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- 2026-04-14 06:50:27
- Policy
- Moderna vaccine has been approved for lot release
- by Lee, Tak-Sun Jun 18, 2021 05:53am
- The MFDS said it approved lot release of 55,000 doses of Moderna COVID-19 vaccine on the 15th. The national lot release is a system in which country evaluates the results of the verification test and the review of the manufacturer's data before the vaccine is distributed on the market and checks the quality once more. The MFDS measured efficacy based on genetic materials and the amount of lipid nanoparticles surrounding them through invitro translation of the first import of Moderna COVID-19 vaccine. The purity test and endotoxin test confirmed that the vaccine was safe because it was not contaminated. The MFDS explained that quality test data issued by the plant quality assurance director were reviewed to ensure consistency in quality. Moderna vaccine is licensed and distributed by GC Pharma. GC Pharma also applied for the national lot release. Starting this week, Moderna vaccine will be inoculated to health care workers under the age of 30, medical students, and nursing students from general hospitals. When Moderna vaccine is used on site, the total number of vaccines inoculated in Korea will be increased to four, including AstraZeneca, Pfizer and Janssen.
- Policy
- AZ vaccine's side effects are reviewed
- by Lee, Tak-Sun Jun 17, 2021 08:02pm
- The MFDS has begun a review on the addition of side effects of capillary leakage syndrome of AstraZeneca's COVID-19 vaccine recommended by the European Medicines Agency (EMA). The MFDS announced on the 14th that it will take necessary measures such as distributing Dear Healthcare Professional Letter, sharing information recommended by EMA, and adding related precautions to Insert paper. Earlier, the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA recommended that people with a history of capillary leakage syndrome should not be vaccinated against AstraZeneca's COVID-19 vaccine. The PRAC reviewed 6 cases of capillary leakage syndrome in people who received AstraZeneca's COVID-19 vaccine, with 3 having a history of capillary leakage syndrome, and one of them fatal. Capillary leakage syndrome is a very rare and serious condition that causes fluid leakage from the capillaries, resulting in edema of the arms and legs, low blood pressure, blood concentration and hypoalbuminemia. No patients have yet been reported in Korea. The MFDS shared relevant information with medical experts, saying that people who have experienced capillary leakage syndrome should not be vaccinated with the AstraZeneca's COVID-19 vaccine. It also said it will take necessary measures such as adding related precautions to the insert paper by combining the status of abnormal cases at home and abroad and safety information.
- Company
- Cancer immunotherapy combo seeks 1st-line reimbursement
- by Eo, Yun-Ho Jun 17, 2021 06:04am
- Activity to reimburse ‘Opdivo’ has begun again after a long standstill. According to industry sources, Ono and BMS recently submitted an application to extend reimbursement for the PD-1 inhibitor ‘Opdivo (nivolumab)’ in combination with the CTLA-4 inhibitor ‘Yervoy (ipilimumab)’ to first-line treatment of non-small cell lung cancer (NSCLC). This is the first time in a long while that a discussion for listing Opdivo is being resumed in the field of lung cancer since Opdivo’s reimbursement attempt to receive reimbursement ‘as monotherapy for second-and third-line treatment of lung cancer regardless of PD-L1 expression’ was turned down by the authorities in 2019. The Opdivo and Yervoy combination has initially been approved in Korea for the renal cell carcinoma indication, and its listing process is currently underway. As with MSD’s ‘Keytruda (pembrolizumab),' Ono and BMS had discontinued the reimbursement extension discussions as they were unable to accept the condition set by the government requesting the company to ‘cover the initial 3 cycles’ worth of administration cost.' Whether Opdivo will be able to be listed for reimbursement with the new ‘cancer immunotherapy combination' card is receiving attention. Also, with the PD-L1 inhibitor ‘Tecentriq (atezolizumab)’ and Keytruda’s reimbursement as first-line treatment for lung cancer expected to be discussed in July at HIRA’s Review Committee for Cancer Diseases meeting, whether Opdivo will also be put as an agenda for deliberation then remains to be seen. Opdivo in NSCLC was approved in Korea ▲ as first-line treatment of advanced or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations, in combination with Yervoy and 2 cycles of platinum-based chemotherapy; and ▲as first-line treatment of metastatic or recurrent NSCLC expressing PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations, in combination with Yervoy. Opdivo’s efficacy in lung cancer was confirmed through the two Phase III trials, CheckMate-227 and CheckMate-9LA. Dr. Dae-ho Lee, Professor of Oncology at the Asan Medical Center, said, “The newly approved combination therapies that use Opdivo have clinical significance not only because it raises the treatment response rate and improves the period of survival in NSCLC patients, but because it also provides more treatment strategy options to first-line NSCLC patients. However, one thing left to be desired is that we lack discovery of appropriate biomarkers that can guide us through the various treatment strategies." he said.
