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- 2026-04-11 21:14:15
- Company
- Japan first approved AZ Evusheld as Coronavirus tx
- by Sep 02, 2022 06:02am
- Japan approved AstraZeneca's long-lasting antibody complex Evusheld for the first time in the world for COVID-19 treatment. On the 30th (local time), Ministry of Health, Labour and Welfare of Japan approved the Evusheld as a prevention of symptomatic diseases caused by COVID-19 infection (pre-exposure prophylactic therapy) and a treatment for symptomatic diseases caused by COVID-19. Evusheld has been approved for COVID-19 prevention in Korea, the United States, and Europe and is being administered to high-risk groups. Furthermore, Japan allowed Evusheld to be used for treatment for the first time in the world. With the approval, the Japanese government purchased Evusheld for 300,000 people. For prevention, Japanese health authorities have allowed adults and adolescents aged 12 or older and weighing 40 kg or more to use the COVID-19 vaccine for immunodeficiency that does not show an appropriate immune response. For treatment, it has a risk factor for severe COVID-19 infection and can be used in adults and adolescents who do not need oxygen assistance. When used for treatment, twice the dose for prevention is administered. In the TACKLE phase 3 clinical trial conducted by AstraZeneca, Evusheld reduced the risk of severe progression or death of mild and moderate COVID-19 patients by 50%. Patients who received treatment within three days of symptom onset decreased their risk of developing severe disease or death by 88% compared to placebo. The risk reduction of administration within 5 days of symptom onset was 67%. Laboratory studies on major omicron mutations worldwide, including BA.5 and BA.2, have also shown that Evusheld maintains neutralization activity. Professor of Microbiological-Infectious Diseases at Toho University said, "COVID-19 continues to have a great influence on the daily lives of the Japanese people. There is still a high risk that the treatment results of severe COVID-19 can be bad in many people, including the elderly, patients with underlying diseases, and immunization degradation. He said, "Evusheld is a necessary new option, which will provide long-term preventive effects for people who do not have an appropriate immune response even after vaccination and help prevent seriousness and death in infected people."
- Policy
- Advance reservations for SKYCovione will begin on the 1st
- by Kim, Jung-Ju Sep 02, 2022 06:02am
- The inoculation of the COVID-19 vaccine SKYCovione developed by SK Bioscience has begun in earnest. Starting with pre-booking tomorrow (1st), day-to-day and door-to-door vaccinations will be started from the 5th. In addition, the COVID-19 bivalent vaccine will be introduced and vaccinated in the fourth quarter of this year. Lee Ki-il, the first general coordinator of the Central Disaster and Safety Countermeasures Headquarters (second vice minister of the Ministry of Health and Welfare), spoke at a meeting of the Central Disaster and Safety Countermeasures Headquarters today (31st) and announced plans for the holiday quarantine. First of all, the government decided to introduce a bivalent vaccine in the fourth quarter of this year to effectively respond to the recent BA.5 mutation and to vaccinate high-risk groups first. Adults over the age of 18 who have completed the second inoculation or higher can also be vaccinated. Domestic COVID-19 vaccination plans have also been set. The government announced that pre-orders for the SKYCovione vaccine developed by SK Bioscience, a domestic pharmaceutical company, will begin on September 1. People can get vaccinations on the same day and door from the 5th, and pre-orders from the 13th. Earlier, the Ministry of Food and Drug Safety approved the national shipment on the 26th for 610,000 SKYCovione multi-stock. This vaccine is a product that induces antibody production by injecting COVID-19 virus antigens into the body after manufacturing them in a gene recombination method. As vaccinations for domestic business development began in earnest, the authorities recommended vaccinations for those who were not vaccinated among adults aged 18 or older. The first general coordinator said, "The SKYCovione vaccine has a 2.9 times higher neutralization antibody value than the existing vaccine, and most of the adverse reactions are insignificant." He said, "We recommend domestic vaccinations for adults over the age of 18 who have not yet been vaccinated."
