- Policy
- Multiple myeloma drug Elrexfio receives conditional approval
- by Lee, Hye-Kyung Jun 17, 2024 05:46am
- The orphan drug ‘Elrexfio (elranatamab)' that is being imported by Pfizer Korea, has been approved subject to the submission of therapeutic confirmatory clinical trial data. Elrexfio is an orphan drug indicated as monotherapy to treat adult patients with relapsed or refractory multiple myeloma who have received three or more prior lines
- Policy
- External reference pricing reevaluations are nearly ready
- by Lee, Tak-Sun Jun 17, 2024 05:46am
- The external reference pricing reevaluation system is expected to be soon launched by the Korean government. At the 9th meeting held on the 10th of this month, there were disagreements over the specific details, but no change had been made in the big picture. The health authorities are reportedly planning to finalize the discussions within t
- Policy
- CKD speeds up developing Duvie+Jardiance+metformin therapy
- by Lee, Hye-Kyung Jun 14, 2024 05:47am
- Chong Kun Dang is conducting a clinical trial to develop a triple combination therapy, aiming to strengthen its competitiveness in the diabetes treatment market. On June 12th, the Ministry of Food and Drug Safety (MFDS) approved Chong Kun Dang’s application for a phase 1 trial for the “Evaluation of the Impact of Dietary Intake on Ph
- Policy
- Yuhan’s NSCLC new drug earns approval for clinical trial
- by Lee, Hye-Kyung Jun 14, 2024 05:47am
- Yuhan Pharmaceutical has initiated the development of a new drug, 'YH42946,' a HER2 TKI, for the treatment of non-small cell lung cancer (NSCLC) in South Korea. On June 11th, the Ministry of Food and Drug Safety (MFDS) approved “A first-in-human 1/2 clinical trial to assess YH42946 treatment in patients with locally advanced or metasta
- Policy
- Drug pricing negotiations complete for Idelvion in KOR
- by Lee, Tak-Sun Jun 13, 2024 05:48am
- The hemophilia B treatment Idelvion is soon expected to be reimbursed in Korea, with CSL Behring completing drug pricing negotiations for the drug with the regulatory authorities. The drug’s advantage is in its convenience in administration, as it can be administered once every 1 to 3 weeks. According to industry sources on the 12th,
- Policy
- "Chickenpox vaccine 'Sky Varicella Inj' is safe…"
- by Lee, Jeong-Hwan Jun 13, 2024 05:48am
- The Korea Disease Control and Prevention Agency (KDCA) reported on June 12th that experts and related agencies have conducted an investigation and analysis in response to an increased number of adverse reactions reported following vaccination with 'Sky Varicella Inj,' a varicella virus vaccine, and they confirmed that there are no safety c
- Policy
- CPAC ‘Scemblix’s orphan drug designation is valid’
- by Lee, Hye-Kyung Jun 13, 2024 05:48am
- The next-generation chronic myeloid leukemia drug ‘Scemblix (asciminib)’ is expected to be available for adult patients with chronic myeloid leukemia (CML) with the T315I mutation or Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL) with the T315I mutation. According to the minutes of the Central Pharmaceutical Affai
- Policy
- 9th meeting held for external reference pricing reevals
- by Lee, Tak-Sun Jun 13, 2024 05:48am
- The government and the pharmaceutical industry held the 9th meeting on external reference pricing reevaluations but reportedly decided to continue discussions. Initially, the 9th meeting was supposed to be the last in the opinion-gathering process, but further meetings were deemed inevitable.&160; According to industry sources, the
- Policy
- Price ceiling for 'atosiban' set to rise under agreements
- by Lee, Tak-Sun Jun 12, 2024 05:45am
- The insurance drug price ceiling for atosiban injection, used to delay pre-term birth in pregnant adult women, will increase. Currently, three products of atosiban for injection are available. With the drug price ceiling adjustment, better supply is expected following negotiations related to expanding the volume of distribution. Acc
- Policy
- Approval for PH-ILD inhalation drug 'Tyvaso' expected soon
- by Lee, Hye-Kyung Jun 11, 2024 05:48am
- The approval of 'Tyvaso Inhalation Solution 0.6 mg/mL (treprostinil)' in South Korea is expected soon. It is approved in the United States as the treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). According to industry sources on the 11th, the safety and eff