- Policy
- PBAC provides cost-effectiveness data to improve integrity
- by Lee, Hye-Kyung Jun 17, 2021 06:04am
- The Health Insurance Review and Assessment Service's Pharmaceutical Management Department was selected as 'best project' among 'self-promoted projects to improve integrity’ for its efforts in improving standard forms and expanding information disclosure systems. The department worked to improve integrity by clarifying and making transparent the application process for the decision-making of pharmaceutical benefits. Specifically, the department expanded the scope of information disclosed from the Pharmaceutical Benefit Appraisal Committee (PBAC) meeting to the cost-effectiveness data. In the past, the data shared after the meeting was focused around clinical efficacy data. The system was improved so that the PBAC evaluation results, which were provided over the phone upon the company’s request, are now provided for all pharmaceuticals that were deliberated, immediately after the meeting without requests from relevant pharmaceutical companies. In addition, the department has been commended for improving work efficiency by clarifying and standardizing the data required for submission when applying for the pharmaceutical benefit. Also, the department developed a status tracking service after applying for the extension of the benefit standard, which subdivides the review process into 7 stages - confirmation of receipt, supplementary data request, academic opinion request, practical review, committee deliberation, report to the Ministry of Health and Welfare, and process completion - to be checked by the applicant. In addition to the Pharmaceutical Management Department, the integrity promotion projects proposed by the Safety Management Department, Customer Services & Public Relations Department, Claims Review Department, and Medical Fee Schedule Department were also selected as Best Projects. HIRA has been making efforts to improve the integrity of its organization through various efforts including raising integrity awareness of its internal employees and enhancing communication with partner firms, improving employee satisfaction by achieving worker-customer balance, holding a mutual respect day, establishing and operating an anti-corruption relief program, promoting a Clean&Clear Cost (3C) system, preparing criteria for handling out-of-town business trips, etc. At the press briefing held on the 15th with the Korea Special Press Association, Shin Cho, standing auditor of HIRA said, “Analysis of the integrity score last year showed that the institution recorded high scores in illegal solicitation, bribery, and private use of budget categories, but scored relatively low in the organizational culture category. To increase the integrity of our institution, we will work to establish a healthy organizational culture and strengthen the virtuous circle for anti-corruption and integrity."
