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Brenda Sandburg

New York, NY
Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She spent 10 years writing for legal publications between stints at The Pink Sheet and blends these experiences to provide in-depth analysis of events. An aspiring photographer, she enjoys taking photos to accompany news stories.

Latest From Brenda Sandburg

US FDA’s Confidentiality Policies Seen As Big EUA Shortcoming

System needs to be changed to enable US FDA to share COVID-19 application data and inspection reports with other regulatory authorities, stakeholders urge. Merck’s Julie Gerberding and former FDA Commissioner Hamburg criticize company announcement of data via press release prior to submission.

Coronavirus COVID-19 Vaccines

Could FDA And CDC’s COVID-19 Vaccine AdComs Be Better Coordinated? FDA’s Marks Thinks So

Federal government needs to make sure its messaging on vaccines is harmonized, CBER director Marks says. Vaccine development could have been accelerated in pregnant, pediatric and immunocompromised populations, he notes.

Coronavirus COVID-19 Advisory Committees

US FDA Loses Orphan Exclusivity Case While HHS Wins Dismissal Of Pfizer Kickback Complaint

In rare loss for FDA, appeals court reverses district court decision tossing Catalyst’s suit over Orphan Drug Act, saying deference should not have been granted to agency’s interpretation. District court finds it is too early to rule on one Pfizer charity co-pay program but backs broad reading of Anti-Kickback Statute.

Rare Diseases Pricing Strategies

Generic Entry Reforms Gain Steam In Congress With House Committee Passage

Bills to reign in petitions, pay-for-delay, product hopping, and patent thickets clear House Judiciary Committee. Legislation may have better shot at enactment this time around given bipartisan support in both House and Senate Committees.

Intellectual Property Legislation

US FDA Tweaks Guidance On Sameness Of Gene Therapies, But Questions Remain

In response to industry input, the agency made a few changes to its draft guidance but several issues remain uncertain, such as what constitutes ‘minor differences’ between gene therapy products.

Guidance Documents Gene Therapy

USPTO Faces Growing Pressure To Enter Battle Over Drug Pricing

Members of Congress, companies and government agencies want the Patent Office to change policies that they say impede generic drug competition. The latest effort is focused on PTO’s discretionary denial of inter partes review petitions, which is the subject of a bipartisan congressional letter and cert petition to the US Supreme Court.

Intellectual Property Legal Issues
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