- Company
- Trelegy Ellipta lands in Big 5 tertiary hospitals in Korea
- by Eo, Yun-Ho Sep 01, 2022 05:56am
- The COPD treatment ‘Trelegy Ellipta’ has landed in general hospitals in Korea. The company has been making rapid entry into the market since its reimbursed release in June this year. According to industry sources, GSK Korea’s triple inhaled therapy for COPD (Chronic Obstructive Pulmonary Disease), “Trelegy Ellipta (fluticasone·umeclidinium·vilanterol)" has passed the review of drug committees (DCs) of 50 medical institutions nationwide, including the ‘Big-5’ general hospitals of Korea - Samsung Medical Center, Seoul National University Hospital, St. Mary’s Hospital, Severance Hospital, and Seoul Asan Medical Center. Trelegy Ellipta is the first triple combination therapy for COPD that was approved in Korea in May 2018. The drug can be prescribed as maintenance treatment for moderate-to-severe COPD in adult patients who are not adequately treated by a combination of a long-acting beta2- agonist (LABA) and inhaled corticosteroid (ICS) or a combination of a LABA and a long-acting muscarinic antagonist (LAMA). Its reimbursement is approved in Korea for the following three cases: ▲Patients whose FEV1
- Policy
- MFDS sets next year's budget at ₩669.4 billion
- by Lee, Hye-Kyung Sep 01, 2022 05:56am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) had compiled its budget plan for 2023 at ₩669.4 billion, a ₩5.4 billion (0.8%) increase from the ₩664 billion that had been set for this year. The next year’s budget proposal is focused on the definite implementation of the new administration’s national tasks – reinforcing food safety management and supporting innovative growth of the bio-health industry – and preparing a safe basis for the future of the new food and drug industry. The MFDS' budget proposal for 2023 was mainly allocated to 4 major areas – fostering a safe food and healthy dietary life environment, reinforcing safety management and basis for innovative growth in the biohealth sector, building a safe supply system for essential medicines, and expanding regulatory science research to lead future safety regulations. From the ₩174 billion set out for safety management and the basis for innovative growth in the biohealth, ₩13.1 billion was allocated to support the Korea Institute of Drug Safety & Risk Management, ₩6 billion to support the National Institute of Medical Device Safety Information, ₩7.9 billion to advance the quality of pharmaceuticals, ₩2.3 billion to strengthen international cooperation and competitivity for regulatory approval of pharmaceuticals, ₩1.8 billion to support licensing review, ₩1.9 billion to establish a support and management system for innovative medical devices, and ₩2.8 billion in building a computer modeling-based medical device. The MFDS plans to establish a common data model collection system to collect and analyze real-world data (RWD) from medical institutions and reinforce verification of drugs’ side effects, and conduct long-term follow-ups on implantable medical devices with the next year's budget. Also, technical support will be provided to develop and disseminate a demo model for the actual production of syringes implementing Quality by Design (QbD) principles to foster an optimal foundation for process design to ensure drug quality and safety. Also, to expand international cooperation for global regulatory standards, the MFDS plans to issue an English version of the Korean pharmacopeia and work to join the Pharmacopeial Discussion Group (PDG), and conduct customized professional education for drug license reviewers to strengthen their capabilities. Also, to reinforce verification of in vitro diagnostic devices such as COVID-19 diagnostic kits, etc., the MFDS will strengthen performance assessments of the products in distribution, and promote the research and development of a safety assessment system for computer modeling based medical devices to drive regulations on high-tech medical devices in the global market. Also, ₩14.2 billion was allocated to building a stable supply system for essential medicines. The ministry will stockpile appropriate amounts of orphan drugs to stably supply such drugs at the right time to patients in need, and expand state-led consigned production of essential medicines that have been discontinued supply due to low demand in Korea. Also, to establish a basis for the stable supply of medical devices that are rare or in emergent need, the MFDS will increase pre-purchases and stockpiling of medical devices while operating regional depots to facilitate prompt supply, and establish an integrated system that can supply and manage emergency medicines for crisis response and facilitate smooth procurement and management of treatments, etc. in public health crises like COVID-19. In addition, in order to establish a stable supply system for import-dependent essential medicines, the ministry will continue to pursue R&D to manufacture finished products in Korea. Also, it will expand regulatory science research to lead to future safety regulations. Furthermore, the ministries will join forces to prepare for the future environment by participating in pan-ministerial medical device R&D throughout the entire cycle to support the commercialization of safe medical devices. In response to the digital era, the ministry will establish a 'Smart Food QR' platform that issues unique QR codes for each food that provides combined safety management functions and consumer-oriented information ranging from e-label, real-time safety information to history and convert information such as food labeling and distribution history as data.
