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Company
No. of employees decline sharply due to restructuring/reorgs
by
Apr 12, 2022 06:04am
The number of employees at multinational pharmaceutical companies has declined sharply due to their active restructuring and reorganizations. Over 200 employees have been laid off in just 4 companies - Roche Korea, Lilly Korea, Sanofi-Aventis Korea, and Zuellig Pharma Korea. According to the Financial Supervisory Service, the number of employees at Roche Korea, Lilly Korea, Sanofi-Aventis Korea, and Zuellig Pharma Korea was 1,109, which was a 16% decrease from the 1,326 of the previous year. Approximately 80 employees left Sanofi-Aventis Korea last year. The number of employees in the company had been 492 at the end of 2020 but was reduced to 413. In the same period, the number of Zuellig Pharma Korea employees decreased by 58, from 293 to 235. Roche Korea’s employees decreased by 52 from 309 to 257. Lilly Korea’s employees decreased by 28 from 232 to 204. The companies above have all actively carried out restructuring and reorganizations last year, influenced by the business model reorganizations conducted to remove or reduce non-core departments by the companies’ global headquarters. Also, the sales department became the main target of restructuring due to the increasing preference for online-based, non-face-to-face sales activities due to COVID-19. The number of employees at Sanofi-Aventis Korea decreased greatly following the split-off and merger of its consumer healthcare business with Opella Healthcare Korea. Before the spilt-off, the company had also offered an early retirement program for its CHC and GenMed divisions. The GenMed division is in charge of non-core prescription drugs of the company other than vaccines (Pasteur), and specialty care (Genzyme). Zuellig Pharma Korea had reduced the number of employees while withdrawing its local pharmacy retail business. The company had notified employees of its plans to dissolve the pharmacy retail business and large-scale restructuring in March last year. The company had decided to undergo such measures due to continuous operating deficits brought on by the lower distribution fees and intensified market competition. The company aimed to lay off about 80 people by eliminating direct sales and leaving only a small number of personnel in online sales services, Lilly Korea had downsized its offline sales services while increasing its online sales. For this, the company had carried out a large-scale ERP since November 2020. At the time, the company explained that its purpose was “The purpose of the reorganization is to increase the productivity and efficiency of the sales division and reinforce various multi-channels including digital programs.” The company had expected 25% of the 100-something employees in its sales division to opt for the ERP, and it is analyzed that a corresponding number of employees have voluntarily retired. Roche Korea had also conducted two ERPs at the end of 2020 and in the previous year. The main subject of the ERP was the sales department. Although around 20% of the 60-70 workforce in sales were expected to opt for ERP, the number that left had exceeded expectations. The number of employees at Roche Korea, which had exceeded 300, was reduced to 250 after ERP.
Company
Lutathera’s partner ‘LysaKare’ may be prescribed at GHs
by
Eo, Yun-Ho
Apr 11, 2022 05:58am
‘LysaKare’, the drug concomitantly used with the neuroendocrine tumor treatment ‘Latathera’ may soon be prescribed at general hospitals. According to industry sources, Novartis Korea’s ‘LysaKare (L-arginine hcl/L-lysine hcl) has passed the drug committee (DC) reviews at 3 of the Big 5 general hospitals – Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center - in Korea. LysaKare was approved as a drug to be used concomitantly with Novartis’s orphan drug Lutathera (lutetium), a neuroendocrine tumor treatment that was approved in July 2020. Lutathera is a radioactive targeted therapy that increases the dose of radiation in the tumor areas. It is an ultra-high-priced but highly effective drug used to treat a very small number of patients. The drug was listed for insurance benefit in March last year and cost ₩104 million for 4 injections before then. LysaKare is used to reduce damage caused by renal radiation exposure during the use of Lutathera. The Ministry of Food and Drug Safety had also designated LysaKare as an orphan drug recently. Specifically, LysaKare is indicated for ‘reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.’ Meanwhile, Lutathera’s efficacy had been demonstrated through the Phase III NETTER-1 trial and Phase I/II ERASMUS studies. The primary efficacy endpoint of the NETTER-1 study was progression-free survival (PFS). At the time of primary analysis, the median PFS was not reached for Lutathera and was 8.4 months for the control group, showing that Lutathera reduced disease progression and death by 82% compared to the control group. In particular, the drug had significantly prolonged PFS in patients regardless of tumor size, including those with liver tumors, and demonstrated the possibility of effectively treating various types of patients.
