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- 2026-03-17 02:03:11
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- Powder-type child antipyretic analgesics have been released
- by May 10, 2022 06:07am
- Johnson & Johnson Korea (CEO Baek Joon-hyuk) announced on the 9th that it has released the first powder-type children's antipyretic painkiller Children's Tylenol powder 160 mg in Korea. Children's Tylenol powder has various effects such as headache, neuralgia, muscle pain, sprain pain, menstrual pain, toothache, and joint pain, as well as fever and pain caused by a cold, so it can be widely used for fever and labor. The new product with the unique technology of Tylenol, an original Acetaminophen product, is a fever reducer of "powder formulation" that relieves the discomfort of liquid and syrup types and improves the convenience of taking pills for consumers who are unable to swallow them. As soon as the powder touches the tongue, it melts immediately in 23 seconds, so it can be taken without water, and it is easy to carry in the form of a stick pouch. It can be eaten quickly and comfortably with a small amount, so the packaging material can be used hygienically without touching the mouth. Children's Tylenol powder has both taste and effect with its special coating. The special coating of Ethyl cellulose in children's Tylenol powder prevents the bitter taste of Acetaminophen from the tongue. Wild berries and natural berries make it easy for children who had difficulty taking medicine without feeling repulsed. Parents who had to watch their children refuse the medicine for reasons such as taste, formulation, and dosage will be able to provide new options to save them the trouble of taking the medicine. The age of taking is children aged 7 to 12 years old (can be taken by elementary school students with a weight of more than 23kg), and the recommended dose is taken directly every 4-6 hours without water. It should not be taken more than 5 times a day (75 mg/kg). It is sold at pharmacies based on 12 bags per product, and if you need to divide it separately, it is recommended to fold the pouch and divide it into small quantities such as measuring cups or spoons provided at home. "Children's Tylenol Powder is the first powder-type new product in Korea that can meet needs for young children who have difficulty swallowing pills or children who are too big to eat syrup, in the form of 15mg powder per packet," said Kim Hanna, a group manager at Johnson & Johnson's self-care division. She said, "At this point when the risk of children's COVID-19 infection continues, child Tylenol powder is expected to function as a home remedy for more convenient management of fever pains for the whole family."
- Company
- Sales of generic for Galvus are not affected
- by Kim, Jin-Gu May 10, 2022 06:07am
- A reversal occurred once again in the patent dispute for the DPP-4 inhibitor-based diabetes treatment Galvus. The original signing Novartis won the remand hearing that took place after the Supreme Court's dismissal. The pharmaceutical industry believes that the decision will not have a significant impact on sales of generic for Galvus, which was released earlier this year. This is because the material patent in question expired during the dispute. According to the pharmaceutical industry on the 4th, the Korean Intellectual Property Tribunal overturned the previous ruling in a lawsuit to invalidate the extension of the duration of the material patent of Vildagliptin and decided to win Novartis. The Galvus patent dispute has been complicated by the reversal. Ahngook and Hanmi filed a trial in 2017, claiming that some of the extended duration of material patent of Galvus was invalid. In the first trial, Generic companies won. In 2019, the Patent Tribunal ruled that 187 days of the extended duration were invalid. Novartis won the second trial. In 2020, the Patent Court ruled that 55 of 187 days were invalid. The case went to the Supreme Court on Novartis' appeal. In October last year, the Supreme Court ruled against the company and sided with the company. It was a ruling that Novartis, which won the second trial, was not eligible to appeal. The case was dealt with in the first trial. In the end, the Patent Tribunal took Novartis' side. Even 55 days recognized by the patent court did not constitute invalidity. However, the pharmaceutical industry predicts that there will be no problem with the sale and prescription of generic for Galvus even with the Korean Intellectual Property Tribunal's decision. This is because the material patent expired during the dispute. The Galvus material patent expired on March 4. Hanmi Pharmaceutical, Ahngook Pharmaceutical, Angooknewpharm, Kyongbo, Korea United Pharmaceutical, Samjin, and Shin Poong then released the generic. Hanmi Pharmaceutical, which launched Vildagle as generic for Galvus in January this year, is also determined to continue marketing and sales of its products as usual. An official from Hanmi said, "The material patent of Vildagliptin has already expired on March 4, and there is no impact on the distribution, sale, and prescription of the previously released Vildagle. We plan to appeal to continue to focus the company's capabilities for the success of Vildagle."
