- Policy
- Generic for Daxas was applied
- by Lee, Tak-Sun Jun 23, 2020 06:20am
- Generic for Daxas (Roflumilast, AZ), which was approved in Korea, was first applied. Particularly, the generic that has been applied are noted because they also contain low doses (250 mcg). According to the MFDS on the 19th, Generics for DAXAS (Roflumilast), were applied for approval as of the 5th and notified to patent holder AstraZeneca.
- Company
- Daewoong wins first patent dispute in Belkyra after 2 years
- by Kim, Jin-Gu Jun 22, 2020 06:10am
- Daewoong has passed the first gateway for the release of generic for Belkyra (Deoxycholic acid), which targets and eliminates fat cells under the chin. Daewoong won the patent dispute that has been leading for two years with Allergan. The IPT ( Intellectual Property Trial and Appeal Board) made a trial decision on the 19th at Daewoong P
- Company
- Big 5 DC pass HIV treating two-drug regimen Dovato
- by Eo, Yun-Ho Jun 22, 2020 06:08am
- General hospitals in Korea are reviewing the prescription of GlaxoSmithKline’s (GSK) Dovato, a two-drug regimen indicated to treat HIV-1 infection. The pharmaceutical industry sources reported the drug committees (DC) at the Big Five general hospitals like Seoul National University Hospital and Severance Hospital have passed Dovato (dol
- Policy
- 26 million flu vaccines will be released this year
- by Lee, Tak-Sun Jun 22, 2020 06:08am
- It is expected that 26 million flu vaccines will be released this year. The MFDS is planning to cooperate closely with the industry in preparation for an increase in demand for inoculation due to the prevalence of COVID-19 and the flu at the same time in the second half of the year. On the 18th, the MFDS announced that it will hold a briefing
- Company
- Yuyu Pharma exports FDA-approved COVID-19 test kit
- by Lee, Seok-Jun Jun 22, 2020 06:08am
- In partnership with SD Biosensor, Yuyu Pharma is to export COVID-19 test kit. At SD Biosensor headquarters office in Suwon on June 17, two companies signed a supply deal on real time polymerase chain reaction (RT-PCR) test kit for COVID-19. SD Biosensor’s COVID-19 test kit has received the U.S. Food and Drug Administration’s (FD
- Company
- Outpatient Rx amount for major chronic diseases decreased
- by Chon, Seung-Hyun Jun 22, 2020 06:08am
- Prescriptions for chronic diseases such as hyperlipidemia, hypertension, and diabetes, which have the largest sales due to COVID-19, have been reduced by half. According to UBIST, a drug research agency on the 17th, the outpatient prescription size was &8361;2,360 billion in April and May, a 9.0% decrease from the same period last year. In A
- InterView
- EASY-ON opens up new opportunity to Xarelto amid COVID-19
- by Eo, Yun-Ho Jun 19, 2020 06:24am
- COVID-19 has brought dramatic changes to our lives. Witnessing these changes, scholars stress the importance of responding and planning for the prospective changes in the post-coronavirus era. And many pharmaceutical companies are also seeking for new changes in business model amid COVID-19 pandemic. For the pharmaceutical industry,
- Policy
- What is the solution for Remdesivir/generic competitiveness?
- by Lee, Tak-Sun Jun 19, 2020 06:21am
- There was no communication between the MFDS and the pharmaceutical industry due to the COVID-19 crisis that began in Korea from the end of January. Since the 'Director of pharmaceutical safety bureau at the MFDS-CEO Meeting in 2020' was postponed indefinitely on February 12, the news of the MFDS was only occasionally available through data
- Policy
- Lee Nak-yeon, would continue to support COVID-19 development
- by Lee, Jeong-Hwan Jun 19, 2020 06:20am
- Chairman Lee Nak-yeon urged the MOHW and the MFDS to fully compensate for the cost of R&D so that domestic COVID-19 vaccines and therapeutics can contribute to the world. On the 17th, Chairman Lee attended the 'One-Health Strategy Debate on Future Infectious Diseases X' hosted by the Democratic Party of Korea’s COVID-19 National Overcomin
- Policy
- Dexamethasone would be difficult to use as direct treatment
- by Lee, Jeong-Hwan Jun 19, 2020 06:20am
- While Dexamethasone focused global attention as a candidate for the COVID-19 treatment, the government decided that Dexamethasone would be difficult to use as a direct treatment. The government explained that Dexamethasone, which is considered a relatively old drug, is used to alleviate severe inflammation rather than directly treating COV
