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Policy
Moderna's COVID-19 vaccine has been applied for approval
by
Lee, Tak-Sun
Apr 15, 2021 05:56am
Moderna's COVID-19 vaccine has begun to be approved in Korea. If Moderna vaccine is approved, it will be the fourth vaccine after AstraZeneca, Pfizer and Janssen vaccines. The MFDS announced on the 12th that GC Pharma has applied for approval as an import item for COVID-19 vaccine from Moderna in the US. Moderna vaccine is one of the va
Policy
NHIS and choline alfoscerate makers fail to reach agreement
by
Kim, Jung-Ju
Apr 14, 2021 06:06am
Negotiations on the retrieval of health insurance benefits paid for 60 choline alfoscerate products have all fell through despite the series of extensions made on its negotiation period. The key cause of the negotiation breakddown was that the payer, National Health Insurance Service (NHIS), and the pharmaceutical companies were unable t
Policy
MFDS to support domestic vaccine for COVID-19
by
Lee, Tak-Sun
Apr 14, 2021 06:06am
The MFDS has announced that it will establish a new indicator that eases the phase 3 clinical criteria for the existing COVID-19. Through this, the plan is to support the rapid commercialization of domestically developed vaccines. Director Kang-rip Kim made such a statement at a briefing at the special quarantine inspection meeting i
Policy
Hanmi¡¯s Rosuzet with annual sales of ₩99.1 billion
by
Lee, Tak-Sun
Apr 13, 2021 05:46am
Rosuzet (Hanmi, Rosuvastatin-Ezetimibe), a blockbuster drug with annual prescriptions of &8361;99.1 billion, expects to add a new dose. Rosuzet is currently licensed for three doses, and the new dose is known to contain unlicensed doses in Korea. According to industry sources on the 12th, Hanmi recently applied for a new dose of Rosuzet
Policy
Sanofi withdraws 'EVE QUICK' from domestic market
by
Lee, Tak-Sun
Apr 13, 2021 05:46am
Imported pain relievers that entered the Korean market late are not faring well in Korea's market. This is because brand products like Tylenol, Geborin, and EZN have already settled in the market, and the fierce competition ongoing between multiple companies has left no room for late entrants. As a result, Sanofi has withdrawn its li
Policy
New drug Leclaza, only drug price negotiations remain
by
Lee, Hye-Kyung
Apr 13, 2021 05:45am
'Leclaza (Lazertinib)', a non-small cell lung cancer treatment by Yuhan Corporation, the 31st new drug developed in Korea, has passed the first step of reimbursement. After receiving approval from the Ministry of Food and Drug Safety on January 18, the HIRA's Pharmaceutical Benefits Advisory Committee recognized the appropriateness of reimbur
Policy
1st Gen. Economic Evaluation Expert Retires from Teaching
by
Lee, Hye-Kyung
Apr 12, 2021 05:55am
Chung-Ang University College of Pharmacy professor Dong-Churl Suh (65), an economics and policy expert in the domestic and foreign pharmaceutical industry, will be retiring in August this year. After graduating from Chung-Ang University College of Pharmacy in 1979, Suh went to the U.S. and obtained a Master of Business Administration fr
Policy
Approval of Moderna's COVID-19 vaccine is imminent
by
Lee, Tak-Sun
Apr 9, 2021 05:55am
Moderna is applying for approval of COVID-19 vaccine from the MFDS sooner or later. It is reported that GC Pharma, in charge of the license and distribution of the vaccine, will have the necessary data for the license and will submit an application for approval next week as soon as possible. On the 8th, a government official said, "GC Phar
Policy
Review underway for nation's first DPP-4+SGLT-2 inhibitor
by
Lee, Tak-Sun
Apr 8, 2021 05:55am
Domestic companies are one step closer to commercializing DPP-4 inhibitor and SGLT-2 inhibitor combination therapies in Korea. Until now, there were only imported DPP-4+SGLT-2 inhibitor combination therapies available, but Korean pharmaceutical companies have now started to target the market with new developments. According to indust
Policy
Novo applies for approval of the first oral GLP-1 treatment
by
Lee, Tak-Sun
Apr 8, 2021 05:55am
An oral tablet formulation of the GLP-1 receptor agonist diabetes treatment that was previously only available as an injection is preparing to launch in Korea. The drug is Novo Nordisk¡¯s ¡®Rybelsus (semaglutide).' Novo Nordisk has recently applied for the approval of its Rybelsus tablet to the Korean Ministry of Food and Drug Safety (MF
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