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Germany To Tackle Cell And Gene Therapy Funding Barriers

If approved, new legislation would allow hospitals to apply for funding for ATMPs before marketing authorization.

Europe Germany Gene Therapy

Will COVID Finally Help US FDA And Sponsors Overcome Their ‘Angst’ On Innovative Trial Designs?

The ‘sea change’ inside White Oak should be seen as very encouraging for sponsors, FDA official says.

Clinical Trials Coronavirus COVID-19 Drug Review

BIO 2021 Notebook: Biogen CEO On Corporate Responsibility

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains. 

Clinical Trials Companies Diversity & Inclusion

Spotlight On Coronavirus

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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 Pfizer’s Prevnar 20; Dermavant Submits Tapinarof; Adamis Returns With Zimhi

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

US FDA Performance Tracker Drug Approval Standards Approvals

Global Pharma Guidance Tracker – May 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

Pink Sheet Podcast: Adcoms Too Emotional, Pushing Gene Therapy Science, Congress Gets UFA Update

Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.

Advisory Committees Gene Therapy

Coronavirus Notebook: EMA Says ‘Wait And See’ On CureVac Data, EU Ministers Want Voluntary Approach To Sharing IP

AstraZeneca and the European Commission have both claimed victory in the Vaxzevria supply case brought against the company by the commission. The Moderna coronavirus vaccine is now under review by the European Medicines Agency for use in younger people.

Europe Coronavirus COVID-19

Takeda Test Drives EMA’s Parallel Review Route For EU And Non-EU Markets

A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate. 

Review Pathway Vaccines

Domestic In-Person Inspection Work Could Be Back To Normal This Summer, Woodcock Says

Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.

Coronavirus COVID-19 Manufacturing

Ophthalmic Bevacizumab Reaches Critical Review Stage In EU

The sponsor of what could become the EU’s first approved ophthalmic formulation of bevacizumab needs to address outstanding issues raised by the European Medicines Agency about its filing.

Review Pathway Europe

EMA’s Revised Guide On Additional Risk Minimization ‘Overly Detailed’

Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.

Europe Drug Safety

Latest From Policy

340B Contract Pharmacy Feud: Court Undercuts HHS Position Against Drug Firms In Ruling

Federal district court denies HHS request to dismiss AstraZeneca’s lawsuit, but also suggests Congress needs to clarify the contract pharmacy issue.

Medicaid Pricing Strategies

BIO Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety

EU Council Calls for Discussions On New Pricing Mechanisms

Transparency on pricing and cost calculations could improve and inform public policy on medicines access, say EU health ministers.

Europe Health Technology Assessment

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Latest From Research & Development

US FDA Plans To Get Tougher On Oncology Dose Optimization

FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.

ASCO Cancer

BIO Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety

BIO 2021 Notebook: A Breakthrough Year For Emerging Companies?

News and views from day two of the BIO Digital annual meeting include the increasing number of small companies driving US product approvals, an update on the Reagan-Udall RWE Accelerator project and Merck & Co.'s Julie Gerberding on the need for continued HIV/AIDS research.

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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

BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work

BARDA’s suspension of funding for COVID-19 therapeutics risks repeating mistakes of past pandemics as it may cause industry to pull out of the development space, experts say. Industry sources are concerned the Biden administration is focusing on funding NIH at the expense of BARDA.

Coronavirus COVID-19 Research & Development

Pfizer’s Outlier Quarter, At Both Extremes

Investors are trying to wrap their minds around exactly how big Pfizer’s COVID vaccine business will end up being. But they also have questions about Pfizer’s prospects at the opposite end of the patient-population spectrum.

FDA Gene Therapy

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Latest From Manufacturing

Domestic In-Person Inspection Work Could Be Back To Normal This Summer, Woodcock Says

Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.

Coronavirus COVID-19 Manufacturing

Memo To File: How US FDA Decided Which Janssen Vaccine Drug Substance Batches Were OK To Use

Two batches were authorized because they were made before production waste jammed Emergent BioSolutions' Bayview plant.

Manufacturing Quality

US FDA’s Botanical Drugs Guidance Will See Rare Outing For Amryt’s Filsuvez NDA

Amryt’s birch bark extract oleogel-S10 for Epidermolysis Bullosa patients might become only the third botanical drug to clear the FDA.

Drug Approval Standards Drug Review
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