Erweiterungen Und Änderungen Der ATC- Klassifikation
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International Blood/Plasma News© Is Protected by Copyright Law
EDITOR: KEITH BERMAN PUBLISHER: PATRICK ROBERT ISSN 0742-7719 Published by: The Marketing Research Bureau, Inc. 284 Racebrook Rd. Orange, CT 06477 VOLUME 35 ISSUE 12 JULY 2018 BUSINESS BRIEFS 166 BLOOD & BIOTECHNOLOGY 171 RESEARCH & DEVELOPMENT 173 PRODUCT SAFETY UPDATE 174 PEOPLE 175 NEW PRODUCTS 176 RECENT U.S. PATENTS 177 MEETINGS / SUBSCRIPTION FORM 180 ____________________COMPANIES IN THIS ISSUE__________________ ACCELERON PHARMA GRIFOLS ADMA BIOLOGICS HAEMONETICS ALKAHEST HARPOON THERAPEUTICS AMAG PHARMACEUTICALS HEMARUS THERAPEUTICS ARSANIS BIOSCIENCES GmbH ICER ARTHREX INSERM BAYER HEALTHCARE JEFFREY MODELL FOUNDATION BIO PRODUCTS LABORATORY NOVO NORDISK BIOPROTEIN TECHNOLOGIES OCTAPHARMA BIOVERATIV PHARMING CCRE HOLDINGS PLATOD CELGENE REGEN LABS SA CERUS ROCHE CHINA BIOLOGICS RUBIUS THERAPEUTICS CITIC CAPITAL HOLDINGS SANGAMO THERAPEUTICS CORD BLOOD REGISTRY SANQUIN CORD:USE CORD BLOOD BANK SHIRE CRISPR THERAPEUTICS SHIRE SINGAPORE CRTS des Armées SK CHEMICALS CRYO-CELL INTERNATIONAL TERUMO BCT CSL BEHRING VERTEX PHARMACEUTICALS DOVA PHARMACEUTICALS VFMCRP GI PARTNERS VIFOR PHARMA Notice: International Blood/Plasma News© is Protected by Copyright Law. Reproduction or Photocopy of Any Part Without The Publisher‘s Permission is Prohibited by Law. Page 166 JULY 2018 international blood/plasma news BUSINESS BRIEFS * Reflecting strong global demand for human polyvalent immunoglobulin products, HAEMONETICS reported 10.6% growth in fourth quarter revenues for its Plasma busi- ness unit, to $111.6 million from $100.9 million in the same period in 2017. Plasma business revenues for the full fiscal year ended March 31, 2018 increased by 6.7%, or by 7.1% on a con- stant currency basis. Specifically for the North American market, Plasma business revenue growth was 14.2% in the fourth quarter and 8.5% for fiscal year 2018. -