Policy
The adverse drug reaction rate of Trulicity is 19%
by
Lee, Hye-Kyung
Apr 11, 2022 05:58am
As a result of a six-year post-marketing survey of Type 2 diabetes treatment Trulicity in Lilly Korea, 15 cases of serious adverse drug reactions that cannot be excluded from causal relationships were reported. The permit will be changed as 62 unexpected adverse drug reactions, which cannot exclude causal relationships, also occurred. The MFDS recently announced that it will pre-announce and reflect the order to change the permission according to the results of the re-examination of Trulicity 1.5 mg/0.5ml and Trulicity 0.75 mg/0.5ml disposable pens from July 6. Trulicity was developed as a disposable syringe formulation as a long-acting GLP-1 analog and obtained domestic permission in 2015. As a result of a post-marketing survey of 3,022 people for 6 years for re-examination in Korea, the incidence of abnormal cases was reported to be 19.49% (589/3,022 people, total 819 cases), regardless of causality. Significant adverse drug reactions were found to be 0.46% (14/3022 patients, 15 cases), with occasional blood sugar increases and rare dizziness, poorly controlled diabetes, diabetic gastritis, gastroesophageal reflux disease, acute kidney damage, and diabetic kidney disease. In the case of unexpected adverse drug reactions such as weight loss, weight gain, sensory degradation, and gastroenteritis, 1.99% (60/3,022 cases, 62 cases) occurred. Trulicity is administered as an adjuvant to dietary and exercise therapy to improve blood sugar control in adult type 2 diabetes patients. Among patients who have difficulty controlling sufficient blood sugar with Metformin and Sulfonylurea combination therapy, insurance benefit is being applied to the combination therapy of patients who cannot perform body mass index ≥25kg/㎡ or insulin therapy. Last year, it recorded 47 billion won in outpatient prescriptions based on UBIST, up 23% from 38.2 billion won in the previous year.
Policy
NHIS to study measures on improving the PVA system
by
Lee, Tak-Sun
Apr 11, 2022 05:58am
With a study on improving the price-volume agreement (PVA) system in plan, the possibility that the improvement may increase drugs subject to PVA is being raised. According to industry sources on the 8th, the National Health Insurance Service is preparing to conduct a research to ‘evaluate the performance of and improve the Price-Volume Agreement system’ and will post a bid for its research services soon. Its plan, as disclosed by the NHIS, indicates that the study will be conducted for 6 months from the period of its initiation and be completed at the end of the month. Through the study, the authorities plan to establish a mid-to-long-term roadmap for the PVA system and ensure the appropriateness of the drug expenditures to save excess resources and strengthen Korea’s NHI coverage. Feasibility reviews on alternatives that go beyond the existing agreement system and reference formulas will also be developed in the study. For example, the current system applies the rate of increased claims in the formula, but the study will review the application of a reference formula that considers the absolute claims amount and the amount of increase. In addition, the study will be used to prepare a reasonable plan that considers the fiscal impact of the selection/exclusion criteria that were already revised this month, and review diversifying the method used to make PVA. Based on the research results, NHIS also plans to hold public hearings with relevant institutions to improve the PVA system to prepare a system improvement plan that can enhance both acceptability and negotiation power, and propose a mid-to-long-term development direction for the PVA system based on legal and institutional review. NHIS announced its plan to research measures to improve the PVA system earlier this year. At a policy roundtable meeting on the ‘Rational improvement of the PVA system’ that was held by the National Assembly in January, Hyun-Deok Kim, Director-General of the Pharmaceutical Management Department, said, “We are aware of the issue caused by reviewing only the rate of increase without consideration of the absolute increase in claims amount. We agree that there is a need to conduct a comprehensive review on the PVA system and prepare improvements, and will be posting a bid for research services within the year.” As the main purpose of the study is to save NHI pharmaceutical expenses, friction with pharmaceutical companies seems inevitable in the process of its implementation. An industry official expressed regrets, "Contrary to the pharmaceutical industry’s opinion of reducing or deferring the PVA system, the government’s only plan seems to be to reduce its expenses. By the contents of the study alone, it seems that subject drugs and discount rate would only increase further."
