MoFo Life Sciences

March 09, 2022 - Global, FDA, Healthcare, Pharma, Regulatory
FDA’s Loud and Clear Message: Engage with FDA Early and Formally
By: Brigid DeCoursey Bondoc
On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in China. Rather than following the traditional paradigm of assessing the risk-benefit profile
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February 25, 2022 - United States, FDA, Healthcare, Pharma, Regulatory
Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations
By: Brigid DeCoursey Bondoc and Rachel Park
Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC , a dispute concerning labeling for fluoride products that raised a variety of issues with broader implications for industries regulated by the U.S.
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February 15, 2022 - United States, FDA, Healthcare, Pharma, Intellectual Property
PATENT TERM EXTENSION FOR BIOLOGICS
By: Meghan McLean Poon and Yuying (Kate) You
Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA). To be eligible for
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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 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 14, 2022 - United States, Digital Health, Biotech, Pharma, Intellectual Property, Bioinformatics
USPTO Launches Program to Defer Subject Matter Eligibility Responses
By: Meghan McLean Poon
Starting February 1, 2022, the U.S. Patent and Trademark Office (USPTO) will begin inviting selected applicants to participate in a pilot program to defer subject matter eligibility examination until final disposition of the application or all other rejections have been addressed. The theory behind
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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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Topic Archives: Pharma

FDA’s Loud and Clear Message: Engage with FDA Early and Formally

By: Brigid DeCoursey Bondoc

Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations

By: Brigid DeCoursey Bondoc and Rachel Park

PATENT TERM EXTENSION FOR BIOLOGICS

By: Meghan McLean Poon and Yuying (Kate) You

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

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

USPTO Launches Program to Defer Subject Matter Eligibility Responses

By: Meghan McLean Poon

Life Sciences Patent Trends in 2022 – Doctrine of Equivalents

By: Meghan McLean Poon