Topic
Biotech
245 published works
China Law Insight
管线分拆出海：中国BIO-TECH的新机遇？
By King & Wood
作者：张逸瑞 傅广锐 马俊豪 随着全球生物医药行业的快速发展，中国Bio-tech企业面临着前所未有的机遇与挑战。为了突破融资瓶颈、实现全球化布局，管线分拆出海以寻求海外市场的认可与资本支持成为诸多企业考虑的方向。2024年7月9日，K公司发布公告，将2款双抗新药CM512、CM536的大中华区外全球权益授权给境外的B公司。 CM512于今年5月申报IND，CM536处于临床前阶段。B公司由境外的医疗专业基金控股，持股比例50.26%，K公司全资的附属公司持股30.01%，K公司的董事长将加入B公司的董事会。更早些时候，知名医药H公司宣布通过将GLP-1产品组合的全球权利授权给境外的H公司，并获得H公司 19.9%股权。两个项目都展示了中国Bio-tech企业出海的新范式。 阅读更多
Health Law Prof Blog
Integrating the Biological and the Technological: Time to Move Beyond Law’s Binaries?
Muireann Quigley (University of Birmingham), Laura Downey (University of Birmingham), Integrating the Biological and the Technological: Time to Move Beyond Law’s Binaries? (Law and Legacy in Medical Jurisprudence: Essays in…
IP IQ
Preliminary Injunction Halts Sales of Tumor-Informed Cancer Screening Test
Late last week in Natera, Inc. v. NeoGenomics Laboratories, Inc. (24-1324), the Federal Circuit affirmed a preliminary injunction ruling from the lower court that mostly prohibits NeoGenomics from selling its…
The Daily Intake
USDA, FDA, EPA Release Joint Regulatory Plan for Biotechnology
In a press release issued on May 8, 2024, the U.S. Department of Agriculture (USDA) announced that has developed a joint regulatory plan with the U.S. Environmental Protection Agency (EPA)…
Al-Mirsal
Healthcare and Life Sciences Trends and Developments Across MENA
The healthcare and life sciences ecosystem is witnessing significant growth in the Middle East as the GCC continues to seek economic diversification. By Brian A. Meenagh, Sara Patel, and Lucy…
BioSlice Blog
Commission Communication on biotechnology and biomanufacturing
By Alexander Roussanov, Ana Gonzalez-Lamuno
On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing…
Health Law Prof Blog
Legal Regulation of Whole Genome Sequencing of Listeria monocytogenes in the Food Industry: Challenges, Attitudes, Possibilities
Christiane Hunsbedt, Lee A. Bygrave (University of Oslo), Annette Fagerlund (Nofima), Solveig Langsrund (Nofima), Legal Regulation of Whole Genome Sequencing of Listeria monocytogenes in the Food Industry: Challenges, Attitudes, Possibilities…
Health Law Prof Blog
Patentability – Impacts of Biotechnology following Association for Molecular Pathology v Myriad Genetics and D’Arcy v Myriad Genetics
Theresa-Marie Shaw (University of Queensland), Patentability – Impacts of Biotechnology following Association for Molecular Pathology v Myriad Genetics and D’Arcy v Myriad Genetics (2024):In Association for Molecular Pathology v Myriad…
Big Molecule Watch
Post-Trial Updates on Regeneron v. Mylan (Aflibercept) BPCIA Litigation
By Grace Truong
Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case…
Big Molecule Watch
Federal Circuit Remands to USPTO to Clarify Analysis of Jepson-Format and Means-Plus-Function Claims in the Field of Biotechnology
By Stephanie Dusaban Gonzales|Sabrina Poulos
On January 23, 2024, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) issued its decision granting the USPTO’s request to remand Xencor’s appeal of the rejection of…