- Opinion
- [Reporter's view] Looking forward to another K-COVID vaccine
- by Lee, Hye-Kyung Jul 4, 2022 05:55am
- A pure domestic COVID-19 Vaccine No. 1, which was conducted by a domestic pharmaceutical company in charge of the entire process from development to production of raw materials and finished products, was released. The MFDS approved SK Bioscience's SKY Covione on the 29th. It took 549 days (1 year and 6 months) from approval of the initial
- Company
- CKD voluntarily discontinues P3T on its COVID-19 therapy
- by Kim, Jin-Gu Jul 4, 2022 05:55am
- Chong Kun Dang issued a public notice on the 1st that it will discontinue the Phase III trial on its CKD-314 (Nafabeltan Inj.) it had been developing as a COVID-19 treatment. Chong Kun Dang explained, “We found it difficult to conduct a clinical trial to identify the patients’ rate of progression to severe disease due to the reduced inc
- Company
- Lotte Biologics cooperates with Sigma
- by Jul 4, 2022 05:54am
- Lotte Biologics announced on the 1st that it has signed a business agreement with Millipore Sigma, Merck's North American life science division to strengthen its bio business capabilities. With this agreement, the two companies will cooperate in promoting new biopharmaceutical businesses such as next-generation treatments and expanding Syr
- 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
- Product
- “Need to raise awareness and seek early diagnosis of Sjogre
- by Eo, Yun-Ho Jul 1, 2022 05:49am
- “We can fully provide the standard of care at local rheumatoid clinics. Have trust and visit a local clinic near you.” If you are experiencing symptoms such as dry mouth, eyes, nose and mucous membrane, skin, or indigestion without underlying diseases or other medication histories for over 3 months but haven’t found its cause, it can b
- Company
- Tdap vaccine Adacel can be prescribed in general hospitals
- by Eo, Yun-Ho Jun 30, 2022 05:53am
- Sanofi Pasteur's new Tdap vaccine Adacel can be prescribed in general hospitals. According to related industries, the Tdap vaccine for teenagers and adults aged 11 or older has passed the DC of 100 medical institutions, including Seoul National University Hospital, Korea University Guro Hospital, Gangbuk Samsung Hospital, and Hallym Univer
