- Company
- Anemia drug ‘Vadanem’ makes 2nd attempt at reimb listing
- by Nho, Byung Chul Mar 8, 2024 05:18am
- Vadanem, Mitsubishi Tanabe Pharma’s new tablet anemia drug, will likely receive approval from the U.S. Food and Drug Administration by early April and make a second attempt at getting a reimbursement listing in Korea. If the company gets the drug reasonably priced comparable to a weighted average price of the substitute during drug pri
- Policy
- 2yr use restriction lifted for Alimta+Keytruda combo reimb
- by Lee, Tak-Sun Mar 8, 2024 05:18am
- The reimbursement period for the Alimta+Keytruda+platinum-based chemotherapy is set to be extended. Previously, the 3-drug combination was covered for up to 2 years, but the Cancer Disease Deliberation Committee decided to remove this restriction from the reimbursement standards. The Health Insurance Review and Assessment Service announced th
- Policy
- DPK urges doctors to return to work
- by Lee, Jeong-Hwan Mar 7, 2024 07:16am
- The Democratic Party of Korea (DPK) urged trainee doctors who walked off the job en masse to return to their medical sectors. Furthermore, the DPK suggested that medical community negotiate a reasonable capacity of medical school admissions. The ruling party has temporarily allowed non-face-to-face medical treatment to address the curr
- Policy
- High-strength Ebixa generics start receiving approval again
- by Lee, Hye-Kyung Mar 7, 2024 07:16am
- Approvals for generic versions of the high-strength Ebixa 20mg (memantine hydrochloride), a treatment for severe Alzheimer's, that had been slowing down lately, have begun to gain momentum again. On March 5, the Ministry of Food and Drug Safety approved Dongkook Pharmaceuticals 'Memantine Tab 20mg.' Eighteen years after the 10mg formulatio
- Policy
- Once-weekly growth hormone Sogroya is approved in Korea
- by Lee, Hye-Kyung Mar 7, 2024 07:16am
- A growth hormone that can be administered once weekly was approved in Korea. The Ministry of Food and Drug Safety approved Novo Nordisk’s ‘Sogroya Prefilled Pen (somapacitan-beco)’ 5mg, 10mg, and 15mg on June 6. Sogroya is a once-weekly treatment for adult hormone deficiency and is indicated for the replacement of endogenous growt
- Company
- Oral PNH drug Fabhalta to soon be released in Korea
- by Eo, Yun-Ho Mar 7, 2024 07:15am
- Novartis' new PNH drug Fabhalta is set to land in Korea. According to industry sources, Novartis Korea has submitted an application for the marketing authorization of its Paroxysmal Nocturnal Hemoglobinuria (PNH) drug Fabhalta (iptacopan) to the Ministry of Food and Drug Safety. Therefore, the drug is expected to be approved within this
- Policy
- The RSA track to include drugs for chronic diseases, asthma
- by Lee, Tak-Sun Mar 7, 2024 07:15am
- The Risk Sharing Agreement (RSA) will cover chronic and severe diseases that cannot be treated with substitute drugs and result in irreversible deterioration in the quality of life. It was announced last year as part of ‘The drug pricing system to ensure fair-value compensation for innovative new drugs.’ Since the announcement, the
- Opinion
- [Reporter’s View] On MFDS’s new drug management team
- by Lee, Hye-Kyung Mar 6, 2024 06:03am
- A new drug management support team will be established under the Ministry of Food and Drug Safety’s Pharmaceutical Safety Bureau. According to the 'Partial Amendment of the Enforcement Rules of the Ministry of Food and Drug Safety and its Affiliated Institutions' that was released by the MFDS on February 7, the MFDS will newly establish a d
- Company
- Rare drug Ultomiris posts KRW 40 billion in sales in 3 yrs
- by Nho, Byung Chul Mar 6, 2024 06:03am
- Becoming a KRW 40 billion blockbuster in just 3 years since its launch, the growth potential of AstraZeneca’s Ultomiris Inj (ravulizumab) is gaining industry-wide attention. The biological orphan drug Ultomiris Inj. is considered to be the successor to Soliris Inj. (eculizumab) with significant improvements in dosing convenience. T
- Company
- Reimb for Verzenio in early breast cancer undergoes review
- by Eo, Yun-Ho Mar 6, 2024 06:03am
- Verzenio, the first CDK4/6 inhibitor to apply for insurance reimbursement in early breast cancer, is taking the second step to extend its reimbursement coverage. According to a report, the agenda of reimbursing Lilly Korea’s Verzenio (abemaciclib) will be presented to the Health Insurance Review and Assessment Service's Cancer Disease De
