- 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
- Company
- Elafibranor receives orphan drug designation in Korea
- by Eo, Yun-Ho Jun 17, 2024 05:46am
- The biliary cholangitis drug 'elafibranor' has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an announcement. Elafibranor, a dual peroxisome-activated peroxisome receptor alpha/delta (PPAR α,δ) agonist that is being developed by Ipsen, received accel
- 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
- Company
- Pfizer immediately reapplies to extend reimb for Lorviqua
- by Eo, Yun-Ho Jun 14, 2024 05:47am
- Pfizer Korea has quickly reapplied for reimbursement of Lorviqua, its third-generation ALK anticancer drug whose reimbursement review process recently broke down at the drug pricing negotiation stage. According to Dailypharm’s coverage, Pfizer Korea submitted an application to expand insurance reimbursement for the ALK-positive non-small
- Product
- 92 patient groups implore doctors to stop the strike
- by Kang Hye-Kyung Jun 14, 2024 05:46am
- “We strongly demand the doctors withdraw their resolutions to take a collective leave of absence and indefinite leave of absence as they threaten the patients' lives and health." Ninety-two patient advocacy organizations have called for the withdrawal of the medical community's collective strike that is set to start on the 18th. Ninet
- Company
- Industry concern rises over the spread of the medical strike
- by Kim, Jin-Gu Jun 14, 2024 05:46am
- The pharmaceutical industry's situation worsens as the medical community is threatening to take a collective leave of absence due to conflict with the government over increasing medical school admissions. There are voices that say if the leave of absence, which is being made by doctors and some medical professors, spreads throughout the
- 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,
- Company
- The first APDS drug 'Joenja' gets orphan drug status in KOR
- by Eo, Yun-Ho Jun 13, 2024 05:48am
- A rare disease treatment 'Joenja' has received orphan drug designation in South Korea. The Ministry of Food and Drug Safety (MFDS) states this through the report on the designation of Orphan Drugs. Joenja (leniolisib), developed by the Dutch company Pharming group, is the first treatment for activated phosphoinositide 3-kinase delta synd
