Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
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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
The Supreme Court recently rendered two important decisions for the biopharma industry. In the first decision, the Supreme Court ruled on enablement of genus claims for therapeutic antibodies, unanimously affirming the...more
Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - The COVID-19 pandemic has entrenched telehealth into the fabric of modern health care...more
With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the...more
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
The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (the...more
The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more