Close Icon We use cookies to improve your website experience. To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. By continuing to use the website, you consent to our use of cookies.

Pharma Intelligence is part of the Informa Intelligence Division of Informa PLC

This 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.

Products:

Conferences 2021

Awards

Upcoming Webinars

Webinar recordings

Close Icon

Global Search Configuration

Search Site Products & Services
Close Icon

Search by Keyword

Focus
Needs

Pink Sheet: global policy and regulatory coverage

Inform your strategic decisions with unparalleled access to worldwide pharmaceutical regulatory affairs and compliance-related intelligence. Rely on the exclusive industry expertise of Pink Sheet.

Successfully navigate the complex worlds of compliance, legislation, policy regulation, and industry developments with the expertise of our worldwide network of expert analysts and journalists.

Start a free trial

Get a global view
Go beyond the news
Hear from news makers

Minimize risks, maximize opportunities

Our team of global contributors helps you to anticipate challenges, minimize risks and maximize opportunities. Pink Sheet is the biopharma industry’s go-to source for business-critical insights and policy and regulatory intelligence.

How it helps

Pink Sheet gives you the power to go behind the regulatory and compliance headlines to understand the implications of worldwide industry developments on your business.

How it works

With a network of journalists and analysts crisscrossing the globe, our industry experts and thought leaders track product progress from submission to approval. We also draw on the strength and expertise of the rest of the Pharma Intelligence family of analytical and market intelligence tools.

Analysis and opinion covers key topic areas such as:

Review pathways
Drug safety
Legislation
Legal and IP
FDA advisory committee
Drug approvals
Market access and reimbursement
Manufacturing
Consumer drugs
Clinical / R&D
Commercial

Start a free trial

What's included

Get a global view

Gain a deep understanding of profound insights into policy and regulatory developments, directly from key markets

Go beyond the news

Get exclusive access to accurate data, timely insights and trusted analysis that delivers to gain competitive advantage

Hear from news makers

Access interviews with leading decision makers, industry experts and thought leaders, across the industry.

Ask the expert

Put your questions about any of our news stories, data and analysis to our expert journalists and analysts.

Stay compliant

Explore our complete range of pharma regulatory and compliance news, data and analysis.

Be the first to know

Turn to Pink Sheet for implications in market advancements to inform your decision making and strategy planning.

Pink Sheet

Download your free accelerated trials article pack for insights into the latest developments

07 Dec 2021

Don’t miss updates on recent news in accelerated trials and its implications for drug development in the United States.

Topic Business Strategies

View article
Pink Sheet

Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies

By Brenda Sandburg 01 Dec 2021

In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.

View article
Pink Sheet

11 Going On 12: CDC Panel Pays Special Attention To Kids Caught In Middle Of Pfizer/BioNTech Vaccine Dose Increase

By Sue Sutter 03 Nov 2021

Whether a child receives the 10 mcg dose of COVID-19 vaccine authorized for 5-11 year-olds or the 30 mcg dose authorized for ≥12 year-olds should be based on age on day of vaccination, CDC says, but FDA is allowing some dosing flexibility for kids who celebrate their 12th birthday in the middle of the primary series.

View article
Pink Sheet

Moderna COVID-19 Vaccine: Booster Study Hits Only One Of Two Immunogenicity Endpoints

By Sue Sutter 13 Oct 2021

Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.

View article
Pink Sheet

CureVac Pulls Covid Vaccine From European Review Process

By Francesca Bruce 12 Oct 2021

The company behind the CVnCOV COVID-19 vaccine candidate says the decision to withdraw from regulatory review is strategic. The EMA says outstanding issues affecting the benefit-risk balance remained to be answered at the time of withdrawal.

View article
Pink Sheet

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

By Sue Sutter 16 Aug 2021

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.

View article
Pink Sheet

Expectations Are High But What Precisely Will England’s New IMF Deliver?

By Leela Barham 03 Aug 2021

The Innovative Medicines Fund, due for launch in England later this year, may provide industry with an opportunity to hold key public bodies to account.

View article
Pink Sheet

Merck, Pfizer Pneumococcal Vaccines: More Serotype Protection Vs. Pneumonia Indication

By Brenda Sandburg 03 Aug 2021

Ahead of CDC advisory committee this fall, Merck highlights additional bacteria serotypes its Vaxneuvance protects against while Pfizer touts Prevnar 13’s indication for pneumonia.

View article
Pink Sheet

Global Regulatory Harmonization Discussions Ongoing About COVID-19 Vaccine Boosters

By Derrick Gingery 14 Jul 2021

US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.

View article
Pink Sheet

COVID-19 Causes Further Delay To Canada’s Controversial Pricing Reforms

By Francesca Bruce 30 Jun 2021

A delay to implementing drug pricing reforms is an opportunity for Canadian authorities to come up with better proposals, say industry representatives, while authorities remain adamant that action is necessary to lower prices.

View article
Pink Sheet

Woodcock Attributes Aduhelm Approval Controversy To ‘Process Problems’

By M. Nielsen Hobbs 23 Jun 2021

US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.

