- Policy
- SK Bio regains license for 'SKYPneumo'
- by Lee, Tak-Sun Jun 7, 2021 06:06am
- SK Bioscience regained its license for its ‘SKYPneumo,’ the first-ever pneumococcal vaccine developed in Korea. This approval comes in less than a year since the company had withdrawn its license in October last year in the aftermath of losing a patent suit. On the 4th, the Korean Ministry of Food and Drug Safety (MFDS) approved SK Bios
- Policy
- Botulinum Toxin is poorly managed
- by Lee, Jeong-Hwan Jun 7, 2021 06:05am
- Poor management of some domestic botulinum strains has been detected. Illegal circumstances have also been detected, including analysis of strains' sources and characteristics, security management of fungus handlers, illegal acquisition of strains, and suspected cases of false separation reports. Authorities are planning to jointly come up
- Policy
- Improvements to exempted calculation of psoriasis are urged
- by Kim, Jung-Ju Jun 7, 2021 06:05am
- iThe registration for exempted calculation of severe psoriasis is just a year away. Patients have pointed out the difficulties and problems of the system. The point is that there are many unequal and unreasonable conditions, so the system should be improved to ensure quality before re-registration. The Korea Organization For Patient Group is
- Policy
- NA prepares bill to prevent 'price cut lawsuit' gimmicks
- by Lee, Jeong-Hwan Jun 4, 2021 06:06am
- A bill to prevent pharmaceutical companies from filing administrative suits for the purpose of evading or delaying drug price cut dispositions made by the government is expected to be introduced at the National Assembly. The bill will prevent the recurrence of cases similar to the suspended execution of drug price cuts ruling for the brai
- Policy
- Humira's price cut 30% due to Adalloce Prefilled Pen listing
- by Kim, Jung-Ju Jun 4, 2021 06:06am
- Abbvie Korea’s lead product line Humira is facing an insurance price cut of 30%. This ex officio adjustment by the government is to be made due to the introduction of the two biosimilars earlier this year by Samsung Bioepis, including its Adalloce prefilled pen inj.. The Ministry of Health and Welfare (MOHW) is preparing to amend the 'drug b
- Policy
- Suspension extended due to prolonged lawsuit of Betmiga
- by Kim, Jung-Ju Jun 3, 2021 06:12am
- The price will be temporarily extended again as Astellas Korea, which had been expected to plunge last year due to the government's adjustment to insurance prices, has prolonged its refusal to lower the price of Betmiga PR. The 14th administration of the Seoul Administrative Court has decided to extend the suspension until the 30th day of
- Policy
- Bill to strengthen fines on rebates pass NA plenary session
- by Lee, Jeong-Hwan Jun 3, 2021 06:11am
- A bill to increase the upper limit of the penalty surcharge imposed on drugs caught doing illegal rebates, and allowing the use of the surcharge as a resource for catastrophic health projects passed the plenary session of the National Assembly on the 21st. In the session, the NA passed the bill for the partial amendment of the National He
- Policy
- The new rheumatoid oral drug Smyraf was revoked after a year
- by Lee, Tak-Sun Jun 2, 2021 06:10am
- Astellas' Smyraf, which has drawn attention as a treatment for rheumatoid arthritis, withdrew the license in a year. Smyraf is the third domestically licensed inhibitor of Januskinase (JAK) after Xeljanz (Tofacitinib, Pfizer) and Olumiant (Baricitinib, Lilly). However, it failed to complete the registration process and withdrew from the Ko
- Policy
- Comparing Cellid with Janssen·AZ… SK Bio with Novavax
- by Lee, Tak-Sun Jun 1, 2021 06:11am
- With the Ministry of Food and Drug Safety announcing lowered standards for conducting Phase III clinical trials to promote the development of domestically developed COVID-19 vaccines, commercialization of Korean COVID-19 vaccines is likely to happen sooner than expected. In particular, domestic vaccines that were not able to enter the Pha
- Policy
- Objections to post-marketing premium reevaluation submitted
- by Lee, Hye-Kyung May 31, 2021 06:02am
- The Health Insurance Review & Assessment Service’s reevaluations of premiums applied to listed drugs are being finalized. On the 28th, HIRA held a post-marketing drug management subcommittee meeting to finalize its decision on the items for which the premiums would be terminated (products for price ceiling recalculation) according to the reo
