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Scientific Wave Pushes CBER Into Brighter Light

What are US regulators doing to prepare for adequate review of the upcoming wave of gene therapy applications, and what other actions could CBER take to ensure it is able to facilitate the expected onslaught of breakthroughs in this field? Consultant Nancy Bradish Myers weighs in.

FDA Biologics

Gilead's Request To Revoke Remdesivir Orphan Designation Reflects Pandemic Pressures

Two days after US FDA granted remdesivir orphan status for treatment of COVID-19, Gilead told the agency it is unnecessary. EMA says it would not grant orphan drug designation to a COVID-19 treatment.

Coronavirus COVID-19 Rare Diseases

EU Biosimilar Filings, Opinions and Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

European Performance Tracker Approvals

Gilead's Expanded Access Shift Offers New Data Collection Opportunities For Remdesivir

Pivot from individual- to multi-patient protocols for expanded access may help generate data to inform regulatory filings and even payer determinations for Gilead’s potential COVID-19 treatment.

Coronavirus COVID-19 Drug Approval Standards

As Chloroquine Demand Surges, Bayer Looks To Emergency Use Authorization To Enter US Market

Unlike diagnostics, EUAs for drugs are rare and the fact that there already are FDA-approved competitors for Bayer’s chloroquine phosphate product may make the decision more complicated.

Coronavirus COVID-19 Review Pathway

Transition Day In The US: 96 Drugs Make The Move To Biologics Regulation

Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.

Biologics Biosimilars

Gilead’s Robust Expanded Access For Remdesivir Signals Confidence In Study Enrollment

US FDA has granted about 250 COVID-19 patients expanded access to Gilead’s investigational antiviral; the adaptive trial now underway in US aims for 400 patients.

Coronavirus COVID-19 Review Pathway

The Last Days Of NDAs: Uncertainties Remain Ahead Of 23 March Move From Drugs To Biologics

Exactly how many NDAs ultimately will make the switch, the impact of pending applications on 'Orange Book' listings, and the ramifications for ‘authorized generics’ are areas of focus as the regulatory transition date looms.

Biosimilars Biologics

Pink Sheet Podcast: US FDA Announces Coronavirus Containment Strategy, Issues Updated Type 2 Diabetes Guidance

Pink Sheet reporter and editor consider the fall-out from the FDA decision to cancel meetings and postpone inspections due to the coronavirus pandemic, as well as look at the new cardiovascular recommendations for Type 2 diabetes drug development.

Coronavirus COVID-19 Clinical Trials
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