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Senior Editor
New York, {6D506EDE-F0E4-4964-93FF-D8A3DA23BDA0}
+38 year(s) experience
Pink Sheet
By Brenda Sandburg 07 Feb 2019
'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.
Pink Sheet
By Brenda Sandburg 01 Feb 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.
Topic Drug approval Strategy
Medtech Insight
By Brenda Sandburg 28 Jan 2019
Federal courts and the US Patent and Trademark Office will soon run out of funds that have allowed them to continue normal operations under the partial government shutdown so far.
Topic US Shutdown
Scrip
By Brenda Sandburg 23 May 2018
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
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US FDA revises draft guidance issued in 2013 to allow research targeting cognition as single endpoint and studies solely evaluating biomarkers; document offers 'potential for multiple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 Alzheimers
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.
Scrip
By Brenda Sandburg 29 Mar 2018
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 08 Nov 2017
House IP Subcommittee Chair Issa suggests legislation may address sovereign immunity.
Pink Sheet
By Brenda Sandburg 02 Nov 2017
Pharma is criticized for aggressive marketing, but the report also seeks industry help in research on innovative medication.
Topic FDA
Pink Sheet
By Brenda Sandburg 27 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 17 Oct 2017
Research centers are collaborating on projects to find causes of disease
Pink Sheet
By Brenda Sandburg 01 Oct 2017
Agreement with AbbVie allows Amgen to launch its Humira biosimilar in Europe in 2018 and in the US in 2023.
Topic Biosimilars
Pink Sheet
By Brenda Sandburg 21 Sep 2017
Janssen, Teva, Allergan, Endo, and Purdue – as well as several distributors
Pink Sheet
By Brenda Sandburg 16 Sep 2017
Commissioner Gottlieb says FDA is looking to work with provider groups to set dosage based on indication.
Pink Sheet
By Brenda Sandburg 14 Sep 2017
US FDA's preclinical policies should be 'more closely matched to the complexion of modern technologies,' commissioner explains.
Topic Clinical trials
Pink Sheet
19 Apr 2019
Pink Sheet
17 Apr 2019
Scrip
16 Apr 2019
Pink Sheet
14 Apr 2019
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10 Apr 2019
Pink Sheet
09 Apr 2019
Pink Sheet
05 Apr 2019
Pink Sheet
04 Apr 2019
Pink Sheet
04 Apr 2019
Pink Sheet
02 Apr 2019
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28 Mar 2019
Pink Sheet
27 Mar 2019
Pink Sheet
26 Mar 2019
Pink Sheet
26 Mar 2019
Pink Sheet
25 Mar 2019
