- Policy
- Impurity detected in single-agent entacapones
- by Kang, Shin-Kook Apr 19, 2024 06:24am
- t has been confirmed that impurities have been detected in entacapone, a single-agent drug used to treat symptoms of Parkinson's disease. According to medical and pharmaceutical organizations on the 18th, the Ministry of Food and Drug Safety began reviewing safety measures, including setting necessary temporary permissible limits based
- Policy
- Four Otezla generics were authorized simultaneously in Korea
- by Lee, Hye-Kyung Apr 19, 2024 06:24am
- Four generic versions of Amgen's oral psoriasis drug Otezla (Apremilast) have been approved simultaneously in Korea. With the resolution of Otezla’s 'use patent' issue, which had served as an obstacle to the launch of generics, domestic pharmaceutical companies that have previously succeeded in avoiding the drug’s composition patent see
- Policy
- PVA exemptions expanded to drugs below KRW 3 billion
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- Effective this year, the price-volume agreement (PVA) criteria will be expanded to provide an exemption to products with a claim amount below KRW 3 billion. This amount represents an increase from the previous criteria, which was below KRW 2 billion. Also, any product that has undergone more than two price reductions in the last five yea
- Policy
- KRW 10 Bil antiemetic drug Akynzeo seeks reimb for injection
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- HK inno.N is expanding the lineup of 'Akynzeo,' a medicine used to prevent vomiting in cancer patients. In addition to the capsule formulation currently covered by health insurance, the company has applied for reimbursement to the Health Insurance Review and Assessment Service (HIRA) for Akynzeo inj. According to industry sources on the
- Policy
- Will Fasenra be applied RSA for reimbursement in KOR?
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- AstraZeneca has entered into drug price negotiations with the National Health Insurance Service for its ‘Fasenra Prefilled Syringe Inj (benralizumab, AZ),’ a severe eosinophilic asthma treatment that passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review in March. With other drugs wit
- 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