Policy
National Responsibility for the Side Effects of Vaccines
by
Lee, Jeong-Hwan
Apr 11, 2022 05:58am
Ahn Cheol Soo, the chairman of the presidential transition committee/the special chairman of the COVID-19 emergency response committee said they would provide wide support for adverse reactions to the COVID-19 vaccine while significantly easing the burden of public proof. On the 7th, Chairman Ahn held the 6th meeting of the COVID-19 Special Committee at the Transition Committee in Samcheong-dong, Jongno-gu, Seoul, and discussed ways to realize a national responsibility system for adverse vaccine reactions and secure treatments. Chairman Ahn said, "We have emphasized the importance of scientific quarantine and focused on policy implementation measures based on objective data such as the national antibody positive rate and vaccine abnormalities." "From next week, we plan to release related data one by one with the KDCA and the NHIS," he said. The COVID-19 Emergency Response Special Committee asked the government to come up with measures to compensate for damage from adverse reactions to vaccines, expand diseases subject to support, and ease the burden of public proof to provide quick and fair damage compensation. The KDCA promised to strengthen support by reflecting this request. Specifically, abnormal reactions registered by pharmaceutical departments in major overseas countries will be recognized as related diseases first, and the scope of causal recognition will be expanded if the COVID-19 Vaccine Safety Committee comprehensively analyzes the causalities of related diseases. A project to be supported will also be established, and if the disease is suspected after vaccination and is treated or tested, actual expenses will be provided for the cost. In order to ease the public's burden of submitting evidentiary documents, rapid compensation procedures will also be implemented, such as simplifying submission centered on necessary evidentiary documents in the case of related diseases. The number of objections will also be expanded from one to two. The transition committee said, "We decided to provide consolation money for sudden deaths within 30 days of vaccination, where the cause of death is unknown even as a result of the autopsy." In addition, he said, "There was no support if not diagnosed as a disease subject to vaccine abnormal response compensation and support, but in the future, if the disease is suspected and treated or tested, we plan to provide actual support for the cost."
Company
HK inno.N's K-CAB has ended Phase 1 in US
by
Kim, Jin-Gu
Apr 11, 2022 05:58am
HK inno.N announced on the 7th that its flagship drug, "K-CAB (Tegoprazan), has successfully ended phase 1 clinical trials in the U.S., a treatment for gastroesophageal reflux disease. The clinical trial was conducted on 30 healthy adults with random assignment, double blinding, placebo control, and repeated administration. K-CAB 25 mg, 50 mg, and 100 mg were administered to clinical participants orally for 7 days, respectively, and pharmacokinetic characteristics and safety were evaluated. As a result of pharmacokinetic evaluation, the blood concentration of K-CAB was proportional according to the content, and similar profiles were maintained on both the 1st and 7th days of administration. In the pharmacological evaluation to measure the acidity (pH) in the stomach, both the 1st and 7th days of administration showed higher acidity than the placebo for 24 hours. In particular, it showed rapid medicinal effects regardless of the dose on the first day of administration. In terms of safety, all doses of K-CAB did not differ from placebo. HK inno.N has been conducting a phase 1 clinical trial of K-CAB with the aim of entering the U.S., the world's largest pharmaceutical market. HK inno.N signed a technology export contract worth about 640 billion won to Braintree Laboratories, a subsidiary of Sebela, a U.S. digestive medicine company, last year when it was undergoing local clinical trials. HK inno.N explained that Braintree Laboratories will be in charge of follow-up clinical trials in the United States and Canada. Braintree Laboratories plans to carry out follow-up clinical trials in the U.S. and Canadian markets as soon as possible. Starting with the smooth completion of the phase 1 clinical trial in the U.S., It will work closely with our local partners to ensure that the Korean new drug K-CAB can be successfully launched in the U.S. market, said Kwak Dal-won, CEO of HK inno.N. K-CAB recorded 109.6 billion won in outpatient prescriptions in Korea last year. Cumulative prescriptions amount to 236.4 billion won over the three years after release. Based on its domestic success, HK inno.N is actively seeking overseas expansion. It has made inroads into 27 countries around the world, including the U.S. In the Chinese market, Luoxin, a local partner, is planning to license and release items in the first half of this year.