- Company
- Drug exports in May amounted to ₩650 billion
- by Kim, Jin-Gu Jun 17, 2021 06:04am
- Korea's drug exports reached ₩650 billion in May. Exports are still export boom following last year. However, as imports increased, the trade balance posted in deficit for the second straight month from April. Monthly drug exports for the last two years (unit: $1 million, data: Korea Custom Service) By country, drug exports to Germany surpassed ₩1 trillion in five months. Pharmaceutical exports to Germany exceeded ₩2 trillion last year, reaching an all-time high, and exports are increasing more steeply this year. According to the Korea Customs Service on the 15th, Korea exported $585.07 million (about ₩650 billion) in May. Compared to $588.43 million in May last year, there is little difference. Last year's exports of medicines were the highest ever. The export boom continues until May. Monthly exports of medicines include $696.56 million in January, $714.57 million in February, $816.6 million in March, $468.19 million in April and $585.57 million in May. Drug imports include $634.76 million in January, $519.61 million in February, $727.51 million in March, 652.37 million dollars in April, and 689.42 million dollars in May. Compared to January-May of last year, it increased by 6%. Exports are similar to the previous year, and as imports increase, the drug trade balance has been in deficit since April. Korea's drug trade balance hit surplus for five consecutive months from November last year to March this year. However, it was $184.18 million in April and $14.35 million in May, respectively. By May, Germany had the largest cumulative export volume of $1210.77 million. Germany has become the largest exporter of medicines since 2019. In particular, exports increased even more this year. The figure has more than doubled from $553.39 million during the same period last year. From January to May, exports of medicines to Japan ranked second with US$197.24 million. It increased 40% from $141.04 million (₩160 billion) in exports from January to May last year. Exports to Netherlands also increased significantly. It was only $42.81 million (about ₩50 billion) until May last year, but it more than quadrupled to $189 million (about ₩210 billion) this year. Exports to the United States declined significantly. By May, exports to the U.S. amounted to $163.75 million (about ₩180 billion), down by half from $331.17 million (about ₩370 billion) during the same period last year. By 2018, Korea had been the largest exporter of medicines to the United States.
- Company
- Companies are nervous about investigating Varenicline
- by An, Kyung-Jin Jun 16, 2021 05:42am
- ChampixCompanies selling anti-smoking drugs, generic for Champix are on alert. Health authorities are investigating Nitrosamines impurities in Varenicline. It seems that sales are facing difficulties due to unfavorable factors such as COVID-19 incident and follow-up measures of impurities after passing the patent dispute in Korea. According to an industry on the 15th, pharmaceutical companies that manufacture and sell generics for Champix (Varenicline) are preparing documents related to testing impurities in Nitrosamine. This is because the MFDS identified the possibility of Nitrosamines impurities in Varenicline and ordered follow-up measures. As the possibility of detection of Nitrosamine impurities has been confirmed by Varenicline, it has taken follow-up measures of domestic products. Varenicline is the main active ingredient in Pfizer's anti-smoking drug, Champix. 34 domestic pharmaceutical companies that own generics for Champix, including Pfizer Korea, which sells original product, CTC Bio, The U, Medic Pharm, AusKorea, Hanmi, Jeil, PharmGen Science, Joonghun, Litepharm, Genuonesciences, TELCON RF, Ahn-gook, Ilhwa, Theragen Etex, Daewon, Whanin, Daewoong Bio, Crystallifescience, Alvogen Korea, JW Shinyak, Kyongbo, Kwang Dong, Vivozon, Korean Drug, Hutecs, Samjin, Mcnulty, Boryung, Yuyu, Hana, Ildong, and Pharvis are included. According to IQVIA, which is a pharmaceutical market research institute, Varenicline market formed ₩4.8 billion in first quarter of last year. Sales of Pfizer Korea's Champix are ₩4 billion, accounting for 83.9% of the total market. Only 12 generic companies, including Hanmi, Hutecs, Whanin, Alvogen Korea, Vivozon, CTC Bio, Boryung, Daewoong Bio, Mcnulty, and Jeil, generated sales in the first quarter. Sales of Hanmi's Nocotin S amounted to ₩500 million, the highest among Varenicline products. Other products were less than ₩100 million in quarterly sales. Sales of Hutecs' Nicopix are ₩76 million, while Hwanin's Nicover and Alvogen Korea's Topfix are in the top sales list with ₩50 million. Quarterly sales of Champix fell below ₩3 billion until 2014, but it surpassed ₩5 billion for the first time in the first quarter of 2015 and quarterly sales soared to ₩21.4 billion in the first quarter of 2017. As the market size decreased following the reduction in drug prices in 2018, Korean companies actively wanted to enter the Varenicline market. Some companies, including Hanmi, Chong Kun Dang, and Kyung Dong, started selling generics before the expiration of the patents, but lost the lawsuit of material patent avoidance, and were dismissed from the market. The generic market reopened in July last year with the expiration of the patent of Champix, but it has rarely recovered in the aftermath of COVID-19. Domestic pharmaceutical companies are concerned that the anti-smoking drug market will be further reduced if measures such as suspension of sales are taken due to the detection of excess impurities at a time when new cash cow excavation is urgently needed. Related companies are anxious because the MFDS' investigation of impurities has not been confirmed in detail. It is known that measures such as recovery due to the detection of impurities in Varenicline have not been taken overseas. "The Champix market is not large, but it is an area that is recently expected as a new cash cow," an official from a pharmaceutical company said. "There are many concerns that the market may be hit by unexpected detection of impurities."
