Pub Date : 2023-05-30DOI: 10.1089/blr.2023.29311.cip
Christopher M. Holman
{"title":"Arbutus Biopharma Corp. v. ModernaTX, Inc.","authors":"Christopher M. Holman","doi":"10.1089/blr.2023.29311.cip","DOIUrl":"https://doi.org/10.1089/blr.2023.29311.cip","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41626033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-05-24DOI: 10.1089/blr.2023.29307.ww
Zhou Chen, Wu Wanqiang
{"title":"The Legislative Paradigm of China's Biosafety Law and Its Positive Significance for the SARS-CoV-2 Prevention and Control","authors":"Zhou Chen, Wu Wanqiang","doi":"10.1089/blr.2023.29307.ww","DOIUrl":"https://doi.org/10.1089/blr.2023.29307.ww","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43838392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-05-24DOI: 10.1089/blr.2023.29308.hp
Wang Gang, Huang Peng
{"title":"China Releases Document on Ethics Review of Life Sciences: Comments and Compliance Guidelines","authors":"Wang Gang, Huang Peng","doi":"10.1089/blr.2023.29308.hp","DOIUrl":"https://doi.org/10.1089/blr.2023.29308.hp","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47681149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-05-22DOI: 10.1089/blr.2023.29309.xs
Laura Çami (Vorpsi), Xhon Skënderi
{"title":"Biotechnology and Intellectual Property Law: Theoretical and Practical Reflections on Albanian National Law and Jurisprudence in Comparison with EU Acquis and ECJ Case Law","authors":"Laura Çami (Vorpsi), Xhon Skënderi","doi":"10.1089/blr.2023.29309.xs","DOIUrl":"https://doi.org/10.1089/blr.2023.29309.xs","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43951616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-05-16eCollection Date: 2023-12-01DOI: 10.1002/wjo2.99
Mandy K Salmon, Rijul S Kshirsagar, Jacob G Eide, Auddie M Sweis, Kathleen Davin, Aman Prasad, Heather Ungerer, Elizabeth Stevens, Kevin Ig-Izevbekhai, Siddhant Tripathi, Tran B Locke, Theodore Lin, Brian M Sweis, Michael A Kohanski, Nithin D Adappa, James N Palmer
Objectives: The use of topical corticosteroids to manage postoperative sinonasal symptoms after endoscopic skull base surgery (ESBS) has not been well studied. We quantified long-term impact of postoperative steroid irrigations (SIs) on quality of life of patients after ESBS.
Methods: Retrospective review of patients at the University of Pennsylvania undergoing ESBS from 2010 to 2019. Data on patient demographics and postoperative treatment with nasal saline irrigation twice daily with and without dissolved steroids (mometasone or budesonide) was collected. Preoperative, and 1-, 3-, 6-, 12-, 18-, and 24-month postoperative Sino-Nasal Outcome Test (SNOT-22) scores were assessed.
Results: A total of 727 patients were assessed (53.4% males), with 479 patients in the no SI group and 248 patients in the SI group. Preoperative SNOT-22 scores did not differ significantly (P = 0.19). 1-, 3-, 6-, 12-, 18-, and 24-month post-op SNOT-22 scores did not significantly differ between groups. However, mometasone irrigations resulted in significantly lower postoperative 2-year SNOT-22 scores compared to budesonide (P < 0.01) and saline (P = 0.03).
Conclusions: Though corticosteroid irrigations are routine in managing inflammatory sinus disease, their role in postoperative management after ESBS for tumors is unclear. Our findings suggest that mometasone irrigation may be effective at improving postoperative quality of life in patients after ESBS.
