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2025-10-30 04:14
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Company
SK Biopharm's new epilepsy drug licensed in Europe
by
An, Kyung-Jin
Apr 6, 2021 06:08am
SK Biopharmaceuticals announced on the 31st that Cenobamate, a new epilepsy drug, has obtained sales permission from the EC on the 30th (local time). It has been about two months since it received a recommendation for marketing approval from CHMP under the European Medicines Agency (EMA) last month. Through this sales permit, SK Biopharm has
Policy
Dongkoo is targeting the market as a vendor.
by
Lee, Tak-Sun
Apr 6, 2021 06:08am
In January, Dongkoo started as a vendor of generic for Atozet (Atorvastatin¡¤Ezetimibe), a licensed hyperlipidemia complex, and started targeting the market in April. Dongkoo is the most entrusted company of generic for Atozet. However, generics for Atozet are scheduled to release in May, but Dongkoo is going to enter the market a month a
Policy
The clean reporting center will be opened
by
Lee, Tak-Sun
Apr 5, 2021 05:53am
The MFDS opened the Clean Report Center for Drug Manufacturing and Quality Illegal Activities in order to revitalize public interest reporting after Binex drug manufacturing incident. The center operates anonymously to increase the reporting rate. The MFDS announced on the 1st that it has opened the Clean Report Center for Drug Manufacturi
Opinion
[Reporter¡¯s Eye] MNC CEOs' response to ¡®Korea passing'
by
Eo, Yun-Ho
Apr 5, 2021 05:52am
MNC CEOs¡¯ response to the ¡®Korea passing¡¯ phenomenon ¡°Have you ever received pressure from corporate headquarters to consider ¡®Korea passing¡¯?¡± This question was asked to every multinational pharmaceutical company CEO interviewed by the reporter. Although the answer differed for each company and CEO, all the answers shared one
Company
Dispute over Eliquis patent will be closed in six years
by
Kim, Jin-Gu
Apr 5, 2021 05:51am
The six-year-old Eliquis (Apixaban) substance patent lawsuit will be closed next week in the Supreme Court. If the Supreme Court overturns the judgment of the first and second trials and takes the side of the original company, BMS, an all-round lawsuit for damages against related generic companies is expected and attracts attention. The r
Company
OB-GYNs fume over the price hike of HPV vaccines
by
Moon, sung-ho
Apr 5, 2021 05:51am
The medical community is in turmoil over the news that MSD Korea will raise the price of ¡®Gardasil 9,¡¯ its 9-valent HPV vaccine. Relevant doctors¡¯ associations are determined to discuss countermeasures for the unilateral price increase carried out by the pharmaceutical company. The Korean company in charge of domestic sales of the vaccine
Policy
Janssen vaccine was confirmed to maintain an immune response
by
Lee, Tak-Sun
Apr 5, 2021 05:50am
The COVID-19 vaccine license verification advisory group composed of external experts recognized the preventive effect of Janssen's COVID-19 vaccine. Janssen vaccine was confirmed that the immune response was maintained for up to 12 weeks with only one administration. The COVID-19 vaccine safety and effectiveness verification advisory grou
Company
Novartis' Xolair self-administration prescribed at GHs
by
Eo, Yun-Ho
Apr 2, 2021 06:06am
The self-administration formulation of the asthma treatment ¡®Xolair¡¯ can now be prescribed at general hospitals. According to industry sources, Novartis Korea¡¯s Xolair (omalizumab) prefilled syringe 75mg solution has passed the review of drug committees (DCs) in 8 general hospitals nationwide, including the Seoul National University
Policy
Are there less than 20 licensed generic drugs?
by
Lee, Tak-Sun
Apr 2, 2021 06:05am
The pharmaceutical industry is looking for generics with less than 20 identical ingredients/same content due to the effect of stepped drug prices. This is because there is a large difference in drug price depending on whether there are more than 20 or less than 20 outsourced generics permitted to use bioequivalence test data. The recent in
Policy
Levitra was withdrawn from the Korean market after 20 years
by
Lee, Tak-Sun
Apr 2, 2021 06:05am
Levitra, which Bayer launched on the Korean market for erectile dysfunction drugs, withdrew completely on the 1st. It was withdrawn due to expiration of the validity period because Bayer Korea did not renew the license. Only Kyongbo Vardenafil HCl of Kyongbo, a subsidiary of Chong Kun Dang, remains in the active ingredient containing Varden
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