- 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’
- Company
- Leclaza demonstrates efficacy as combo therapy in NSCLC
- by Son, Hyung-Min May 27, 2024 05:48am
- Clinical data demonstrating the efficacy of the Leclaza and Rybrevant combination in lung cancer will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. An abstract published for the ASCO 2024 Annual Meeting (ASCO 2024), a five-day conference that is set to start on the 31st, confirmed the additional
- Company
- Bukwang subsidiary’s IPO in Korea will be postponed
- by Kim, Jin-Gu May 24, 2024 05:49am
- Bukwang Pharmaceutical announced that the IPO schedule for its subsidiary Contera Pharma would inevitably need to be postponed. Initially, Contera Pharma planned to gain momentum for its IPO listing in Korea and abroad based on the Phase II results of its new drug candidate for Parkinson's disease, JM-010, but the schedule was postponed a
- 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
- Company
- HLB·Jiangsu "FDA, facility issues not related to efficacy"
- by Son, Hyung-Min May 24, 2024 05:48am
- "It appears that there are no issues related to the efficacy of Rivoceranib plus camrelizumab therapy. However, we were pointed out of the manufacturing facility during the monitoring of Jiangsu Hengrui Pharmaceuticals. We do not need an additional clinical trial. By closely cooperating with the U.S. FDA, we will introduce a novel drug to
- Company
- Keytruda posts KRW 100 bil in quarterly sales
- by Chon, Seung-Hyun May 24, 2024 05:48am
- The immuno-oncology drug Keytruda has strengthened its dominance in the domestic drug market, maintaining quarterly sales in the KRW 100 billion range. After being granted reimbursement expansion as a first-line treatment, Keytruda’s sales surged even greater, tripling the sales gap with the runner-up in the market. Also, other new anticancer d
- Company
- Pharmas face a heavy burden from high-interest loans
- by Kim, Jin-Gu May 24, 2024 05:48am
- Pharmaceutical and biotech companies’ bank loan interest rates have been set high for over two years. A high-interest rate, up to 8%, has been maintained, and key companies face a heavy burden from this. The pharmaceutical industry raises concerns that an extended financial burden due to high interest rates may decrease investment. Mo
- Company
- Enhertu gets expanded indications for NSCLC·breast cancer
- by Son, Hyung-Min May 23, 2024 05:49am
- Daiichi-Sankyo Korea and AstraZeneca Korea announced that Enhertu (trastuzumab deruxtecan) received expanded indication for HER2-low metastatic breat cancer and metastatic non-small cell lung cancer (NSCLC) on May 20. Enhertu is now approved for treating ▲patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast
- 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