目的:使用外用皮质类固醇治疗内窥镜颅底手术(ESBS)后鼻窦症状尚未得到很好的研究。我们量化了术后类固醇冲洗(si)对ESBS术后患者生活质量的长期影响。方法:回顾性分析2010年至2019年在宾夕法尼亚大学接受ESBS治疗的患者。收集患者人口统计数据和术后治疗的数据，每日两次鼻盐水冲洗，有或没有溶解的类固醇(莫米松或布地奈德)。评估术前、术后1、3、6、12、18和24个月的鼻内镜预后测试(SNOT-22)评分。结果:共评估727例患者(男性53.4%)，其中未穿刺组479例，穿刺组248例。术前SNOT-22评分差异无统计学意义(P = 0.19)。术后1个月、3个月、6个月、12个月、18个月和24个月的SNOT-22评分在两组间无显著差异。然而，与布地奈德相比，莫米松冲洗导致术后2年SNOT-22评分显著降低(P P = 0.03)。结论:虽然皮质类固醇冲洗是治疗炎性窦病的常规方法，但其在ESBS术后肿瘤治疗中的作用尚不清楚。我们的研究结果表明，莫米松冲洗可能有效地改善ESBS后患者的术后生活质量。
{"title":"Postoperative mometasone irrigations improve quality of life in skull base tumor patients.","authors":"Mandy K Salmon, Rijul S Kshirsagar, Jacob G Eide, Auddie M Sweis, Kathleen Davin, Aman Prasad, Heather Ungerer, Elizabeth Stevens, Kevin Ig-Izevbekhai, Siddhant Tripathi, Tran B Locke, Theodore Lin, Brian M Sweis, Michael A Kohanski, Nithin D Adappa, James N Palmer","doi":"10.1002/wjo2.99","DOIUrl":"10.1002/wjo2.99","url":null,"abstract":"<p><strong>Objectives: </strong>The use of topical corticosteroids to manage postoperative sinonasal symptoms after endoscopic skull base surgery (ESBS) has not been well studied. We quantified long-term impact of postoperative steroid irrigations (SIs) on quality of life of patients after ESBS.</p><p><strong>Methods: </strong>Retrospective review of patients at the University of Pennsylvania undergoing ESBS from 2010 to 2019. Data on patient demographics and postoperative treatment with nasal saline irrigation twice daily with and without dissolved steroids (mometasone or budesonide) was collected. Preoperative, and 1-, 3-, 6-, 12-, 18-, and 24-month postoperative Sino-Nasal Outcome Test (SNOT-22) scores were assessed.</p><p><strong>Results: </strong>A total of 727 patients were assessed (53.4% males), with 479 patients in the no SI group and 248 patients in the SI group. Preoperative SNOT-22 scores did not differ significantly (<i>P</i> = 0.19). 1-, 3-, 6-, 12-, 18-, and 24-month post-op SNOT-22 scores did not significantly differ between groups. However, mometasone irrigations resulted in significantly lower postoperative 2-year SNOT-22 scores compared to budesonide (<i>P</i> < 0.01) and saline (<i>P</i> = 0.03).</p><p><strong>Conclusions: </strong>Though corticosteroid irrigations are routine in managing inflammatory sinus disease, their role in postoperative management after ESBS for tumors is unclear. Our findings suggest that mometasone irrigation may be effective at improving postoperative quality of life in patients after ESBS.</p>","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"16 1","pages":"314-319"},"PeriodicalIF":0.0,"publicationDate":"2023-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10696264/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82894140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-04-01DOI: 10.1089/blr.2023.29303.cmh
Christopher M. Holman
{"title":"A 2023 Review of Legislation Aimed at Increasing Generic and Biosimilar Competition","authors":"Christopher M. Holman","doi":"10.1089/blr.2023.29303.cmh","DOIUrl":"https://doi.org/10.1089/blr.2023.29303.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48141858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-04-01DOI: 10.1089/blr.2023.29302.sjz
STEVEN J. ZWEIG
Biotechnology Law ReportVol. 42, No. 2 News BriefsSelected Developments in Biotechnology Law and the Biotechnology IndustryBy Steven J. ZweigBy Steven J. ZweigSteven J. Zweig is the Managing Editor of Biotechnology Law Report.Search for more papers by this authorPublished Online:6 Apr 2023https://doi.org/10.1089/blr.2023.29302.sjzAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 42Issue 2Apr 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:By Steven J. Zweig.Selected Developments in Biotechnology Law and the Biotechnology Industry.Biotechnology Law Report.Apr 2023.65-67.http://doi.org/10.1089/blr.2023.29302.sjzPublished in Volume: 42 Issue 2: April 6, 2023Online Ahead of Print:March 24, 2023PDF download
生物技术法律报告卷。《生物技术法和生物技术产业的发展》作者:Steven J. Zweig作者:Steven J. Zweig是《生物技术法报告》的总编辑。搜索本文作者的更多论文出版在线:2023年4月6日https://doi.org/10.1089/blr.2023.29302.sjzAboutSectionsView文章查看全文pdf /EPUB权限& citationspermissions下载CitationsTrack citations添加到收藏回到出版物共享在facebook上分享推特链接在redditemail查看文章figuresreferencesrelateddetails第42期2023年4月信息版权2023,Mary Ann Liebert, Inc.，出版商引用这篇文章:由Steven J. Zweig。生物技术法和生物技术产业的若干发展。生物技术法律报告。Apr 2023.65-67.http://doi.org/10.1089/blr.2023.29302.sjzPublished卷:42期:2023年4月6日在线提前打印:2023年3月24日pdf下载
