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- 2021-04-22 00:14
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- Policy
- AZ vaccine’s import authorization still under review
- by Lee, Tak-Sun Apr 21, 2021 05:50am
- Attention has been rising on the reason for the delayed approval of the imported AstraZeneca’s COVID-19 vaccine, which was the first vaccine to submit its application in Korea. Although the Ministry of Food and Drug Safety (MFDS) had shortened the review period to 40 days, 3 months have passed and no news on the approval of the importe
- Policy
- The domestic COVID-19 vaccine is still some way off
- by Lee, Jeong-Hwan Apr 21, 2021 05:49am
- It was pointed out that amid intensifying competition in countries around the world over the supply and demand of COVID-19 vaccine, there is a low possibility that a domestic vaccine will be marketed within this year, increasing public anxiety. Compared to the fact that about three domestic-made COVID-19 treatments are expected to be marketed
- Policy
- Donepezil patch has been applied for permission
- by Lee, Tak-Sun Apr 19, 2021 05:56am
- While Icure applied for permission for the world's first dementia treatment Donepezil patch, it was found that domestic competitors are still in the Phase I stage. Icure is expected to preoccupy the domestic market if it obtains a license because it is faster to commercialize than its competitors. In particular, Donepezil is most often
- Policy
- Abbott Korea·Medtronic Korea caught subsidizing doctors
- by Lee, Tak-Sun Apr 19, 2021 05:56am
- Abbott Korea Co. and Medtronic Korea Co. were found to have unfairly supported doctors to participate in overseas seminars to encourage the use of their cardiovascular stents. As a result, the Korea Fair Trade Commission (KFTC) decided to impose a 16 million won fine on Abbott Korea. Both companies have kept a record of sales for eac
- Policy
- Leclaza’s clinical trial targeting Tagrisso is launched
- by Lee, Tak-Sun Apr 19, 2021 05:55am
- 'Leclaza (Lazertinib)', a Korean anticancer drug developed by Yuhan, is conducting a Sponsor Initiated Clinical Trial for patients with non-small cell lung cancer Leptomeningeal metastasis. Since the competitive drug Tagrisso (Osimertinib, AZ) has proven effective in metastasis to the central nervous system such as brain and soft meninge
- Policy
- Korean CMO will produce MNC's COVID-19 vaccine from August
- by Kim, Jung-Ju Apr 16, 2021 06:03am
- A COVID-19 vaccine developed by a multinational pharmaceutical company will be produced by a Korean pharmaceutical company under a CMO deal. The government plans to officially announce the specific company and manufacturing plan in the near future. Young-Ha Baek, head of vaccine procurement at the pan-government vaccine procurement task
- Policy
- Nicobreak ODF was approved for the first time in Korea
- by Lee, Tak-Sun Apr 16, 2021 06:02am
- CTC Bio's'Nicobreak ODF', a smoking cessation treatment that melts and eats, was approved for the first time in Korea. this. This product has been confirmed to be equivalent to the existing Champix (Varenicline, Pfizer), which is the same ingredient product. The Ministry of Food and Drug Safety approved two items of Nicobreak ODF1mg/0.5mg
- Policy
- SK's Cosca 25mg was first approved
- by Lee, Tak-Sun Apr 15, 2021 05:56am
- SK Chemical introduces generic for Losartan 25mg earlier than the original. At one time, SK Chemicals had the experience of selling delegated generics of the original Cozaar, so it is drawing attention. On the 14th, the MFDS approved SK Chemical's Cosca25mg (Losartan potassium). Losartan potassium 25mg has been widely used, but it has not
- 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
