- Policy
- MFDS grants EUA of Moderna’s adapted COVID-19 vaccine
- by Lee, Hye-Kyung Sep 27, 2023 05:44am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) approved the emergency use of Moderna’s monovalent vaccine ‘Spikevax Inj (andusomeran)’ that targets the COVID-19 Omicron subvariant (XBB 1.5) on September 26. The emergency use approval was granted per request by the Korea Disease Control and Prevention Agency to carry out
- Policy
- Resolving Conflicts in Non-face-to-face Medical treatment
- by Lee, Jeong-Hwan Sep 27, 2023 05:44am
- The Ministry of Health and Welfare cited the legalization of non-face-to-face treatment through the revision of the Medical Act as a solution to resolve the conflict between the medical community and the medical community surrounding non-face-to-face-face treatment. In addition, the MOHW expressed his will to improve the non-face-to-face
- Policy
- Why did the original Ninlaro voluntarily cut its price 34%
- by Lee, Tak-Sun Sep 27, 2023 05:44am
- The insurance ceiling price of Takeda Pharmaceuticals Korea’s multiple myeloma treatment ‘Ninlaro Cap’ will be discounted by 34% from October. 10% of the price cut is made due to the price-volume agreement system, but the company had voluntarily lowered the price significantly over the set 10%. It is rare for an original drug with no
- Policy
- Madopar triggers bioequivalence test verification requests
- by Lee, Hye-Kyung Sep 26, 2023 05:50am
- The demand has been rising for the government to verify the validity of bioequivalence tests conducted by generic versions of Madopar Tab (levodopa-benserazide), Roche Korea’s Parkinson's disease drug that had withdrawn from the domestic market. Opinions are being collected on the post ‘Regarding the validity of bioequivalence tests tha
- Policy
- Pfizer’s Bosulif in pricing negotiations for reimb in KOR
- by Lee, Tak-Sun Sep 26, 2023 05:49am
- The reimbursement listing process for Pfizer’s Philadelphia chromosome-positive chronic myeloid leukemia (CML) treatment Bosulif (bosutinib) is gaining momentum. The drug has entered the drug pricing negotiation stage only 8 months after it received approval in January in Korea. As a late 2nd-gen Ph+ CML drug entrant to Korea, the drug
- Policy
- Hanmi is the first to release Zytiga generic at half price
- by Lee, Tak-Sun Sep 25, 2023 05:35am
- Hanmi Pharm has become the first to launch the first generic of Janssen's prostate cancer treatment ‘Zytiga (abiraterone acetate).’ In particular, the drug is expected to greatly reduce the financial burden borne by patients as it is sold at a much lower price than the original Zytiga. According to industry sources on the 22nd, Hanmi
- Policy
- Mifegyne, inadequate national essential drug system
- by Lee, Jeong-Hwan Sep 25, 2023 05:34am
- Rep. Nam In-soon applies as a reference to the Pharmaceutical Society for a Healthy Society Anticipation of questions such as transparency of essential medicines. Problems with the national essential drug designation system and the issue of the miscarriage inducer Mifegyne not being designated as a national essential drug are expected to be
- Policy
- Vabysmo·Evrysdi will be reimbursed in October
- by Lee, Jeong-Hwan Sep 25, 2023 05:34am
- New reimbursement standards for Vabysmo, SMA treatment Evrysdi, and hemophilia A treatment Jivi (Damoctocog Alfa Pegol) will be established from the 1st of next month. The scope of reimbursement for Spinraza, a cure for spinal muscular atrophy, will be expanded, and the reimbursement standard for the emergency introduction drug Ivexproglycem
- Policy
- How Samsung’s biosimilar became covered in the US
- by Lee, Hye-Kyung Sep 22, 2023 05:41am
- Language barriers, insufficient handling of administrative issues related to regulations and visas, difficulties in recruiting and managing local personnel, and lack of a network infrastructure were pointed to as barriers to the Korean pharmaceutical companies’ entry into the U.S. Entry into the U.S. market holds significance in the industr
- Policy
- Vabysmo·Evrysdi, listed as reimbursement
- by Lee, Tak-Sun Sep 22, 2023 05:41am
- It is reported that Vabysmo and Spinal Muscular Atrophy Evrysdi Dry Syrup 0.75mg/mL will be listed on the benefit in October. Additionally, the upper limit for 2 Jardiance items and 2 Ninlaro items is expected to be reduced due to PVA. It is reported that the upper limit price of pseudoephedrine ingredient preparations that have completed ne