Vonicog Alfa
STATEMENT ON A NONPROPRIETARY NAME ADOPTED BY THE USAN COUNCIL USAN VONICOG ALFA PRONUNCIATION voe' ni kog al' fa THERAPEUTIC CLAIM Prophylactic treatment of bleeding episodes and Von Willebrand disease CHEMICAL NAMES 1. Blood-coagulation factor VIII, von Willebrand's 2. [618-threonine,709-aspartic acid]von Willebrand factor Homo sapiens (1381A>T,1472H>D variant) STRUCTURAL FORMULA Monomer / Monomère / Monómero SLSCRPPMVK LVCPADNLRA EGLECTKTCQ NYDLECMSMG CVSGCLCPPG 50 MVRHENRCVA LERCPCFHQG KEYAPGETVK IGCNTCVCRD RKWNCTDHVC 100 DATCSTIGMA HYLTFDGLKY LFPGECQYVL VQDYCGSNPG TFRILVGNKG 150 CSHPSVKCKK RVTILVEGGE IELFDGEVNV KRPMKDETHF EVVESGRYII 200 LLLGKALSVV WDRHLSISVV LKQTYQEKVC GLCGNFDGIQ NNDLTSSNLQ 250 VEEDPVDFGN SWKVSSQCAD TRKVPLDSSP ATCHNNIMKQ TMVDSSCRIL 300 TSDVFQDCNK LVDPEPYLDV CIYDTCSCES IGDCACFCDT IAAYAHVCAQ 350 HGKVVTWRTA TLCPQSCEER NLRENGYECE WRYNSCAPAC QVTCQHPEPL 400 ACPVQCVEGC HAHCPPGKIL DELLQTCVDP EDCPVCEVAG RRFASGKKVT 450 LNPSDPEHCQ ICHCDVVNLT CEACQEPGGL VVPPTDAPVS PTTLYVEDIS 500 EPPLHDFYCS RLLDLVFLLD GSSRLSEAEF EVLKAFVVDM MERLRISQKW 550 VRVAVVEYHD GSHAYIGLKD RKRPSELRRI ASQVKYAGSQ VASTSEVLKY 600 TLFQIFSKID RPEASRITLL LMASQEPQRM SRNFVRYVQG LKKKKVIVIP 650 VGIGPHANLK QIRLIEKQAP ENKAFVLSSV DELEQQRDEI VSYLCDLAPE 700 APPPTLPPDM AQVTVGPGLL GVSTLGPKRN SMVLDVAFVL EGSDKIGEAD 750 FNRSKEFMEE VIQRMDVGQD SIHVTVLQYS YMVTVEYPFS EAQSKGDILQ 800 RVREIRYQGG NRTNTGLALR YLSDHSFLVS QGDREQAPNL VYMVTGNPAS 850 DEIKRLPGDI QVVPIGVGPN ANVQELERIG WPNAPILIQD FETLPREAPD 900 LVLQRCCSGE GLQIPTLSPA PDCSQPLDVI LLLDGSSSFP ASYFDEMKSF 950 AKAFISKANI GPRLTQVSVL QYGSITTIDV -
