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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.
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Latest From Brenda Sandburg

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Commercial

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Reimbursement

Rare Diseases: US FDA Gives More Guidance On Premarket Safety Evaluation, Historical Controls

Agency specifies several approaches to augment safety assessment in a new draft guidance, which also encourages participation by patients and their advocates in the drug development process.


Rare Diseases Drug Approval Standards

Vanda Puts Dog Studies In Spotlight In Suit Challenging FDA Clinical Hold

Vanda seeks court order requiring US FDA to lift partial clinical hold on its gastroparesis treatment tradipitant; calls on drug makers to oppose agency's animal research policy, saying it requires unjustified killing of dogs.

Legal Issues Clinical Trials

Federal Circuit Tosses Diagnostic Patent, Spurring Biopharma Calls For Congressional Action

A divided panel finds Athena Diagnostics' patent on method to diagnose myasthenia gravis is invalid; in dissent, Judge Newman cites industry concerns that the decision will deter development of new diagnostic methods.

Intellectual Property Legal Issues

US Initiative To End HIV Epidemic Will Boost PrEP Access

'Number of different initiatives' coming in next several months to make drugs more affordable, including for PrEP prophylaxis, HHS Assistant Secretary for Health Giroir says. Multi-agency approach is key strategy.

Policy Infectious Diseases
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