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2025-05-12 19:35
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Policy
Samsung reigns over Avastin biosimilar market in Korea
by
Lee, Tak-Sun
Jul 14, 2022 05:54am
No new biosimilars of ¡®Avastin (Roche, bevacizumab)' are being introduced to the market after Samsung Bioepis¡¯s biosimilar. The Avastin biosimilar market is estimated to have a &8361;120 billion market in Korea. In terms of approvals, Pfizer Korea and Alvogen Korea had also received approval for their biosimilars after Samsung Bioepis
Policy
No social distancing obligations are introduced
by
Lee, Jeong-Hwan
Jul 14, 2022 05:54am
People in their 50s and 18s and older are also vaccinated with underlying diseases. In order to respond to the COVID-19 pandemic, the government has decided to expand the scope of the fourth vaccination to those in their 50s and 18 years of age or older. The mandatory quarantine period shall be maintained for seven days, but distancing shall
Policy
Companies are worried about the result of Godex revaluation
by
Lee, Tak-Sun
Jul 13, 2022 06:04am
The result of the revaluation of Celltrion Pharmaceutical's Godex raised concerns for some pharmaceutical companies. This is because the re-evaluation results came out around the time the development of generics began in earnest. According to an industry on the 8th, some pharmaceutical companies are developing generic drugs for Godex. Godex c
Policy
Hanall Biopharma's Glucofree OR is back
by
Lee, Tak-Sun
Jul 12, 2022 05:53am
Metformin OR products, which had been suspended due to the detection of excess NDMA of carcinogenic substances, are returning. Hanall Biopharma products have also returned to the reimbursed market with their names changed. With the emergence of them, competition is expected to intensify as the imbalance in supply and demand of Metformin OR is
Policy
Reimbursement of new migraine drugs gain momentum
by
Lee, Tak-Sun
Jul 11, 2022 06:04am
New migraine drugs are competitively pushing to receive reimbursement listing in Korea. Following Lilly¡¯s ¡®Emgality (galcanezumab)¡¯ in May, Ildong Pharmamceutical¡¯s ¡®'Reyvow (lasmiditan)¡¯ has also passed deliberations by the Health Insurance Review and Assessment Service¡¯s Drug Reimbursement Evaluation Committee (DREC) on the
Policy
¡èRosuvastatin when combined with Brilinta/Rosuvastatin
by
Lee, Hye-Kyung
Jul 11, 2022 06:04am
According to a recent review of EMA safety information, the MFDS decided to establish a new clause on the interaction that combination of Ticagrelor and Rosuvastatin can affect kidney excretion and increase the risk of Rosuvastatin accumulation. According to the new clause, the exact mechanism of action for side effects was not known, but com
Policy
New Donepezil & a dilemma over low drug prices
by
Lee, Tak-Sun
Jul 11, 2022 06:03am
Domestic pharmaceutical companies are releasing a new form of Donepezil, a component of dementia treatment, but existing low-cost drugs are acting as a dilemma. Donepezil accounts for about 80% of dementia treatments, so competition among the same products is fierce. As there are 150 pharmaceutical companies with the same ingredient products,
Policy
Hemophilia Type A tx, Bayer's Jivi has been approved
by
Lee, Hye-Kyung
Jul 10, 2022 03:35pm
Bayer's hemophilia type A treatment Jivi has been approved for domestic items. The MFDS recently granted Jivi to routine prophylaxis for on-demand and suppression of bleeding episodes in adults and adolescents (blood coagulation factor VIII birth deficiency) who have been treated before, management of bleeding before and after surgery, and r
Policy
The MFDS announced the designation of 4 temporary narcotics
by
Lee, Hye-Kyung
Jul 7, 2022 05:54am
The MFDS (Director Oh Yoo-kyung) announced on the 5th that it will designate four types, including 1V-LSD, which are used as substitute substances for drugs. 1V-LSD is newly designated as Class I temporary drug, and CH-PIATA is newly designated as Class II temporary drug. 1V-LSD has a structure similar to that of LSD and is a material whic
Policy
Antiepileptic perampanel¡¯s adverse event rate at 32%
by
Lee, Hye-Kyung
Jul 5, 2022 05:59am
Results of the 6-year post-marketing surveillance (PMS) on the antiepileptic ingredient perampanel showed that 17 cases of serious adverse reactions whose causal relationship cannot be ruled out were reported. As 287 cases of unexpected adverse reactions whose causal relationship cannot be ruled out were also reported, the indication for
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