- Policy
- The Committee recommended AZ vaccine approval
- by Lee, Tak-Sun Feb 9, 2021 06:04am
- The Central Pharmaceutical Affairs Review Committee of the MFDS, which consulted on AstraZeneca's approval of the COVID-19 vaccine, recommended item approval, subject to the submission of ongoing clinical results. In addition, for vaccinations over 65 years of age, it was gathered that opinions should be made carefully in the matters of appr
- Company
- What now for Vyndamax failing essential drug designation?
- by Eo, Yun-Ho Feb 8, 2021 06:08am
- A transthyretin amyloid cardiomyopathy (ATTR-CM) new drug Vyndamax (tafamidis) seems to be struggling to receive National Health Insurance (NHI) reimbursement in South Korea. A pharmaceutical industry source reported Pfizer’s new drug treating patients with ATTR-CM Vyndamax (tafamidis 61 mg) has failed to get a treatment-purpose essentia
- Company
- Oncaspar for acute lymphocytic leukemia was approved
- by Eo, Yun-Ho Feb 8, 2021 06:08am
- According to the related industry, Servier Korea's Oncaspar (Pegaspargase) was approved from the MFDS as a rare specialty medicine as a combination therapy with other anti-tumor drugs when treating Acute Lymphoblastic Leukemia (ALL) in children and adults under the age of 8 years. Oncaspar is a drug that dramatically reduces the frequency
- Policy
- Will the Committee allow AZ vaccine in the elderly?
- by Lee, Tak-Sun Feb 8, 2021 06:08am
- This is because the Central Pharmaceutical Affairs Review Committee, a specialized advisory body for the MFDS, determines the adequacy of the approval from 2pm. While it is expected that the Central Pharmaceutical Affairs Review Committee has decided on item approval, it is noteworthy how it will decide on the administration of the elder
- Company
- Sanofi disturbs distributors with first vaccine bidding
- by Feb 8, 2021 06:08am
- Sanofi Pasteur, a first pharmaceutical manufacturer to jump into the vaccine bidding market and stir up the pharmaceutical distributor industry, could not ink the final procurement agreement. The company dropped its agreement offer as it failed to meet the bidder qualification standards. A pharmaceutical distributor industry reported on
- Policy
- Government-pharmaceutical organizations discuss measures
- by Lee, Jeong-Hwan Feb 8, 2021 06:07am
- The MOHW and medical groups discussed COVID-19 vaccination plan and comprehensive measures to strengthen health insurance non-reimbursement management. The operation plan of the Health and Medical Personnel Policy Deliberation Committee was also on the agenda of the meeting. On the 3rd, the MOHW (Minister Kwon Deok-cheol) held the 4th
- Company
- What is the expert evaluation of the single dose COVID-19 va
- by Whang, byung-woo Feb 8, 2021 06:07am
- Johnson & Johnson's COVID-19 vaccine, which has the advantage of a single vaccination, has been evaluated as not as expected, revealing 66% of the preventive effect. Experts are suggesting that approval is expected as long as they exceed the minimum standards of the WHO, but the evidence should be supplemented. On the 29th, Johnson & Jo
- Company
- Elyson challenges patent of Entresto
- by Kim, Jin-Gu Feb 5, 2021 10:09am
- Novartis' heart failure treatment Entresto (Sacubitril / Valsartan) is expected to be challenged by domestic companies. Interest is focused on whether domestic companies can overcome Entresto's patents, in which a total of 4 patents are registered. According to the pharmaceutical industry on the 4th, Elyson recently filed a judgment agains
- Policy
- Phase III fast track for Leclaza·Lynparza was approved
- by Lee, Jeong-Hwan Feb 5, 2021 05:54am
- While a bill was proposed to upgrade the fast track system in phase III to the pharmaceutical affairs law from the public announcement, 62 new drugs were counted to have taken the fast track so far. Most of domestic and overseas anticancer drugs such as Leclaza (Lasertinib) developed by Yuhan, AstraZeneca's Lynparza, Tagrisso (Osimertinib)
- Company
- Delstrigo seeks reimbursement to join the HIV drug market
- by Eo, Yun-Ho Feb 5, 2021 05:51am
- MSD’s HIV new drug Delstrigo has started the National Health Insurance (NHI) reimbursement application process. The pharmaceutical industry reported, MSD Korea has submitted an application for the NHI reimbursement on an once-daily fixed-dose combination tablet Delstrigo (doravirine / lamivudine / tenofovir disoproxil fumarate) treating
