- Policy
- Losartan, which has a high proportion of consignment
- by Lee, Tak-Sun Nov 25, 2021 05:55am
- Concerns are growing as the proportion of consignment production is high in HBP treatment "Losartan" formulation, which is known to have excess Azido-based impurities. If it appears as an impurity problem at the raw material stage, there is a possibility that many pharmaceutical companies tied up with consignment will start collecting product
- Policy
- Discussions began on the scope of Mifegymiso license
- by Lee, Tak-Sun Nov 24, 2021 05:53am
- An expert meeting was held on the 24th, and the review was conducted regardless of the revision of the criminal law. The MFDS, which is reviewing the product license of Mifegymiso, a drug for abortion, has begun a discussion process on the specific scope of use rights. It is a policy to decide through collecting opinions from all walks of lif
- Policy
- Betmiga PR prices fluctuated 3 times Between 15 days
- by Kim, Jung-Ju Nov 24, 2021 05:53am
- It is a drug with a lot of stories. Betmiga PR (Mirabegron) of Astellas Pharmaceutical of Korea, which is in a lawsuit with the government to cancel the drug price drop, is a drug with a lot of price fluctuations. The drug has repeatedly filed lawsuits against the government's drug price cut, returning, cutting and raising drug prices as t
- Policy
- MFDS cautious on waiving bridging trial for abortion pill
- by Choi-sun Nov 24, 2021 05:53am
- The Ministry of Food and Drug Safety, which had been accelerating the approval of the induced abortion pill Mifegymiso (misoprosto + mifepristone), has taken a step back in response to the caution urged by the National Assembly among others at the NA audit. Despite being advised to waiver the bridging study by the Central Pharmaceutical Affai
- Policy
- Nam In-soon's drug price recovery bill excludes rebates
- by Lee, Jeong-Hwan Nov 23, 2021 05:55am
- The "Return and refund of suspension of execution of drug prices" bill proposed by Rep. Nam In-soon of the Democratic Party of Korea varies in scope of application to benefits deletion, suspension of benefits, and drug price reduction due to revaluation of starting drugs. However, Rep. Nam In-soon's bill does not include the disposition of dr
- Policy
- Brilinta’s price cut 30%, Nexavar’s premium stays 1 year
- by Kim, Jung-Ju Nov 23, 2021 05:54am
- The insurance price of AstraZeneca Korea’s Brilinta tab. 90mg (ticagrelor) and Daxas tab. 500μg (roflumilast) will be reduced by 30% through the government’s ex-officio adjustment starting next month. On the other hand, the price of Bayer Korea’s Nexavar 200mg (sorafenib tosylate) will be maintained at its level for one more year. The pri
- Policy
- Benefit for 46 generics for Eliquis will be kicked out
- by Kim, Jung-Ju Nov 22, 2021 05:52am
- BMS won the patent dispute between BMS' Eliquis (Apixaban) and it's generics, which had a patent dispute between companies due to generics released before the patent expired. Dozens of generics have been forced to withdraw their benefits. Generics will be legally removed from the list immediately on the 1st of next month due to the establishment
- Policy
- Lixiana latecomers apply for approval as an ODT
- by Lee, Tak-Sun Nov 22, 2021 05:52am
- Latecomers of Daiichi Sankyo’s novel oral anti-coagulant (NOAC) ‘Lixiana (edoxaban tosylate hydrate)’ were found to have applied for approval to the Ministry of Food and Drug Safety. Although Lixiana’s substance patent does not expire until November 10th, 2026, with the PMS (post-marketing surveillance on new drugs) period expiring on
- Policy
- AML drug that returned after 7 years is approved in Korea
- by Lee, Tak-Sun Nov 19, 2021 05:52am
- An acute leukemia treatment that withdrew its new drug application (NDA) and then was reapproved by the FDA in 2017 has now been approved in Korea. The drug is Pfizer’s ‘Mylotarg (gemtuzumab ozogamicin).’ On the 18th, the Ministry of Food and Drug Safety approved Prizer’s 'Mylotarg inj.4.5mg.’ The drug is indicated for the treatment
- Policy
- The CSO reporting system will be reviewed
- by Lee, Jeong-Hwan Nov 19, 2021 05:52am
- A bill that mandates government reporting of drug sales and promotional agencies (CSOs) and a bill that regulates illegal hospital subsidies between hospitals, pharmacies, and agents in exchange for prescriptions will be reviewed by the National Assembly's subcommittee on the 24th.The government has also published a bill to designate late ni