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Med J Chin PLA, Vol. 42, No. 12, December 1, 2017 ǂ1029 䃲eڝeᠳࢃ̺ ӵϔߙᡇϊҍᣴ໓͌ܠᣴ̹ࢴҝᣱ ͙ࡧጴࡻцᕑ䃶ܲц ᕑࡧ႒̿͆ༀцۇ͙Ϧℽ㼏ᩪ 䛹⫳ࡧ႒̿͆ༀцۇ͙Ϧℽ㼏ᩪ ͙ࡧጴࡻцᕑ䃶ܲцᕑ䃶โ̿͆ༀц 喞ᕑٷ䩚䃹]Ȟ݇ѐ喞㵬ᕓнڟ] [͙పܲㆧण]ȞR605.97ȞȞȞȞ[᪳⡚ᴳᔃⴭ]ȞAȞȞȞȞ[᪳「㑂ण]Ȟ0577-7402(2017)12-1029-10 [DOI]Ȟ10.11855/j.issn.0577-7402.2017.12.02 Chinese emergency medicine expert consensus on diagnosis and treatment of traumatic hemorrhagic shock Emergency Medicine Branch of Chinese Medical Doctor Association People’s Liberation Army Professional Committee of Emergency Medicine People’s Liberation Army Professional Committee of Critical Care Medicine Professional Committee of Emergency Surgery, Emergency Medicine Branch of Chinese Medical Doctor Association 1ȞẮȞȞ䔜 ㏒10%⤯ڔѐ᭛ᠳᱦᷜ߇҈⩔κϦѿऺᝬ䕌⮰ᱦѿ㏿ᲰႸ᪠ᕓ⮰ⵠ౻সߋ㘩䯈ⶹȠᢚWHO㐋䃍喏݇ 40ᆭБ̷Ϧ㓐⮰仂㺭₧ఌ[1]Ƞ⤯ڔ⮰₧ύস16%⮰㜠₷⫱ҷఌ݇ѐᝬ㜠喏सᬢ݇ѐ᭛ ᄽȟ㏰㏳╸∔̹䋟ȟ㏲㘊Џ䅎㈶Νসۻ᭛ᠳ݇ѐ䕌ᱦѿ๓䛻㵬ᝬ㜠ᰵᩴᓖ⣛㵬䛻ٷѐ㵬ᕓн݇ ፤፤ऴᎢѺ㵬ࢷ(͵ͦᩢ㑕ࢷ┯90mmHg喏㘵ࢷ┯20mmHg喏ᝂ࣋ᰵ倄㵬ٷஔჄߋ㘩ःᢋ⮰⫱⤲⩋⤲䓳⼷Ƞн ࢷ㔱ᩢ㑕ࢷ㜖ദ㏫̷䭹Ĺ40mmHg)Ƞ30%~40%⮰݇ѐᗏ㔱₧ύ᭛ఌ㵬䓳ๆᝬ㜠喏ₐㆧᗏ㔱͙喏ᰵ̬䘔ܲ ఌͦ䩅䄛⮰⇧ᵴࣶ̹ᖜᑿ⮰⇧⫃ᣖ㔸₧ύ喏ࢌ10%~20%Ƞᕑᕓ㵬᭛݇ѐ仂㺭⮰छ䶰䭞ᕓ₧ఌ[2-3]Ƞ ᄽๆஔჄߋ㘩䯈ⶹ㐨ऴᒭۻ䛹㺭喏छᰵᩴڟᄥκ͑䛹݇ѐᗏ㔱㜟ٷ㵬喏㏌㵬ᕓнܦࣶᬢȟᔗ䕋ᣓݢ (multiple organ dysfunction syndrome喏MODS)⮰ࣽ⩋喏䭹Ѻ₧ύ⢳Ƞ ⮰ᕑ䃶ٷ䃲ᬔ㻰㠯স倄݇ѐ㵬ᕓнڝᠳࢃȠ᱘ڟᕑ⇧⮰Ⱔ㉓ٷⰚݹᅆᬌ݇ѐ㵬ᕓн ⇧喏ͦᕑ䃶ࡧጴӇ䃶⫃ӉᢚȠ ⤲⩋⤲⫱⮰ٷ2Ȟ݇ѐ㵬ᕓн ᭛㵬ქ䛻̺㵬ネქ⼛⮰̹ࡥ䙹喏䕌โঔ㏰㏳╸∔̹䋟喏Ϻ㔸ᑁٴ⮰⫱⤲⩋⤲ऄࡂ仂ٷѐ㵬ᕓн݇ 㘻ஔჄ⮰㐓ࣽᕓᢋჟȠڱ㵬䯈ⶹБࣶ܉䊣ᓚᓖ⣛ऄࡂȟ⅓Џ䅎ߔ߇႒ᐮ፤ȟ►⫳ࣹᏀȟ ᭛䛹㺭㘻ڢᰬᵥ᱘⮰⫱⤲⩋⤲ᩥऄ᭛㵬ᝬ㜠⮰ᓚᓖ⣛ߋ㘩䯈ⶹ喏ᅐٷ2.1Ȟᓚᓖ⣛ऄࡂȞ݇ѐ㵬ᕓн ၼὍᐻ(damage associatedܲڟϓ⩋ᢋѐⰤٷஔᓚᓖ⣛ᩥऄȠᄨ㜠ᓚᓖ⣛ߋ㘩䯈ⶹ⮰ͧ㺭ᱦݢ࠱᠘喝Ŗн Ꮐむࣶᣓᕓ►⫳ࣹᏀ喏ᑁ䊣㵬⫗ٹ㯷⮩স倄䓭⼧⢳㯷⮩1㼒ࣽٷmolecular patterns喏DAMP)[4-5]喏ຮ☙н 㵬㈧܉⯚ᢋѐᑁ䊣ڱᄽ喏ᰬ㏴ᄨ㜠㏰㏳╸∔̹䋟ȟ㏲㘊㑦⅓喞ŗۻ⯚ᢋѐȟℇ㏲㵬ネ⍃ȟᓖ⣛ქ䛻ڱネ 㐋⓬≧ȟᓚ㵬ᴿᒎ喏䭧ඊℇ㏲㵬ネࣶ㵬ネ㜾㑕ߋ㘩䯈ⶹ喏ߌ䛹㏰㏳㑦㵬㑦⅓喞Ř݇ѐᝬ㜠⮰ᠭ㐙ȟᑦ◴ ᓚᓖ⣛䯈ⶹȠޓߋ㘩喏ᄨ㜠ࣹᄰᕓ㵬ネ㜾㑕ߋ㘩㈶Ν喏ߌ⇸ܲڱ⮰ݦ⓬ᒝ৹⺊㏻ ⅓̺(ᗏ㔱ႄ⅓Џ䅎ߔ߇႒ᐮ፤喏࢟⅓ӇᏀ(DO2ٷ2.2Ȟ⅓Џߔ߇႒ᐮ፤ࣶ㏲㘊Џ䅎ᩥऄȞ݇ѐ㵬ᕓн -
Urinary Trypsin Inhibitor: Miraculous Medicine in Many Surgical Situations?