- Company
- The diagnosis of rheumatoid arthritis has been activated
- by Eo, Yun-Ho May 09, 2022 06:04am
- The treatment environment for rheumatoid arthritis has improved significantly. As the diagnosis became accurate, it increased, and the application of the new drug developed greatly. Recently, the number of patients has been steadily increasing every year as the diagnosis of rheumatoid arthritis has been activated in Korea. The HIRA updates disease statistics last year at the end of April every year. Recently confirmed and found that the number of patients with rheumatoid arthritis in 2021 was about 131.68 million, an increase of more than 25% over five years compared to 104,354 in 2016. Rheumatoid arthritis is an autoimmune disease in which the immune system attacks joint tissue, causing inflammation and pain, causing joint damage, dysfunction, and painful swelling. Early treatment is known as a disease that can be managed by positively improving the patient's prognosis. In the past, diagnostic criteria were diagnosed as rheumatoid arthritis if more than four of the seven symptoms, such as morning stiffness or osteoarthritis of the hand. This criterion was useful as a method for diagnosing rheumatoid arthritis, which has already progressed a lot, but it was pointed out that it was not suitable for early diagnosis. However, in 2010, ACR and EULAR set a new standard for diagnosing rheumatoid arthritis if the number of joint invasion, the results of rheumatoid factors and anti-CCP antibody tests through blood tests, the increase in inflammation levels, and the duration of symptoms are scored. This was a turning point in quickly and accurately diagnosing rheumatoid arthritis. An official from the association said, "It is understood that rheumatoid arthritis is being diagnosed well compared to the past due to the recent continuous development of diagnostic methods and the increase in disease awareness. However, there are patients who do not know the disease well yet and do not receive proper treatment, or who need pain improvement even if they receive treatment," he said. In fact, since bony erosion occurs in about 60-70% of rheumatoid arthritis within two years of the outbreak, rapid diagnosis and drug treatment are important to prevent the progression of the disease. However, there are still patients with poor treatment prognosis, so more diverse treatment options are required. In an overseas meta-analysis study of about 80,000 patients with rheumatoid arthritis, the rate of achieving remission was found to be only about 20% despite biological two-year treatment. As time goes by, various drugs are introduced, creating a smooth treatment environment. The latest treatments, such as biological drugs and JAK inhibitors introduced since the 2000s, are showing effects on patients who lack treatment effects with existing treatments or have difficulty improving symptoms. Among them, the most recently introduced JAK inhibitors show significant results in clinical remission, pain, and improvement of body function. Although these drugs differ slightly, they show significant improvements compared to anti-TNF drugs in the rate of reaching various criteria. "With the recent introduction of accurate diagnostic standards and new drugs, the treatment environment for rheumatoid arthritis has been dramatically improved. As it is possible to achieve and improve pain through the introduction of continuous treatments such as JAK inhibitors, if you have symptoms of rheumatoid arthritis, please visit the rheumatoid internal medicine immediately for an accurate examination.
