- Policy
- Evusheld granted emergency use for preventing COVID-19
- by Lee, Hye-Kyung Jul 1, 2022 05:50am
- With the emergency use authorization has been granted for ‘Evusheld Inj,’ the first-ever preventive antibody therapy for COVID-19 in Korea, the drug is expected to be used in immunocompromised patients who are unlikely to mount an adequate response to COVID-19 vaccinations. The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) a
- Policy
- Follow-up of impurity inspection
- by Lee, Hye-Kyung Jul 1, 2022 05:49am
- The MFDS received the results of testing and testing of Nitrosamine impurities from domestic pharmaceutical companies, and prepared safety management guidelines as a follow-up measure. This guideline is for safety management of N-Nitrosamines, a mutagenic and carcinogenic impurity among drugs, and it should be implemented by raw and finish
- Policy
- Opdivo succeeded in setting the standard as the first treatm
- by Lee, Tak-Sun Jul 1, 2022 05:49am
- Ono's Opdivo succeeded in setting the benefit standard as the first treatment for gastric cancer for the first time as an immuno-cancer drug. The HIRA held its sixth meeting in 2022 on the 29th and set the standard for the efficacy of Opdivo's primary treatment for gastric cancer. This is the first time that immuno-cancer drugs have passed
- Policy
- SKY Covione is promoted the registration of the WHO EUL
- by Lee, Hye-Kyung Jul 1, 2022 05:49am
- SKY Covione, a COVID-19 vaccine developed in Korea and approved, is conducting a rolling review to promote the registration of the WHO Emergency Use List (EUL) and to go through the European EMA approval process. The MFDS (Director Oh Yoo-kyung) held a briefing at 2 p.m. today (29th) and announced that it decided to approve the product on Jun
- Policy
- SK Bioscience gets final approval for SKYCovione
- by Lee, Hye-Kyung Jun 30, 2022 05:52am
- Permission for the item COVID-19 Vaccine No. 1 developed and manufactured in Korea is imminent. As a result of discussing SKYCovione's safety and effectiveness, the Central Pharmaceutical Review Committee said that it was recognized for the purpose of preventing COVID-19 based on the immunogenic clinical results compared to Vaxzevria, which was
- Policy
- ↑The cost of drugs for severe dz by ₩1.79 trillion
- by Lee, Tak-Sun Jun 29, 2022 05:53am
- The proportion of drug costs for four major serious diseases such as cancer and rare diseases is increasing significantly every year. Another reason is the increasing number of expensive new drugs that are listed. As the proportion of drug costs for these four major serious diseases increases, the need for efficient financial management measures
- Policy
- Fexclu reimb at ₩939, Kadcyla reimb extended from July
- by Kim, Jung-Ju Jun 29, 2022 05:53am
- Four items including Daewoong Pharmaceutical’s Fexclu Tab (fexuprazan hydrochloride) will be listed at &8361;939 per tablet starting next month as latecomers of the homegrown novel drug K-CAB indicated to treat erosive gastroesophageal reflux disease (GERD). Also, reimbursement of Kadcyla (trastuzumab emtansine), Roche Korea’s second-line
- Policy
- Low strength Esomezole Plus Tab priced same as Eso Duo
- by Lee, Tak-Sun Jun 28, 2022 06:09am
- Hanmi Pharmaceutical has decided to set the ceiling price of its gastroesophageal reflux disease (GERD) treatment combo ‘Esomezole Plus (esomeprazole+ magnesium hydroxide)’ at the same level as Chong Kun Dang’s ‘Eso Duo (esomeprazole+sodium bicarbonate)’ to directly target Eso Duo in the market. Its lower strength formulation, in add
- Policy
- Phase 3 of Danicopan will be conducted in Korea
- by Lee, Hye-Kyung Jun 28, 2022 06:09am
- Phase 3 clinical trials of Danicopan (ALXN2040), which is called a competitive drug for rare drug Soliris, will be conducted in Korea. The MFDS recently approved a phase 3 clinical trial for patients with seizure night hemoglobinuria (PNH) who had previously been administered Danicopan in a clinical trial commissioned by IQVIA. This cli
- Policy
- The first COVID-19 vaccine is expected to be approved
- by Lee, Hye-Kyung Jun 28, 2022 06:09am
- SK Bioscience's "SKY Covione," Korea's No. 1 COVID-19 vaccine, is expected to receive product permission within this month. Seo Kyung-won, Director General of the National Institute of Food and Drug Safety Evaluation, held a briefing at 10 a.m. on the 27th and said, "We will hold a final inspection committee within this month as possible a