Korean J Anesthesiol 2010 Apr; 58(4): 325-327 Editorial DOI: 10.4097/kjae.2010.58.4.325 Urinary trypsin inhibitor: miraculous medicine in many surgical situations? Jong In Han Department of Anesthesiology and Pain Medicine, School of Medicine, Ewha Womans University, Seoul, Korea Recently, we encounter several articles regarding urinary Trypsin inhibitors act to suppress the proteolytic action trypsin inhibitor (UTI) published nationally [1,2]. When we take of trypsin on a variety of tissues and exert a localized anti- a glance at these articles, it feels like UTI acts as a miraculous inflammatory effect [8]. Therefore UTI is indicated for acute medicine on patients under general anesthesia because of inflammatory disorders, including acute pancreatitis, systemic its protection effect against surgical stress. Yet, even after the inflammatory reaction syndrome, circulatory insufficiency, first report on antitryptic action of urine by Bauer and Reich Stevens-Johnson syndrome, Toxic epidermal necrolysis (TEN), III in 1909 [3]; the start of use of the term UTI by Astrup and disseminated intravascular coagulation (DIC) and multiple Sterndorff in 1955 [4]; and numerous animal experiments and organ failure [9]. Previous studies of UTI have focused mainly clinical research done about UTI (803 articles about UTI and on modulating inflammatory reaction. UTI attenuates the 982 articles about ulinastatin in SCOPUS), UTI is not yet to elevation of neutrophil elastase release, thereby blunting the be used commonly. Therefore, it is important to understand rise of pro-inflammatory cytokine level; however, the actual the reason behind this situation. According to the webpage of mechanism in vivo is not clear [10]. -
A Study on Ulinastatin in Preventing Post ERCP Pancreatitis
International Journal of Advances in Medicine Vedamanickam R et al. Int J Adv Med. 2017 Dec;4(6):1528-1531 http://www.ijmedicine.com pISSN 2349-3925 | eISSN 2349-3933 DOI: http://dx.doi.org/10.18203/2349-3933.ijam20175083 Original Research Article A study on ulinastatin in preventing post ERCP pancreatitis R. Vedamanickam1, Vinoth Kumar2*, Hariprasad2 1Department of Medicine, 2Department of Gasto and Hepatology , SREE Balaji Medical College and Hospital, Chrompet, Chennai, Tamil Nadu, India Received: 19 September 2017 Accepted: 25 October 2017 *Correspondence: Dr. Vinothkumar, E-mail: [email protected] Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: Pancreatitis remains the major complication of endoscopic retrograde cholangiopancreatography (ERCP), and hyperenzymemia after ERCP is common. Ulinastatin, a protease inhibitor, has proved effective in the treatment of acute pancreatitis. The aim of this study was to assess the efficacy of ulinastatin, compare to placebo study to assess the incidence of complication due to ERCPP procedure. Methods: In this study a randomized placebo controlled trial, patients undergoing the first ERCP was randomizing to receive ulinastatin one lakh units (or) placebo by intravenous infusion one hour before ERCP for ten minutes duration. Clinical evaluation, serum amylase, ware analysed before the procedure 4 hours and 24 hours after the procedure. Results: Total of 46 patients were enrolled (23 in ulinastatin and 23 in placebo group). -
Early Local Drug Therapy for Pancreatic Contusion and Laceration
Pancreatology 19 (2019) 285e289 Contents lists available at ScienceDirect Pancreatology journal homepage: www.elsevier.com/locate/pan Early local drug therapy for pancreatic contusion and laceration Cong Feng a, 1, Hao Yang e, 1, Sai Huang c, 1, Xuan Zhou a, 1, Lili Wang a, Xiang Cui d, *** ** * Li Chen a, , 2, Faqin Lv b, , 2, Tanshi Li a, , 2 a Department of Emergency, First Medical Center, General Hospital of the PLA, Beijing, 100853, China b Department of Ultrasound, Hainan Hospital of the PLA General Hospital, Sanya, 572000, China c Department of Hematology, First Medical Center, General Hospital of the PLA, Beijing, 100853, China d Department of Orthopedics, First Medical Center, General Hospital of the PLA, Beijing, 