- Company
- Imported shingles vaccine that has been suspended & delayed
- by Sep 01, 2022 05:56am
- The imported shingles vaccine is in short supply. This is because MSD's Zostavax has been out of stock for a while and the introduction of Shingrix, which was approved last year, continues to be delayed. According to the pharmaceutical industry on the 31st, Zostavax has been out of stock for about two months. MSD, which announced the news of its out of stock at the end of June, said it would resume supply at the end of July, but it is expected that it will not be able to supply again until September due to the postponement of the schedule. Zostavax was sold out in some regions due to a sudden increase in demand in 2020. In this regard, an MSD official said, "Zostavax is experiencing a short-term out of stock, and we are trying to speed up the lot release screening process as much as possible." "If we complete the process quickly, we expect to resume supply in early September," he explained. On top of that, GSK's new shingles vaccine Shingrix, which has been newly approved, has not been able to enter the domestic market for about a year due to continuous delay in its introduction schedule. Shingrix, which was approved by the Ministry of Food and Drug Safety in September last year, was originally scheduled to be released in February this year, but it continued to be delayed to the middle and second half of this year due to the delay in the introduction schedule. Shingrix was expected to rebound the size of the domestic shingles vaccine market. Recently, sales in the shingles vaccine market have been falling. According to IQVIA, a pharmaceutical market research firm, the size of the vaccine market for shingles prevention was KRW 45.1 billion last year, down 37.6% from KRW 72.3 billion a year earlier. In the first half of this year, it was also worth 20.4 billion won, almost no difference from the previous year. This is because many of the main target groups of shingles have been vaccinated, and in the case of shingles vaccines, they only need to be vaccinated once in their lives. After 8 years, the immune effect decreases, so additional vaccinations are recommended, but the additional vaccination rate is relatively low. The emergence of Shingrix is likely to increase the additional inoculation rate. Shingrix gained attention by demonstrating stronger shingles prevention effects than Zostavax. Clinical trials (ZOE-50) of adults aged 50 and older demonstrated a 97.2% ERA in 3.2 years of follow-up observation, and 3.7 years of follow-up observation (ZOE-70) showed 89.8% efficacy. Compared to Zostavax's 5% ERA in patients over the age of 50 and 41% over the age of 70. The industry predicts that Singrix will not be released this year at all. GSK is in a position that "no decision has been made on the schedule for introducing Singrix," which is bolstered by this prospect. GSK is also known to have decided on Singrix's domestic partner this year, but the release date is being delayed without any promise as the introduction in Korea is delayed. Some say that Singrix's global demand is increasing and it is not able to secure supplies to enter the country. This is because demand for Singrix, which had shrunk due to COVID-19, has risen significantly this year as it has been recovering since the second half of last year. In the first half of last year, Singrix's sales more than doubled from the same period last year to 1.429 billion pounds (2.26 trillion won). The industry this year, singgeuriksseu is looking to break sales a year.
