Topic
Biotech
244 published works
Life Sciences Perspectives
Navigating China-Related Transactions: Legal and Strategic Considerations
As part of Goodwin’s week of exclusive programming during the BIO International Convention in Boston, we’re excited to invite you to a session focused on China-based NewCos and the dynamics…
The Faculty Lounge
The Fate of Early Stage Medical Trials in the US
Reuters spoke to 7 biotech executives, investors, & consultants who said that "the staff departures & policy changes at the FDA had prompted some firms to consider launching trials in…
Big Molecule Watch
Join Us! The Future of Biotech Regulation Webinar
By Sarah Clarke
As part of Goodwin’s webinar series, What’s Next: Life Sciences at a Crossroads, Matthew Wetzel and Elizabeth Mulkey will be diving into highlights from the Trump 47 Executive Orders on…
Inside EU Life Sciences
The Covington European Life Sciences Symposium 2025
By Grant Castle, Peter Bogaert, Marie Doyle-Rossi, Anna Wawrzyniak, Dr. Dr. Adem Koyuncu, Raj Gathani, Sarah Cowlishaw, Jonathan Gimblett, Monique O'Donoghue, Mark Young, Paul Maynard, Cándido García Molyneux, Bart Van Vooren, Seán Finan, James Halstead, Winsome Cheung, Ben Land-Maycock, Inga-Marlene Pietsch, Bethan Lukey, Guy Dingley, Mark Mitchell, Sibel Yilmaz, Robin Blaney, Mark Finucane, Antonio Michaelides
On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry…
The Daily Intake
FDA Updates Guidance on Premarket Engagement for Genome-Edited Plant Varieties
On December 16, 2024, FDA released a new inventory of voluntary premarket meetings that the Agency has held with developers of foods from new genome-edited plant varieties. FDA holds voluntary…
Big Molecule Watch
Recent Biologics Deals
Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 On December 4, 2024, Duality Biologics (“DualityBio”), a clinical-stage biotech company focusing on the…
Global Supply Chain Law Blog
U.S. House Of Representatives Passes The BIOSECURE Act During “China Week”
On September 9, 2024, the U.S. House of Representatives commenced “China Week,” during which the House passed 25 bills intended to limit the influence of the Chinese Communist Party in…
Joe Raczynski | Technologist
CRISPR: The Future of Humanity
If you have a baby today, it is highly likely the child will live until they are 125 years old. Many years ago, I used this teaser introduction slide in…
The Daily Intake
APHIS Announces Flexibility Allowing for Reuse of BRS Import Labels
On August 2nd USDA’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Service (BRS) announced a new flexibility which permits the reuse of BRS import labels. BRS administers the…
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