- 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
- Company
- 'China approves new drugs after completing trials in China'
- by Lee, Tak-Sun May 23, 2024 05:48am
- China's drug approval authorities grant first-in-class drug approvals to drugs as soon as their multi-regional clinical trials (MRCTs) in China are complete, regardless of whether they are approved by the U.S. Food and Drug Administration (FDA) or other national drug regulatory agencies. Tigermed’s Senior Consultant Jessica Liu respond
- Company
- Clinical trial failures…novel PD drugs face challenges
- by Son, Hyung-Min May 23, 2024 05:48am
- Novel candidates for Parkinson’s disease that have gathered the industry’s attention are repeatedly failing to prove effectiveness in clinical trials. Bukwang Pharmaceutical was developing novel drugs for Parkinson’s disease but failed to prove its efficacy in Europe phase 2 clinical trials. D&D Pharmatech and Peptron also failed in phase
- Company
- Leclaza’s sales soar with reimbursement expansion
- by Chon, Seung-Hyun May 23, 2024 05:48am
- The sales of Yuhan Corp’s new anti-cancer drug 'Leclaza' have jumped significantly. Sales have more than tripled in one year since the drug has been granted reimbursement as a first-line treatment for lung cancer this year. Leclaza’s sales quickly reached the KRW 20 billion mark in quarterly sales, paving the way for the drug to achieve the KR
- Company
- Oral renal anemia drug meets reimb listing terms
- by Nho, Byung Chul May 22, 2024 05:47am
- An application for drug pricing has been filed for two items of renal anemia drugs that are equivalent in efficacy to conventional EPO injections but cost much less. New treatment options are expected to become available. According to industry sources, Mitsubishi Tanabe Pharma and JW Pharmaceutical have filed an application to the Heal
- Company
- MSD applies for Welireg’s reimbursement in Korea
- by Eo, Yun-Ho May 22, 2024 05:47am
- The rare anti-cancer drug ‘Welireg’is seeking insurance coverage in Korea. According to industry sources, MSD Korea recently submitted an application for the reimbursement of its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan). The drug is beginning its reimbursement voyage a year after its approval in Kor
- Company
- FDA approves Samsung and Biocon’s Eylea biosimilars
- by Son, Hyung-Min May 22, 2024 05:47am
- Samsung Bioepis’s Opuviz became the first Eylea biosimilar to be approved in the US. In particular, due to its interchangeability designation, Opuviz can be administered interchangeably with Eylea, increasing its chances of gaining an advantage in the market over its competitors. According to KoreaBIO on the 21st, the US FDA approved Sam
