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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

Trove Of Opioid Documents May Help Shape Public Health Policy

As sponsors and US FDA continue to face fallout, newly launched digital archive of industry documents from opioid litigation and settlements will be free public resource for those investigating activities that led to the opioid epidemic. It is modeled on the archive of tobacco industry documents, which has been the basis of about 1,000 scientific publications.

Advertising, Marketing & Sales Drug Safety

COVID-19 Therapeutic Trials: Investigators Should Join Forces Rather Than Conduct Single Site Studies

‘Treacherous combination’ of small clinical trials, lagging enrollment, unreported results and uncompleted trials is hindering COVID-19 research, former FDA Commissioner Califf says. Yale professor calls for a ‘Manhattan Project’ around knowledge and a change in the academic star system.

Coronavirus COVID-19 Clinical Trials

Operation Warp Speed Had Trouble Enrolling Patients In COVID-19 Therapeutic Research

US FDA Acting Commissioner Woodcock says there is ‘a long list’ of lessons learned in the OWS therapeutics group, noting trial bureaucracy and the lack of resources and support for community centers.

Clinical Trials Cancer

J&J COVID-19 Vaccine Pause Expected To Be Brief, But Subsequent Use May Be Restricted

CDC’s ACIP likely to discuss criteria needed to lift pause and whether to recommend that the vaccine not be used in specific groups. Former CBER official says FDA and CDC will look at reports for other adenovirus vector vaccines, including J&J’s Ebola vaccine, and the biological plausibility that cases of rare blood clots are directly associated with the vaccine.

Coronavirus COVID-19 Vaccines

NCI’s Clinical Trial Accrual Is ‘Better’ Than Pharma Industry’s, Director Sharpless Says

NCI networks had vast under accrual in the past year, but Sharpless says industry has been affected to a greater degree. He says the institute also has been better at accruing minority patients.

Clinical Trials Coronavirus COVID-19

Health Care Providers Have Knowledge Gap On Biosimilars, Accelerated Approval

FDA’s 2019 survey of 2,000 providers finds 31% do not know what biosimilars are and 30% of primary care physicians do not know what an accelerated approval drug is. Another survey of low- or non-internet users finds a toll-free number is the best way for them to find information about a drug’s risks.

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