Topic Archives: Pharma

March 17, 2020 - Biotech, COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Pharma, United States

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

By: Keunbong (KB) Do and Bethany J. Hills

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 11, 2020 - Biotech, COVID-19, Healthcare, Medical Devices + Diagnostics, Pharma, United States

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

By: Tina D. Reynolds and Bethany J. Hills

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 to companies …›

March 9, 2020 - Biotech, Blockchain, COVID-19, FDA, Pharma

Blockchain and The Drug Supply Chain Security Act (DSCSA)

By: Hilary R. Hoffman and Bethany J. Hills

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 …›

January 23, 2020 - Biotech, FDA, Healthcare, Pharma, Regulatory, United States

FDA and Real-World Evidence in 2019

By: Keunbong (KB) Do and Bethany J. Hills

Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the agency in evaluating the potential use of real-world evidence (RWE) in regulatory decisions involving drug and biological products.[2] The …›

January 10, 2020 - Biotech, FDA, Healthcare, Litigation, Medical Devices + Diagnostics, Pharma, Regulatory, United States

2019 FDA Enforcement and Related Litigation Trends (Part 3)

By: Hilary R. Hoffman and Bethany J. Hills

Our earlier posts (part 1 and part 2) looked at a few overall trends at FDA as well as the impact of consent decrees issued in 2019. Today we will highlight some enforcement trends at the Department of Justice. Department of Justice Enforcement Trends In 2019, …›

January 9, 2020 - Biotech, FDA, Healthcare, Litigation, Medical Devices + Diagnostics, Pharma, Regulatory, United States

2019 FDA Enforcement and Related Litigation Trends (Part 2)

By: Hilary R. Hoffman and Bethany J. Hills

Yesterday, we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees. FDA Consent Decrees FDA published press releases about …›

January 8, 2020 - Biotech, FDA, Healthcare, Litigation, Medical Devices + Diagnostics, Pharma, Regulatory, United States

2019 FDA Enforcement and Related Litigation Trends (Part 1)

By: Hilary R. Hoffman and Bethany J. Hills

The year 2019 was one of uncertainty for FDA, as former Commissioner Scott Gottlieb announced his departure in March, ultimately stepping down in April. For the bulk of the year, FDA was led by Acting Commissioner, Ned Sharpless, until Brett Giroir took over …›

December 9, 2019 - Intellectual Property, Litigation, Pharma, United States

Striking the Balance in Trade Secret and Corporate Espionage Disputes

By: Matthew A. Chivvis and Anthony Michael Parenti

In 2017, the Commission on the Theft of American Intellectual Property issued a report to Congress estimating that the theft of trade secrets could cost the United States economy as much as $600 billion annually. In the years following, news reports indicate that alleged …›

November 22, 2019 - Biotech, FDA, Healthcare, Intellectual Property, Litigation, Pharma, Regulatory, United States

FDA Approves 25th Biosimilar

By: Steve Keane

On November 15, Pfizer’s adalimumab product became the 25th biosimilar approved by FDA under the Biologics Price Competition and Innovation Act (BPCIA). The road to the 25th approval has been long and has involved some of the biggest companies and medications in the …›

September 19, 2019 - AI + Robotics, Data Analytics, FDA, Pharma, Product Liability + Class Action, Regulatory, United States

Artificial Intelligence and Pharma

By: Bethany J. Hills

Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have developed. …›