- Company
- “Will become a CRO specializing in cell·gene therapy”
- by Lee, Tak-Sun May 09, 2022 06:04am
- Director Eun-Kyung Sohn, HCO at Seoul CRO “I believe the cell·gene therapy market will expand the greatest among biopharmaceuticals. The number of new clinical trials entering the field increased over threefold from 2016, and the role of CROs that have strengths in conducting clinical trials for cell· gene-based therapies will further increase in the coming future.” Director Sohn explained her vision of growing the company into a cell·gene therapy specialized CRO in line with the industry trend. Director Eun-Kyung Sohn, HCO (Head of Clinical Operation·46) at Seoul CRO, joined the company in December last year. Sohn aims to find a breakthrough in the midst of the intensifying competition in the CRO market by developing Seoul CRO’s own area of expertise. In an interview held at Seoul CRO’s Gangnam office, Sohn relayed the company’s vision for growth into a cell·gene therapy specialized CRO. Director Sohn is a seasoned veteran that has over 20 years of experience accumulated in various prominent CROs in Korea, including Dream CIS and C&R Research. During her previous work at QVIS, Sohn was in charge of general project management for bioventure companies. Sohn said, “Bioventure companies are highly dependent on CRO companies due to their weak clinical infrastructure, and I was in charge of providing consulting, management, and training for our clients that contracted their research to the company.” Sohn’s career in the field fits will with Seoul CRO’s direction in attracting more cell·gene therapy venture companies for research. After joining Seoul CRO, Director Sohn has been in charge of the overall management of CRO-related clinical tasks that were by the pharmaceutical and bio company clients. Seoul CRO’s plan to become a cell·gene therapy specialized CRO reflects the company’s strategy to embrace the market situation while incorporating the company’s strengths. Sohn said, “With the number of CROs increasing recently, I believe each CRO should have a specialized area of expertise rather than cover all services. Seoul CRO aims to attract bioventures, especially those that develop cell·gene-based therapies.” Seoul CRO is part of the CHA Medical & Bio Group. The group has companies that specialize in the development of cell therapy products, including CHA Biotech. It also has hospitals that can actually conduct clinical trials for contracted cell therapy products. Seoul CRO plans to fully utilize its internal infrastructure and actively conduct clinical trials related to cell therapies. "The CHA Bundang Medical Center of the CHA Medical & Bio Group has a Global Stem Cell Clinical Trials Center that offers a one-stop service from incubation to administration for more effective cell therapy trials. We plan to utilize such strengths to attract and conduct more clinical trials.” The company is also preparing to establish a logistics system for cell·gene therapies. Sohn said, “Unlike general chemical drugs that can be transported at room temperature, logistics is a sensitive issue for cell therapies as these drugs are sensitive to temperature and have time constraints, requiring rapid transport before entering clinical trials." "This is why logistics is a sensitive and important issue from the client’s perspective, and why we are planning to set a separate department dedicated to cell and gene therapies with logistics companies." The company will also strengthen training in related areas. Seoul CRO will provide training to its employees for accurate understanding and application of relevant clinical laws and guidelines, and hold seminars in cooperation with affiliate hospitals for its external clients. Seoul CRO has accumulated a broad range of clinical experience in biopharmaceuticals, managing over 40 clinical cases including those for antibody treatments, protein drugs, vaccines, and cell therapies. The company has the most clinical experience in cell therapies, with experience accumulated from 16 cases. The company plans to further strengthen its existing strengths while specializing in cell and gene therapies. Seoul CRO also has strengths in medical devices and post-marketing clinical trials. “We plan to expand our scope to the global market in the mid-to-long term in the growing field of post-marketing clinical trials. Seoul CRO focuses on providing customer-oriented communication and service, and owns specialized vendors and the internal infrastructure to provide consulting and clinical trial-based services for the whole cycle from early stages of development to post-approval marketing strategies.” “It is important to have the expert personnel and infrastructure to conduct clinical research for cell and gene therapies. Bioventures will look for CROs that own such infrastructure and networks, which makes it ever more important for local CROs to be equipped with such competitivity." “After serving over 20 years in this field, I believe I acquired a good understanding of what is desired and needed by the clients. In essence, the mindset of taking responsibility into my own hands until the end is important. I plan to incorporate this into my work at Seoul CRO.”
