Announcements

Welcome to Mofo Life Sciences

MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

March 26, 2020 - United States, COVID-19, Antitrust
Federal Antitrust Agencies Encourage Appropriate Competitor Collaboration to Address the COVID-19 Crisis
The U.S. antitrust agencies – the Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission (FTC) – have recognized a need for “unprecedented cooperation between federal, state, and local governments and among private businesses to protect Americans’ health and safety” during the
... ›
March 25, 2020 - FDA, COVID-19, Healthcare
FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked
By: Erin M. Bosman and Julie Y. Park
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based
... ›
March 24, 2020 - COVID-19, European Union, Regulatory, Intellectual Property
Hard Knocks Keep Coming for Europe’s Unified Patent Court
By: Wolfgang Schönig and Robert Grohmann
With brexited UK announcing that it will not join Europe’s long-awaited Unified Patent Court (UPC), the establishment of an efficient pan-European patent litigation system faces ever‑mounting challenges. Last Friday, the German Federal Constitutional Court declared that the German Act of Approval of the UPC
... ›
March 24, 2020 - FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action
Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis
By: Erin M. Bosman and Julie Y. Park
COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical
... ›
March 22, 2020 - United States, FDA, COVID-19, Product Liability + Class Action, Healthcare
FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus (COVID-19); State Attorneys General Follow Suit
By: Erin M. Bosman and Julie Y. Park
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of
... ›
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
... ›
March 12, 2020 - United States, COVID-19, Healthcare, Privacy + Data Security
OCR Bulletin on HIPAA Privacy and Coronavirus (COVID-19)
By: Melissa M. Crespo
In response to the recent outbreak of the novel coronavirus (2019-nCoV or COVID-19) and associated preparation and response, the Department of Health and Human Services Office for Civil Rights (OCR) recently released a bulletin (the “Bulletin”) outlining how entities subject to HIPAA may share
... ›
March 12, 2020 - AI + Robotics, Global, Corporate + Venture Capital, Blockchain
The New ABC's: Artificial Intelligence, Blockchain and How Each Compliments the Other
By: Vivian L. Hanson and Lee Adam Nisson
Artificial intelligence (AI) and blockchain technology are two novel innovations that offer the opportunity for us to move beyond our legacy systems and streamline enterprise management and compliance in ways previously unimaginable. Each technology augments the strengths and tempers the weaknesses of the other.
... ›
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
... ›
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
... ›

Never miss a post from MoFo Life Sciences. Enter your email below to stay up-to-date.

Welcome to Mofo Life Sciences

Federal Antitrust Agencies Encourage Appropriate Competitor Collaboration to Address the COVID-19 Crisis

FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked

By: Erin M. Bosman and Julie Y. Park

Hard Knocks Keep Coming for Europe’s Unified Patent Court

By: Wolfgang Schönig and Robert Grohmann

Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

By: Erin M. Bosman and Julie Y. Park

FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus (COVID-19); State Attorneys General Follow Suit

By: Erin M. Bosman and Julie Y. Park

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

OCR Bulletin on HIPAA Privacy and Coronavirus (COVID-19)

By: Melissa M. Crespo

The New ABC's: Artificial Intelligence, Blockchain and How Each Compliments the Other

By: Vivian L. Hanson and Lee Adam Nisson

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)