100853, China e Department of Radiation Oncology, Inner Mongolia Cancer Hospital & Affiliated People's Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, 010020, China article info abstract Article history: Objectives: To study the therapeutic effect of early local drug therapy on pancreatic contusion and Received 18 September 2018 laceration. Received in revised form Methods: Twenty pigs were divided into 4 groups: model(PL), 1 ml of saline; medical protein glue (EC), 12 December 2018 1 ml of medical protein glue; ulinastatin (UL), 50000U of ulinastatin; combined treatment (UE), 1 ml of Accepted 16 January 2019 medical protein glue and 50000U of ulinastatin. 30 min after model establishment, different groups Available online 17 January 2019 received different local drug treatments. The pancreatic function, peritoneal effusion and pancreatic pathology were observed. Keywords: Pancreatic contusion and laceration Results: The UE group got the best therapeutic effect. -
Vonicog Alfa for Severe Von Willebrand Disease
Horizon Scanning Research February 2016 & Intelligence Centre Vonicog alfa for severe von Willebrand disease LAY SUMMARY People with von Willebrand disease either have a deficiency of a blood protein called von Willebrand factor, or this protein doesn't work properly. This means that their blood cannot clot properly and they are prone to prolonged or excessive bleeding. There are three different types of von Willebrand disease – types 1, 2, and 3. Type 3 is rare and This briefing is people with this type have very low levels of von Willebrand factor in based on their blood, or none at all. information available at the time of research and a Vonicog alfa is a new drug that is given in a drip (directly into a vein). It limited literature is being studied to see whether it reduces bleeding in people with search. It is not severe von Willebrand disease, and that it is safe to use. If vonicog intended to be a alfa is licensed for use in the UK, it could provide a new treatment for definitive statement people with severe von Willebrand disease. on the safety, efficacy or effectiveness of the NIHR HSRIC ID: 5818 health technology covered and should not be used for commercial purposes or commissioning without additional information. This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. NIHR Horizon Scanning Research & Intelligence Centre, University of Birmingham. Email: [email protected] Web: www.hsric.nihr.ac.uk Horizon Scanning Research & Intelligence Centre TARGET GROUP Von Willebrand disease (VWD): severe – first line. -
Antiproteases in Preventing Post-ERCP Acute Pancreatitis
JOP. J Pancreas (Online) 2007; 8(4 Suppl.):509-517. ROUND TABLE Antiproteases in Preventing Post-ERCP Acute Pancreatitis Takeshi Tsujino, Takao Kawabe, Masao Omata Department of Gastroenterology, Faculty of Medicine, University of Tokyo. Tokyo, Japan Summary there is no other randomized, placebo- controlled trial on ulinastatin under way. Pancreatitis remains the most common and Large scale randomized controlled trials potentially fatal complication following revealed that both the long-term infusion of ERCP. Various pharmacological agents have gabexate and the short-term administration of been used in an attempt to prevent post-ERCP ulinastatin may reduce pancreatic injury, but pancreatitis, but most randomized controlled these studies involve patients at average risk trials have failed to demonstrate their of developing post-ERCP pancreatitis. efficacy. Antiproteases, which have been Additional research is needed to confirm the clinically used to manage acute pancreatitis, preventive efficacy of these antiproteases in would theoretically reduce pancreatic injury patients at a high risk of developing post- after ERCP because activation of proteolytic ERCP pancreatitis. enzymes is considered to play an important role in the pathogenesis of post-ERCP pancreatitis. Gabexate and ulinastatin have Introduction recently been evaluated regarding their efficacy in preventing post-ERCP ERCP is widely performed for the diagnosis pancreatitis. Long-term (12 hours) infusion of and management of various pancreaticobiliary gabexate significantly decreased the incidence diseases. Early complications after ERCP of post-ERCP pancreatitis; however, no include acute pancreatitis, bleeding, prophylactic effect was observed for short- perforation, and infection (cholangitis and term infusion (2.5 and 6.5 hours). These cholecystitis) [1, 2]. Of these ERCP-related results may be due to the short-life of complications, pancreatitis remains the most gabexate (55 seconds). -
Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG . -
PRAC Draft Agenda of Meeting 08-11 March 2021
08 March 2021 EMA/PRAC/145863/2021 Human Medicines Division Pharmacovigilance Risk Assessment Committee (PRAC) Draft agenda for the meeting on 08-11 March 2021 Chair: Sabine Straus – Vice-Chair: Martin Huber 08 March 2021, 10:30 – 19:30, via teleconference 09 March 2021, 08:30 – 19:30, via teleconference 10 March 2021, 08:30 – 19:30, via teleconference 11 March 2021, 08:30 – 16:00, via teleconference Organisational, regulatory and methodological matters (ORGAM) 25 March 2021, 09:00 – 12:00, via teleconference Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, this agenda is a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on - going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006, Rev. 1). Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. -
Draft PDCO Agenda 07-10 September 2021
7 September 2021 EMA/PDCO/494499/2021 Human Medicines Division Paediatric Committee (PDCO) Draft Agenda for the meeting on 07-10 September 2021 Chair: Koenraad Norga – Vice-Chair: Sabine Scherer 07 September 2021, 14:00- 19:00, virtual meeting 08 September 2021, 08:30- 19:00, virtual meeting 09 September 2021, 08:30- 19:00, virtual meeting 10 September 2021, 08:30- 13:00, virtual meeting Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the PDCO Committee meeting reports (after the PDCO Opinion is adopted), and on the Opinions and decisions on paediatric investigation plans webpage (after the EMA Decision is issued). Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. -
Ulinastatin Treatment for Acute Respiratory Distress Syndrome In
Zhang et al. BMC Pulmonary Medicine (2019) 19:196 https://doi.org/10.1186/s12890-019-0968-6 RESEARCH ARTICLE Open Access Ulinastatin treatment for acute respiratory distress syndrome in China: a meta-analysis of randomized controlled trials Xiangyun Zhang1,2†, Zhaozhong Zhu3†, Weijie Jiao2, Wei Liu1, Fang Liu1* and Xi Zhu4* Abstract Background: Epidemiologic studies have shown inconsistent conclusions about the effect of ulinastain treatment for acute respiratory distress syndrome (ARDS). It is necessary to perform a meta-analysis of ulinastatin’s randomized controlled trials (RCTS) to evaluate its efficacy for treating ARDS. Methods: We searched the published RCTs of ulinastatin treatment for ARDS from nine databases (the latest search on April 30th, 2017). Two authors independently screened citations and extracted data. The meta-analysis was performed using Rev. Man 5.3 software. Results: A total of 33 RCTs involving 2344 patients satisfied the selection criteria and were included in meta- analysis. The meta-analysis showed that, compared to conventional therapy, ulinastatin has a significant benefit for ARDS patients by reducing mortality (RR = 0.51, 95% CI:0.43~0.61) and ventilator associated pneumonia rate (RR = 0.50, 95% CI: 0.36~0.69), and shortening duration of mechanical ventilation (SMD = -1.29, 95% CI: -1.76~-0.83), length of intensive care unit stay (SMD = -1.38, 95% CI: -1.95~-0.80), and hospital stay (SMD = -1.70, 95% CI:-2.63~−0.77). Meanwhile, ulinastatin significantly increased the patients’ oxygenation index (SMD = 2.04, 95% CI: 1.62~2.46) and decreased respiratory rate (SMD = -1.08, 95% CI: -1.29~-0.88) and serum inflammatory factors (tumor necrosis factor-α: SMD = -3.06, 95% CI:-4.34~-1.78; interleukin-1β: SMD = -3.49, 95% CI: -4.64~-2.34; interleukin-6: SMD = -2.39, 95% CI: -3.34~-1.45; interleukin-8: SMD = -2.43, 95% CI: -3.86~-1.00).