View article
Pink Sheet

US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion

By Sarah Karlin-Smith 16 Jun 2021

CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.

View article
Pink Sheet

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

By Sue Sutter 08 Jun 2021

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

View article
Pink Sheet, Scrip

Drug Pricing eBook

25 May 2021

Tap into expert coverage of the complex world of drug pricing with insights from analysts at Scrip and Pink Sheet. This eBook includes vital information about issues affecting drug pricing for the US, EU, and other global markets, including patient access, regulatory issues, commercial challenges, value-based pricing, and more.

Topic Drug Pricing

View article
In Vivo, Pink Sheet

Manufacturing and Distribution: Challenges and Opportunities

13 May 2021

The COVID-19 pandemic has brought about significant manufacturing and distribution challenges and opportunities for Pharma. Seize new opportunities and avoid risk with the strategic commercial and regulatory intelligence you need to stay competitive by subscribing to Pink Sheet and In Vivo.

Topic Strategy

View article

Latest headlines

Pink Sheet

07 Dec 2021

UK To Reveal How Sponsors Are Performing On Trial Transparency Expectations

Link
Pink Sheet

07 Dec 2021

Achieving A Resilient Flu Vaccine Supply Chain Requires Retooling Most Of The Links

Link
Pink Sheet

06 Dec 2021

New EU Clinical Trials System Could Support Patient Recruitment

Link
Pink Sheet

06 Dec 2021

Coronavirus Notebook: EMA OKs Roche's Tocilizumab For Severe COVID-19, Bavarian Nordic Reports ‘Positive’ Booster Results

Link
Pink Sheet

06 Dec 2021

Robert Califf’s Chance To Make History At The US FDA

Link
Pink Sheet

06 Dec 2021

OIG Still Wary Of Anti-Kickback Safe Harbors For Value-Based Arrangements Involving Drugs

Link
Pink Sheet

06 Dec 2021

Unforced Error: Reata’s Decision To Ignore US FDA Endpoint Advice May Haunt Bardoxolone

Link
Pink Sheet

06 Dec 2021

US FDA Vaccination Rate Exceeds 96%, But Will It Lead To More In-Office Work?

Link
Pink Sheet

05 Dec 2021

US FDA Mum On Whether Woodcock Would Stick Around Long-Term For Califf

Link
Pink Sheet

03 Dec 2021

Recent And Upcoming FDA Advisory Committee Meetings

Link
Pink Sheet

03 Dec 2021

Pandemic Treaty Could Have IP & Other Implications For Pharma

Link
Pink Sheet

03 Dec 2021

USP Nitrosamine Impurities Chapter Reflects Careful Coordination With US, EU Authorities

Link
Pink Sheet

03 Dec 2021

Pink Sheet Podcast: Woodcock’s Legacy, Merck’s Oral COVID-19 Pill, 340B Case At Supreme Court

Link
Pink Sheet

03 Dec 2021

Payer Transparency Reforms: Moving From Rebates To Drug Access Restrictions

Link
Pink Sheet

03 Dec 2021

Cancer Drug Dose Optimization Benefits Include Better Pivotal Trial Retention, Fewer Clinical Holds

Link

Meet the team

Editor

Brenda Sandburg

Editor, Senior Editor

New York, USA

Brenda specializes in

Policy & Regulation
Biosimilars
Biotech
Generics
Pricing & Reimbursement

39+ years of experience

Editor

Cathy Kelly

Editor, Senior editor

Washington DC, USA

Cathy specializes in

Policy & Regulation
Market Intelligence
Market Access
Pricing & Reimbursement

39+ years of experience

Management

Denise Peterson

Management, Editor In Chief, Pharma US

Washington DC, USA

Denise specializes in

Commercial Strategy
Policy & Regulation

38+ years of experience

See all analysts

Next steps

Request a Trial

Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.

Start a free trial

Speak to Sales

Our team is ready to hear from you for a particular request or area of interest. Please do not hesitate to reach out and discuss.

Contact Sales

Client Services

US Toll-Free : +1 888 670 8900
US Toll : +1 212-600-3520
UK & Europe : +44 (0) 208 052 0700

Contact Customer Services

Pharma Report Store

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now:

Shop now

Pink Sheet: global policy and regulatory coverage

Minimize risks, maximize opportunities

What's included

Below are the Feature List

Get a global view

Go beyond the news

Hear from news makers

Ask the expert

Stay compliant

Be the first to know

Pharma Intelligence: latest

Latest headlines

Meet the team

Below are the Analyst Profile

Brenda Sandburg

Editor, Senior Editor

Cathy Kelly

Editor, Senior editor

Denise Peterson

Management, Editor In Chief, Pharma US

Related Products

Biomedtracker: see the drug development process through analysts’ eyes

Generics Bulletin

HBW Insight: Health, Beauty and Wellness

Next steps

This is Contactus Section

Request a Trial

Speak to Sales

Client Services

Pharma Report Store