News & Analysis as of

Life Sciences Research and Development Biopharmaceutical

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Perkins Coie

BARDA BioMaP-Consortium Up and Running

Perkins Coie on

In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

Perkins Coie on

The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

Epstein Becker & Green

Is CMS Ignoring the Realities of Biopharmaceutical Costs?

On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of...more

Goodwin

Navigating The New Normal: Disruption And Reinvention: The Pivot to Local Supply Chains

Goodwin on

It seems like there is a new article every day about how the COVID-19 pandemic has impacted the supply chain, particularly as economies reopen and we move into the next phase of the “new normal.” The disruptions in the supply...more

Womble Bond Dickinson

Getting Closer to a Definitive Biomarker for Parkinson’s Disease

Womble Bond Dickinson on

Parkinson’s disease is a devastating, incurable, progressive and degenerative neurological disease that affects movement. There are no biomarkers available and it is diagnosed by symptomology alone. Unfortunately, the...more

Kramer Levin Naftalis & Frankel LLP

Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19

SARS-CoV-2, the virus that causes COVID-19, is a novel coronavirus never before seen in humans. To date, it has caused 60,000 deaths in the United States – 56,000 of those in the last month alone. There does not yet exist an...more

Hogan Lovells

The Belgian AFMPS warns about risk of hemolysis associated with the use of hydroxychloroquine

Hogan Lovells on

On 14 April 2020, the Belgian Federal Agency for Medicines and Health Products (AFMPS), published a news flash warning physicians of the risk of hemolysis associated with the use of hydroxychloroquine in patients with...more

Kramer Levin Naftalis & Frankel LLP

Biopharmaceutical Industry Fights COVID-19 Pandemic with Innovation and Speed

The COVID-19 pandemic has created unprecedented challenges for almost every industry. Most acute is the clinical challenge facing overwhelmed and underequipped hospitals and health care workers....more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

Hogan Lovells on

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Jones Day

Artificial Intelligence and the Biopharmaceutical Industry: What's Next?

Jones Day on

The Situation: Artificial intelligence ("AI") is emerging as a key driver of innovation in the biopharmaceutical industry, which uses AI in research and development ("R&D") to analyze big data. The Result: AI is already...more

Hogan Lovells

HHS announces public meeting on ways to accelerate clinical innovation

Hogan Lovells on

Government seeks industry comment on expediting medical product development - The U.S. Department of Health and Human Services' (HHS) Immediate Office of the Secretary (IOS) has announced it will hold a public meeting...more

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