- 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
- Policy
- Amivantamab designated as a rare drug
- by Lee, Tak-Sun Mar 8, 2021 06:19am
- Janssen's Amivantamab, which is promoting joint development with Yuhan's non-small cell lung cancer treatment Leclaza, has been newly designated as an orphan drug. The MFDS announced that it will newly designate five drugs, including Amivantamab, as orphan drugs, and announce additional target diseases for three drugs, including 5-Aminolevuli
- Policy
- 1 free dose of rare cancer treatment Lutathera
- by Lee, Tak-Sun Mar 5, 2021 06:25am
- Apparently, South Korea’s Ministry of Food and Drug Safety (MFDS) is to lessen the patient’s financial burden through a patient aid program for a rare cancer treatment Lutathera until it gets officially listed for reimbursement. The government program would grant a free dose of the treatment. MFDS announced the Lutathera patient aid p
- Policy
- Jardiance generics win approvals one after another
- by Lee, Jeong-Hwan Mar 4, 2021 06:10am
- A series of generics of Boehringer Ingelheim Korea’s antidiabetic sodium-glucose co-transporter-2 (SGLT2) inhibitor Jardiance (empagliflozin) seem to be receiving the market authorization one after another. On Mar. 3, South Korea’s Ministry of Food and Drug Safety (MFDS) authorized Korea Prime Pharm’s Empazin 10 mg and 20 mg tablets.
- Policy
- Single-dose Janssen COVID-19 vaccine requests authorization
- by Lee, Tak-Sun Mar 4, 2021 06:10am
- Janssen’s COVID-19 vaccine to be introduced to South Korea in the second quarter has officially requested for authorization to the Ministry of Food and Drug Safety (MFDS). Following AstraZeneca and Pfizer, the multinational company would be a third company to apply for the authorization on COVID-19 vaccine in the country. On Feb. 27, MF
- Policy
- How GC Pharma obtained the copyright of Moderna vaccine?
- by Lee, Jeong-Hwan Mar 4, 2021 06:10am
- Moderna signed distribution agreement with GC Pharma for its COVID-19 vaccine in Korea, and GC Pharma has the final copyright. On the 26th, GC Pharma was a successful bidder as a domestic pharmaceutical company in charge of licensing and distribution of Moderna’s mRNA-1273 vaccine. GC Pharma's CEO Eun-cheol Huh bids for &8361;34.2 billio
- Policy
- Pfizer vaccine can be administered over the age of 16 years
- by Lee, Tak-Sun Mar 3, 2021 06:23am
- The Central Pharmaceutical Affairs Review Committee, an expert advisory body for the MFDS, recommended the approval of Pfizer's COVID-19 vaccine. They gathered opinions that it is possible to administer them even over the age of 16. The MFDS explained the results by announcing the results of the Central Pharmaceutical Affairs Review Commi
- Policy
- Will Kymriah be approved?
- by Lee, Tak-Sun Mar 2, 2021 06:25am
- The market approval of Kymriah by Novartis, a commercially available CAR-T (chimeric antigen receptor-T cell) treatment in the domestic market, is imminent. Kymriah is the first CAR-T treatment approved by the US FDA, and it applied for approval in Korea earlier last year. According to the industry on the 1st, Kymriah recently complete
- Policy
- Celltrion abandoned clinical trials of CT-P59
- by Lee, Jeong-Hwan Mar 2, 2021 06:25am
- It was found that Celltrion gave up the clinical trial of CT-P59, a prophylactic antibody treatment to respond to COVID-19. Celltrion decided to suspend the project selection agreement in less than a month after it was selected for the government support project in December of last year. Celltrion cited the difficulty of developing vaccine
- Policy
- KDCA on cost-effectiveness of expanding HPV vaccination
- by Lee, Tak-Sun Mar 2, 2021 06:25am
- The government is apparently conducting a study on the cost-effectiveness of expanding the human papillomavirus (HPV) vaccination subject and vaccine types. The outcome of the research could affect the pharmaceutical industry. On Feb. 24, the Korea Disease Control and Prevention Agency (KDCA) official answered Democratic Party Lawmaker C