- Company
- Companies reattempt to avoid Dukarb's patent in 2nd trial
- by Kim, Jin-Gu May 09, 2022 06:03am
- Companies that have failed to challenge the patent of Boryung’s antihypertensive combo drug ‘Dukarb (fimasartan+amlodipine)’ are continuing on their challenge with a second trial. As the companies are also working to invalidate the patent apart from the trial being conducted to avoid the patent, this two-track challenge on a single patent is expected to continue on for a while. According to industry sources on the 6th, Arlico Pharm, Hutex Korea Pharmaceutical, Shinpoong Pharm, and Hana Pharm filed an appeal against a ruling to the Patent Court of Korea. In other words, the four companies are taking the matter to the next trial, dissatisfied with the ruling of defeat given to them in the first trial. Around 40 companies are currently challenging Dukarb’s patent and can be divided into 4 groups: One group centered around Arlico Pharm; the DongKoo Bio&Pharma group; the Navipharm group; and the Genuone Sciences group. Since March. the four groups had filed a passive trial to confirm the scope of patent on Dukarb’s combination composition patent, one after another. Only Arlico Pharm’s group received a ruling in the first trial. The Intellectual Property Trial and Appeal Board ruled in favor of the original company, Boryung Pharmaceutical. Although the ruling hasn’t been made yet for the other generic companies, as the IPTAB conventionally makes similar rulings on the same cases, the industry forecasts defeat for the other groups as well. In this situation, the Arlico Pharm and others group has decided to continue its challenge with a second trial, forewarning a prolonged dispute. The other groups that lose their first trial in the future are now also highly likely to continue on their challenge in the second trial, just like Arlico Pharm. Apart from the trial being conducted to avoid Dukarb’s patent, the Arlico Pharm and others group is also attempting to invalidate Dukarb’s patent. In other words, the group is targeting the same patent in two ways (avoidance·invalidation). Other generic companies are also considering filing invalidation trials on Dukarb’s patent. Currently, 27 companies have filed invalidation trials against Dukarb’s patent besides Arlico Pharm. Dukarb’s patent is set to expire in August 2031. If the companies succeed in evading or invalidating the drug’s patent, generic versions of Dukarb can be released early on, as soon as Dukarb’s single-agent ingredient Kanarb’s substance patent expires in February next year. Dukarb is an antihypertensive combination drug that contains the antihypertensive ingredient fimasartan (Kanarb) which was developed by Boryung Pharmaceutical, and amlodipine. According to the market research institution UBIST, Dukarb’s prescriptions recorded ₩41.1 billion last year, a 14% increase YoY compared to the ₩36.1 billion in 2020.
- Company
- GLP-1 diabetes drugs are being released one after another
- by May 09, 2022 06:03am
- Novonodisc is expected to change the market for type 2 diabetes treatment as GLP-1 similarity products are released one after another. Novonodisc received domestic approval for Rybelsus (Semaglutide) on the 2nd following Ozempic on the 28th of last month. Ozempic is a long-lasting injection administered once a week, and Rybelsus is a drug that has changed it to an oral drug. Ozempic is expected to emerge as a strong competitive drug for Eli Lilly Trulicity, which currently dominates the GLP-1 analog market. Trulicity is a injection once a week that monopolizes the GLP-1 similarity market worth 50 billion won in Korea. According to IQVIA, a pharmaceutical market research firm, Trulicity posted 49.9 billion won in sales out of 50 billion won in the total GLP-1 similarity market. Trulicity replaced all GLP-1 analogs that had to be administered daily. Sanofi Lyxumia and AstraZeneca Byetta have been withdrawn from the market. Novonodisc's Viktoza only sold 200 million won. Unlike Trulicity, Ozempic has indications for reducing the risk of cardiovascular events. This indication is based on the SUSTAIN 6 study among Ozempic's eight SUSTAIN clinical studies. As a result of conducting clinical trials on 3,297 type 2 diabetes patients with cardiovascular disease or cardiovascular risk factors, the Ozempic group reduced the risk of major cardiovascular events (MACE) compared to the placebo group by 26%. Not only the United States but also domestic academic societies recommend GLP-1 analogs or SGLT-2 inhibitors that have confirmed cardiovascular benefits when choosing type 2 diabetes drugs, so the Ozempic's sa;es is expected to rise further. The world's first oral GLP-1 analog Rybelsus will then join, and changes are expected in the market for oral diabetes treatments such as DPP-4 inhibitors. Rybelsus can be used as a dietary and exercise supplement to improve blood sugar control in adults with insufficient control of type 2 diabetes. It is taken once a day, and there is no need to control the dosage of drugs in patients with renal or hepatic dysfunction or in the elderly. Oral drugs such as DPP-4 inhibitors and SGLT-2 inhibitors are commonly used as