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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

Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies

In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.

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US FDA Cast As Culpable Player In Opioid Epidemic In Hulu’s Dopesick Series

Show depicts former agency officials approving OxyContin labeling that enabled Purdue to market it as nonaddictive and subsequently refusing pleas to restrict its use.

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Employee’s Decoy Laptop Did Not Trick Pfizer Security, Trade Secret Suit Says

Pfizer alleges its associate director of statistics transferred 12,000 files from her company laptop ahead of move to Xencor. Company seeks a temporary restraining order to prevent her from disclosing confidential information, including information on Pfizer’s COVID-19 vaccine and monoclonal antibodies for treatment of cancer.

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Lilly’s Alzheimer’s Drug Will Get ‘Easier Ride’ Than Aduhelm But Does Not Show Clinical Benefit, Prof Says

Harsh assessment of Lilly’s Phase II study by UCL and UCSF professors suggests donanemab may face same hurdles as Biogen’s Aduhelm. Lilly exec says the drug slowed disease progression by six months, but UCL prof says that won’t make a difference.

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Clozapine REMS Program Paused After Problems With Re-Certification

US FDA says pharmacists may dispense the antipsychotic without a REMS authorization and wholesalers may continue to ship it during temporary suspension of REMS. A high call volume and long wait times have impacted patient access since the modified REMS launched on 15 November.

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Could This Be Pfizer’s Biggest Week At The US FDA For COVID Products?

With an EUA submission for its Paxlovid treatment pill and expected authorization for universal adult vaccine boosters, Pfizer is establishing a portfolio of COVID products that could be used well after the eventual lifting of the public health emergency.

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