- Policy
- Report find MFDS cleared 112 IMDs in past decade
- by Lee, Tak-Sun Jan 2, 2020 06:05am
- Apparently, more than half of incrementally modified drugs (IMDs) approved in the past decade were combination drug. And majority of them were approved for treating chronic disease. On Dec. 30, Korea’s Ministry of Food and Safety (Minister Lee Eui-kyung) published ‘IMD Approval Report’ reviewing current status and past cases of approv
- Company
- What's the court ruling on the claim of CSO's money?
- by Jung, Hye-Jin Jan 2, 2020 06:05am
- Medical personnel who received rebates from the CSO in exchange for prescriptions of drugs pleaded not guilty in medical law, the court was found guilty. Doctors insisted that the money they received could not be rebated because the CSO was not a 'medical supplier' as defined by the Medical Law, but the court found that the amount provided
- Company
- Round 2 of Eliquis pricing reduction litigation to begin
- by Kim, Jin-Gu Jan 1, 2020 10:35pm
- Bristol-Myers Squibb (BMS) has decided to make an appeal after losing the Eliquis (apixaban) pricing reduction litigation suit. The twice postponed Eliquis pricing reduction could be postponed, yet again. According to pharmaceutical industry sources, BMS has filed an appeal on Dec. 23 at Seoul High Court. Seemingly, the legal dispute bet
- Company
- The NPS, strengthen management intervention of companies
- by Chon, Seung-Hyun Dec 31, 2019 06:45am
- The nation's largest institutional investor, the National Pension Service declared that it will actively participate in management of investment companies. Starting next year, the possibility of exercising shareholder rights, such as dismissal of directors, will be raised against “bad companies” that violate laws such as embezzlement and resig
- Policy
- Keytruda-Lenvima already got 9 trials approved in Korea
- by Lee, Tak-Sun Dec 31, 2019 05:51am
- MSD Korea and Eisai Korea are conducting a series of clinical studies in Korea to confirm cancer-treating efficacy of combination therapy of immunotherapy Keytruda (pembrolizumab) and targeted therapy Lenvima (lenvatinib). In Korea alone, nine clinical protocols on the combination therapy have been approved. The pharmaceutical industry
- Policy
- Maviret, liver & kidney transplant patients benefit extended
- by Kim, Jung-Ju Dec 31, 2019 05:51am
- Liver and kidney transplant patients will be expanded and added to the administration of adult chronic hepatitis C treatment drug, Maviret (Glecaprevir + Pibrentasvir), and the reimbursed period of administration will be divided. reimbursed indication of Jext inj (Epinephrine bitartrate)150μg is changed to anaphylaxis, and covered up to
- Policy
- IMD pricing reduction dispute to continue on
- by Lee, Jeong-Hwan Dec 30, 2019 09:48pm
- Pharmaceutical industry and lawmakers are reprehending the government for not laying down any specific plan, despite their demand for the government to abolish or revise the pricing reduction policy on new incrementally modified drugs (IMDs). The criticism is on the lack of any follow-up action from the government, although Minister of
- Opinion
- [Reporter’s View] Next year wishes for the industry
- by An, Kyung-Jin Dec 30, 2019 09:47pm
- “Last year, not one of Korean-made new drug was approved by the U.S. Food and Drug Administration (FDA). Ever since hemophilia treatment Aftyla was passed in 2016, Korean drugs have not been able to get a green light from the U.S. health regulator for two consecutive years. However, the industry is expected to bring a series of good news th
- Policy
- Impurity checks are left to the industry
- by Lee, Tak-Sun Dec 30, 2019 09:47pm
- As announced after the 2018 Valsartan incident, the MFDS focused on regulating generic entry this year. In the sense that all restrictions can be made, irrational systems were introduced as soon as possible to prevent the entry of generics. Generic regulatory measures, including restrictions on cooperative and entrusted activities, the i
- Policy
- NHIS "providing reliable and reasonably priced generics"
- by Lee, Hye-Kyung Dec 30, 2019 06:19am
- Korea’s National Health Insurance Service (NHIS) has reported it would take over the generic management from next year. The Price-volume Agreement (PVA) system currently limited to new drug only would be also applied on generic pricing negotiation. The government agency plans to form a task force team to support Ministry of Health and Welfa