Policy
CAR T-cell therapy has shown the disappearance of leukemia
by
Kim, Jung-Ju
Apr 11, 2022 05:57am
A research team of domestic CAR-T (Chimeric Antigen Receiver-T Cell) treatment confirmed the disappearance of leukemia cells in clinical trials of pediatric and adolescent leukemia patients. The government plans to positively evaluate the treatment of children and adolescents with leukemia through advanced regenerative medical clinical research and continue to provide related policy support. The MOHW (Minister Kwon Deok-cheol) announced on the 7th that the results of the disappearance of leukemia cells in children and adolescents through advanced regenerative medical clinical research research at Seoul National University Hospital (Director Kang Hyung-jin). CAR-T introduces a gene that combines the receptor site of an immune cell (T cell) and the characteristic antigen recognition site on the surface of a cancer cell into a patient's T cell and is a cell with a function of specifically recognizing and attacking the surface antigen of a cancer cell. This study is a high-risk clinical study, which was approved and approved as the first high-risk clinical study by the Advanced Regenerative Medical and Advanced Biopharmaceutical Review Committee and the MFDS in December. Seoul National University Hospital said it administered its own CAR-T treatment to an 18-year-old leukemia patient on February 28, and that a bone marrow test conducted on March 28 confirmed that leukemia cells completely disappeared. This project is to support research funds for clinical studies approved or approved by the Council and the MFDS. In addition to this clinical study at Seoul National University Hospital, it is also supporting clinical research conducted by Samsung Medical Center and Catholic University Industry-Academic Cooperation. Seoul National University Hospital receives 1.25 billion won in research funds from 2022 to 2023, Samsung Medical Center 1.83 billion won from March 2022 to December 2023, and Catholic University Industry-Academic Cooperation Group 1 billion won from 2022 to 2023. As of the end of March, a total of five clinical studies were finalized and approved by the Deliberation Committee and the MFDS, and one high-risk clinical study and one medium-risk clinical study will also apply for research funding to the Advanced Regenerative Clinical Research Support Group. The MOHW explained that the number of applications and applications for advanced regenerative medical clinical research has been on the rise since the Advanced Regenerative Bio Act took effect in August 2020 and the deliberation committee began to form and operate in January 2021. The deliberation committee is determining whether or not to make a decision on the suitability of clinical research in consideration of the validity and safety of the research plan, and the proportion of clinical research that has recently been approved is increasing. Among them, the number of suitable resolutions through the deliberation committee so far has been 10. Recently, the advanced regenerative medical field is attracting attention as a future food in the biohealth field, and as the number of advanced regenerative medical institutions capable of conducting clinical research continues to increase, advanced regenerative medical research is expected to be further activated. Accordingly, the government will strengthen legal essential education for clinical research personnel, R&D for virus production and human transplantation, and GMP support to promote joint research between hospitals and startups. "It is encouraging to provide treatment opportunities for pediatric leukemia patients through the first high-risk clinical study," said Kim Young-hak, head of the MOHW. "We will do our best to provide treatment opportunities to more patients through pan-ministerial regenerative medical technology development projects."
