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Senior Editor
New York, USA
41+ years of experience
Medtech Insight
By Brenda Sandburg 02 Nov 2021
The once and likely future FDA commissioner emphasized the value of randomized controlled trials, the fact that not all trials are good for people, and how decentralization and digitization are leaving people behind during a panel discussion.
Pink Sheet
By Brenda Sandburg 18 Mar 2021
Peter Marks says agency is getting first RWE readouts of vaccine safety; AstraZeneca’s vaccine has no expiration date, so stockpile is not currently at risk of being thrown out, the CBER director tells a House hearing.
Pink Sheet
By Brenda Sandburg 17 Nov 2020
Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.
Pink Sheet
By Brenda Sandburg 03 Jul 2019
Fallout from Supreme Court's Escobar decision and Department of Justice memos could impact types of healthcare fraud complaints in which the government intervenes.
Scrip
By Brenda Sandburg 02 Jul 2019
Xtandi use in early prostate cancer, lorlatinib as second-line treatment for non-small cell lung cancer and dacomitinib for first-line NSCLC have upcoming user fee dates.
Topic Cancer
Scrip
By Brenda Sandburg 28 May 2019
Bernstein analyst looks into J&J's average net price decline in 2017 and notes average sales price hikes for growth products Darzalex and Imbruvica are offset by price cuts for drugs facing competition. All products had single digit increases, though.
Topic Biosimilars
Pink Sheet
By Brenda Sandburg 15 May 2018
US FDA revises draft guidance issued in 2013 to allow research targeting cognition as single endpoint and studies solely evaluating biomarkers; document offers 'potential for multiple advances,' Alzheimer's Association says.
Topic Alzheimer's Disease
Pink Sheet
By Brenda Sandburg 15 May 2018
Allergan's novel tactic to derail inter partes review of Restasis patents ends for now as Patent Trial and Appeal Board denies Tribe's request to terminate proceeding; Board sets June 6 deadline for final written decision on IPR petition.
Pink Sheet
By Brenda Sandburg 08 Nov 2017
House IP Subcommittee Chair Issa suggests legislation may address sovereign immunity.
Pink Sheet
By Brenda Sandburg 26 Oct 2017
In 8-7 vote, Advisory Committee on Immunization Practices recommends GSK's Shingrix as preferred shingles vaccine given its higher efficacy compared to Merck's Zostavax.
Topic BioPharmaceutical
Pink Sheet
By Brenda Sandburg 15 Sep 2017
Commissioner Gottlieb says FDA is looking to work with provider groups to set dosage based on indication.
Pink Sheet
By Brenda Sandburg 30 Aug 2017
AbbVie seeks injunction against Boehringer Ingelheim's Cyltezo claiming infringement of 74 patents.
Topic Biosimilars
Scrip
By Brenda Sandburg 13 Feb 2017
Letter initiated by six CEOs drew 'absolutely overwhelming' response as 163 leaders of primarily small biotech and venture capital firms signed on; tech firms join court fight.
Pink Sheet
By Brenda Sandburg 26 Jan 2017
Draft guidance sums up agency’s policies for determining exclusivity, clarifies when the clock starts for failure to market.
Topic BioPharmaceutical FDA
Pink Sheet
21 Jul 2022
Pink Sheet
20 Jul 2022
Pink Sheet
19 Jul 2022
Pink Sheet
13 Jul 2022
Medtech Insight
11 Jul 2022
Pink Sheet
07 Jul 2022
Pink Sheet
06 Jul 2022
Generics Bulletin
01 Jul 2022
Pink Sheet
30 Jun 2022
Pink Sheet
30 Jun 2022
Pink Sheet
22 Jun 2022
Generics Bulletin
02 Jun 2022
Pink Sheet
01 Jun 2022
Pink Sheet
31 May 2022
Pink Sheet
24 May 2022
