- Policy
- Keytruda’s reimb expansion under review by CDRC
- by Lee, Tak-Sun Apr 17, 2024 06:06am
- 'Keytruda (pembrolizumab, MSD),' a cancer immunotherapy drug, will be considered for review by the Cancer Disease Review Committee this afternoon to discuss its expanding reimbursement. Keytruda’s reimbursement expansion has been submitted to the Cancer Disease Review Committee three times, but it has received re-evaluation decisions eac
- Policy
- A Korean 4th gen NSCLC drug starts clinical trial
- by Lee, Hye-Kyung Apr 16, 2024 05:47am
- A Phase 1 clinical trial for a domestically developed 4th generation non-small cell lung cancer (NSCLC) drug has been approved in Korea. The Ministry of Food and Drug Safety approved the Phase I trial for Oncobix’s oral ALK/EGFR inhibitor 'OBX02-011' on patients with advanced NSCLC on the 12th. The trial will be conducted at the Natio
- Policy
- Merck withdraws Tepmetko’s reimb application
- by Lee, Tak-Sun Apr 16, 2024 05:47am
- I1 Merck voluntarily withdrew its reimbursement application for its Tepmetko’s Tab (tepotinib) after failing to establish reimbursement standards at the Health Insurance Review and Assessment Service's Cancer Disease Review Committee meeting in March After two unsuccessful attempts, the industry’s eyes are on whether the company will reapp
- Policy
- K-pharma industry added 480 new jobs in Q4 of last year
- by Lee, Hye-Kyung Apr 16, 2024 05:47am
- As of the fourth quarter of last year, 81,000 people were employed in the pharmaceutical industry, a 2.4% increase year-over-year (YoY). New jobs in the medical service area included 4,757 jobs (80.4% of the total count), including healthcare professionals, followed by 480 jobs in the pharmaceutical industry, 438 jobs in the medical devices,
- Policy
- Will the COVID-19 drug Paxlovid be reimbursed in H1 2024?
- by Lee, Tak-Sun Apr 16, 2024 05:46am
- Whether the reimbursement of the COVID-19 drug Paxlovid (nirmatrelvir and ritonavir, Pfizer), which the government has been working to make part of Korea’s general healthcare system after the end of the COVID-19 pandemic, will be able to be listed within the originally planned date is gaining attention. The Korea Disease Control and Prev
- Policy
- Drugs with 'amlodipine' formulation get pediatric indication
- by Lee, Hye-Kyung Apr 15, 2024 06:06am
- Now, the 109 items of 'amlodipine besylate' monotherapy, which is used for the treatment of hypertension and angina, can be used for treating pediatric patients with hypertension. The Ministry of Food and Drug Safety (MFDS) ordered the change of approval conditions for 'amlodipine besylate monotherapy (doses 5mg, 10mg, tab)'. The change of a
- Policy
- Reimb price of Forxiga generics fluctuates amid changes
- by Lee, Tak-Sun Apr 12, 2024 05:41am
- How the changes in reimbursement status of Forxiga (dapagliflozin propanediol monohydrate) generics will affect market competition is gaining industry-wide attention. The generic versions, which had been introduced to the market in April last year, are facing price changes due to changes in their reimbursement status. The premium pricing
- Policy
- Clopidogrel recall due to 1 CMO…’no issue escalation’
- by Lee, Hye-Kyung Apr 11, 2024 05:44am
- The issue that stirred up the clopidogrel recall that had been ongoing since March was found to have been caused by a single contract manufacturer, making the concern of it escalating to a series of recalls unlikely. Starting with Daewoong Bio's 'Clovons Tab' on March 17, the Ministry of Food and Drug Safety recalled a total of 29 items f
- Policy
- 4th-generation, 3 chamber IV nutrition receives reimb
- by Lee, Tak-Sun Apr 11, 2024 05:44am
- Fourth-generation 3 chamber Total Parenteral Nutrition (TPN), with enhanced amino acids contents, are being introduced into the market. Following the reimbursement listing of related products by Baxter and JW Pharmaceutical, HK inno.N and Fresenius Kabi have joined the competition. Companies that competed previously in the third-generat
- Policy
- Approval of Beyfortus imminent in Korea
- by Lee, Hye-Kyung Apr 9, 2024 05:50am
- Beyfortus (nirsevimab), a long-acting antibody designed to prevent respiratory syncytial virus (RSV) in infants that was jointly developed by Sanofi and AstraZeneca, is soon to receive marketing authorization in Korea. According to the minutes of the Central Pharmaceutical Affairs Council meeting held on March 6, which was released by the
