MoFo Life Sciences

June 07, 2021 - Agtech, Biotech
Alternative Protein Industry Series
By: Andrew Boyd, Michael Ward Ph.D. and Simon Arlington
With an expanding global population and finite resources, our food systems are under significant pressure. Alternative proteins are increasingly presented as the solution to relieving the pressure that our food systems are under and to improving global food security. They can provide excellent nutritional
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March 01, 2021 - FDA, COVID-19, Rare Disease, Biotech, Healthcare, Pharma, Regulatory
Rare Disease: Sustained Progress in Development Regardless of the Pandemic
By: Catherine M. Polizzi Ph.D.
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In addition, a number of policies implemented in response
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December 17, 2020 - COVID-19, Biotech, European Union, Pharma, Data Analytics, Intellectual Property
The European Commission’s New Pharmaceutical Strategy for Europe
By: Wolfgang Schönig
Nina Schäfer and Jin Ito contributed to this article. On November 25, 2020, the European Commission (the “Commission”) published its “ Pharmaceutical Strategy for Europe ” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system. The strategy aims to achieve various
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September 09, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
Pediatric Exclusivity for Biologics
The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights. At
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July 22, 2020 - Biotech, Pharma, Regulatory, Asia
China to Criminalize Human Genetic Resources Violations
On June 28, 2020, the draft 11 th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for review. The Draft added a number of crimes intended to “connect” with certain provisions in China’s Human
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July 10, 2020 - Biotech, Pharma, Regulatory, Asia
China’s Biosecurity Law will cover Human Genetic Resources
During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Biosecurity Law. At the conclusion of the meetings, the second draft of the Biosecurity Law (the “Draft”) was published for
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April 22, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
FDA Uses EUAs Broadly In The Fight Against Covid-19
By: Julie Y. Park
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel
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April 09, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
CARES Act of 2020: Guide for Drug and Device Companies
The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. The
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March 18, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Biotech, Healthcare, Pharma
FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers
On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health
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March 11, 2020 - United States, Medical Devices + Diagnostics, COVID-19, Biotech, Healthcare, Pharma
U.S. government announces new federal funding opportunities related to COVID-19
By: Tina D. Reynolds
The Biomedical Advanced Research and Development Authority ( BARDA ), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, has modified an existing broad agency announcement (BAA) through which it will award government funding
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Topic Archives: Biotech

Alternative Protein Industry Series

By: Andrew Boyd, Michael Ward Ph.D. and Simon Arlington

Rare Disease: Sustained Progress in Development Regardless of the Pandemic

By: Catherine M. Polizzi Ph.D.

The European Commission’s New Pharmaceutical Strategy for Europe

By: Wolfgang Schönig

Pediatric Exclusivity for Biologics

China to Criminalize Human Genetic Resources Violations

China’s Biosecurity Law will cover Human Genetic Resources

FDA Uses EUAs Broadly In The Fight Against Covid-19

By: Julie Y. Park

CARES Act of 2020: Guide for Drug and Device Companies

FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

U.S. government announces new federal funding opportunities related to COVID-19

By: Tina D. Reynolds