- Policy
- Coverage of 19 new drug items will be reinforced this year
- by Kim, Jung-Ju Aug 31, 2022 05:40am
- [Nineteen new drugs have been newly listed on the pharmaceutical reimbursement list or expanded reimbursement standards from January to this month this year. Among the drugs, 4 items were newly listed drugs, and 2 were already-listed drugs receiving reimbursement expansions. An estimated 1,320,371 patients will benefit from the new drug coverage enhancement policy this year, and the amount of pharmaceutical expense is expected to be in the ￦437.76 billion range. First, 19 new drugs have been newly listed on the pharmaceutical reimbursement list or expanded reimbursement standards (indication, administration standards) from January to this month this year. By month, coverage expansions this year started with the new listing of Vyzulta Eye Drops and Skilarence Enteric Coated Tab and the reimbursement standard expansion of Besponsa Inj in February. In March, five osteoarthritis treatments including Zospata Tab 40mg, Lutathera Inj, and Resyno-ONE Inj were newly listed, and the reimbursement standard for Keytruda Inj was extended. In April, Vitrakvi Cap and Sol, Rozlytrek Cap, and the ultra-high-priced treatment Kymriah Inj. were newly listed, followed by the reimbursement standard expansion of Tecentriq Inj in May. Last month, the reimbursement standards for Tecentriq Inj and Kadcyla Inj has been expanded and Fexclu Tab newly listed, improving treatment accessibly for 726,658 patients. The estimated cost spent by the newly increased patients is expected to be around ￦97.6 billion. With the new listing of the ultra-high-priced one-shot treatment Zolgensma and other reimbursement standard expansions, access and coverage to drugs have been further widened and diversified this year. Although only 7 patients are eligible to receive Zolgensma in Korea, being an ultra-high-priced drug, the estimated cost of treatment has been set at ￦13.87 billion for the 7 patients. On the other hand, Sonazoid Inj is expected to cost ￦0.5 billion per year to benefit 7,000 patients in Korea. Dopa check Inj will cost ￦90 million for 455 patients, Donerion Patch and Donhesive Patch will cost ￦9.2 billion to benefit 28,600 patients. Xtandi Soft Cap, which had already been listed but was approved to expand reimbursement standards, will further benefit 649 patients and cost ￦11.3 billion, and Ketyruda will benefit 649 patients and cost an additional ￦10.9 billion.
- Opinion
- [Reporter’s View] Novartis's restructuring path similar
- by Eo, Yun-Ho Aug 31, 2022 05:40am
- Mergers, split-off, purchases, and sales... Global biopharmaceutical companies are busy making transformations to their respective businesses. Among the various transformations being made, the spin-offs and sales of the multinational pharmaceutical companies’ divisions have received particular attention over the past few years. Although such transformations are made under the premise of adopting a "selection and concentration" strategy, the spin-offs and sales draw out various positive and negative responses from society. One thing to note is that this phenomenon is being serially observed in various Novartis, one of the leading Big Pharmas, is currently integrating and spinning off its business at the same time. The company had integrated its Oncology and Pharmaceuticals business units that had been virtually operated like separate entities and announced its decision to separate its generics and biosimilars division, Sandoz. Although Novartis's spin-off of Sandoz was not unexpected, the integration of its other business units may have seemed less usual at first. However, the goal of the company - in conducting the spinoff and merger – has always remained the same. Like the other companies, Novartis is making corporate transformations to “separate innovation with legacy” in its business. Although being in the same company, Novartis’s Pharmaceuticals and Oncology Business Units had been on quite different paths. Its Pharmaceutical Unit focused on sales of relatively low-cost drugs for chronic diseases such as diabetes and respiratory diseases, whereas the Oncology Unit focused on premium-priced oncology drugs like Gleevec. However, at some point, the Pharmaceutical Unit started deviating from its usual path. Including ‘Zolgensma,’ high-priced premium drugs have now become flagship products in non-cancer areas as well. This is why the company decided to integrate the units into one combined unit - Innovative Medicines. Did the company’s separation from Sandoz also affect the company’s internal integration? Of course. With the integration, Novartis is also preparing to create a business unit dedicated to off-patent drugs. Corporate spin-offs cause separation in corporate size and profit structure. In other words, the company is seeking rebirth by dividing its business by concept, into an investment-oriented unit and a legacy unit. Such spin-offs do not impose a financial burden on companies because no claims for stock purchases are made in the process. Since it becomes a legally independent company after the split, the separate company may immediately be listed on the stock market upon spin-off. Most multinational companies conduct split-offs prior to such measures, which then would serve as a stepping stone for improving financial soundness and support sales of companies. For example, Pfizer established three business units (BUs), including its Upjohn Business Unit (BU) that was dedicated to its legacy brands, before initiating the separation of Viatris. Afterward, news of its merger with Mylan had been reported in line with the spin-off. In this sense, Novartis’s separation of Sandoz and integration of its business units are consistent with the steps that had been taken by other multinational companies in the past.
