- Opinion
- [Reporter's view] COVID-19 vaccination strategy
- by Aug 9, 2022 05:56am
- The MFDS has begun a preliminary review of the vaccine for COVID-19 in Moderna and Pfizer. The preliminary review is to review the submitted clinical data in advance and to quickly determine whether to grant permission when the company applies for an item permit by adding non-clinical and quality data in the future. The divalent vaccine, w
- Opinion
- [Reporter’s View] New guideline refrains off-label NOAC use
- by Eo, Yun-Ho Aug 2, 2022 06:02am
- Off-label refers to the use of drugs for an indication other than those approved by the Ministry of Food and Drug Safety. Although people may question the need for off-label use when the appropriate use for a drug has already been set by the health authorities, these off-label prescriptions are made at the doctor’s discretion. Often,
- Opinion
- [Reporter’s View] MFDS minister wills regulatory innovation
- by Lee, Hye-Kyung Aug 1, 2022 05:58am
- The Ministry of Food and Drug Safety’s determination to seek regulatory innovation has surfaced with the inauguration of President Suk-Yeol Yoon’s administration. The MFDS had previously conducted 7 internal debates for each of its fields during the past 2 months to come up with a plan for ‘administrative innovation in food and drug at a
- Opinion
- [Reporter’s View] Secrecy no more in pricing negotiations
- by Eo, Yun-Ho Jul 18, 2022 06:06am
- The importance of providing a clear explanation about an administrative decision is essential in the process of handling administrative affairs. This becomes all the more important when an exception arises in the application of a regulation, which raises more questions than an introduction or abolition of a system. But the National Health
- Opinion
- [Reporter’s View] Postponing clinical reevaluations by 1 yr
- by Lee, Tak-Sun Jul 18, 2022 06:05am
- The National Health Insurance Service’s Drug Reimbursement Evaluation Committee conducted its first reevaluation to assess the reimbursement adequacy on the anti-inflammatory streptokinase/streptodornase combo and decided that the combination is inadequate for insurance benefit. The drug has been used to ▲relieve acute inflammatory edem
- Opinion
- [Reporter's view] The 2nd Danaher, SD BioSensor
- by Jul 13, 2022 06:05am
- Danaher is considered one of the leading companies in the global diagnostic market along with Roche and Abbott. Danaher's growth engine, born in 1984, lies in aggressive M&A. So far, it has grown in size with more than 50 M&As. Rather than developing its own technology when entering a new market, it mainly used the method of acquiring promisi
- Opinion
- [Reporter’s View] COVID-19 trials still in smooth progress?
- by Kim, Jin-Gu Jul 8, 2022 06:25am
- COVID-19 developers have been announcing that they will discontinue their clinical trials one after another. In just 10 days, Celltrion, Chong Kun Dang, and CrystalGenomics publicly announced that they will discontinue their COVID-19 clinical trials. When counting from January, the number increases to 5 with Genexine and HK Inno.N. The n
- Opinion
- [Reporter's view] Revlimid passed the committee
- by Eo, Yun-Ho Jul 6, 2022 05:47am
- It is the first step forward in about four years. The maintenance therapy of the multiple myeloma treatment Revlimid has finally passed the Cancer Disease Review Committee. Maintenance therapy of Revlimid was approved in Korea in June 2018 and an application for expansion of insurance benefits was made in the same year. Since 2019, BMS has ac
- Opinion
- [Reporter's view] Looking forward to another K-COVID vaccine
- by Lee, Hye-Kyung Jul 4, 2022 05:55am
- A pure domestic COVID-19 Vaccine No. 1, which was conducted by a domestic pharmaceutical company in charge of the entire process from development to production of raw materials and finished products, was released. The MFDS approved SK Bioscience's SKY Covione on the 29th. It took 549 days (1 year and 6 months) from approval of the initial
- Opinion
- [Reporter's view] Negotiation of Zolgensma
- by Jun 30, 2022 05:52am
- Attention is focused on negotiating the drug price of Zolgensma, a one-shot treatment and the most expensive drug in Korea. Conflicts are in full swing between the government to set the lowest price and pharmaceutical companies to be recognized as much as possible for new drugs. Zolgensma is a gene therapy approved in May last year. It is us