- Company
- Daewoong registers patient for Phase 3 trial of Coviblock
- by Nho, Byung Chul Jun 16, 2021 05:42am
- Clinical trial approval status of Daewoong Pharmaceutical’s COVID-19 treatment Coviblock as registered on the Pharmaceutical Integrated intelligence system (image: screen capture of the Pharmaceutical Integrated intelligence system webpage) The first patient for the Phase III trial of Daewoong Pharmaceutical's COVID-19 treatment candidate 'DWJ1248 (brand name: Coviblock)’ has been registered. According to the clinical trial approval status disclosed on the Pharmaceutical Integrated intelligence system webpage, Daewoong Pharmaceuticals had registered its first patient on the 7th this month for its double-blind, randomized, controlled Phase III clinical trial for Coviblock to assess its effectiveness in preventing infections after exposure to the COVID-19 virus. The clinical trial will investigate the efficacy of Coviblock in preventing infections in people in self-isolation due to exposure to the COVID-19 virus. This is the only treatment study in Korea that investigates the preventive effect of a treatment after exposure to the COVID-19 virus. Coviblock contains the same active ingredient as Foistar, camostat mesylate. According to the eligibility criteria disclosed by the clinical trial patient recruitment company E.Jo Connections, subjects are selected among those exposed to the COVID-19 virus who are in self-isolation or have been tested negative for COVID-19 at an RT-PCR test; those that have been in contact with a COVID-19 confirmed individual within 5 days; those who do not have the 14 types of symptoms that suggest COVID-19 such as fever, cough, chills, muscle pain, etc. Camostat, the active ingredient of Coviblock, inhibits the multiplication of the COVID-19 virus by blocking the viral host cell entry and improves inflammation. Based on this mechanism of action, Coviblock is expected to prevent a person who was in close contact with the COVID-19 virus from being infected with COVID-19 by blocking the virus from entering the body's cells. On the 4th, Daewoong Pharmaceutical had completed the administration of Coviblock in a phase-2b trial that was conducted on mild COVID-19 patients. A total of 300 patients were recruited for the trial, and the company will start data analysis after observing the patients’ conditions for a certain period. If the company obtains positive results, it plans to seek conditional approval in the third quarter and consecutively conduct the phase 3 trial. An official from Daewoong Pharmaceutical said, “We will do our best to develop Coviblock as a treatment for COVID-19. We have implemented multiple approaches for the development of Coviblock to fulfill our social responsibility in overcoming COVID-19 as a pharmaceutical company." Coviblock’s main ingredient, camostat, has also been shown to be effective in various variants of the COVID-19 virus in several efficacy tests. In April, Institut Pasteur Korea (IPK) announced study results on the effects of camostat and niclosamide among others on Covid-19 virus variants in cell tests. Results showed that the drugs inhibited cell infection to a similar level in the Covid-19 virus, the U.K. variant (B.1.1.7) and the South African variant (B.1.351)." Various countries including the U.S. and Japan have been developing treatments, with some using camostat’s COVID-19 treatment effect. The Korean government is also making active efforts to overcome COVID-19 by providing support for the development of an oral treatment that is easy to administer, etc. Whether these global efforts will bring a breakthrough in the development of a treatment for COVID-19 is receiving attention.
