- Policy
- GSK’s dutasteride+tamsulosin combo finally enters Korea
- by Lee, Tak-Sun May 20, 2021 05:57am
- GSK will be introducing its fixed-dose ‘Avodart(dutasteride)’ and tamsulosin combination for the treatment of prostatic hyperplasia for the first time in Korea. The domestic approval has come 10 years after the approval by EMA and FDA. Considering that the combined prescription of the abovementioned two drugs is common in the prostatic hype
- Policy
- Generic for Madopar by Myungin was first licensed
- by Lee, Tak-Sun May 20, 2021 05:56am
- Madopar (Benserazide HCl/Levodopa) by Roche is the treatment for Parkinson's syndrome, and the generic was approved in Korea. Myungin, which is drawing attention in related markets for Perkin and Trilevo, is expected to expand its sales with the joining of generic for Madopar . The MFDS approved Myungdopar by Myungin on the 14th. Myungdop
- Policy
- Generic exclusivity of Alicoxib has been extended by one mon
- by Lee, Tak-Sun May 18, 2021 05:52am
- Arlico Pharm's "Alicoxib," which acquired generic exclusivity, has been extended for one month. The MFDS allowed the application for extension in consideration of the listing period. According to the MFDS on the 17th, Alicoxib will be guaranteed exclusive rights until January 30 next year. It was extended by about a month from December 25.
- Policy
- No. of clinical trials rise despite COVID-19
- by Lee, Tak-Sun May 18, 2021 05:51am
- Despite the COVID-19 outbreak last year, the number of clinical trials conducted in Korea had increased, which raised Korea’s global clinical trial rank by two steps. In particular, this was the first time the proportion of early clinical trials (Phase I, II) had exceeded the Phase III trials. Such positive results were possible with the Minist
- Policy
- RSA isn't enough to evaluate the benefit of first in class
- by Lee, Jeong-Hwan May 18, 2021 05:51am
- It was pointed out that in order to enhance patient accessibility of first-in-class, which costs tens of millions to billions of won per dose, and maintain national health insurance financial soundness, the first-in-class customized reimbursement model should be found. They argue that a system should be created that combines risk-sharing d
- Policy
- Will Moderna’s COVID-19 vaccine be introduced in H1?
- by Lee, Tak-Sun May 17, 2021 05:53am
- The process for the rollout of Moderna COVID-19 vaccine in the first half of this year is gaining momentum. As the possibility obtaining marketing authorization for the imported vaccines on Friday(21st) is high, its rollout in the first half of the year is promising due to the Korea-US Summit event. In addition, the overall inspection of th
- Policy
- Off-label use of Olumiant and Botox denied
- by Lee, Hye-Kyung May 17, 2021 05:53am
- An application for the use ‘Olumiant(baricitinib) in patients with alopecia areata was rejected by the health authorities in Korea. In addition, the application to administer Botox injections for the primary suture of facial lacerations and recurrent pancreatitis was also disapproved due to lack of medical evidence. The Health Insuranc
- Policy
- 1+3 restrictions bill for generics & IMDs was passed
- by Lee, Jeong-Hwan May 17, 2021 05:53am
- The number of joint biological equivalence tests and joint clinical trials of generic and data IMDs is expected to be limited to three consignment companies per manufacturer. Only three additional medicines can be licensed for biological equivalence tests or clinical trials. However, biological drugs such as high-tech new drugs and vaccine
- Policy
- Combination of Epidiolex & Clobazam are reimbursed
- by Lee, Hye-Kyung May 17, 2021 05:52am
- Starting this month, detailed standards for the health insurance application of "Epidiolex (Cannabidiol)," used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex, have been unveiled. The HIRA recently released 'Question and Answer on Applying Benefit Standards to Epidiolex' and guided
- Policy
- Will vaccination gather pace? MFDS approves 2.6 M doses
- by Lee, Tak-Sun May 14, 2021 05:50am
- Vaccination in Korea is expected to speed up as a large number of COVID-19 vaccines have been approved national lot release. Through the fast track review and approval system, the Ministry of Food and Drug Safety also (MFDS) approved the national lot release of AstraZeneca’s vaccine earlier than expected. Since the 12th, as many as 2,640,0
