Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Drug Review Profiles

Set Alert for Drug Review Profiles

Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements

European Medicines Agency insisted on a stricter statistical analysis than the US FDA for demonstrating equivalence on the primary endpoint for both Coherus/BioEq’s Cimerli and Samsung Bioepis’ Byooviz; there also were differences in the regulators' preferred primary analysis population and primary endpoint interval.

Drug Review Profile Biosimilars

Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis

Information on mechanism of action, pharmacokinetics, immunogenicity and toxicity convinced the US FDA there was no risk in terms of safety or diminished efficacy of switching between Cimerli and the reference product, Genentech’s eye drug Lucentis.

Drug Review Profile Biosimilars

US FDA's Spikevax Review By The Numbers

A timeline of the development and approval of Moderna's mRNA vaccine, and a listing of FDA reviewers on the biologics license application.

Drug Review Profile Coronavirus COVID-19

COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US

Five of the six modeling scenarios in the FDA’s quantitative benefit-risk assessment on myocarditis with Moderna’s vaccine assumed Omicron as the dominant circulating strain, with assumed average vaccine effectiveness of only 30% against COVID-19 cases and 72% against hospitalizations.

Drug Review Profile Coronavirus COVID-19

Proactive US FDA Propelled Review Of Genentech’s Actemra In Systemic Sclerosis Amid Evolving Regulatory Landscape

Pink Sheet’s Drug Review Profile series looks at the unusual history of a systemic sclerosis interstitial lung disease indication for Genentech’s Actemra that was revived at the FDA’s behest and vetted by CDER’s high-level CDER policy council.

Drug Review Profile Approvals

Actemra Review Chronology For SSc-ILD

Detailed timeline of the development and review of Genentech’s Actemra (tocilizumab) in systemic sclerosis-associated interstitial lung disease

Drug Review Profile Approvals

Ponvory’s Regulatory Timeline At The US FDA And EMA

Janssen’s ponesimod for relapsing multiple sclerosis had a slightly faster review in the US.

Europe Drug Review Profile

Fatigue Benefit With Janssen’s MS Drug Ponvory Not Clinically Relevant – US/EU Regulators

In approving ponesimod for relapsing multiple sclerosis, neither the FDA nor EMA included in labeling data from a novel patient-reported outcomes fatigue instrument; FDA said the PRO was not shown to be capable of measuring within-patient change, while EMA said the difference relative to Sanofi’s Aubagio fell short of the threshold for a clinically meaningful benefit.

Drug Review Profile Drug Review

EU, US Reviewers Differed On Ponvory’s Secondary Endpoints, But Hierarchy Didn’t Matter In The End

Janssen went against EMA’s advice on the choice of secondary endpoints for its multiple sclerosis drug Ponvory (ponesimod), but still enjoyed a relatively brisk review. The hierarchical order of endpoints did not seem to ruffle any feathers among US FDA reviewers.

Drug Review Profile Drug Review

US FDA’s Comirnaty Review By The Numbers

A timeline of the review and development of the first COVID-19 vaccine to win BLA approval.

Drug Review Profile Coronavirus COVID-19

Pfizer’s Comirnaty: Emerging Myocarditis Signal Drew Flurry Of Attention During Compressed BLA Review

Multiple offices within CBER worked to get a handle on the myocarditis issue in the midst of a three-month review of the COVID vaccine, with US FDA staff undertaking a quantitative benefit-risk assessment and negotiating with Pfizer on postmarket safety studies.

Drug Review Profile Vaccines

Placebo Unblinding Process For Pfizer’s COVID Vaccine No Detriment To US FDA Safety Analysis

Despite initial concerns among FDA staff and its advisory committee about unblinding the Comirnaty pivotal trial after emergency authorization, agency’s review of the first COVID vaccine to receive full licensure suggests its safety conclusions were not adversely affected.

Drug Review Profile Clinical Trials
See All
UsernamePublicRestriction

Register