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Senior Editor
New York, USA
+39 year(s) experience
Pink Sheet
By Brenda Sandburg 17 Feb 2020
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).
Pink Sheet
By Brenda Sandburg 16 Jan 2020
An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.
Topic FDA Policy and regulation
Pink Sheet
By Brenda Sandburg 06 Dec 2019
Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.
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.
Topic Drug approval Strategy
Pink Sheet
By Brenda Sandburg 03 Jul 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.
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US FDA revises draft guidance issued in 2013 to allow research targeting cognition as single endpoint and studies solely evaluating biomarkers; document offers 'potential for multiple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 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.
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
20 Feb 2020
Pink Sheet
18 Feb 2020
Pink Sheet
16 Feb 2020
Pink Sheet
16 Feb 2020
Pink Sheet
13 Feb 2020
Pink Sheet
13 Feb 2020
Pink Sheet
10 Feb 2020
Pink Sheet
06 Feb 2020
Pink Sheet
06 Feb 2020
Pink Sheet
05 Feb 2020
Generics Bulletin
04 Feb 2020
Pink Sheet
03 Feb 2020
Pink Sheet
05 Dec 2019
Pink Sheet
04 Dec 2019
Pink Sheet
03 Dec 2019
