- 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
- 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
- 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
- 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
- Policy
- A suspected Monkeypox patient entered Korea
- by Lee, Jeong-Hwan Jun 24, 2022 05:46am
- With two suspected Monkeypox infections confirmed to have entered Korea, President Yoon ordered accelerated approval of vaccines and antiviral drugs from quarantine authorities. On the 22nd, President Yoon ordered, "Strengthen the management of entry and quarantine through airports and closely monitor the additional occurrence in Korea." C
- Policy
- Abnormal cases of Inlyta in PMS for 9 yrs is 82.8%
- by Lee, Hye-Kyung Jun 24, 2022 05:45am
- As a result of a post-marketing survey of Korea Pfizer Pharmaceutical's kidney cancer treatment Inlyta, the incidence of abnormal cases was 82.88% regardless of the causal relationship. As a result of conducting PMS on 111 people over 9 years for re-examination, 92 people (338 cases in total) showed abnormal cases regardless of causality.
- Policy
- Kadcyla to recieve reimb in early breast cancer from July
- by Lee, Tak-Sun Jun 22, 2022 05:59am
- Roche Korea’s Kadcyla inj. (ado-trastuzumab emtansine) is expected to additionally receive insurance benefits for early breast cancer in Korea. Kadcyla, a breast cancer treatment that Roche released to succeed Herceptin, has been limitedly used in patients with locally advanced or metastatic breast cancer in Korea until now. The Health
- Policy
- Alecensa's price cut 4.5%, Remodulin 4% due to excess sales
- by Kim, Jung-Ju Jun 22, 2022 05:59am
- Roche Korea’s non-small cell lung cancer treatment Alecensa 150mg Cap. (alectinib hydrochloride) became subject to negotiations under the Price-Volume Agreement (PVA) and will be supplied at a 4.5% discounted price starting next month. Price of Remodulin Inj. (treprostinil) that is used to treat patients with pulmonary arterial hypertension wil
