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Senior Editor
New York, USA
41+ years of experience
Pink Sheet
By Brenda Sandburg 01 Dec 2021
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.
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 03 Aug 2021
Ahead of CDC advisory committee this fall, Merck highlights additional bacteria serotypes its Vaxneuvance protects against while Pfizer touts Prevnar 13’s indication for pneumonia.
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 27 Nov 2020
The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
Topic Coronavirus Vaccines
Pink Sheet
By Brenda Sandburg 27 Nov 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 & Regulation
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 17 Nov 2020
Commissioners vote 3-2 that Mylan and Pfizer’s Upjohn can combine after divesting seven products; dissenting votes focus on price fixing allegations as commissioners Chopra and Slaughter criticize majority for not addressing government’s case against Pfizer and Mylan. Former FTC attorneys note that if Biden wins the presidential election, he could nominate one of the dissenters to FTC chair and give more traction to their views.
Topic US Election 2020 M A Legal Issues
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).
Topic 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.
Topic Legal Issues
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.
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 Alzheimer's Disease
Pink Sheet
16 May 2022
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11 May 2022
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10 May 2022
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06 May 2022
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04 May 2022
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03 May 2022
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03 May 2022
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28 Apr 2022
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27 Apr 2022
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25 Apr 2022
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21 Apr 2022
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18 Apr 2022
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18 Apr 2022
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14 Apr 2022
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13 Apr 2022