- Company
- '100 Tylenols per pharmacy' provided to relieve shortage
- by Jun 16, 2021 05:41am
- Tylenols awaiting shipment at a pharmaceutical distribution company The shortage of Tylenol in pharmacies will be somewhat relieved with one hundred Tylenol 500mg being supplied to each pharmacy starting today. This measure to relieve the Tylenol shortage was made under the government’s request to Johnson & Johnson to release the 5 million the company stockpiled for next year, and Johnson & Johnson shipped the products to the wholesalers in charge of distributions yesterday, on the 14th. The first shipment contains 2.4 million Tylenols. The Korean Pharmaceuticals Distribution Association divided the pharmacies by region to allow ‘fair distribution to all pharmacies’ and selected 40 wholesale companies to cover the regions. The 40 wholesalers in charge of distribution started taking preorders last week. An official from one wholesale company said, “We started taking orders from last week, and as of the 14th, some wholesalers have already started receiving their supply. So companies will be able to distribute the supply from today (15th).” In the second supply, 2.6 million more Tylenols will be released. Therefore, the 23,000 pharmacies that have ordered its 100 Tylenols from the first supply will be able to order additional Tylenols on an as-needed basis. An official from the pharmaceuticals distribution industry said, “The equal supply of Tylenol to pharmacies in all regions rather than in some pharmacies will improve patient access to the drug.” On this, the Ministry of Food and Drug Safety said, “With support from relevant organizations, the ministry will work to enable smooth supply of acetaminophen to the people in need at the right time in line with the government's vaccination plan. Also, we will share the supply and demand status with relevant institutions through regular monitoring and immediately support the administrative matters necessary to suppliers to increase production of acetaminophen products.” Earlier, the Ministry of Food and Drug Safety, Korean Pharmacists’ association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Pharmaceuticals Distribution Association, and Tylenol’s manufacturer Johnson & Johnson had met to discuss measures to stabilize the supply of acetaminophen that has faced shortage following COVID-19 vaccinations. The organizations decided to designate 40 pharmaceutical distributors by region to ensure a stable supply of Tylenol in all regions.
- Company
- Jeil Pharma's new OAB treatment ‘vibegron’ nears release
- by Kim, Jin-Gu Jun 16, 2021 05:41am
- Vibegron product that is being sold by Kyorin Pharmaceutical ‘Vibegron,' a new drug indicated for the treatment of overactive bladder (OAB) that Jeil Pharmaceutical acquired a domestic license for from Kyorin Pharmaceutical, is soon to be approved in Korea. Two clinical trials related to the domestic approval and manufacturing of Vibegron have been completed or are near completion. At the earliest, it is expected that the drug may be released within this year. According to industry sources on the 14th, Jeil Pharmaceutical had recently completed its Phase I clinical trial on vibegron. The trial investigated the safety and pharmacokinetics of JLP-2002 in comparison with the original drug. The trial was conducted for the purpose of receiving approval for Jeil Pharmaceutical's direct manufacturing of Vibegron in Korea. Prior to this study, Jeil Pharmaceutical had received approval for its IND application and conducted the trial on 33 patients in Korea in January this year. In addition, the bridging study (Phase III trial) for the domestic approval of Vibegron is also in its final stages of completion. Jeil Pharmaceutical had started the bridging study for the domestic approval of Vibegron in May last year. The study was conducted on 201 patients in 20 hospitals in Korea, including the Seoul Asan Medical Center. The company enrolled its final subject mid-last month. The investigation for the last participant is expected to be completed near the end of this month. Jeil Pharmaceutical plans to proceed with the domestic production and marketing approval procedures as soon as the clinical trial results are released. This raises the possibility that the product may be released in the market within this year at the earliest. Jeil Pharmaceutical had signed an exclusive domestic licensing agreement for vibegron with Japan's Kyorin Pharmaceuticals in 2019. Vibegron, Kyorin’s new overactive bladder (OAB) treatment, was in-licensed by Kyorin from MSD, and released as ‘Beova’ in Japan in November 2018. The drug received U.S. FDA's approval last December. In the U.S., Urovant Sciences received approval for the drug under ‘Gemtesa.’ Urovant Sciences is a subsidiary of Japan’s Sumitomo Dainippon Pharma. After vibegron is released, the OAB market in Korea is expected to heat up from its full-scale competition with the existing market leader ‘mirabegron (Betmiga).’ Betmiga is the most-prescribed treatment for overactive bladder in Korea. According to the pharmaceutical market research frim UBIST, out-patient prescription sales of Betmiga recorded 65.1 billion won last year. Also, Betigma's prescriptions recorded 15.4 billion won in the first quarter of this year. Vibegron's mechanism of action is similar to mirabegron's as the two drugs are both selective β3-adrenoceptor agonists. The recommended dosage is also 50mg once daily for both. However, medication adherence is known to be higher for vibegron as it has fewer adverse events than existing treatments. Vibegron's has also shown positive sales in Japan. According to Kyorin Pharmaceutical's annual report, sales of vibegron recorded 4.3 billion yen (about 43.8 billion won) in 2019 and 7.3 billion yen (about 74.3 billion won) in 2020 in Japan.
- Company
- Investigation of Varenicline has been undertaken
- by Chon, Seung-Hyun Jun 16, 2021 05:41am
- Health authorities have launched an investigation into Nitrosamines impurities in non-smoking drugs "Champix" and generics for Champix. According to industries on the 14th, the MFDS recently ordered pharmaceutical companies to follow up on Varenicline's impurities (Nitrosamines). The MFDS said, "Recently, there is a possibility of Nitrosamines impurities among Varenicline." The MFDS requested, "To take preventive measures, we will review the manufacturing process and follow-up measures such as testing impurities in Nitrosamines." Varenicline is a major active ingredient in Pfizer's anti-smoking drug Champix. 34 domestic pharmaceutical companies have generics for Varenicline. As the possibility of detection of nitrosamines impurities was confirmed by Varenicline, follow-up measures of domestic distribution products have been taken. "We requested follow-up measures to collect information on impurities from Varenicline," said an official from the MFDS. N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) detected in Valsartan, Losartan, Nizatidine, Ranitidine and Metformin in Korea since 2018. Pharmaceutical companies have completed inspections of Nitrosamine impurities such as NDMA and NDEA. In November 2019, the MFDS ordered pharmaceutical companies to submit a report on the possibility of Nitrosamine-based impurities in all raw materials and finished drugs, and the data submission was completed in a year and a half. The MFDS must submit data on impurities in all medicines to allow lot release without testing for Nitrosamines impurities. It is the second time this month that the MFDS has ordered investigations into impurities. Earlier on the 4th, the MFDS asked pharmaceutical companies to submit Azido impurities evaluation and test results of three raw materials, Irbesartan, Losartan and Valsartan, by the 14th. The MFDS ordered the raw material manufacturer to submit a statement of reasons even if it is impossible to obtain related data. This is a follow-up to the recent recovery of drugs with excess Azido impurities in Canada. Health Canada took measures on the 31st of last month to recover Irbesartan, Losartan and Valsartan that exceeded Azido from nine pharmaceutical companies, including Teva and Sandoz. Azido is a type of azide carcinogen. There is no known specific risk of cancer in the human body, although it may increase the risk of cancer. Nitrosamines impurities such as NDMA have been detected in Korea since 2018, but no recovery measures have been taken due to the detection of Azide-based impurities.