many patients are reluctant to inject injections such as insulin and GLP-1 analogs when treating type 2 diabetes. Based on the drug market research agency UBIST, the amount of DPP-4 inhibitor prescriptions reached 151.2 billion won last year. The prescription amount for SGLT-2 inhibitors is around 40.2 billion won. Rybelsus demonstrated superior glycemic effectiveness over SGLT-2 inhibitors and DPP-4 inhibitors through global clinical study PIONEER. In PIONEER 2, 822 patients with type 2 diabetes whose blood sugar is not controlled by metformin were compared with the SGLT-2 inhibitor Empagliflozin group. At 26 weeks, the Empagliflozin group had a 0.9% decrease in glycated hemoglobin levels, while the Rybelsus group had a 1.3% decrease. Subsequently, in a PIONEER 3 study comparing Rybelsus and DPP-4 inhibitor Sitagliptin in patients whose blood sugar is not controlled by combination administration of Metformin and Sulfonylurea, the glycated hemoglobin level in the control group decreased by only 0.8% at 26 weeks. In the Empagliflozin group, glycated hemoglobin levels decreased by 0.9% compared to the baseline, while in the Rybelsus group, they decreased by 1.3%. Subsequently, in a PIONEER 3 study comparing Rybelsus and DPP-4 inhibitor Sitagliptin in patients whose blood sugar is not controlled by combination administration of Metformin and Sulfonylurea, the glycated hemoglobin level in the control group decreased by only 0.8% at 26 weeks. Even globally, Rybelsus is emerging as an emerging competitive drug. Rybelsus, which was released in more than 20 countries starting with the U.S. in September 2019, posted sales of 867.2 billion won last year. Immediately after its launch, it slowed down due to the COVID-19 pandemic, but it quickly increased sales by aggressive marketing last year. Rybelsus is expected to change depending on the price of Rybelsus and the results of CVOT confirming the ongoing cardiovascular benefits.
- Company
- Sales of Losartan are plummeting due to the impurity crisis
- by Chon, Seung-Hyun May 09, 2022 06:03am
- The prescription market for the hypertension drug "Losartan" has shrunk significantly. It is analyzed that a large number of prescription gaps occurred due to detection of excess impurities at the end of last year. According to UBIST, a pharmaceutical research agency, on the 2nd, the outpatient prescription amount of Losartan-containing drugs in the first quarter was 60 billion won, down 24.4% from the same period last year-on- The prescription market for Losartan drugs rose 20.7% in four years from 65.8 billion won in the first quarter of 2017 to 79.5 billion won in the first quarter of last year, showing a stable upward trend every year. In the third quarter of last year, it formed a market size of 81.2 billion won. However, it fell to 75.7 billion won in the fourth quarter of last year and fell for the second consecutive quarter. The recent sluggish prescription market for Losartan drugs is directly attributed to the impurity wave that erupted last year. The manufacturing numbers of 183 items of 73 items of Irbesartan 3 ingredients were recovered due to the detection of excess impurities. At the end of last year, impurity problems were exposed throughout Losartan products. In December last year, 295 items made by Losartan were voluntarily recovered from 98 companies that were detected in excess of the standard or feared to be detected in excess. As many as 96.4% of 306 items from 99 companies on the market were included in the recall list. At that time, 94 items from a total of 34 companies out of 295 Losartan products were virtually avoided by having available products. Since then, many Losartan drugs have solved the problem of impurities and returned to the market. It is observed that many of the impurities excess detection Losartan formulations have been changed to the same formulation without problems. However, there is a possibility that the prescription may have been changed to other drugs of the same angiotensin II receptor blocker (ARB) as the impurity problem was exposed throughout the Losartan formulation. In the first quarter of last year, the prescription performance of Losartan was 17.4 billion won, down 35.2% from the same period last year. The single Losartan showed a total of 26 billion won in prescriptions from the first quarter to the third quarter of last year. Following a drop of 24 billion won in the fourth quarter of last year, the decline has widened this year. Combination drugs including Losartan had a prescription amount of 42.7 billion won in the first quarter, down 18.9% from the previous year. The Losartan complex has been around 50 billion won since the second quarter of 2019, but it has fallen to 40 billion won in three years. Combination of Losartan+Amlodipine and Combination of Losartan+HCTZ were significantly sluggish. The combination, which combines Losartan and calcium channel blocker (CCB)-based hypertension drug Amlodipine, was 22.2 billion won in the first quarter, down 14.6% from the previous year. The compound of Losartan and diuretic HCTZ shrank 43.8% from 17 billion won in the first quarter of last year to 9.5 billion won in a year.
