- Policy
- Sales of 6 BINEX items have been temporarily suspended
- by Lee, Jeong-Hwan Mar 10, 2021 06:27am
- he MFDS decided on the 8th to temporarily suspend the manufacture and sale of six medicines manufactured by BINEX and to collect them. The MFDS is also launching an investigation into a factory located in Busan. Drugs subject to disposal are Amorin (Glimepiride), Xelectin (Fluoxetine), Daxfen (Dexibuprofen), Rofsin 250 mg (Ciprofloxacin)
- Company
- Chong Kun Dang applied for COVID-19 treatment
- by An, Kyung-Jin Mar 10, 2021 06:27am
- Chong Kun Dang announced on the 8th that it has applied to the MFDS for approval of the conditional marketing authorization (CMA) and phase 3 clinical trial plan of Nafabelltan (Nafamostat) as a treatment for COVID-19 for patients with severe and high risk. Nafabelltan is a drug used as a therapeutic agent for acute pancreatitis and as an
- Product
- KMA recommends Tylenol for fever after AZ vaccination
- by Kang, Shin-Kook Mar 10, 2021 06:26am
- After the AstraZeneca COVID-19 vaccination, the frequency of fever or muscle pain was found to be 20-30%, and the KMA recommended taking Tylenol. The KMA (Chairman Choi Daejip) released a recommendation containing countermeasures after the COVID-19 vaccine vaccination to the public on the 6th. The KMA said, "In the case of the AstraZenec
- Policy
- Promote disclosure of anticancer drug Expedite Review result
- by Kim, Jung-Ju Mar 9, 2021 06:24am
- A revision of the law is being promoted to revise up the relevant laws and regulations, so-called Fast Track (Expedite Review) for drugs that treat serious diseases, such as anticancer drugs and AIDS drugs, and make the review process transparently disclosed. On the 5th, Rep. Nam In-soon of the Democratic Party of Korea, a member of the Na
- Company
- First CAR-T treatment Kymriah was approved in Korea
- by Eo, Yun-Ho Mar 9, 2021 06:24am
- The first CAR-T treatment drug Kymriah was approved in Korea. The MFDS announced on the 5th that it has approved the world's first chimeric antigen receptor T cell (CAR-T) treatment Kymriah (Tisagenlecleucel), which was applied for approval by Novartis Korea, as the first advanced biopharmaceutical under the Advanced Renewable Bio Act.
- Policy
- Soliris follow-on Ultomiris conditionally listed
- by Lee, Hye-Kyung Mar 9, 2021 06:24am
- Handok’s paroxymal nocturnal hemoglobinuria (PNH) treatment Ultomiris (ravulizumab) is getting closer to the National Health Insurance (NHI) reimbursement. On Mar. 4, the Health Insurance Review and Assessment Service (HIRA) convened a second meeting of the year for the Drug Reimbursement Evaluation Committee (DREC) and deliberated list
- Company
- Antihypertension Zofenil and Adalat Oros to halt supply
- by Mar 9, 2021 06:24am
- Zofenil (zofenopril calcium) tablet and Adalat Oros (nifedipine) 60 mg tablet that had shortage issues are ultimately ceasing the supply. On Mar. 5, pharmaceutical distribution industry source reported Menarini Korea has informed of halting the supply of an antihypertension drug Zofenil in 7.5 mg, 15 mg and 30 mg doses. Menarini Kore
- Company
- Mercilon's sales fell 16%
- by Kim, Jin-Gu Mar 8, 2021 06:20am
- The OTC oral contraceptives market is fluctuating. Sales of Mercilon and MYVLAR, the existing No. 1 and 2 items, declined significantly for each reason. Sales of new products such as Senseday and Daon succeeded in establishing a very stable market. The cause of the change in the market is the change of vendor and the launch of new produc
- Opinion
- [Reporter’s Eye] Needs transparency in Cancer Committee
- by Eo, Yun-Ho Mar 8, 2021 06:20am
- The cases of healthcare reimbursement expansion on novel drug in South Korea has plummeted last year. The drug use has diversified but the actual use volume has not been increased. A survey on pharmaceutical reimbursement status found the increase in reimbursement expansion for each item in 2020 compared to 2019 has plunged by 70 percen
- Policy
- GC Pharma-Moderna-KCDC ink COVID-19 vaccine contract
- by Lee, Jeong-Hwan Mar 8, 2021 06:20am
- GC Pharma has officially announced it would supply the COVID-19 vaccine developed by Moderna. The decision is made for the vaccine distribution deal signed between the multinational company and the Korea Disease Control and Prevention Agency (KDCA).. On Mar. 4, GC Pharma (President Heo Eun-cheol) stated it would distribute 40 million dos
