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Brenda Sandburg

Senior Editor

New York, NY
Brenda covers FDA regulatory policy and legal issues, including patent suits, Supreme Court cases, and government investigations, as well as developments at the US Patent and Trademark Office and Federal Trade Commission. Between stints at the Pink Sheet, she was a reporter for America Lawyer Magazine and a daily legal newspaper in San Francisco where she won several awards, including first place in investigative reporting for an article about the emergence of patent trolls. She is based in New York City.

Latest From Brenda Sandburg

Supreme Court Seems To Support Government’s Later Dismissal Of False Claims Act Cases

Justices cite changing circumstances, constitutional concerns in preventing government from seeking dismissal of a case in which it initially declined to intervene. They also question whether government should intervene before moving to dismiss.

Enforcement Legal Issues

Battle Over Patents And Drug Pricing Engulfs FDA And USPTO

President Biden and Congress are pressuring the agencies to change patent policies so brand manufacturers cannot delay generic and biosimilar competition to keep monopoly prices. Timeline shows how they have responded to these demands.

Pricing Debate Intellectual Property

CSL’s Hemgenix Gene Therapy Does Not Need A REMS, FDA Tells National Hemophilia Foundation

Peter Marks says labeling for CSL’s hemophilia B treatment adequately conveys its risks. He also denies NHF request that the label cite eligibility criteria used in clinical trials, responding to a citizen petition on the day the agency approves the therapy.

Gene Therapy Drug Safety

Pharma Could Face Fewer False Claims Act Suits If Supreme Court Concurs With Government

High court is to determine whether the government can dismiss an FCA complaint after initially declining to take it on. In recent years, the government has dismissed numerous qui tam suits against pharma companies in which it did not intervene.

Enforcement Medicaid

Gilead Wins Breach Of Contract Suit Against CDC But Damages, Patent Dispute Are Unresolved

Court finds government failed to promptly notify Gilead of its PrEP-related patent applications as required under agreements for supply of HIV drugs used in CDC studies. Whether Gilead will have to license government patents remains undecided.

Intellectual Property Legal Issues

Patient-Focused Drug Development Grants May Be Program’s ‘Most Significant’ Accomplishment Since 2019

US FDA has issued five grants for development of standard core clinical outcome assessments and related endpoints that can be used across disease areas and may produce more reliable data for regulatory decision-making.

FDA Clinical Trials
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