- Company
- Breast cancer supplement Nerlynx is available in hospitals
- by Eo, Yun-Ho May 06, 2022 05:46am
- Breast cancer supplement Nerlynx has become available in hospitals. According to related industries, Tyrosine kinase inhibitor Nerlynx (Neratinib), which inhibits Bixink's HER2 protein, passed the Drug Committee (DC) of medical institutions such as Seoul National University Hospital. However, as it is still non-reimubrsement, it is expected to take time until Rx is activated. It was submitted to the HIRA's Cancer Disease Review Committee in February, but the standard was not set. Bixink plans to submit an application again in the second half of this year. HER2-positive early breast cancer has a 1.89 times higher risk of epilepsy than HER2-negative breast cancer. The high incidence of brain metastasis is interpreted as having a direct effect on the survival rate. Comparing the 5-year survival rate of metastatic breast cancer in Korea, the 5-year survival rate of patients with epilepsy is only 10.7%, which is a clear difference compared to the 34% 5-year survival rate of patients who have metastasized to other areas. Compared to the past, a number of HER2-positive early breast cancer target treatments have been developed, diversifying treatment options for patients and gradually improving survival rates. However, in the case of current standard therapy treatments, drugs that prevent epilepsy or prove therapeutic effects are still insufficient. In a five-year long-term follow-up study, Nerlynx reduced the risk of recurrence or death in women with HER2-positive early breast cancer by 42% and reduced the risk of developing or death of epilepsy by more than 59%. Nerlynx was originally a drug developed by Puma Biotechnology in the U.S., and was first approved by the U.S. FDA in July 2017 as an extension aid for early HER2 positive breast cancer patients. In February 2020,it was expanded to treat metastatic HER2 positive breast cancer. Bixink introduced Nerlynx in Korea in October last year, and the current indication is "extension therapy for patients with early breast cancer who are positive for HER2 and hormone receptor within one year of completion of Herceptin-based treatment after surgery."
- Company
- Hospitals Busy Introducing Kymriah
- by Moon, sung-ho May 06, 2022 05:45am
- The full-fledged administration of Kymriah, a Korean Novartis CAR-T treatment called an "ultra-high-priced anticancer drug," has begun. Hospitals have also become busy as the administration of treatments at four large hospitals in Korea has begun in earnest. At the beginning of last year's domestic approval, it was a wait-and-see attitude, but as the number of inquiries from patients increased at the same time as the benefit increased, it is eager to complete the facility. According to the medical community, starting with Asan Medical Center in Seoul, Kyungpook National University Hospital, Chonnam National University Hospital, and Pusan National University Hospital are currently undergoing preliminary work for Kymriah administration, focusing on the metropolitan area and national and public university hospitals. At the same time as health insurance was applied in April, there are currently four hospitals that have completed the certification process conducted by the MFDS and Novartis on their own. Specifically, they include Seoul St. Mary's Hospital, SMC, Seoul National University Hospital, and Severance Hospital. Some professors from local university hospitals raised complaints about Novartis' first certification work at only four places, but the controversy subsided as public opinion prevailed that the introduction should not be delayed anymore. The situation has changed since April when Kymriah's benefit was applied. "After Kymriah's domestic approval last year, Novartis first certified four large hospitals, raising equity issues at local university hospitals," said a professor of blood medicine at Seoul National University Hospital, who asked not to be identified. He supported public opinion, saying, "Some professors publicly raised problems by saying that they would introduce CAR-T treatments for other global pharmaceutical companies to be introduced after Kymriah." According to the MOHW, the number of non-Hodgkin lymphoma patients, including DLBCL, in 2017, is counted as 1904 per year. "Last year, the process of collecting patient cells and sending them to Novartis in the United States was not established," said a professor of blood medicine at another local university hospital. It is true that there