- Product
- Change of insurance code for Tylenol ER 650mg
- by Kim JiEun Aug 31, 2022 05:40am
- Pharmacists say, "There's no inventory, but there's no point changing the billing code."Should we just fill up the existing medicine?" While the billing code for Tylenol ER, which ran out of stock at pharmacies, has changed, the company's notice itself has become meaningless at pharmacies. According to Johnson & Johnson and the pharmacy in Korea on the 29th, the prescription code for the existing Tylenol ER 650mg will be deleted as of September 1. The move comes after Tylenol's manufacturer was changed from Janssen Korea to Johnson & Johnson Korea, and the company announced the details to retailers and pharmacies in July. In the announcement, Johnson & Johnson Korea said, "After the change of the billing code, the new product was newly announced on June 23, 2022, and the existing product before the change is recognized as a target of medical care benefits by August 31." The billing code will be changed from 646900690 to 646902600. The company also announced that new products will be shipped sequentially from mid-July. In the pharmacy, various opinions were made ahead of the change in Tylenol ER 650mg claim code. Originally, inventory before the change of the claim code can be prepared and claimed by August 31 according to the notice of the Ministry of Health and Welfare, and after that, it is not possible to claim. Existing inventory must be returned to pharmaceutical companies through purchased wholesalers. All products of Acetaminophen are in severe shortage, and in particular, Tylenol ER 650mg has not been in stock at pharmacies for months. Due to this situation, some pharmacies that have existing inventory are known to have set up a policy to prepare existing billing code products by entering them into new codes. A local pharmacist said, "In fact, it is the same drug, but the billing code has been changed, so we cannot use it, and we have to discard the medicine that we cannot get because there is no one." And he said, "Some pharmacists say that they input and use existing code products in new code, but this is not what they should do originally." Pharmacist Lee said, "We can't get the medicine, but we have to ignore the regulations and just prepare it," adding, "More ridiculous, neither the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, nor the Pharmaceutical Association have taken any action during the grace period from July to August." Some say that the change in the billing code is meaningless at a time when Tylenol cannot even be seen at pharmacies. The company said it would ship new products with changed billing codes after July, but in fact, related products are not properly stocked in pharmacies. A pharmacist in Seoul said, "If the code changes, a new product must be released, but there is no news," adding, "In fact, the pharmacy has given up Tylenol for several months."
