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Biopharmaceutical Food and Drug Administration (FDA) FDA Approval

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Rivkin Radler LLP

OIG: Biopharma Company’s Provision of Free Genetic Tests Does Not Warrant Sanctions Under AKS

Rivkin Radler LLP on

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

Proskauer - Life Sciences

In the Orphan Drug Approval Race, Winner Takes All? Ramifications of Catalyst Pharms. v. Becerra

How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more

Wilson Sonsini Goodrich & Rosati

Microbes and Medical Foods: A Growing Area of Commercial Importance

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Global Patent Prosecution - June 2019: Hemp Legalization and the International CBD Boom

Products containing cannabidiol (“CBD”), a compound derived from cannabis plants, are part of a growing market segment that is on a fast-track to becoming global within the next five years. CBD-containing products, from gummy...more

Knobbe Martens

Aralez’s YOSPRALA wins FDA approval

Knobbe Martens on

On September 15, 2016, the U.S. Food and Drug Administration approved once-daily YOSPRALA™, a tablet that combines the anti-platelet agent, aspirin, with the anti-acid drug, omeprazole for decreasing the risk of...more

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