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US FDA Rebates Biosimilar Fees, Limits Generic Fee Hike In FY 2022

The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.

Biosimilars Generic Drugs User Fees

England To Get ‘First Ever’ Patient Safety Commissioner Next Year

The UK government has revealed a number of changes it is making to the health care system in response to a report that found serious lapses regarding the safety of patients who were using certain treatments. 

United Kingdom Drug Safety Regulation

Any Medicare Study Requirements For Alzheimer’s Drugs Should Be Time Limited, CMS Told

Alliance for Aging Research worries the studies could drag on as long as the nine years Biogen is allowed for collecting Phase IV clinical data on its Aduhelm.

Medicare Reimbursement Neurology

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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 Bylvay, Fexinidazole, Gives Retifanlimab CRL; JAK Inhibitor Class Delays

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

US FDA Performance Tracker Approvals Drug Review


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 Should Take Its Time With COVID Vaccine BLAs

Agency is pledging to act well ahead of the six-month review deadline in reviewing full applications for COVID 19 vaccines that are already authorized for emergency use. Going too fast may be counterproductive, in more ways than one.

Coronavirus COVID-19 Vaccines

EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Europe Drug Review

Rare Or Common Events? COVID Vaccine Trials In Children Boost Safety Databases, Triggering Fears Of Heart Events

US FDA seems to want Moderna and Pfizer to study their mRNA vaccines in 3,000 people ages five to 11, suggesting the rate of myocarditis in younger children may be higher than in older teens. Such a finding, and even the hunt for it, could push back any COVID-19 vaccine authorization for this population.

Coronavirus COVID-19 Clinical Trials

Gene Therapy AAV Vector Toxicities Get US FDA's Attention

Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting in September, which follows some recent high-profile instances of adverse events that have delayed development programs.

Gene Therapy Regenerative Medicine

US FDA Seeking New Orphan Products Office Director Amid Internal Moves

OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.

Rare Diseases Leadership

ANDA Approval Decline Continues, But Why?

US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.

Generic Drugs Review Pathway

Latest From Policy

Pemazyre 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

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

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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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