- Opinion
- [Reporter's view] Reflecting opinions on cold medicine
- by Lee, Hye-Kyung Aug 31, 2022 05:39am
- The Ministry of Food and Drug Safety has been monitoring the supply and demand of cold medicines since March. The targets for monitoring are NSAIDs and Expectorants such as complex cold medicines, Acetaminophen, Ibuprofen, Dexibuprofen, Loxoprofen, and Erdosteine. When pharmaceutical companies computer-report the production (import), sales, and inventory of products to the Drug Safety Country's Weekly Production and Import Status Report system, they have identified cold drugs in circulation and encouraged them to produce insufficient or unproduced items. However, there was a big difference between the results of monitoring the supply and demand status and the distribution of cold medicines felt at the front-line pharmacy site. The Ministry of Food and Drug Safety said that if there are items that are producing and distributing even a little, they are not "out of stock." It is an opinion that pharmacies cannot have inventory of cold medicines with certain ingredients. In the end, officials from the Ministry of Food and Drug Safety said they wanted to resolve the supply and demand of cold medicines only with monitoring results, and the Ministry of Food and Drug Safety established a quick response system for cold medicines using a small-packed drug supply guide system. The Korean Pharmaceutical Association selects 10 items of cold medicines requested by pharmacies and reports them to the Ministry of Food and Drug Safety every week, and when the Ministry of Food and Drug Safety groups the items requested and provides them to the Pharmaceutical Association, the pharmaceutical company enters the system. Although the cold medicine supply and demand monitoring and rapid response system are operating at the same time, the front-line pharmacies still complain that supply and demand are disrupted even if they check inventory in the system and ask wholesalers to supply supplies. The Ministry of Food and Drug Safety is also asking for cooperation from individual pharmaceutical companies and wholesalers in connection with pharmaceutical and distribution associations and distributed prescriptions for cold medicine ingredients that are smooth in supply and demand, but they have no significant effect. The operation of such a system has not caused the cold medicine to be sold out, which occurred during the re-proliferation of COVID-19 earlier this year. It is necessary to solve practical problems about the fact that the supply of cold medicines for specific ingredient preparation is not smooth, and pharmacists who have to prepare prescribed Rx are burdened with difficulties. Just as the public mask system was introduced during the mask crisis, the government plans to establish a public supply management system to actively prevent cold medicine from being sold out in the future. It is commendable that the Ministry of Food and Drug Safety has been continuously checking the distribution status by monitoring the supply and demand status since March in the wake of the cold medicine sold out earlier this year. However, if they respond only with statistics entered into the system, they will have no choice but to file complaints at the front-line sites. In the future, we look forward to actively preparing countermeasures to prevent the second cold medicine from being sold out by steadily reflecting the opinions of the site.
- Policy
- Reevaluation of Amosartan plus & Twotops Plus
- by Lee, Tak-Sun Aug 30, 2022 05:55am
- Hanmi's Amosartan plus & Twotops plus cause the same formulation, whether or not listed. The Ministry of Health and Welfare announced the plan to revalue the addition in November 2020, and said that IMD will maintain its addition if the number of companies with the same product registered, individual single agents, complex agents, and administrative routes, ingredients, and formulations is less than one. Amosartan plus was scheduled to end its addition on September 1, but it was maintained with such an improved new drug preferential measure because there was no other drugs. The Company does in law would be unfair to do. This is because Telmidipine Plus was registered in March 2020 before the announcement of the additional revaluation. In addition, Telmidipine plus the joint development of pharmaceuticals, Ildong is produced. For this reason, Ildong filed a lawsuit to suspend and cancel the execution of the drug price reduction in response to the Twotops Plus additional termination. The application for suspension of execution to accept the drug price is maintained, but the last defeat in the litigation on the merits of a trial held in Seoul Administrative Court on Tuesday to cut drug price inevitable now. Accordingly, from 30 days after the date of judgment, Twotops Plus 40/5.12.5mg will be reduced from 792 won to 713 won, Twotops Plus 80/5/12.5mg from 956 won to 860 won and Twotops Plus 80/10/12.5mg will be reduced from 1,018 won to 919 won. In the end, Ildong's joint development drug registration was a negative factor in the additional re-evaluation. The additional revaluation plan announced by the Ministry of Health and Welfare in November 2020 is evaluated to contain preferential treatment for IMD rather than the plan first disclosed in the previous year. However, in all cases, it can be seen that IMD preferential treatment has retreated compared to before the additional revaluation. This is because before the additional revaluation, the addition of less than three identical companies could be maintained. Therefore, Ildong was likely to maintain additional value like Hanmi.
