MoFo Life Sciences

February 09, 2022 - United States, COVID-19, Healthcare
DOJ Releases False Claims Act Statistics for Fiscal Year 2021
By: Brian K. Kidd, Adam L. Braverman and Demme Doufekias
On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it collected more than $5.6 billion in False Claims Act (FCA) settlements and judgments in fiscal year 2021. This is the largest annual total since 2014, and the second largest in FCA history. Though
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February 03, 2022 - FDA, Medical Devices + Diagnostics, Digital Health, Healthcare, Pharma
MoForum Recap: Transformation Across the Industry
Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and the trends that are driving the industry across the digital health, diagnostic, and drug markets. Digital Transformation in the Life Sciences
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January 31, 2022 - United States, Digital Health, Biotech, Healthcare, Pharma
RECORDINGS NOW AVAILABLE: 2022 LIFE SCIENCES MOFORUM – GROWTH, INNOVATION, AND STRATEGY
Last week, Morrison & Foerster’s Life Sciences & Healthcare Group hosted its first program of the year with the firm’s 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy. We welcomed 100+ participants over the three-day virtual program to hear from leaders from across the
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January 27, 2022 - FDA, Biotech, Healthcare, Pharma
FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use
By: Rachel Park and Brigid DeCoursey Bondoc
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and through telemedicine in order to reduce the burden on patient access.
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January 25, 2022 - United States, Digital Health, Biotech, Healthcare, Pharma
2022 Life Sciences MOFORUM Starts This Week
By: Matthew Karlyn
Morrison & Foerster kicked off its virtual 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy on January 25, 2022. With three days of programming planned, the series started with a discussion on the “Digital Transformation in Life Sciences,” featuring digital health advisor Melinda
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January 21, 2022 - United States, Medical Devices + Diagnostics, Healthcare, Privacy + Data Security
Latest Genetic Data Privacy Law Goes into Effect
By: Melissa M. Crespo
California is ringing in the New Year with new privacy and security protections for genetic data. On January 1, 2022, California’s new Genetic Information Privacy Act (GIPA) became the latest state genetic data privacy law to go into effect, adding to a growing number
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January 20, 2022 - FDA, Biotech, Healthcare, Pharma, Regulatory
FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products
Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product
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January 13, 2022 - United States, Digital Health, Healthcare, Data Analytics, Intellectual Property, Bioinformatics
Bioinformatics Patents – Subject Matter Eligibility in 2022
By: Jean Nguyen
The increasing presence of data-driven solutions in the healthcare and life sciences sector is apparent from the rise in numbers of patents and patent applications. The number of published bioinformatics patents and patent applications in the last decade has nearly doubled. Bioinformatics patents face
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January 05, 2022 - Litigation, Biotech, Healthcare, Pharma, Intellectual Property
Life Sciences Patent Trends in 2022 – Doctrine of Equivalents
By: Meghan McLean Poon
The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims directed to specific sequences. At the same time, reliance on the
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December 23, 2021 - FDA, Medical Devices + Diagnostics, Litigation, Healthcare
3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session
By: Rachel Park
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022. The session included presentations from Ann Oxenham (CFSAN),
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Topic Archives: Healthcare

DOJ Releases False Claims Act Statistics for Fiscal Year 2021

By: Brian K. Kidd, Adam L. Braverman and Demme Doufekias

MoForum Recap: Transformation Across the Industry

RECORDINGS NOW AVAILABLE: 2022 LIFE SCIENCES MOFORUM – GROWTH, INNOVATION, AND STRATEGY

FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use

By: Rachel Park and Brigid DeCoursey Bondoc

2022 Life Sciences MOFORUM Starts This Week

By: Matthew Karlyn

Latest Genetic Data Privacy Law Goes into Effect

By: Melissa M. Crespo

FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

Bioinformatics Patents – Subject Matter Eligibility in 2022

By: Jean Nguyen

Life Sciences Patent Trends in 2022 – Doctrine of Equivalents

By: Meghan McLean Poon

3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session

By: Rachel Park