- 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
- Company
- Kwangdong will sell GSK’s allergic rhinitis treatment
- by Chon, Seung-Hyun Jun 28, 2022 06:09am
- Kwangdong Pharmaceutical announced on the 27th that it has signed a sales partnership agreement with GSK for its allergic rhinitis treatment, ‘Avamys nasal spray.’ Avamys, which was granted marketing authorization in Korea in 2009 is a steroid nasal spray indicated for the treatment of seasonal and perennial (year-round) allergic rhinit
- Policy
- Fenofibrate regardless of meals will be listed next month
- by Lee, Tak-Sun Jun 28, 2022 06:09am
- Fenofibrate tablets, which can be taken regardless of meals, will be listed for the first time in Korea. Fenofibrate is a drug used for primary hyperlipidemia. Existing drugs should be administered after meals. Therefore, the newly registered product is expected to improve the convenience of patients. According to the MOHW on the 24th, Yuh
- Company
- Oral SMA drug Evrysdi may be prescribed at general hospitals
- by Eo, Yun-Ho Jun 27, 2022 05:58am
- The oral spinal muscular atrophy (SMA) treatment ‘Evrysdi’ may be prescribed at general hospitals. According to industry sources, Roche Korea’s SMA treatment Evrysdi (risdiplam) passed the drug committee (DC) reviews of several medical institutions including Seoul National University Hospital. Evrysdi was first approved in Korea in
- Policy
- The use of Benzalconium chloride is not interrupted
- by Lee, Hye-Kyung Jun 27, 2022 05:58am
- As a result of reviewing the feasibility of safety management measures for drugs containing Benzalconium chloride used as humidifier disinfectants, it was concluded that there was no basis for restricting the use of drugs. Benzalconium chloride is used as daily necessities such as hand sanitizers, nose sanitizers, eyewash, preservatives, pres
- Company
- This time it’s acyclovir… impurity issue rises again
- by Chon, Seung-Hyun Jun 27, 2022 05:57am
- The drug impurity risk issue has spread to the antiviral acyclovir. According to the impurity issue that arose abroad, the health authorities have started making safety measures on pharmaceutical companies. According to industry sources on the 23rd, the Ministry of Food and Drug Safety has recently ordered pharmaceutical companies to con
- Company
- Belvarafenib confirmed its safety & effectiveness
- by Chon, Seung-Hyun Jun 27, 2022 05:57am
- A study showed that the new anticancer drug Belvarafenib, which Hanmi Pharmaceutical exported technology to Genentech, confirmed its safety and effectiveness overseas. According to Hanmi Pharmaceutical on the 22nd, Roche revealed the progress of clinical research on "Belvarafenib," which is being developed by its subsidiary Genentech, at a co
- Company
- The flu is going around in the southern hemisphere
- by Whang, byung-woo Jun 27, 2022 05:57am
- Concerns are growing that the influenza epidemic may begin as the COVID-19 pandemic turns into an endemic and social distancing such as lifting outdoor masks is eased. As the flu is showing signs of a full-fledged epidemic in Australia, one of the southern hemisphere countries that uses the flu as an indicator of the flu epidemic in the se
- Policy
- Is "Platform of Drug Delivery" starting?
- by Lee, Jeong-Hwan Jun 24, 2022 05:46am
- Will the new government's implementation of the OTC teleconference bending machine demonstration special case serve as a signal for full-fledged activation of the "drug delivery platform"? Analysts say that as the government introduced the OTC teleconference bending machine, which is virtually not allowed by the Pharmaceutical Affairs Act, re
