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- 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
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- 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
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- 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
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- 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
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- RET-targeted anticancer drugs are being released in Korea
- by Whang, byung-woo Sep 21, 2022 05:47am
- By disease in patients, is a small but some hospitals were already prescribing patients ahead of the clinical site in anticipation that there is high. But now excluded from prescription for pay from entering that the burden of costs and likely to be consideration of the prescription side effects. According to the pharmaceutical industry on th
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- Influenza alert in three years
- by Chon, Seung-Hyun Sep 20, 2022 05:57am
- The influenza (flu) alert, which disappeared after the spread of COVID-19, was issued. September 12 years after 2010, influenza alert has come. The pharmaceutical industry is Corona 19 that virtually died out after the spread of flu drug market to expect a revival of the atmosphere. According to the industry on the 19th, the Korea Centers for
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- Patent term extensions for advanced biologicals under review
- by Kim, Jin-Gu Sep 20, 2022 05:56am
- The Korean Intellectual Property Office (KIPO) is pursuing a plan to apply the patent term extension system to advanced biological products that were left unattended within the system through law amendments. According to the pharmaceutical and biopharmaceutical industry on the 19th, KIPO prepared a systemic reform plan that contained the
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- 41 were vaccinated in 11 days with K-COVID-19 vaccines
- by Sep 19, 2022 05:57am
- To address the low vaccination rate for Korea’s first homegrown COVID-19 vaccine, SKYCovione, the government has greatly expanded the eligibility for the vaccine. With the expansion, whether allowing the use of domestic vaccines to those who received their 1st to 3rd vaccinations will increase utilization of homegrown vaccines is gaining at
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- Breast cancer drug Nerlynx can be prescribed
- by Eo, Yun-Ho Sep 19, 2022 05:56am
- Breast cancer drug Nerlynx can be prescribed in general hospitals. According to related industries, the oral tyrosine kinase inhibitor Nerlynx, which inhibits Bixink Therapy's HER2 protein, passed the Drug Committee (DC) of the Big 5 Advanced General Hospital, including Samsung Medical Center, Seoul National University Hospital, Asan Medical
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- Companies are ending a series of phase 3 of core R&D
- by Lee, Seok-Jun Sep 15, 2022 05:55am
- Samchundang ends phase 3 of Eylea biosimilar. Top line of Ildong's Zochova will be unveiled around November. Pharmaceutical companies' core R&D phase 3 is ending one after another. Corporate value is expected to change depending on the results. Some companies are seeking foreign permission using phase 3 data. DAE HWA recently completed an applic
