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Senior editor
USA
24+ years of experience
Pink Sheet
By Sue Sutter 03 Nov 2021
Whether a child receives the 10 mcg dose of COVID-19 vaccine authorized for 5-11 year-olds or the 30 mcg dose authorized for ≥12 year-olds should be based on age on day of vaccination, CDC says, but FDA is allowing some dosing flexibility for kids who celebrate their 12th birthday in the middle of the primary series.
Pink Sheet
By Sue Sutter 13 Oct 2021
Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.
Pink Sheet
By Sue Sutter 16 Aug 2021
After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.
Pink Sheet
By Sue Sutter 08 Jun 2021
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.
Pink Sheet
By Sue Sutter 23 Jul 2020
Considerations for switching from in-person to remote collection of patient- and observer-reported outcomes addressed in latest update to Q&A guidance, which also discusses Part 11 compliance requirements in the context of the pandemic and electronic collection of informed consent through MyStudies app.
Topic Coronavirus Clinical Trials
Pink Sheet
By Sue Sutter 18 Feb 2020
The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.
Topic Coronavirus Vaccines Manufacturing
Pink Sheet
By Sue Sutter 08 Jan 2020
Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.
Topic Drug Review Quality Control
Pink Sheet
By Sue Sutter 13 Nov 2019
REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.
Topic Drug Review FDA
Pink Sheet
By Sue Sutter 02 Jul 2019
Exhaustion of US FDA's PDUFA funds before partial federal government shutdown ends could lead sponsors or agency to assert that reviews for certain types of drugs should continue under an exception to the Anti-Deficiency Act, former FDA officials say.
Topic US Shutdown FDA
Pink Sheet
By Sue Sutter 10 Jun 2019
Internal group headed by Principal Deputy Commissioner Rachel Sherman will develop implementation recommendations, which could include new guidance, regulations, a Q&A document or ‘nothing at all,’ Commissioner Gottlieb tells BIO annual meeting; he promises consultation with the law’s supporters and critics on Capitol Hill ‘to fully understand what the intent was with different provisions.’
Topic FDA
Scrip
By Sue Sutter 07 Jun 2019
News and views from day two of the BIO International Convention: US FDA's Sharpless decries the focus on the price of "medical miracle" Zolgensma; Takeda explains why its business development philosophy leads to the valuation seen in the Ariad buyout; and CBER Director Marks talks about how his division will staff up to review cell and gene therapy candidates.
Topic FDA
Pink Sheet
By Sue Sutter 22 Aug 2018
Accrual difficulties force changes that nullify Special Protocol Assessment; ongoing, randomized FOCUS trial in patients with ocular melanoma that has metastasized to liver will become single-arm study and target enrollment will be reduced by 66%.
Pink Sheet
By Sue Sutter 15 May 2018
At meeting on Pacira's Exparel, advisory committee members warn against rushing to adopt products purported to reduce opioid consumption absent long-term longitudinal data showing beneficial public health impacts and clinical data linking reduced opioid use to functional outcomes or other clinical benefit.
Topic Approvals Drug Review
Pink Sheet
By Sue Sutter 19 Jan 2018
US FDA pilot program linking drug approval documents to sponsors' clinical study reports will improve review efficiency and access to information.
Topic Clinical Trials
Pink Sheet
By Sue Sutter 26 Nov 2017
BioMarin's sale of voucher earned with approval of rare pediatric disease drug Brineura the fourth publicly disclosed voucher sale.
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21 Jul 2022
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20 Jul 2022
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19 Jul 2022
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15 Jul 2022
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13 Jul 2022
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07 Jul 2022
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06 Jul 2022
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04 Jul 2022
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04 Jul 2022
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27 Jun 2022
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23 Jun 2022
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15 Jun 2022
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10 Jun 2022
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08 Jun 2022
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06 Jun 2022
