- Policy
- Leclaza to receive first monitoring for PVA negotiations
- by Lee, Tak-Sun Sep 23, 2022 05:52am
- The National Health Insurance Service disclosed drugs subject to monitoring for Type A and Type B of the Price-Volume Agreement negotiations in the fourth quarter of 2022. The list is attracting attention as Yuhan Corp’s novel non-small-cell lung cancer drug Leclaza was also selected for monitoring, as well as domestic homegrown drugs s
- Opinion
- [Reporter's view]Bio-Administrative Orders of the USA
- by Kim, Jin-Gu Sep 23, 2022 05:51am
- Korea's CDMO (consignment development production) industry, which has just begun in earnest, has a hurdle. U.S. President Joe Biden recently signed an executive order for the "National Biotechnology and Bio Manufacturing Initiative," which calls for the production of biopharmaceuticals in the country. The Biden administration is emphasizin
- Company
- Aricept grows to make ₩70B ... Ebixa nears ₩15B
- by Nho, Byung Chul Sep 22, 2022 06:02am
- Eisai Korea’s Aricept (donepezil hydrochloride) continued on its solid lead in the original Alzheimer’s treatment market, occupying nearly 70% of the KRW 100 billion market. According to drug distribution performance data, Aricept’s made KRW 71 billion, 65.5 billion, 69.2 billion, and 70.3 billion in 2018, 2019, 2020, and 2021, respect
- Policy
- Janssen's Imbruvica succeeded in setting a standard
- by Lee, Tak-Sun Sep 22, 2022 06:02am
- Janssen's anti-cancer drug Imbruvica, which has started to expand its benefit, has succeeded in setting standards for now. The HIRA announced that it held the 8th Cancer Disease Review Committee in 2022 on the 21st and made the decision. Through this deliberation committee, Imbruvica has set benefit standards for monotherapy in patients with
- Company
- Moderna releases first Omicron-specific vaccine, Spikevax-2
- by Sep 22, 2022 06:02am
- On the 21st, Moderna announced it will be releasing ‘Spikevax-2,’ its Omicron-containing bivalent booster vaccine. When released, the vaccine will be the first Omicron-specific vaccine to be released in Korea. Modern’s mRNA vaccine, Spikevax-2 (elasomeran/imelasomeran) has been approved by the Ministry of Food and Drug Safety on the
- Company
- Hanmi Poziotinib has greater patient benefits than risks
- by Nho, Byung Chul Sep 22, 2022 06:02am
- Regarding the opinion that Poziotinib's clinical results are not enough to support prompt approval in a briefing released by the U.S. FDA on the 20th (local time) ahead of the Oncology Drug Advisory Committee (ODAC), Hanmi Pharmaceutical said, "We will fully explain the usefulness of Poziotinib at the ODAC scheduled for the 22nd." Poziotinib
- Company
- From Factive to Rolontis, commercial success or failure
- by Chon, Seung-Hyun Sep 22, 2022 06:01am
- Domestic development biosimilar and botulinum toxin drugs expand their influence in the U.S Hanmi Pharmaceutical's neutropenia treatment Rolvedon has succeeded in entering the U.S. market. Starting with LG Chem's Factual in 2003, a total of six new drugs made with domestic technology passed the U.S. licensing gate. However, it is evaluated t
- Policy
- MOHW's advisory council to respond to US’s Bio initiative
- by Lee, Jeong-Hwan Sep 21, 2022 05:47am
- The government has organized a trade advisory council to address the trade issues that may arise from the National Biotechnology and Biomanufacturing Initiative that the Biden administration launched via an Executive Order. Through the council, the government plans to strengthen communication with the pharmaceutical and bio industry and prom
- Company
- Enhertu lands in Korea...hopes rise for indication extension
- by Sep 21, 2022 05:47am
- The new breast cancer drug Enhertu (trastuzumab deruxtecan), which 50,000 people had petitioned for expedited approval, has finally landed in Korea. The Ministry of Food and Drug Safety announced on the 19th that it had granted marketing approval for Enhertu, the HER2-directed antibody-drug conjugate (ADC) that was jointly developed by
- Policy
- Domestic authorization for the Quadrivial Adjuvant Flu Vac
- by Lee, Tak-Sun Sep 21, 2022 05:47am
- With the flu warning issued in September, the beginning of Autumn, an upgraded flu vaccine was also approved in Korea. It is a tetravalent Adjuvant vaccine that can be used for people aged 65 or older, and is a product of a pharmaceutical company called CSL Seqirus, which is still unfamiliar in Korea. The Ministry of Food and Drug Safety ann
