- 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
- Policy
- Chong Kun Dang is approved for its Jardiance Duo latecomer
- by Lee, Tak-Sun Nov 16, 2021 05:52am
- Chong Kun Dang became the first to receive approval for its latecomer of the SGLT-2 inhibitor combination drug for diabetes, ‘Jardiance Duo (empagliflozin-metformin hydrochloride). In addition, the company received the first generic exclusivity provided to companies that succeed challenging the original patent and be the first to apply f
- Policy
- Rx drugs,allowed according to CTD starting from next year
- by Lee, Tak-Sun Nov 15, 2021 05:56am
- The MFDS announced on the 11th that it will partially revise the Regulation on Drug Product Authorization, Declaration, & Review to secure the quality reliability of generics in accordance with international standards. The revision includes improving the management of manufacturing methods such as Rx drugs manufacturing processes, deleting
- Policy
- More convenient new dementia treatments introduced to market
- by Lee, Tak-Sun Nov 12, 2021 05:54am
- With a series of new dementia treatments being approved in Korea, whether the market dominated by Aricept will falter is gaining attention. Aricept (donepezil hydrochloride, Eisai Korea) has been dominated the market with an 80% share in the Korean prescription market. The Ministry of Food and Safety approved Lundbeck Korea’s ‘Ebixa tab
