- Policy
- Moderna vaccine has been approved for lot release
- by Lee, Tak-Sun Jun 18, 2021 05:53am
- The MFDS said it approved lot release of 55,000 doses of Moderna COVID-19 vaccine on the 15th. The national lot release is a system in which country evaluates the results of the verification test and the review of the manufacturer's data before the vaccine is distributed on the market and checks the quality once more. The MFDS measured
- Policy
- AZ vaccine's side effects are reviewed
- by Lee, Tak-Sun Jun 17, 2021 08:02pm
- The MFDS has begun a review on the addition of side effects of capillary leakage syndrome of AstraZeneca's COVID-19 vaccine recommended by the European Medicines Agency (EMA). The MFDS announced on the 14th that it will take necessary measures such as distributing Dear Healthcare Professional Letter, sharing information recommended by EMA,
- Company
- Cancer immunotherapy combo seeks 1st-line reimbursement
- by Eo, Yun-Ho Jun 17, 2021 06:04am
- Activity to reimburse ‘Opdivo’ has begun again after a long standstill. According to industry sources, Ono and BMS recently submitted an application to extend reimbursement for the PD-1 inhibitor ‘Opdivo (nivolumab)’ in combination with the CTLA-4 inhibitor ‘Yervoy (ipilimumab)’ to first-line treatment of non-small cell lung cancer
- Policy
- PBAC provides cost-effectiveness data to improve integrity
- by Lee, Hye-Kyung Jun 17, 2021 06:04am
- The Health Insurance Review and Assessment Service's Pharmaceutical Management Department was selected as 'best project' among 'self-promoted projects to improve integrity’ for its efforts in improving standard forms and expanding information disclosure systems. The department worked to improve integrity by clarifying and making transparent
- Company
- Drug exports in May amounted to ₩650 billion
- by Kim, Jin-Gu Jun 17, 2021 06:04am
- Korea's drug exports reached &8361;650 billion in May. Exports are still export boom following last year. However, as imports increased, the trade balance posted in deficit for the second straight month from April. By country, drug exports to Germany surpassed &8361;1 trillion in five months. Pharmaceutical exports to Germany exceeded &
- Company
- Companies are nervous about investigating Varenicline
- by An, Kyung-Jin Jun 16, 2021 05:42am
- Companies selling anti-smoking drugs, generic for Champix are on alert. Health authorities are investigating Nitrosamines impurities in Varenicline. It seems that sales are facing difficulties due to unfavorable factors such as COVID-19 incident and follow-up measures of impurities after passing the patent dispute in Korea. According to an
- Company
- Daewoong registers patient for Phase 3 trial of Coviblock
- by Nho, Byung Chul Jun 16, 2021 05:42am
- The first patient for the Phase III trial of Daewoong Pharmaceutical's COVID-19 treatment candidate 'DWJ1248 (brand name: Coviblock)’ has been registered. According to the clinical trial approval status disclosed on the Pharmaceutical Integrated intelligence system webpage, Daewoong Pharmaceuticals had registered its first patient on the
- Company
- '100 Tylenols per pharmacy' provided to relieve shortage
- by Jun 16, 2021 05:41am
- The shortage of Tylenol in pharmacies will be somewhat relieved with one hundred Tylenol 500mg being supplied to each pharmacy starting today. This measure to relieve the Tylenol shortage was made under the government’s request to Johnson & Johnson to release the 5 million the company stockpiled for next year, and Johnson & Johnson shipp
- Company
- Jeil Pharma's new OAB treatment ‘vibegron’ nears release
- by Kim, Jin-Gu Jun 16, 2021 05:41am
- ‘Vibegron,' a new drug indicated for the treatment of overactive bladder (OAB) that Jeil Pharmaceutical acquired a domestic license for from Kyorin Pharmaceutical, is soon to be approved in Korea. Two clinical trials related to the domestic approval and manufacturing of Vibegron have been completed or are near completion. At the earlies
- Company
- Investigation of Varenicline has been undertaken
- by Chon, Seung-Hyun Jun 16, 2021 05:41am
- Health authorities have launched an investigation into Nitrosamines impurities in non-smoking drugs "Champix" and generics for Champix. According to industries on the 14th, the MFDS recently ordered pharmaceutical companies to follow up on Varenicline's impurities (Nitrosamines). The MFDS said, "Recently, there is a possibility of Nitro