were complaints as pharmaceutical companies pushed for it from Seoul's mega hospital. We are currently pushing for the introduction of Kymriah, and the full-scale discussion began last November. While full-scale discussions have been underway since this year, we have been in a hurry as we have been reimbursed," he explained. A professor at a local national university hospital, who is promoting the introduction, said, "Since we have certified Kymriah from Seoul's super-large hospital, local hospitals are somewhat late. However, in the second half of the year, more than 13 university hospitals will be able to administer Kymriah, he said. "Novartis also has know-how while signing contracts with hospitals, so it will proceed quickly in the future." "What's worrisome is that CAR-T treatments are being developed in Korea in addition to Kymriah," he said. "The same facility standards should be applied to them, but the evaluation process for the GMP standards of the MFDS is needed." Novartis explained that the university hospital that first introduced Kymriah was comprehensively considered such as the GMP certification situation of the MFDS. An official from Novartis explained, "The hospital approved as a CAR-T center (Kymriah treatment available) is Samsung Medical Center, Seoul National University Hospital, Severance Hospital, and Seoul St. Mary's Hospital, and Asan Medical Center will soon open." He emphasized, "CAR-T treatment is a one-person customized treatment that requires completely new procedures, and various facilities, manpower, and technical aspects should be equipped for approval of the MFDS' management business, including human cells." He added, "The certification process of the four hospitals has been completed and opened as a Kymriah center first, and soon, the center certification will be completed at Asan Medical Center in Seoul with permission for management such as human cells."
- Company
- Risk of Impurities in Treatment of Schizophrenia
- by Chon, Seung-Hyun May 04, 2022 06:04am
- The health authorities have started to check for impurities on Quetiapine-based drugs used as schizophrenia treatments. It is a new type of nitrosamines impurity that has not appeared before. The number of drugs that have raised the risk of impurities in Korea has increased to 10. According to the industry on the 3rd, the MFDS recently ordered pharmaceutical companies to submit data for reviewing impurities N-Nitroso-Aryl Piperazine of Quetiapine-containing drugs. This is a proactive measure based on safety information that NNAP has been detected in Quetiapine recently. The MFDS ordered pharmaceutical companies to submit test results for representative manufacturing numbers among commercially available Quetiapine finished products by July 28. Representative lot numbers refer to more than three units of manufacture that are nearing their use date every year. If three lot numbers or less are produced each year, the test results of all lot numbers shall be submitted. Quetiapine is a drug used to treat schizophrenia, and the original product is Alvogen Korea's Seroquel. Currently, more than 30 domestic pharmaceutical companies are selling generic products. The size of the domestic prescription market is about 30 billion won per year. This is the first time that a risk of impurities has been raised in Quetiapine formulations. NNAP is a nitrosamines impurity that has not been exposed to risks in existing drugs. Since 2018, two types of Nitrosamines impurities, NDMA and NDEA, have been detected in Valsartan, Ranitidine, and Nizatidine. Recently, the MFDS launched an inspection according to safety information that another nitrosamines impurity NDPA was detected in Montelukast, a treatment for asthma and allergic rhinitis. In March, NMOR exceeded the daily intake allowance of drugs containing the vascular reinforcement Flavonoid Fraction ingredient, and voluntary recovery was carried out. Last year, two types of Azido-based impurities were found in Sartan products. As a result, drug impurities triggered by the first NDMA expanded to seven species in four years. Valsartan, Ranitidine, Losartan, Nizatidine, Metformin, following Varenicline, Irbesartan, Montelukast, and Flavonoid, the number of drugs exposed to the risk of impurities increased to nine. Among them, Valsartan, Losartan, Nizatidine, Metformin, Varenicline, and Irbesartan were suspended and recovered from sales of some products, and Ranitidine was expelled. Montelukast has not yet recovered any products due to the detection of excess impurities.
