- Policy
- The revaluation of Streptokinase could be maintained for 1yr
- by Lee, Tak-Sun Jul 5, 2022 05:59am
- The pharmaceutical industry expects some components to be suspended in this year's benefit revaluation. The benefit revaluation of Streptokinase and Streptodornase, which are scheduled to submit a report on clinical revaluation results next year, could be suspended for one year. However, the final plan is expected to be decided through delibe
- Policy
- Support for online conferences will be extended for 1 yr
- by Kim, Jung-Ju Jul 5, 2022 05:58am
- On-off events can be supported on an offline basis if certain conditions are met Temporary support for online academic conferences in medical, pharmaceutical, and medical devices will be extended for another year. This is because infectious diseases such as COVID-19 and monkeypox continue to occur, leaving room for reinforcement of social dis
- Policy
- Korea joined the COVID-19 vaccine development country
- by Lee, Hye-Kyung Jul 4, 2022 05:54am
- As SK Bioscience's COVID-19 vaccine SKY Covione received an item permit today (29th), Korea has become a country with both COVID-19 treatments and vaccines along with Celltrion's COVID-19 treatment Regkirona. Oh Yu-kyung, Minister of Food and Drug Safety announced on June 29 that it decided to grant item permission on condition that SKY Covi
- 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
