• Title/Summary/Keyword: a virus disease

Search Result 1,588, Processing Time 0.034 seconds

The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
    • /
    • v.21 no.1
    • /
    • pp.223-259
    • /
    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

Bacterial Blight-Resistant Medium Maturing Rice Cultivar 'Haepum' with High Grain Quality (벼흰잎마름병 저항성 고품질 중생 벼 '해품')

  • Nam, Jeong-Kwon;Park, Hyun-Su;Baek, Man-Kee;Cho, Young-Chan;Kim, Woo-Jae;Kim, Jeong-Ju;Kim, Bo-Kyeong;Kim, Ki-Young;Shin, Woon-Chul;Ko, Jong-Cheol;Lee, Gun-Mi;Park, Seul-Gi;Lee, Chang-Min;Kim, Choon-Song;Suh, Jung-Pil;Lee, Jeom-Ho
    • Korean Journal of Breeding Science
    • /
    • v.51 no.3
    • /
    • pp.222-233
    • /
    • 2019
  • 'Haepum' is a bacterial blight-resistant, medium maturing rice cultivar with high grain quality. It was derived from a cross between 'Iksan493' (cultivar name 'Jinbaek') and the F1 cross between 'Iksan495' ('Dacheong') and 'Iksan496' ('Jungmo1005'). Of these three cultivars, 'Jinbaek' is a bacterial blight-resistant mid-late maturing rice cultivar with high grain quality, 'Dacheong' is a mid-late maturing rice cultivar with multiple resistance to disease and insects, and 'Jungmo1005' is a mid-late maturing rice cultivar with lodging tolerance. To develop fixed lines, the anther culture method was applied to F1 plants. The cultivar 'Haepum' was selected using the pedigree method, yield trials, and local adaptability tests. The heading date of 'Haepum' was August 11th, three days earlier than that of 'Nampyeong' cultivar. Haepum' is a cultivar tolerant to lodging and it has short culms. Due to its low rate of viviparous germination, 'Haepum' could be useful for preventing pre-harvest sprouting in cultivation of medium maturing rice in the southern plain area of Korea. 'Haepum' carries two bacterial blight resistance genes (Xa3 and xa5), and in our study, it exhibited high-level and broad-spectrum resistance against bacterial blight, including K3a, the most virulent race in Korea. 'Haepum' is also resistant to the rice stripe virus and moderately resistant to rice blast. The yield of 'Haepum' was similar to that of 'Nampyeong'. 'Haepum' showed excellent grain appearance and good taste of cooked rice, and therefore it could contribute to the development of bacterial blight-resistant rice cultivars of improved quality. 'Haepum' would be suitable for cultivation in the southern plain area of Korea as well as in bacterial blight-prone areas. (Registration No. 6068)

'Nokyang', Whole Crop Forage Barley Cultivar with the Stay-Green Character, Resistance to Viral Disease and High-Yielding (내병 다수 후기녹체성 청보리 신품종 '녹양')

  • Park, Tae-Il;Oh, Young-Jin;Park, Hyoung-Ho;Park, Jong-Chul;Cho, Sang-Kyun;Noh, Jae-Hwan;Kim, Dae-Wook;Song, Tae-Hwa;Chae, Hyun-Seok;Jeung, Jae-Hyun;Hong, Ki-Heung;Bae, Jeong-Suk;Huh, Jae-Young;Ku, Ja-Hwan;Park, Ki-Hun;Han, Ouk-Kyu
    • Journal of The Korean Society of Grassland and Forage Science
    • /
    • v.35 no.1
    • /
    • pp.57-62
    • /
    • 2015
  • "Nokyang" (Hordeum vulgare L.), a new whole-crop silage barley cultivar, was developed by the breeding team at the Department of Rice and Winter Cereal Crop, National Institute of Crop Science, RDA, Korea in 2012. It was derived from combining "Nagyoung" and breeding line "SB77368-B-145". Among the combinations made in 2001, a promising line, "SB01T2017", showed good characteristics in terms of potential forage yield in the yield trial at Iksan from 2007 to 2009. In 2009, the promising line was designated as "Iksan457" and placed in regional yield trials at six locations around Korea for three years from 2010 to 2012, and was released under the name of "Nokyang." It has the growth habit of a group III creeping plant type, with a light-green leaf and common spike. Its average heading and maturing dates were on May 6 and June 4, respectively, which were later than cultivar "Youngyang." "Nokyang" also showed strong winter hardiness, and a resistance to shattering and barley yellow mosaic virus (BaYMV) similar to those of the check cultivar. The best thing among the traits of one is a new good quality with the plant green at the latter growing period. The average forage dry matter (DM) yields in the regional yield trial were about 12.8 and 11.5 MT $ha^{-1}$ in upland and paddy field, respectively, which were higher than those of the check cultivar, by 7% and 2%, respectively. This cultivar would be suitable for an area of the Korean peninsula where the daily minimum temperature in January is above $-8^{\circ}C$.

