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Senior editor
USA
24+ years of experience
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 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 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 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 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 30 Sep 2017
Patient testimony to the contrary, advisory committee members were not persuaded that PTC Therapeutics' ataluren.
Topic Drug Review
Pink Sheet
By Sue Sutter 20 Sep 2017
Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find
Topic Approvals
Scrip
By Sue Sutter 09 Aug 2017
FDA advisory committee's concerns about a mortality imbalance in Plivensia clinical trials would appear to reduce the odds.
Topic Drug Review
Pink Sheet
By Sue Sutter 25 Jun 2017
US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit.
Topic Biosimilars
Pink Sheet
By Sue Sutter 13 Jun 2017
Despite facing one-year delay, Coherus is buoyed by FDA’s apparent support for its decision not to conduct clinical study in cancer patients.
Topic Biosimilars
Pink Sheet
By Sue Sutter 19 Dec 2016
Biopharma industry is preparing for the unwelcome possibility that the new Congress and Trump Administration will seek to revisit provisions in the negotiated agreement for the US FDA user fee program's reauthorization.
Topic Policy & Regulation
Pink Sheet
21 Jul 2022
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20 Jul 2022
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15 Jul 2022
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04 Jul 2022
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23 Jun 2022
Pink Sheet
15 Jun 2022
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10 Jun 2022
Pink Sheet
30 May 2022
Medtech Insight
25 May 2022
Pink Sheet
23 May 2022
HBW Insight
12 May 2022
Pink Sheet
10 May 2022
Pink Sheet
10 May 2022
Pink Sheet
04 May 2022
Pink Sheet
03 May 2022
