- 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
- 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
- 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
- Policy
- 23 items have been designated as Fast Tracks in 2yrs
- by Lee, Hye-Kyung Sep 21, 2022 05:47am
- Goal of completion of examination within 75% of general examination period. Over the past two years, 23 items of medicine have been designated as Fast track. Specifically, it appeared as 4 items in 2020, 11 items in 2021, and 8 items until July 2022, and the reason for the increase in Fast track designated drugs last year compared to the previou
- Policy
- GOV engrossed in minimizing damage from US's Bio Initiative
- by Lee, Jeong-Hwan Sep 20, 2022 05:57am
- The Korean government is busy preparing measures to protect the Korean industry from the Executive Order signed in the US by President Biden to launch a National Biotechnology and Biomanufacturing Initiative that focuses on research and manufacturing of pharmaceuticals within the United States, As the US government has not yet finalize
- Policy
- 37 Tenelia's generics will soon be listed
- by Lee, Tak-Sun Sep 20, 2022 05:57am
- Earlier this year, Tenelia's generics followed Galvus generics, and the generic drug market for DPP-4 diabetes treatments began in earnest. According to the industry on the 19th, the Ministry of Health and Welfare recently disclosed the registration of Tenelia's generics next month. Tenelia of material patent is expired on October 25th. A t
- Policy
- NHIS negotiations complete for Erbitux·Zerbaxa·Eylea
- by Lee, Tak-Sun Sep 20, 2022 05:56am
- The National Health Insurance Service’s pricing negotiations for Merck’s anticancer drug Erbitux and MSD’s next-generation antibiotic Zerbaxa among others have been completed. In the case of Erbitux, Merck has been conducting drug pricing negotiations with the NHIS upon the expiry of its risk-sharing agreement (RSA) contract. For Zerb
- Policy
- Empagliflozin's permission changes
- by Lee, Hye-Kyung Sep 19, 2022 05:56am
- Epilepsy neurosurgery is added to the abnormal reaction of a formulation containing Empagliflozin, an SGLT-2 inhibitor used to treat type 2 diabetes. The Ministry of Food and Drug Safety announced a change in permits based on the results of a review of safety information on Empagliflozin-containing drugs by EC and EMA. The drugs that announce
- Policy
- Drug price negotiation completed 307 drugs in 2022
- by Lee, Tak-Sun Sep 16, 2022 05:53am
- The number of drugs that completed drug price negotiations between the NHIS and pharmaceutical companies increased significantly from 15 years ago. As drug price negotiations began in earnest in 2007, the expansion of PVA negotiations is believed to be the cause. According to the NHIS' recent list of drugs that completed drug negotiations,
- Policy
- “GOV to prove causal relationship of vaccine side effects"
- by Lee, Jeong-Hwan Sep 16, 2022 05:53am
- The ruling party has set out to enact a Special Act to obligate the nation to compensate for damages caused by COVID-19 vaccinations. The Special Act was proposed because the compensation for damages caused by COVID-19 vaccinations currently implemented by the government is too passive in recognizing the causal relationship between vaccina