A New Rice Variety with Good Qualilty and Multiple Diseases Resistance "Sangok" (중생 고품질 복합내병성 신품종 벼 "상옥")

  • Park, No-Bong;Yang, Sae Jun;Kwak, Do-Yeon;Oh, Byeong-Geun;Song, You-Chun;Lee, Jeom-Sik;Yeo, Un-Sang;Ha, Woon-Goo;Yi, Gi-Hwan;Chang, Jae-Ki;Lim, Sang-Jong;Nam, Min-Hee;Lee, Jong-Hee;Keun, Oh-Kyeong;Park, Dong-Soo;Hwang, Heung-Gu;Kim, Ho-Yeong;Kim, Soon-Chul
    • Korean Journal of Breeding Science
    • /
    • v.41 no.4
    • /
    • pp.515-519
    • /
    • 2009
  • "Sangok", is a new japonica rice variety (Oryza sativa L.), which is a midium maturing ecotype developed by the rice breeding team of National Yeongnam Agricultural Experiment Station (NYAES) in 2003. This variety was derived from the cross of Milyang 101/YR8697Acp97 (in 1988/1989 winter) and selected by combination of the bulk and pedigree breeding. The pedigree of Sangokbyeo, designated as Milyang 182 in 2000, was YR12950-B-B-B-19-2-4-2-2. It has about 79cm stature in culm length and is medium maturing. This variety is resistant to bacterial blight ($K_1$, $K_2$, and $K_3$), stripe virus and moderately resistant to leaf blast disease. Milled rice kernels of "Sangok" is translucent, clear in chalkness and good at eating quality in the panel test. The yield potential of "Sangok" in milled rice is about 5.16MT/ha at ordinary fertilizer level of local adaptability test. This cultivar would be adaptable to the southern plain of Korea below the Chungnam province by latitude from ordinary transplanting to transplanting after barley harvest.

Clinical features of human metapneumovirus infection in children with acute respiratory tract infections (급성 호흡기 감염증 소아에서 Human metapneumovirus 감염의 임상 양상)

  • Lee, Jae Sook;Seo, Hyun Joo;Woo, Jeong Ju;Jang, Sung Hee;Lee, Jin A;Song, Mi Ok;Park, Hwa Young;Ahn, Young Min
    • Pediatric Infection and Vaccine
    • /
    • v.14 no.1
    • /
    • pp.75-82
    • /
    • 2007
  • Purpose : Human metapneumovirus (hMPV) is a newly identified paramyxovirus that causes a variety of clinical syndromes in children, including upper and lower respiratory tract illnesses. hMPV is considered an ubiquitous virus causing respiratory tract diseases among children especially during late winter and spring seasons. We report clinical features of human metapneumovirus infection in Korean children. Methods : hMPV infection was diagnosed by reverse transcriptase-polymerase chain reaction (RT-PCR) in respiratory specimens obtained from patients with acute respiratory tract infections from October, 2004 to May, 2005. Medical records of all hMPV-positive patients were reviewed, retrospectively. Results : A total of 15 hMPV were identified from 443 nasopharyngeal aspirations by RT-PCR (3.4%). The range of age of the patients with hMPV infection was from 1 month to 62 months (median age, 31.5 months), with similar numbers of females (8/15) and males (7/15). Among hMPV-positive children, 53.3% (8/15) were aged less than 24 months. Fever, cough, rhinorrhea, vomiting, diarrhea, tachypnea, and chest wall retractions were common findings. Most common clinical diagnosis was pneumonia (60%). Two of the 15 hMPV-positive patients were also positive for adenovirus. Fever persisted from 0 to 10 days (mean 4.9 days). The duration of hospitalization ranged from 4 to 7 days (mean 5.6 days). Conclusion : hMPV accounted for a small but significant proportion of respiratory tract infection in infants and children. Future development and application of diagnostic tools will determine the burden of disease caused by this newly discovered pathogen.

  • PDF

A Comparison of Clinical Characteristics between Adenoviral and Group A Streptococcal Pharyngitis in Children (소아의 아데노바이러스와 A군 연쇄구균 인두염의 임상적 특징의 비교)