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Pub Date : 2023-04-01DOI: 10.1089/blr.2023.29306.cip
Christopher M. Holman
Biotechnology Law ReportVol. 42, No. 2 Minerva Surgical, Inc. v. Hologic, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 1371Edited for Biotechnology Law Report by Christopher M. HolmanEdited for Biotechnology Law Report by Christopher M. HolmanChristopher M. Holman is a Professor of Law at the University of Missouri-Kansas City School of Law; a Senior Scholar at the Center for the Protection of Intellectual Property at the Antonin Scalia Law School, George Mason University; and the Executive Editor of Biotechnology Law Report.*The synopsis is original content and the decision itself has been condensed for ease of readability.Search for more papers by this authorPublished Online:6 Apr 2023https://doi.org/10.1089/blr.2023.29306.cipAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 42Issue 2Apr 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Edited for Biotechnology Law Report by Christopher M. Holman.Minerva Surgical, Inc. v. Hologic, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 1371.Biotechnology Law Report.Apr 2023.108-114.http://doi.org/10.1089/blr.2023.29306.cipPublished in Volume: 42 Issue 2: April 6, 2023Online Ahead of Print:March 30, 2023PDF download
生物技术法律报告卷。Minerva Surgical, Inc.诉Hologic, Inc.案美国联邦巡回上诉法院，2023 59 F.4th 1371编辑生物技术法报告Christopher M. Holman编辑生物技术法报告Christopher M. Holman是密苏里大学堪萨斯城法学院的法学教授;乔治梅森大学安东宁·斯卡利亚法学院知识产权保护中心高级学者;也是《生物技术法律报告》的执行主编。*摘要是原创内容，为了便于阅读，决定本身已被浓缩。搜索本文作者的更多论文出版在线:2023年4月6日https://doi.org/10.1089/blr.2023.29306.cipAboutSectionsView文章查看全文pdf /EPUB许可& citationspermissions下载CitationsTrack citations添加到收藏回到出版物ShareShare onFacebookTwitterLinked InRedditEmail查看文章figuresreferencesrelateddetails第42期2023年4月2日信息版权2023,Mary Ann Liebert, Inc.，本文作者:Christopher M. Holman为《生物技术法律报告》编辑。Minerva Surgical公司诉Hologic公司案美国联邦巡回上诉法院，2023年59 f .4 1371。生物技术法律报告。2023年4月108-114.http://doi.org/10.1089/blr.2023.29306.cipPublished卷:42第2期:2023年4月6日在线提前打印:2023年3月30日pdf下载
{"title":"Minerva Surgical, Inc. v. Hologic, Inc. <i>United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 1371</i>","authors":"Christopher M. Holman","doi":"10.1089/blr.2023.29306.cip","DOIUrl":"https://doi.org/10.1089/blr.2023.29306.cip","url":null,"abstract":"Biotechnology Law ReportVol. 42, No. 2 Minerva Surgical, Inc. v. Hologic, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 1371Edited for Biotechnology Law Report by Christopher M. HolmanEdited for Biotechnology Law Report by Christopher M. HolmanChristopher M. Holman is a Professor of Law at the University of Missouri-Kansas City School of Law; a Senior Scholar at the Center for the Protection of Intellectual Property at the Antonin Scalia Law School, George Mason University; and the Executive Editor of Biotechnology Law Report.*The synopsis is original content and the decision itself has been condensed for ease of readability.Search for more papers by this authorPublished Online:6 Apr 2023https://doi.org/10.1089/blr.2023.29306.cipAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 42Issue 2Apr 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Edited for Biotechnology Law Report by Christopher M. Holman.Minerva Surgical, Inc. v. Hologic, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 1371.Biotechnology Law Report.Apr 2023.108-114.http://doi.org/10.1089/blr.2023.29306.cipPublished in Volume: 42 Issue 2: April 6, 2023Online Ahead of Print:March 30, 2023PDF download","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135275105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-03-30DOI: 10.1089/blr.2023.29304.cip
Christopher M. Holman
{"title":"ChromaDex, Inc. v. Elysium Health, Inc.","authors":"Christopher M. Holman","doi":"10.1089/blr.2023.29304.cip","DOIUrl":"https://doi.org/10.1089/blr.2023.29304.cip","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43023056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-03-30DOI: 10.1089/blr.2023.29305.cip
Christopher M. Holman
{"title":"Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC","authors":"Christopher M. Holman","doi":"10.1089/blr.2023.29305.cip","DOIUrl":"https://doi.org/10.1089/blr.2023.29305.cip","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41400620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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