yeon Choi as its new General Manager as of October this year. The position had remained vacant for the past 6 months. At Gilead Sciences Korea, the new GM Choi will oversee Gilead's business operations in Korea, and promote businesses in the fields of HIV, viral hepatitis, COVID-19, an
- Policy
- Imfinzi recieves RSA reevals and seeks to extend reimb
- by Lee, Tak-Sun Sep 15, 2023 05:32am
- The Risk-Sharing Agreement (RSA) reevaluations for term renewal are underway for Imfinzi Inj (durvalumab, AZ), which applied for reimbursement extensions to its biliary tract cancer indication. The reevaluations are being conducted in preparation for the RSA contract renewal set for March next year. According to industry sources on t
- Policy
- Reevaluation difficult for Ildong and Abbott’s Lypsta
- by Lee, Tak-Sun Sep 14, 2023 06:40am
- There are slightly ambiguous aspects to Abbott Korea's ‘Lypsta Plus Tab,’ whose drug price was lowered on the 5th after the insurance price ceiling reevaluations. This drug was jointly developed between Abbott Kore and Ildong Pharmaceutical, and the bioequivalence test data among the clinical trial data was submitted by Abbott. Perhaps
- Company
- Wellysis receives FDA approval for electrocardiograph
- by Nho, Byung Chul Sep 14, 2023 06:40am
- Access Bio (CEO Choi Young-ho), a global in vitro diagnostic company, announced on the 13th that Wellysis' patch-type electrocardiograph S-Patch Ex, with which it formed a strategic partnership last year, has received approval from the U.S. Food and Drug Administration (FDA). Access Bio previously made an investment by acquiring redeemable c
- Policy
- [Reporter's view] Focus on non-face-to-face contraceptives
- by Lee, Jeong-Hwan Sep 14, 2023 06:37am
- The Ministry of Health and Welfare will hold a public hearing to prepare a reform plan for the non-face-to-face medical treatment pilot project from 2 p.m. today (14th). After disclosing the status of the pilot project, the plan is to hold a panel discussion to hear opinions from the medical community, pharmaceutical industry, platform app i
- Company
- Hanmi will focus on anti-obesity drugs... from GLP-1 to DTx
- by Kim, Jin-Gu Sep 14, 2023 06:37am
- Hanmi Science has pointed to obesity management as a future growth engine for the Hanmi Group. Hanmi Science plans to select 5 types of pipelines, including a new GLP-1 obesity treatment, and operate the project under the name, 'H.O.P (Hanmi Obesity Pipeline)'. The H.O.P project includes 5 types of treatment that include ▲'efpeglenatid
- Company
- SMA drugs Spinraza and Evrysdi complete pricing negotiations
- by Eo, Yun-Ho Sep 14, 2023 06:36am
- The spinal muscular atrophy (SMA) treatment ‘Evrysdi (risdiplam)’ finally passed the final hurdle to its reimbursement in Korea According to industry sources, both SMA treatments, Biogen Korea’s ‘Spinraza (nusinersen)’ and Roche Korea’s treatment ‘Evrysdi (risdiplam),’ reached a final agreement with the National Health Insurance S
- Policy
- Monterizine generics prepare for release in Oct
- by Lee, Tak-Sun Sep 13, 2023 05:28am
- Companies are preparing to release their generic versions of Hanmi Pharm’s Monterizine (Montelukast+Levocetirizin) in October at the earliest. The generic drugs that were approved in August obtained first generic exclusivity and were able to move up their reimbursement listing date. According to the industry sources on the 8th, the p
- Opinion
- [Reporter’s View] MFDS makes changes ahead PIC/S reeval
- by Lee, Hye-Kyung Sep 13, 2023 05:28am
- The Ministry of Food and Drug Safety will be amending the ‘Regulations for Good Manufacturing Practices for Medicinal Products’ as preannounced ahead of PIC/S re-evaluations. The main point of the amendment is to amend the GMP for sterile medicinal products to align with those of the Pharmaceutical Inspection Convention and Pharmaceutic
