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Jordi Llinares Garcia, Driver Behind EMA’s Flagship PRIME Initiative, Dies Aged 52

European Medicines Agency says recently deceased colleague Jordi Llinares Garcia will be dearly missed.

Europe Regulation BioPharmaceutical

Roxadustat Rejection Has Lessons For Other Sponsors

A US FDA Advisory Committee’s overwhelming rejection of FibroGen/AstraZeneca’s oral anti-anemia agent is a big setback for the sponsor. But the committee’s reaction to novel strategies used to try to save the application has an important message for all drug developers about the limits of those approaches.

Advisory Committees Clinical Trials Drug Approval Standards

Interchangeable Biosimilars: Insulin Likely First But Humira May Be More Important Precedent

US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.

Biosimilars Reimbursement Policy

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Performance Trackers

Keeping Track: US FDA Clears Vaxneuvance, Rezurock And Karendia, But Not Teplizumab

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals Complete Response Letters


Global Pharma Guidance Tracker – June 2021

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation International

Policy & Regulation Explore this Topic

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Latest From Regulation

US FDA Won't Budge On Nitrosamines Compliance Despite Complaints Of Possible Drug Shortages

Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.

Quality Compliance

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

Advisory Committees Drug Review

Pink Sheet Podcast: Breakthrough Therapy CRLs, Statins While Pregnant, COVID-19 And Clinical Trials

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

Drug Review Clinical Trials

Sanofi Genzyme’s Treatment For Pompe Disease On Track For EU Approval

EU reviewers have recommended marketing approval for two new medicines, but have turned down another product. 

Europe Drug Review

Sanofi/GSK’s Vidprevtyn Is Fifth COVID-19 Vaccine Candidate Under Rolling Review at EMA

Sanofi and GSK are way behind in the COVID-19 vaccine race and the start of a rolling review of Vizprevtyn at the European Medicines Agency is an important step.

Europe BioPharmaceutical

EU Decision Time On Broader Indication For AbbVie’s Skyrizi

The European Medicines Agency is meeting this week to consider applications to broaden the use of approved drugs to include new indications in the EU. 

Drug Review Regulation

Latest From Policy

Pemaryze Wins Cost-Effectiveness Thumbs Up For Rare Bile Duct Cancer In England

Bavencio, Taltz, Cosentyx, and Opdivo plus Yervoy were this week also the subject of final recommendations from the health technology assessment body, NICE, on whether or not they should be used on the National Health Service for certain indications.

United Kingdom Health Technology Assessment

Janssen’s COVID-19 Vaccine Should Continue To Be Available, CDC Panel Concurs

Benefits of the one-shot vaccine outweigh risk, ACIP members agree. One member says he supports its availability but would personally recommend mRNA vaccines instead.

Advisory Committees Coronavirus COVID-19

Drug Pricing Reform As Legislative ‘Pay For’ Gaining Momentum But What About Part D Redesign?

Association for Accessible Medicines makes a case for lowering prices in Part D through benefit design reforms enabling quicker and better access to first generics.

Pricing Debate Medicare

Clinical / R&D Explore this Topic

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Latest From Research & Development

Pink Sheet Podcast: Breakthrough Therapy CRLs, Statins While Pregnant, COVID-19 And Clinical Trials

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

Drug Review Clinical Trials

Accelerated Approval Of Lilly’s Alzheimer’s Drug Could Last About 15 Months, CEO Says

Lilly expects results from donanemab ongoing confirmatory trial in 2023, while Biogen has nine years to finish its postmarket study. CEO David Ricks discusses impact of aducanumab approval backlash, pricing and national coverage decision at STAT summit.

Clinical Trials Drug Approval Standards

China Signals Further Clinical Trial Policy Tightening

The nation’s top drug regulator vows to adopt ICH’s guidelines on drug safety and efficacy, after dropping the industry a bombshell with the tightening of oncology drug clinical trials a week ago.

China Clinical Trials

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Latest From Commercial

The Indemnity Calculus For Covid-19 Vaccines, India’s Path Ahead

Legal experts discuss the intricacies around pharma’s demand for indemnity, a key sticking point for supplies of COVID-19 vaccines from Pfizer and Moderna, and the path forward for countries like India.

Commercial Coronavirus COVID-19

Merger Scrutiny A Bigger Risk To Pharma Than Drug Price Reform, Orzag Predicts

US antitrust regulators appear poised to take a broader view of disease areas when reviewing mergers, Lazard Freres financial advisory CEO Peter Orszag cautioned.

Pricing Debate M & A

Sanofi/Merck Launch First 6-In-1 Combo Vaccine In US After Two-And-A-Half Year Supply Buildup

Five years after European licensure and launch, and 30 months after FDA approval, Vaxelis enters the US market offering an advantage of fewer shots than current pentavalent vaccines for protection against six diseases in children six weeks to four years old.

Vaccines Launches

Manufacturing Explore this Topic

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Latest From Manufacturing

US FDA Won't Budge On Nitrosamines Compliance Despite Complaints Of Possible Drug Shortages

Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.

Quality Compliance

Wait For Stability Results Before Moving Expiring COVID-19 Vaccine, Woodcock Says

Acting FDA Commissioner Janet Woodcock says stability studies are ongoing and that states shouldn’t get rid of expiring inventory yet.

Coronavirus COVID-19 Vaccines

How Inspectorates Will Judge Quality Systems' Ability To Manage Manufacturing Changes

PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.

Manufacturing Quality
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