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2,748 results found

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TMT Law Practice | India | 16 Jun 2022

Orphan drugs and disease : Regulatory and Legal framework

The healthcare system in India and across the globe has been over-burdened with diseases and discovering ways to regulate and control them. In such…
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Hogan Lovells | European Union | 16 Jun 2022

The new Clinical Trials Regulation - what you need to know now

With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode : Protection…
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Knobbe Martens | USA | 13 Jun 2022

BD and Mayo Clinic Collaborate to Share De-Identified Patient Data

Becton, Dickinson and Company (BD) has partnered with Mayo Clinic to gain access to de-identified patient data from Mayo Clinic Platform_Discover, as…
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Cooley LLP | USA | 8 Jun 2022

Liquid Biopsy Technology: FDA’s Latest Guidance Supports Several Uses of ctDNA in Clinical Trials, but Not (yet) as Surrogate Clinical Endpoint

On May 3, 2022, the US Food and Drug Administration issued a draft guidance document on the Use of Circulating Tumor DNA for Early-Stage Solid Tumor…
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SP Law | Brazil | 7 Jun 2022

Draft bill on Human Clinical Trials in Brazil

In recent years, several factors have contributed to the creation of a framework for clinical trials in Brazil. Draft bill 7,082/17 ("Bill") is the…
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Cooley LLP | USA | 6 Jun 2022

In re Nektar Therapeutics: Ninth Circuit Affirms Dismissal of Securities Class Action Arising from Failure of Clinical Drug Trial

On May 19, 2022, a panel of the Ninth Circuit unanimously affirmed the district court’s dismissal of a putative securities fraud class action…
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Zhong Lun Law Firm | China | 31 May 2022

高校院所在创新药研发成果转化过程中的定位探讨与合规风险(下)

上篇(《高校院所在创新药研发成果转化过程中的定位探讨与合规风险(上)》)笔者梳理汇总了部分高校创新药研发科技成果转化的相关政…
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Osborne Clarke | United Kingdom | 19 May 2022

Medical device, clinical trial and safety rules reforms could boost UK life sciences

Innovative technology is heralded as the silver bullet to reduce burgeoning healthcare costs and improve patient outcomes. But will the regulatory…
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Hogan Lovells | France | 28 Apr 2022

Long-awaited update of the French “Convention Unique” for clinical trials finally published

A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the…
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Becerril Coca & Becerril SC | Mexico | 25 Apr 2022

IP protection in clinical trials

If a patentee has conducted sufficient research to obtain publications and a patent out of a new and innovative technology that has shown promising pharmaceutical activity, but then they run out of funding to take their discovery forward, a competitor could come across the investigation and decide to run a clinical trial on it, without letting the patentee know. An early listing of a granted......
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