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Latest From Eagle Pharmaceuticals, Inc.

A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions

As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.

FDA Coronavirus COVID-19

Keeping Track: Viltepso Earns Priority Review Voucher; Manufacturing Trips Fennec; Eagle Drops Ryanodex Exertional Heat Stroke Bid

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Slayback’s Belrapzo Non-Infringement Judgement Is Upheld On Appeal

Slayback Pharma has succeeded in defending itself on appeal that it did not infringe certain patents shielding Eagle Pharmaceuticals’ Belrapzo rapid-infusion bendamustine product, after a district court applied the dedication-disclosure doctrine to bar the originator’s claim.

Intellectual Property Legal Issues

Tech Transfer Roundup: Be Cool Therapeutics Sees Potential In Mimicking Hibernation

Biotech licenses drug composition patents from University of Alaska Fairbanks for study in several disease states. Gilead seeks long-acting HIV therapy or prevention with broadly neutralizing antibodies discovered by Rockefeller U.

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Company Information

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  • Pharmaceuticals
  • Pharmaceuticals
    • Generic Drugs
    • Specialty Pharmaceuticals
    • Drug Delivery
      • Transdermal
  • Biotechnology
    • Large Molecule
      • Antibodies
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    • Arsia Therapeutics
    • Eagle Biologics
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