- Policy
- No recall crisis expected to arise from losartan impurities
- by Lee, Tak-Sun Dec 8, 2021 06:00am
- Although 295 antihypertensive treatments that were found with impurities were ordered recalled, due to the low risk and specificity of the targeted items, no disruption is expected from the exchange, re-prescriptions, or re-dispensing of such drugs. The Ministry of Food and Drug Safety announced on the 7th that 295 losartan items that wer
- Company
- Hanmi’s poziotinib enters final phase for commercialization
- by Kim, Jin-Gu Dec 8, 2021 06:00am
- ‘Poziotinib,’ a drug licensed out by Hanmi Pharmaceuticals, is entering its last phase for authorization in the US. The variables that remain to approval are the US FDA’s interpretation of the clinical trial results and the on-site investigations on the company’s production and manufacturing facilities. If these progress as planned, H
- Company
- Hanmi's lung cancer drug Poziotinib has been applied for NDA
- by Kim, Jin-Gu Dec 8, 2021 06:00am
- The U.S. FDA marketing approval process for Poziotinib, a new lung cancer drug developed by Hanmi Pharmaceutical, has begun. Hanmi Pharmaceutical's partner Spectrum announced on the 6th (local time) that it has submitted an NDA to the U.S. Food and Drug Administration (FDA). This indication is NSCLC with local progression and metastatic H
- Company
- The kit for precocious puberty in Korea has been stopped
- by Moon, sung-ho Dec 8, 2021 06:00am
- The increase in the number of precocious puberty patients in Korea is unusual. As the number of patients, which was 80,000 in 2015, exceeded 130,000 in 2020, there are opinions that it should now be recognized as a social problem. In response, some in the medical community and clinical sites predict that the number of precocious puberty patie
- Company
- Dire need for a rational pricing system for new drugs
- by Nho, Byung Chul Dec 7, 2021 05:57am
- Improving the drug pricing system through social consensus has been proposed as a prerequisite for the government to achieve the 60 trillion won export and 300,000 job creation in the biohealth industry as one of its 3 new growth engine industries. In addition to the primary purpose of fostering the biopharmaceutical industry to create
- Industry is nervous about strengthening quarantine guideline
- by Kim, Jin-Gu Dec 7, 2021 05:57am
- Private gatherings in the Seoul metropolitan area are limited to 6 people. With COVID-19 (step-by-step daily recovery) was suspended after a month of implementation due to the re-proliferation of COVID-19. The pharmaceutical bio industry is also nervous about the worsening COVID-19 situation. On the 6th, the government tightened quarantine
- Company
- Moderna tackles the Omicron variant with booster shots
- by Dec 7, 2021 05:57am
- ” We are developing three vaccine strategies to rapidly respond to the much-concerned Omicron variant. We plan to soon release a booster shot that is most appropriate for the Omicron variant.” Randall N. Hyer, senior vice president of Global Medical Affairs at Moderna, replied so to an inquiry about the company’s plans on responding to
- Policy
- Detailed screening for α -GPC begins in earnest next year
- by Moon, sung-ho Dec 7, 2021 05:57am
- Tensions are rising as the government announces the review of the revised supplementary budget bill starting next year amid deepening concerns among pharmaceutical companies over the issue of Choline Alfoscerate. According to the pharmaceutical industry and the medical community on the 1st, it has been confirmed that the MOHW has decided to s
- Policy
- The original patent's negotiation period will be reduced
- by Kim, Jung-Ju Dec 7, 2021 05:57am
- The period of ex officio adjustment drug price negotiations for the original drug that expires patents collectively cut drug prices will be reduced to one-third. It is aimed at improving cases of health insurance financial leaks by abusing the prescribed negotiation period as much as possible when the legal drug price cut rate is set. The MOH
- Company
- Five companies give up challenging Dukarb’s patent
- by Kim, Jin-Gu Dec 6, 2021 05:54am
- Five out of the 45 companies that set out to evade the patent of Boryung Pharmaceutical's antihypertensive combination drug ‘Dukarb Tab. (fimasartan+amlodipine)’ decided to give up challenging the patent. The industry has pointed to the fierce competition in the two-drug fixed-dose combination market as one of the causes for the compa
