- Policy
- MSD discontinues supply of Zostavax in Korea
- by Lee, Hye-Kyung May 30, 2024 05:50am
- MSD Korea has announced that it will discontinue the domestic supply of the shingles vaccine Zostavax in Korea. According to the Ministry of Food and Drug Safety, MSD reported the suspension of Zostavax to the Ministry of Food and Drug Safety on Monday. The last batch is expected to be delivered within September, but the supply period is
- Policy
- Antengene starts Xpovio's reimb pricing negotiations in KOR
- by Lee, Tak-Sun May 29, 2024 05:45am
- The Chinese pharmaceutical company Antengene has started pricing negotiations with the National Health Insurance Service for its multiple myeloma drug ‘Xpovio Tab (Selinexor),’ bringing near its reimbursement listing in Korea. Xpovio was approved in July 2021 as a treatment for blood cancer. At the time of its approval, it became the fi
- Policy
- Only 15 of the 61 Trajenta generics will be released in KOR
- by Lee, Tak-Sun May 29, 2024 05:45am
- Despite the expiry of the substance patent of the DPP-4 inhibitor diabetes drug Trajenta (linagliptin) set for the 8th of next month, most of its generic versions will not be launched at that time. Only products with the first generic exclusivity will be released, and the rest will only be allowed sale in March next year after the sales
- Policy
- New dementia drug Leqembi receives approval
- by Lee, Hye-Kyung May 27, 2024 05:48am
- The new drug ‘Leqembi (lecanemab-irmb),’ which reduces the rate of disease progression and slows cognitive decline from Alzheimer's disease, has received marketing authorization in Korea. The Ministry of Food and Drug Safety (MFDS) announced on Thursday that it has approved Eisai Korea’s Leqembi, a new drug for Alzheimer's disease.
- Policy
- Tepmetko reapplies for reimb in Korea for the third time
- by Lee, Tak-Sun May 27, 2024 05:48am
- Tepmetko Tab (tepotinib, Merck) is applying for reimbursement in Korea for the third time after failing to set a reimbursement standard at the Cancer Disease Deliberation Committee (CDDC) stage in March. With no other treatment available for patients with MET-mutation positive metastatic non-small-cell lung cancer (NSCLC), the industry’
- Policy
- Companies can apply for multiple clinical protocols at once
- by Lee, Hye-Kyung May 24, 2024 05:48am
- Pharmaceutical companies can now apply for multiple clinical trial at the same time for a single investigational drug that is being approved for the first time. The measure is presumed to have been implemented to accelerate global entry of domestic pharmaceutical companies. The Ministry of Food and Drug Safety has upgraded its computer sy
- Policy
- New drug Tibsovo is approved in Korea
- by Lee, Hye-Kyung May 23, 2024 05:49am
- The Ministry of Food and Drug Safety (MFDS) announced that it has approved the orphan drug Tibsovo Tab (ivosidenib)' that is being imported by Servier&160;Korea on the 22nd. The drug is indicated for use in combination with azacitidine for newly-diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) m
- Policy
- AZ, novel PNH drug 'Voydeya' may soon receive KOR approval
- by Lee, Hye-Kyung May 23, 2024 05:48am
- First-in-class oral paroxysmal nocturnal hemoglobinuria (PNH) treatment will soon be approved in South Korea. According to the pharmaceutical industry on the 23rd, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy review of AstraZeneca Korea’s 'Voydeya (danicopan)' for approval. Completing the safety and eff
- Policy
- 4 Pharmas make bid into low-dose statin combo drug mkt
- by Lee, Tak-Sun May 22, 2024 05:47am
- The popularity of low-dose statin continues. Due to its lower risk of side effects than high-dose statins and a higher cholesterol-lowering effect when combined with ezetimibe than as monotherapy, domestic pharmaceutical companies have been busy launching low-dose statin combination products one after another. According to industry sourc
- Policy
- Forxiga to maintain upper limit price until Korean mkt exit
- by Lee, Tak-Sun May 22, 2024 05:47am
- Forxiga (dapagliflozin propanediol hydrate), an SGLT-2 class of diabetes treatment, will maintain its upper limit price until it leaves the South Korean market. It appears that AstraZeneca’s strategy for defending the upper limit price through the court’s suspension of execution has worked. The price-value agreement (PVA) negotiations,