Policy
Chinese companies are set to debut in the domestic market
by
Lee, Tak-Sun
Apr 11, 2022 05:57am
Chinese pharmaceutical companies' new anti-cancer drugs, which were approved in Korea last year, are more likely to be listed on the Korean health insurance. Expectations for benefits are growing as BeiGene's Bruxinsa passed the HIRA's Cancer Disease Review Committee as a sole treatment for WM adult patients the previous day. Another Chinese pharmaceutical company, Antengene's Xpovio, will also continue to challenge the domestic market. On the 6th, the deliberation committee set a benefit standard for BeiGene's Brukinsa, which applied for a new benefit, for VM that have received more than one treatment before. If the HIRA's Drug Benefit Evaluation Committee recognizes the appropriateness of the benefit and if the drug price negotiation is concluded with the NHIS, it will be on the domestic health insurance benefit list so that patients can easily receive medication. This is expected to be the first case in which a new anti-cancer drug developed by a Chinese pharmaceutical company enters the domestic benefit market. Brukinsa is a target anticancer drug that inhibits the survival and spread of malignant B cells by blocking Bruton kinase protein, a signaling molecule that affects the survival and development of B cells as a Brutons Tyrosine kinase inhibitor. It was first approved as an MCL treatment by the U.S. FDA in November 2019, and was also approved as a WM treatment in September last year. To be approved as a WM treatment, Bruxinsa conducted a comparative clinical trial with Janssen's Imbruvica, the same BTK inhibitor. American businessman John V. Oyler and biochemist Xiaodong Wang, Ph.D co-founded BeiGene in 2010. As the name of BeiGene suggests, it is headquartered in Beijing, China. Brukinsa is currently in 23 countries with approval from around the world. It has established a branch office early in October 2019 and has been preparing to enter the market. Brukinsa, which was approved by the MFDS on February 25, passed the WM indication committee in less than two months, raising expectations for a high-speed listing. The Chinese pharmaceutical company's new anti-cancer drug approved prior to Brukinsa is Antengene's Xpovio. Xpovio received approval from the MFDS in July last year. This drug is a new mechanism that selectively inhibits XPO1, a nuclear export protein. In January, it was submitted to the cancer screening and discussed setting benefit standards, but failed. In recurrent or refractory polymyeloma, it applied for benefits as a combination therapy with Dexamethasone, and treatment for recurrent or refractory diffuse B-cell lymphoma, but failed to pass. Antengene is expected to continue to challenge the domestic benefit market while watching the situation of overseas registration. Xpovio has already passed the so-called Big 5 DCs such as Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, and Seoul Asan Hospital and is being used as non-reimbursement. Founded in 2017, Antengene is a major developer of anticancer drugs invested by global pharmaceutical company BMS and is headquartered in Shanghai, China. In March last year, a local corporation was established.
Company
Rising COVID-19 cases impede progress of bioequivalence test
by
Chon, Seung-Hyun
Apr 08, 2022 06:08am
Pharmaceutical companies are having trouble conducting bioequivalence tests for the development of generics due to COVID-19. The spread of COVID-19 has made it difficult for companies to recruit subjects, and even those recruited are dropping out after being confirmed with COVID-19, causing disruptions in the companies’ schedules. With delays inevitable due to the unexpected pandemic, pharmaceutical companies have been asking authorities to extend the drug pricing reevaluation deadlines that were set for February next year. According to industry sources on the 8th, several pharmaceutical companies have expressed their difficulties in progressing their ongoing bioequivalence tests due to the surge of COVID-19 cases. With hundreds of thousands of people being confirmed with COVID-19 every day, recruiting patients for the bioequivalence test itself is difficult. According to KDCA, 1,683,111 people were confirmed with COVID-19 over the past 1 week since the 6th. With over a million people in self-isolation due to COVID-19, the companies are complaining of difficulties in recruiting necessary subjects. With subject requirements are already stricter than before, difficulties in recruiting subjects for bioequivalent tests have been ongoing for some time. In accordance with the revised Pharmaceutical Affairs Act passed by the National Assembly in November 2018, people who have no experience participating in a clinical trial within 6 months prior to the trial date should be selected as subjects for clinical trials. With the restriction period extended from 3 months to 6 months. the number of participants viable for the tests has also decreased significantly. Also, even the registered subjects are frequently leaving trials to COVID-19. This renders it difficult to conduct a normal bioequivalence test due to the lack of subjects. The drug equivalence standards require 12 or more people in each group -the test group and control group for bioequivalence tests. This means the bioequivalence tests cannot be conducted unless over 24 people register for the tests. If subjects in the test group or control group are reduced to less than 12 due to COVID-19, the bioequivalence test itself may turn to waste. The companies can increase the test group or control group can by recruiting additional subjects, but this would inevitably push back the schedule. An official from a pharmaceutical