- Policy
- Dong-A ST applied for Forxiga's Prodrug license
- by Lee, Tak-Sun Jan 7, 2022 06:06am
- It was found that Dong-A ST applied for permission to the MFDS for Forxiga (Dapagliflozin Propanediol Hydrate, AZ), which has been devoted to development. Dong-A ST succeeded in avoiding material patents (scheduled to expire on April 7, 2023) through prodrug for Forxiga, so there is a possibility that it will dominate the generic market when
- Policy
- An additional purchase contract of pfizer tx has been signed
- by Kim, Jung-Ju Jan 7, 2022 06:06am
- The government said it has signed an additional purchase contract for oral treatments (Paxlovid) with Pfizer Korea. According to the KDCA, a total of 1,004,000 oral treatments were pre-purchased through the contract, including 762,000 with Pfizer and 242,000 with MSD Korea. Pfizer's oral treatment (Paxlovid) will be introduced in Korea in
- Policy
- Is the KRAS gene-targeted drug also released in Korea?
- by Lee, Tak-Sun Jan 6, 2022 06:09am
- The first KRAS gene-targeted anticancer drug approved by the U.S. Food and Drug Administration (FDA) in May last year is expected to be approved soon in Korea. It is Amgen's Lumakras (Sotorasib), which is expected to provide new treatment opportunities to KRAS mutant patients in about 5% to 8% of non-small cell lung cancer patients in Korea.
- Policy
- There were no applications for Ultomiris·Soliris benefits
- by Lee, Hye-Kyung Jan 6, 2022 06:09am
- In November last year, it was confirmed that there was no pre-application for Ultomiris and Soliris benefits for new patients with paroxysmal night hemoglobin (PNH). There were only two applications for pre-approval of Soliris and one application for re-examination approval for new patients with atypical hemolytic uremic syndrome (aHUS), all
- Policy
- Companies obtain generic for exclusivity in proportion
- by Lee, Tak-Sun Jan 6, 2022 06:08am
- Among pharmaceutical companies that use generic for exclusive in the licensed patent linkage system that took effect in 2015, it was found that companies with large sales are more likely to obtain generic for exclusivity. As a result, it was suggested that small and medium-sized pharmaceutical companies need more support such as consulting.
- Policy
- Request for non-reimbursed use of Pahtension in Loop's pts
- by Lee, Hye-Kyung Jan 6, 2022 06:08am
- Application for Pahtension 20mg was rejected for non-reimbursed patients with systemic erythema lupus accompanied by immunosuppressants, vasculitis that does not improve even with antibiotics, and peripheral ulcers. The HIRA is receiving applications in advance for use exceeding the MFDS' permission to prevent the use of drugs that lack medic
- Policy
- ‘Lowest-ever’ number of drugs approved in 4 years
- by Lee, Tak-Sun Jan 5, 2022 05:59am
- The year 2021 is likely to be remembered as the year of reduced marketing authorizations for drugs. This was greatly influenced by the changes in the market and the new regulations that were introduced last year. In particular, the pricing penalty imposed on indirect bioequivalence tested drugs and the restrictions set on consigned bioequivalenc
- Policy
- Combination drugs of PPI+ antacid have also been released
- by Lee, Tak-Sun Jan 5, 2022 05:57am
- In the anti- ulcer drug market, combination drugs of PPI+ antacids have been released. This time, it is a drug that combines Rabeprazole and sodium bicarbonate. The PPI+ antacids, which started with Chong Kun Dang's Eso Duo (Esomeprazole Magnesium Trihydrate+Sodium Bicarbonate), continues to develop new products. The MFDS approved Youngjin
- Policy
- Recovery Action held by the Legislation/Judiciary Committee
- by Lee, Jeong-Hwan Jan 4, 2022 05:56am
- The recovery system of drug prices bill, which drew attention from the government and domestic and foreign pharmaceutical companies, has been held by the National Assembly's Legislation and Judiciary Committee and is in trouble to deal with it. As it was excluded from the Legislation and Judiciary Committee agenda again during the extraordin
- Policy
- President Moon "will make all efforts to return to normalcy"
- by Lee, Jeong-Hwan Jan 4, 2022 05:56am
- During his 2022 New Year’s address, President Moon Jae-in expressed his gratitude and respect to the medical professionals and personnel working to contain and prevent COVID-19 and restressed the excellence of Korea’s disease control and prevention system. The president also expressed his ambition to achieve complete recovery of the peo
