Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

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

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

Tivozanib’s Efficacy Behind Checkpoint Inhibitors In Renal Cell Carcinoma Reassured US FDA

Approximately 25% of patients in the TIVO-3 trial had prior treatment with checkpoint inhibitors, but progression-free survival in this subgroup was similar to the overall population, giving the FDA confidence about tivozanib's role in contemporary treatment regimens, Drug Review Profile finds.

Drug Review Profile Cancer

AVEO’s Fotivda: US FDA Concerns About Overall Survival Put To Rest By TIVO-3 Final Analysis

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.

Drug Review Profile Cancer

Elzonris: A Case Study In Divergent Regulatory Decisions

Stemline Therapeutics’ Elzonris was approved for a rare cancer in Europe in January, following a long and arduous two-year journey through the EU regulatory process that included an initial rejection and a subsequent re-examination by the EMA. Its fortunes were very different in the US, where the review took just six months from filing to approval.

Drug Review Profile Europe

Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study

US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.

Drug Review Profile Coronavirus COVID-19

Pandemic Perspectives: Veklury’s Clinical Development Timeline Compressed By Collaborative Review, Previous Research

Just five and half years elapsed between Gilead’s first remdesivir IND for Ebola virus and Veklury’s US FDA approval for COVID-19.

Drug Review Profile Drug Review

Turalio: Why The EU Said No To The US-Approved Drug

Not everyone reviewing Daiichi Sankyo’s EU marketing application for Turalio agreed that the potential tenosynovial giant cell tumor treatment shouldn't be approved.

Europe Rare Diseases

US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols

Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.

Drug Review Profile Approvals

Inmazeb Brought Regeneron A Priority Review Voucher, But Not The Type It Wanted

Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.

Drug Review Profile Approvals

Regeneron's Inmazeb Overcame FDA Combo Product Requirements With Nonclinical Evidence

The individual contribution of the three mABs in Regeneron’s Ebola treatment could not be clinically tested due to the highly lethal nature of the disease and the potential for development of resistance; instead, the FDA accepted nonclinical data demonstrating the mechanism of action for each component.

Drug Review Profile Approvals
See All
UsernamePublicRestriction

Register