- Policy
- Super-antibiotic Tygacil reauthorized for use in Korea
- by Lee, Tak-Sun Sep 18, 2023 05:26am
- The ‘super-antibiotic’ Tygacil (Tigecycline, Pfizer Korea) received reauthorization in Korea and is expected to be able to avoid the treatment disruptions that had remained a lingering concern in the industry. Due to the lack of other drugs containing the same ingredient, there had been concerns that Tygacil’s failed renewal would cau
- Policy
- Authorization rate for No.16 is still 0%
- by Lee, Hye-Kyung Sep 18, 2023 05:26am
- While the Ministry of Food and Drug Safety recently completed the designation of 'Global Innovative Product Rapid Review (GIFT)' No. 16, there are still no items that have been approved using this system. The Ministry of Food and Drug Safety established the Global Innovative Products on Fast Track in September last year. It also contains innova
- Policy
- Celltrion receives approval for Nesina Met SR
- by Lee, Hye-Kyung Sep 15, 2023 05:33am
- Celltrion, which acquired the Asia-Pacific distribution rights for Takeda Pharmaceutical products, used them to create an improved new drug. One of the acquired products, Nesina Met SR, a type 2 diabetes treatment, received approval from the Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety announced on the 14th that
- Policy
- Which P-CAB generic will come first, K-CAB or Vocinti?
- by Lee, Tak-Sun Sep 15, 2023 05:33am
- Companies have started developing generic versions of the P-CAB (potassium-competitive acid blocker) class gastroesophageal reflux disease (GERD) treatments K-CAB (tegoprazan, HK Inno.N) and Vocinti (vonoprazan, Takeda Pharmaceuticals Korea). The post-marketing surveillance (PMS) period for the original drugs, which are being targeted
- 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
- 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
- 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
- Policy
- BT public-private council will soon resume operations
- by Lee, Jeong-Hwan Sep 13, 2023 05:28am
- The Ministry of Health and Welfare is expected to soon resume the operation of the 'BT (breakthrough therapy) Public-Private Council', a pharmaceutical industry discussion body necessary for establishing and implementing BT price preference policies. The Ministry of Health and Welfare is expected to establish standards for preferential dr
- Policy
- Will Enhertu pass PE evaluations for reimb in KOR?
- by Lee, Tak-Sun Sep 13, 2023 05:28am
- Due to delays in the review of the economic feasibility of the anticancer drug Enhertu (trastuzumab deruxtecan), the industry is seeing delays in its reimbursement agenda being submitted for deliberation to the Drug Reimbursement Evaluation Committee. The agenda had previously passed the Cancer Disease Deliberation Committee review after re