company said, “We are planning to recruit more subjects than originally planned due to the rapid increase in the number of confirmed COVID-19 cases, but it isn’t easy. Even those who already registered are leaving trials after being confirmed with COVID-19, so we’re having much difficulty conducting the required bioequivalence test” Also, if the fallouts are concentrated in a specific group, such as the control or test group, the test itself may not derive significant results. For example, if 30 people were recruited for each group but 15 people from the test group leave due to COVID-19, the reliability of the test statistics may be undermined. Pharmaceutical companies have also had difficulty conducting bioequivalence tests in the early stages of the COVID-19 pandemic. In the early stages of the outbreak in 2020, the tests had been delayed with medical institutions discontinuing face-to-face work related to bioequivalence tests such as administration, screening, and monitoring. The main reason why pharmaceutical companies are expressing concern over their difficulties is because of the pressing deadline of the drug pricing re-evaluations for generic drugs. The Ministry of Health and Welfare announced a plan to re-evaluate the price ceiling of drugs, under which generics that do not meet the highest-price requirements in June 2020 are required to submit data on their ‘performance of bioequivalence tests’ and ‘use of registered APIs’ by February 28th, 2023 to maintain their previous drug price. This is a follow-up measure to apply the new drug pricing system which took effect in July 2020 to registered generic products. Under the revised drug pricing system, generic products can only be priced at the maximum price, which is 53.55% of the original drug’s price before patent expiry only when it satisfies both the requirements – directly-conducted bioequivalence tests and the use of registered raw materials. If either of the requirements is not met, the price cap is lowered by 15%. This means that a generic, which is approved by consigning the entire process to other companies without developing or producing it, will receive a drug price discount and be set at 72.25% of the previous price cap. The requirement of using a registered raw material can be met by switching the API. Due to the revised law, companies were left to decide between accepting the drug pricing discounts or maintaining the previous price by conducting bioequivalence tests. This is why companies have been actively conducting bioequivalence tests on their registered generics. According to the Ministry of Food and Drug Safety, a total of 768 plans for bioequivalence tests were approved in 1.8 years from July 2020 to February this year, which averages at 38 plans per month. Compared to 445 (22 per month on average) that were approved during the 1.8 years prior to July 2020 (November 2018 to June 2020), this is a 72.6% increase. Over half of the bioequivalence test plans approved recently are for registered generics. Of the 51 bioequivalence test plans approved in February, 39 were already on sale as registered generic products. Most of the bioequivalence tests are being conducted for ‘'in-house conversion' of the generics to manufacture in their own companies. If the companies make generics through formulation research and conduct bioequivalence tests that demonstrate bioequivalence, the companies can avoid the price cuts by obtaining change approvals. If companies convert consigned manufacturing to in-house manufacturing while applying for license changes, the companies can satisfy the ‘conducting bioequivalence test’ condition. Whichever way, it is said that it takes up to six months or more for bioequivalence tests to be imitated and render results. However, if the bioequivalence test data cannot be submitted by February next year due to a delay in the test schedules caused by the surge in confirmed COVID-19 cases, generic drugs will have no choice but to bear the drug price cuts. This means that the price of generic drugs may be reduced by 15%, even after the companies spent a lot of money and effort to avoid such discounts.
Policy
The benefit adequacy of Lorviqua was recognized
by
Lee, Tak-Sun
Apr 08, 2022 06:08am
Pfizer Pharmaceutical's Lorviqua has taken a step closer to insurance benefits in recognition of benefit adequacy as a treatment for non-small cell lung cancer. If negotiations with the NHIS are smoothly concluded in the future, the final benefit will be successful. The HIRA announced on the 7th that it held the 4th Drug Reimbursement Evaluation Committee in 2022 and recognized the benefit adequacy of Pfizer Pharmaceutical. The target products were Lorviqua 25 mg and Lorviqua 100 mg, and the Drug Reimbursment Evaluation Committee judged that there was benefit adequacy as a treatment for adult patients with ALK positive progressive non-small cell lung cancer (NSCLC). Results of deliberation by the 4th Drug Reimbursement Evaluation Committee in 2022 Lorviqua was approved in Korea in July last year to use Alecensa Cap or Zykadia Cap as a sole therapy for adult patients with ALK-positive progressive non-small cell lung cancer or as treated with Xalkori and at least one other ALK inhibitor. The Drug Reimbursement Evaluation Committee judged that Sonazoid and Duchembio's Dopa check at GE Healthcare's Korean branch had benefits when accepting less than the evaluation amount. It is subject to acceptance conditions below the evaluation amount. Sonazoid applied for benefits when used for liver gastric tumor lesion ultrasonography in adult patients, and Dopa check applied for use in positron emission tomography (PET).
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