- 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
- Policy
- Is Celltrion developing a combination of HBP?
- by Lee, Tak-Sun Nov 19, 2021 05:51am
- Attention is focusing on whether Celltrion, which has secured domestic copyrights for ARB-based hypertension treatment Edarbi (Azilsartan Medoxomil), will develop a combination that combines Edarbi and Amlodipine. Attention is focusing on whether Celltrion will also stand out in the hypertension treatment market, which is the domain of tra
- Policy
- Competition intensifies in Forsteo market with 4 latecomers
- by Lee, Tak-Sun Nov 19, 2021 05:51am
- Products with the same ingredient as the world’s first bone anabolic agent 'Forsteo(Teriparatide),' which was finally able to receive reimbursement in Korea 10 years after its approval, are rapidly entering the market. Domestic pharmaceutical companies are occupying the follow-on market with their Forsteo latecomers. Already 4 teriparatid
- Policy
- A law, proposed to prohibit overuse of drug price reduction
- by Lee, Jeong-Hwan Nov 19, 2021 05:51am
- The ruling party has proposed an additional bill to regulate the abuse of lawsuits by some pharmaceutical companies, including an injunction to suspend execution of the government's drug price cut. Following Rep. Kim Woni of the Democratic Party of Korea, Rep. Nam In-soon also proposed a partial amendment to the National Health Insurance
- Policy
- MFDS reviews emergency use of Merck’s oral COVID-19 pill
- by Lee, Tak-Sun Nov 18, 2021 05:54am
- The Ministry of Food and Drug Safety announced that it has started review for the Emergency Use Authorization of US Merck’s oral COVID-19 treatment, ‘Lagebvrio (molnupiravir).’ Also, the ministry added that a preliminary review is also in progress for US Pfizer’s ‘Paxlovid.’ On the 17th, the Korea Disease Control and Prevention Agen
- Policy
- Major bills have been piled up
- by Lee, Jeong-Hwan Nov 18, 2021 05:54am
- The National Assembly's Health and Welfare Committee held the first subcommittee on bills on the 23rd and 24th and agreed between the ruling and opposition parties to review the medical law and the Pharmaceutical Affairs Act. The second subcommittee on the bill will be held for two days on the 24th and 25th, and both subcommittees are still
- Policy
- Will impurities again in losartan trigger full recalls?
- by Lee, Tak-Sun Nov 17, 2021 05:45am
- Once again, impurity was detected in ‘losartan,’ an ingredient used in hypertension treatments. The impurity in issue was detected during self-inspections conducted by the individual pharmaceutical companies under the direction of the Ministry of Food and Drug Safety, upon which some companies have been discontinuing the lot release of the
- Policy
- No companies have won suits on Gov's price cut dispositions
- by Lee, Hye-Kyung Nov 16, 2021 05:53am
- The National Health Insurance Service said it needs to be granted the authority to urge or dispose of arrears in order to efficiently collect the losses that were caused by the non-price cuts that occurred during the stay of execution when preparing a bill to recover and refund the drug price cut amount. The NHIS delivered its opinion on modi
