- Policy
- Boryung’s Gemzar switches to domestic production
- by Lee, Hye-Kyung Apr 25, 2022 06:07am
- In 2 years since Boryung Pharmaceutical acquired the domestic rights for Lilly’s anticancer treatment ‘Gemzar (gemcitabine HCl)’ in Korea, the company switched all its items to domestic productions. According to the Ministry of Food and Drug Safety, Boryung Pharmaceutical withdrew its import license for ‘Gemzar’ on the 21st, and swit
- Policy
- Chong Kun Dang salt modified Entresto will be released soon
- by Lee, Hye-Kyung Apr 25, 2022 06:07am
- The market launch of Sacubitril/Valsartan Calcium, developed by Chong Kun Dang is imminent. According to the pharmaceutical industry on the 21st, Chong Kun Dang filed an application with the MFDS for permission for the drug developed by changing Valsartan Sodium, the main ingredient of Novartis' chronic heart failure treatment Entresto.
- Policy
- Expansion of benefit standards such as Tenofovir/Baricitinib
- by Kim, Jung-Ju Apr 24, 2022 06:33pm
- As the scope of benefit of registered drugs such as chronic hepatitis B oral drug Vemlidy expands, the benefit standards for these drugs will also be expanded and changed. In addition, the standards for Baricitinib PO such as oluminant 2mg will be expanded to patients with chronic severe atopic dermatitis. The MOHW unveiled the "revise
- Policy
- Expanding the use of Paxlovid with underlying dz over 12 yrs
- by Lee, Jeong-Hwan Apr 20, 2022 06:05am
- The government said it is considering expanding the scope of the prescription for Paxlovid, an oral treatment for COVID-19, to "underlying patients aged 12 or older." However, considering the fact that there are side effects, it is said that various decision-making processes such as collecting opinions from experts should be carried out. T
- Policy
- MFDS requested supplementary data of Mifepristone
- by Lee, Hye-Kyung Apr 19, 2022 05:52am
- 'The MFDS is conducting a comprehensive review including the need for Bridging Study data. A year and four months have passed since the abortion crime was abolished, but drugs that have been applied for permission by domestic pharmaceutical companies are still being reviewed. According to the press release of the MFDS on the 18th, the MFDS r
- Policy
- Reimb. suspension on rebate drugs unconstitutional
- by Lee, Tak-Sun Apr 18, 2022 05:58am
- A claim that applying the reimbursement suspension system on illegal rebate drugs that had been abolished in 2018 to acts that had been made before the law was revised can be unconstitutional has been raised. Due to unreasonable aspects of applying the existing law, the claim is that it is more reasonable to retroactively apply the law revi
- Policy
- Utilizing RWD for Re-evaluation of Old Drugs
- by Lee, Hye-Kyung Apr 18, 2022 05:58am
- Discussions were conducted at the Central Pharmacist Review Committee on the criteria for clinical re-evaluation of items licensed on the basis of foreign drug formulas without efficacy evaluation. The drug was Hanall Biopharma's "Blistop (p-Aminomethyl Benzoic Acid)" and was approved on May 16, 2001, and its efficacy expired on April 1.
- Policy
- Will losses from drug price cut dispositions be recovered?
- by Lee, Jeong-Hwan Apr 15, 2022 06:03am
- The Ministry of Health and Welfare and the pharmaceutical companies are intensely arguing over the application of an indemnification system where the pharmaceutical company’s damages are refunded by the government if they win the administrative suits for price cuts and reimbursement suspensions. As the system has already met the adminis
- Policy
- Omicron recombinant XL mutation found in Korea
- by Lee, Jeong-Hwan Apr 14, 2022 05:56am
- In Korea, the sub-variant XL in which the Omicron COVID-19 mutant virus has been modified (recombined) has been confirmed for the first time. The quarantine authorities predicted that the XL mutation is a subfamily of omicrons, and that caution is necessary, but there will be no excessive concern. The intention is that there is a possibili
- Policy
- P3T for Roche’s Giredestrant was approved in Korea
- by Lee, Hye-Kyung Apr 14, 2022 05:56am
- A Phase III trial for Roche’s next-generation breast cancer treatment ‘giredestrant’ will be conducted in Korea. The Ministry of Food and Drug Safety approved the company’s application to conduct a randomized, open-label Phase III trial to evaluate the efficacy and safety of ‘giredestrant+ Phesgo’ in comparison to Phesgo in treatmen
