MoFo Life Sciences

September 30, 2020 - Agtech, Pharma, Regulatory, Asia
China Technology Export Update: Amendment of The Export Technology Catalog
On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s Catalog of Technologies the Export of Which is Prohibited or Restricted (the “Catalog”). This is the first time the
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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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August 12, 2020 - United States, Litigation, Pharma, Intellectual Property
Casting a New Light on Diagnostic Patents: “Methods of Preparation” Patent-Eligible
By: Karen G Potter Ph.D.
The ability of life sciences companies to rely on patent protection for diagnostic methods has been eroded over the last ten years, although recent court decisions evidence a rebuilding framework. While courts have consistently invalidated diagnostic methods as lacking patent eligibility, claims re-framed as
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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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March 09, 2020 - FDA, COVID-19, Biotech, Pharma, Blockchain
Blockchain and The Drug Supply Chain Security Act (DSCSA)
As industry continues to grapple with and implement the Drug Supply Chain Security Act (DSCSA) enacted by Congress in 2013, some of the largest pharmaceutical companies believe they may have a solution to track prescription drugs across the supply chain to prevent the distribution
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Topic Archives: Pharma

China Technology Export Update: Amendment of The Export Technology Catalog

Pediatric Exclusivity for Biologics

Casting a New Light on Diagnostic Patents: “Methods of Preparation” Patent-Eligible

By: Karen G Potter Ph.D.

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

Blockchain and The Drug Supply Chain Security Act (DSCSA)