- Company
- Ildong’s new GLP-1 analogue starts clinical trial
- by Chon, Seung-Hyun Sep 7, 2023 05:31am
- Ildong Pharmaceutical announced on the 6th that it recently received investigational new drug (IND) approval from the Ministry of Food and Drug Safety for its ID110521156’s Phase I clinical trial. ID110521156 is Ildong’s new GLP-1 receptor agonist drug candidate. Through the trial, the company plans to evaluate the tolerability, safet
- Policy
- MFDS amends medical device permit renewal regulations
- by Lee, Hye-Kyung Sep 7, 2023 05:31am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) issued a pre-announcement of administration on September 6th regarding the amendment of the ‘Regulations on Renewal of Medical Device Manufacturing Permits.’ and will be receiving opinions until September 26th. The amendment contains changes such as requiring different data submi
- Policy
- What to expect from the upcoming 2-day HIRA DREC meeting
- by Lee, Tak-Sun Sep 7, 2023 05:31am
- The industry’s attention is focused on the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that is being held for an unprecedented 2 days this month. The industry predicts that the 2-day term reflects the difficulty the committee will have in reaching a conclusion on the agendas set for
- Opinion
- [Reporter's view] Massive drug price cuts
- by Kim, Jin-Gu Sep 6, 2023 05:36am
- Generic proliferation. It is the root of all evil. At least that's the case from the government's perspective. When the valsartan incident occurred in 2018 and the ranitidine incident the following year, everyone knew that the essence of the incident was impurities, but the government continued to point out that the proliferation of generics
- Policy
- Daewoong withdraws its Herceptin biosimilar Ogivri from mkt
- by Lee, Hye-Kyung Sep 6, 2023 05:36am
- ‘Ogivri Inj. 150mg (trastuzumab),’ the third Herceptin biosimilar to be approved in Korea, is withdrawing from the Korean market. The Ministry of Food and Drug Safety announced on the 4th that Daewoong Pharmaceutical voluntarily withdrew its license for Ogivri in Korea. Ogivri was developed by the Ind
- Opinion
- [Desk’s View] Compensate for the value of novel drugs
- by Lee, Tak-Sun Sep 6, 2023 05:36am
- The Ministry of Health of Welfare plans to soon announce an appropriate compensation plan for the innovative value of new drugs, including novel homegrown drugs. The health authorities’ plan is to deliberate its plan by the Health Insurance Policy Review Committee within the month and release the results to the public soon. The domestic
- Policy
- What about digital therapy devices awaiting approval
- by Lee, Hye-Kyung Sep 6, 2023 05:36am
- In addition to digital treatment devices for improving insomnia, the Ministry of Food and Drug Safety is expecting applications for licenses for digital treatment devices No. 3 and 4 aimed at improving symptoms in the fields of neurology and psychiatry, respiratory rehabilitation, visual disturbances, and tinnitus. Lee Young-rim, head of the
- Policy
- Reimb of HA eye drops will be restricted in KOR
- by Lee, Tak-Sun Sep 6, 2023 05:36am
- As a result of the government’s reimbursement reevaluations, patients will be unable to receive reimbursement when using hyaluronic acid eye drops for extrinsic diseases, and the amount of their use will also be restricted. The government has also been known to be discussing limiting reimbursement to 4 boxes per year. According to ind
- Company
- Hanmi’s Rolontis post sales of KRW 4.8 bil in H1
- by Chon, Seung-Hyun Sep 5, 2023 05:40am
- Hanmi Pharm’s new drug ‘Rolontis’ has been slowly increasing its influence in the domestic market. In the first half of the year, 2 years into its release, the drug has posted sales of nearly KRW 5 billion. The drug has also been achieving fair results in the early stages of its release in the U.S. According to the pharmaceutical researc
- Policy
- Evaluating Tagrisso's primary benefit
- by Lee, Jeong-Hwan Sep 5, 2023 05:40am
- The Ministry of Health and Welfare announced that it is conducting a cost-effectiveness evaluation regarding the expansion of health insurance coverage for the first-line treatment of AstraZeneca's lung cancer drug Tagrisso. On the 4th, the Ministry of Health and Welfare responded as follows to a written question from People Power Party Rep.
