- Company
- HLB ‘FDA meeting complete...no supplement data required'
- by Son, Hyung-Min Jul 5, 2024 05:48am
- HLB announced on the 2nd that it had completed the meeting with the U.S. Food and Drug Administration (FDA) to resume the license review of its new liver cancer drug. At the meeting, which was attended by HLB's US subsidiary Eleva and Chinese partner Jiangsu Hengrui Pharmaceuticals, the FDA said it "strongly recommends submitting a re-
- Company
- New strength Uptravi may be prescribed at general hospitals
- by Eo, Yun-Ho Jul 5, 2024 05:48am
- A new dosage strength of the pulmonary arterial hypertension treatment Uptravi may now be prescribed at general hospitals in Korea. According to industry sources, the 600㎛ dose of Janssen Korea’s Uptravi (selexipag) passed d the drug committees (DCs) of tertiary hospitals such as the Seoul National University Hospital, Sinchon Severance
- Company
- Celltrion seeks to expand influence in EUR with Remsima SC
- by Hwang, Byung-woo Jul 5, 2024 05:48am
- Celltrion is expanding to expand the drug’s market share with the addition of Remsima SC’s dosing regimens that followed the EMA’s recommendation for the drug’s marketing authorization. The autoimmune disease treatment Remsima SC recently received final approval from the European Commission (EC) for the 'allowance of additional dosing reg
- Policy
- 10th external reference pricing reeval meeting is held
- by Lee, Tak-Sun Jul 5, 2024 05:48am
- The 10th meeting for the external reference pricing reevaluations is scheduled to be held this Friday (July 5). The meeting, which was scheduled to be held on June 27th, has been postponed to this week. The meeting between the government and the pharmaceutical industry, which has been held since November last year, is being held for th
- Company
- Will the shingles market shift affect NIP?
- by Hwang, Byung-woo Jul 4, 2024 05:52am
- The withdrawal of Zostavax from the shingles market is complicating the calculation of the National&160;Immunization Program. In the government's 'National Immunization Program Priorities' study, there had been a large gap between the priorities of live and recombinant shingles vaccines, but with the number of live shingles vaccine options b
- Company
- MBK Partners to acquire Japan pharma for KRW 3 trillion
- by Kim, Jin-Gu Jul 4, 2024 05:52am
- MBK Partners, the largest private equity firm in South Korea, will acquire Japanese company Alinamin Pharmaceutical for JPY 350 billion (around KRW 3.75 trillion). MBK Partners has been actively pursuing M&A in the biopharmaceutical and healthcare sectors in South Korea and overseas. Within the past year and a half, the company acquired M
- Company
- Camzyos’s reimbursement in KOR will be redeliberated today
- by Eo, Yun-Ho Jul 4, 2024 05:52am
- Reimbursement deliberations for Camzyos, a new drug for obstructive hypertrophic cardiomyopathy (oHCM) that had received a redeliberation decision in the past, will again commence today. According to industry sources, BMS Korea's obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten) will be presented to the latest Drug R
- Policy
- Daewoong·Ildong late entries to the dapagliflozin market
- by Lee, Tak-Sun Jul 4, 2024 05:52am
- Daewoong Pharmaceutical and Ildong Pharmaceutical have made late entries in the market for diabetes treatment containing 'dapagliflozin.' Although the door to the biosimilar market for dapagliflozin opened in April last year, these two companies did not join the market immediately. It was presumed because of the contract binding with Astra
- Company
- Avastin biosimilars occupy over 40% of Avastin mkt
- by Chon, Seung-Hyun Jul 3, 2024 05:51am
- Homegrown biosimilars are rapidly expanding their influence in the KRW 100 billion-a-year Avastin market. Biosimilars’ sales have increased to exceed 40% in less than 2 years. Samsung Bioepis' Onbevzi led the growth with sales close to the original drug. According to the market research firm IQVIA, the market size of bevacizumab anticancer d
- Company
- KOR, with 12 items, ranks '2nd' in FDA-approved biosimilars
- by Kim, Jin-Gu Jul 3, 2024 05:51am
- The U.S. Food and Drug Administration (FDA) has approved 56 biosimilars as of the first half of this year. Twelve of these were from Korean companies, ranking second after the United States. Until now, companies from the United States, South Korea, Germany, and Swiss dominated the U.S. biosimilar market. Recently, companies from India, Icela