  • Kim, So Hyong;Jeong, Hye Ryeong;Kim, In Uk;Yang, Mu Yeol;Cho, Sung Min;Kang, Eun Kyeong
    • Pediatric Infection and Vaccine
    • /
    • v.21 no.2
    • /
    • pp.121-128
    • /
    • 2014
  • Purpose: To compare the clinical characteristics and laboratory finding between adenoviral and group A streptococcal (GAS) pharyngitis. Methods: A retrospective review of medical records was performed in the patients with adenovirus infection among those who were admitted for febrile respiratory disease from January 2011 to July 2013 and GAS pharyngitis among those who visited for symptoms of scarlet fever from August 2006 to July 2013. Results: 179 patients (AV1 group) were diagnosed with adenoviral pharyngitis and 37 (AV2 group) of these patients had adenovirus single infection. 26 patients (GAS group) were diagnosed with scarlet fever. Adenoviral infection (AV2 group) developed in younger patients compared to GAS group ($2.8{\pm}2.1$ years vs. $5.4{\pm}1.8$ years, P =0.000). Total durations of fever and admission were longer in AV2 ($6.3{\pm}2.6$ days vs. $3.3{\pm}1.9$ days, P =0.000; $4.1{\pm}1.2$ days vs. $1.9{\pm}1.8$ days, P =0.000, respectively). WBC counts were higher in AV2 ($11,449{\pm}5,680$ cells/$mm^2$ vs. $6,722{\pm}6,941$ cells/$mm^2$, P =0.000). CRP was not significantly different between AV2 and GAS group ($3.8{\pm}3.2$ mg/dL vs. $5.2{\pm}5.1$ mg/dL, P =0.368). No difference was found between two groups in the percentage of antibiotics use (91.9% vs. 100%, P =0.261). Conclusion: Clinical characteristics and measures of inflammation in the laboratory findings were similar between adenoviral and GAS pharyngitis group. It is necessary to conduct the test for respiratory virus and bacteria in early stage to differentiate in the pharyngitis patients with leukocytosis and elevation of CRP level.

Characteristics and Clinical Correlations of Staphylococcus aureus Discovered in Stools from Children Hospitalized at a Secondary Hospital (일개 이차병원에 입원한 소아의 분변에서 발견된 황색포도알균의 특징과 임상적 연관성)

  • Shin, Eun Hye;Eun, Byung Wook;An, Young Min;Song, Mi Ok
    • Pediatric Infection and Vaccine
    • /
    • v.25 no.2
    • /
    • pp.61-71
    • /
    • 2018
  • Purpose: Research on the clinical role of Staphylococcus aureus as a pathogen in acute gastroenteritis (AGE) in children has been scarce. This study aimed to clarify the prevalence and clinical correlation of S. aureus detection in children with AGE. Methods: Fecal samples were collected from children with symptoms of AGE who visited a secondary hospital between January 2012 and December 2015. The samples were sent to the Seoul Metropolitan Government Research Institute of Public Health and Environment to test for pathogenic organisms. Clinical patterns were analyzed through medical record review. Results: Among the 663 participants, the bacteria detection rate was 26.2% (n=174), the virus detection rate was 29.7% (n=197), and the non-detection rate was 43.1% (n=286). S. aureus was tested positive from 102 cases and was confirmed as a single pathogen in 53 cases. It was the third most common pathogen. The prevalence by age was highest (45.3%) in 0-2 year-olds. Most cases occurred in summer. Symptoms included diarrhea (71.7%), vomiting (67.9%), fever (49.1%), and abdominal pain (37.7%). Only vomiting showed a significant difference between the S. aureus group and the non-detection group (67.9% vs. 43.0%; P=0.001). Among enterotoxins, the higher incidence of vomiting was associated with classical staphylococcal enterotoxins (SEA, SEB, SEC, SED, and SEE) and SEH (P=0.027). Conclusions: S. aureus was the bacteria commonly isolated from children with AGE. Our study identified cases of staphylococcal AGE in children based on fecal samples and confirmed the characteristic symptoms, affected age groups, seasonal distribution, and correlation with enterotoxins.

A New Soybean Cultivar, "Sohwang" for Sprout with Disease Resistance, Small Seed Size and High Sprout yielding (내병·소립 고수율 나물콩 신품종 "소황")

  • Cho, Sang-Kyun;Oh, Young-Jin;Kim, Kyong-Ho;Kim, Young-Jin;Kim, Tae-Soo;Kim, Jung-Gon;Park, Ki-Hun;Yun, Hong-Tae;Kim, Hyun-Tae;Han, Won-Young;Baek, In-Youl;Ko, Jong-Min;Kim, Yong-Duk;Kim, Dong-Kwan;Hwang, Hung-Goo
    • Korean Journal of Breeding Science
    • /
    • v.41 no.4
    • /
    • pp.640-644
    • /
    • 2009
  • A new sprout-soybean cultivar, "Sohwang" was developed at the National Institute of Crop Science (NICS) in 2008. "Sohwang" was selected from a cross between Pungsan and Pungsan/Nattosan. The preliminary, advanced, and regional yield trials to evaluate the performance of Iksan 58 were carried out from 2004 to 2008. This cultivar has a determinate growth habit with purple flower, grayish brown pubescence, yellow seed coat, Yellow hilum, lanceolate leaflet shape and small seed size (8.5 grams per 100 seeds). The maturity date of "Sohwang" is 10 days earlier than the check variety, "Pungsan". It has a good seed quality for soybean-sprout. The soybean-sprouts grown from "Sohwang" have high isoflavone ($3,041{\mu}g/g$)contents. This cultivar has resistance to soybean mosaic virus (SMV) and necrotic symptom (SMV-N), and other most troublesome soybean diseases which are bacterial pustule and black root rot. Especially, "Sohwang" has useful characteristics, such as lodging and shattering resistance. The average yield of "Sohwang" was 2.69 ton per hectare in the carried out for three years from 2006 to 2008 regional yield trials(RYT) for double cropping.

'Neulchan', a Middle-seed, Disease-resistant, and High-yield Soybean Cultivar for Soy-paste and Tofu (중립 내병 다수성 장류·두부용 콩 '늘찬')

  • Kim, Hyun Tae;Ko, Jong Min;Baek, In Youl;Han, Won Young;Yun, Hong Tai;Lee, Byoung Won;Shin, Sang Ouk;Seo, Jeong Hyun;Kim, Hong Sik;Kwak, Do Yeon
    • Korean Journal of Breeding Science
    • /
    • v.51 no.4
    • /
    • pp.475-481
    • /
    • 2019
  • The soybean cultivar 'Neulchan' was developed for production of soy-paste and tofu. SS91501-9-1-1 and SS96205 (F2) were crossed in 1998, and F3 to F7 were selected by the pedigree method. A preliminary yield trial (PYT) and an advanced yield trial (AYT) were conducted from 2006 to 2008, and a regional yield trial (RYT) in nine regions was conducted from 2009 to 2011. In the RYT, 'Neulchan' was stable in variable environments and generated high yield. 'Neulchan' was determinate with white flower, light brown pod color, yellow spherical seed, and yellow hilum. Its flowering date and maturity date were Jul. 30 and Oct. 9, respectively. The plant height was shorter than that of 'Daewonkong' (a standard cultivar). 'Neulchan' had the same node number (14), higher first-pod height (12 cm), and lighter seed weight (21.7 g/100-seed weight) than those of 'Daewonkong' (14, 11, and 24.2 g/100-seed weight, respectively). 'Neulchan' had high resistance to bacterial pustule, and its resistance to soybean mosaic virus was similar to that of 'Daewonkong'. The yield and color of 'Neulchan' tofu were similar to those of 'Daewonkong' tofu, but the hardness was lower than that of 'Daewonkong' tofu. The soybean malt scent, fermented soybean yield, and γ-polyglutamic acid (γ-PGA) of 'Neulchan' were 3, 215%, and 24.6 mg/g, respectively. Its yield in adaptable regions was 307 kg/10a, higher than that of 'Daewonkong'. 'Neulchan' was expected to be cultivated and used widely for soy-paste and tofu production. (Registration No. 4904).

Adaptable Tropical Japonica High quality New Rice Cultivar 'Japonica 6' (열대지역 적응 고품질 자포니카 벼 신품종 'Japonica 6')

  • Jeong, O-Young;Torollo, Gideon;Bombay, Maurene;Baek, Man-Kee;Ahn, Eok-keun;Hyun, Woong-Jo;Park, Hyun-Su;Jeong, Jong-Min;Cho, Jun-Hyeon;Lee, Jeong-Heui;Yeo, Un-Sang;Lee, Jeom-Sig;Jeong, Eung-Gi;Kim, Choon-Song;Suh, Jung-Pil;Kim, Bo-Kyeong;Lee, Jeom-Ho
    • Journal of the Korean Society of International Agriculture
    • /
    • v.31 no.3
    • /
    • pp.249-254
    • /
    • 2019
  • 'Japonica 6' is a japonica rice variety developed from a cross between 'MS11', the beginning variety adaptable to tropical region, and 'IR86743-28-1-4', an elite line of high yield and good plant type by a Korea(RDA)-IRRI cooperative breeding program at IRRI in 2017. The growth duration of 'Japonica 6' is 121 days from sowing to harvest. It is 10 days later than that of the check variety 'MS11'. The culm length of 'Japonica 6' is 70 cm, and 1,000-brown rice grain weight is 26.7 g. It has a shorter culm and a larger grain. size than that of MS11. 'Japonica 6' is moderately resistant to blast disease but susceptible to bacterial blight, tungro virus and plant hoppers. The milled rice recovery rate of 'Japonica 6' is improved than that of 'MS11'. The head rice rate of 'Japonica 6' is significantly higher than that of 'MS11'. Yield of 'Japonica 6' is averagely 3.59 MT/ha of milled rice in 5 areas of the Philippines. The 'Japonica 6' was registered in Philippines and would be adaptable to the diverse regions of tropical Asia (Registration No in Philippines. BPI-NSIC-2017-Rc 484SR).