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Support for fast pharmaceutical regulatory approval

Our intelligence on approved and pipeline drugs, plus regulatory information on devices/diagnostics help you plan your route to commercial success.

Your window on the pipeline

To achieve commercial success, you need to connect successful approved drugs and mid-to-late stage pipeline drugs to the underlying trial information. You’ll also want to focus in on the best trial designs and comparator arms that have met with success across target markets.

What we offer

Our solutions give you the tools and intelligence to quickly build up a landscape of approved and pipeline drugs for a disease of interest. We cover where drugs have been approved or are in development, and timeline projections for clinical trials and time to regulatory approvals.
You’ll also be able to find comprehensive, accurate regulatory information on devices/diagnostics, particularly for FDA and CE Mark approvals.
Plus, you can save time filtering information by mechanism of action or drug class.

How it helps

We’ll help you:

Stay up to date with new regulatory trends/changes in pharma and medtech
Anticipate label claims of your competitors and ensure your product has a strong and promising future in the market
Learn from the pitfalls of terminated trials for similar drugs
Understand successful (and unsuccessful) strategies to achieve priority regulatory designations, that you can incorporate into your own development plans
Tap into the industry’s top analysts to help with your research needs

Relevant products

Biomedtracker: see the drug development process through analysts’ eyes

Real-time tracking and analysis of the drug development pipeline

Key benefits:

Market Events & Catalysts
Likelihood of Approval
Deals Coverage

HBW Insight: Health, Beauty and Wellness

The single most comprehensive consumer healthcare information source covering regulatory, legislative, legal and commercial news across the over the counter medicines, vitamins and dietary supplements, and cosmetics industries.

Key benefits:

Get a global view
Be the first to know
Go beyond the news

Pink Sheet: global policy and regulatory coverage

Unparalleled access to global pharma regulatory and compliance intelligence and expertise.

Key benefits:

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

View all content

Biomedtracker

2021 Clinical Development Success Rates

This is both an updated study of clinical drug development success rates from our 2016 report, and an expansion into the drivers of success with the addition of machine learning modeling to analyze the predictive factors contributing to drug development.

Topic Clinical Trials Drug Development Landscape Drug Pricing

View white paper
Datamonitor Healthcare, Pink Sheet, Scrip, Medtech Insight, ...

Pharma Intelligence Podcasts

Listen to the Pharma Intelligence podcasts on Spotify, Apple Podcasts, Soundcloud and Alexa

Topic Coronavirus Manufacturing Market Intelligence Clinical Trials Blog Clinical Trials Drug Pricing

Full podcast
Biomedtracker, Scrip

39th Annual J.P. Morgan Healthcare Conference 2021

Keep up with events as they unfold at the 39th Annual J.P. Morgan Annual Healthcare Conference on January 11-14, 2021. Pharma Intelligence and Insights journalists will bring you real time reporting, highlighting important events and key takeaways from every day of the largest and most informative healthcare investment symposium in the industry.

View analysis
Pink Sheet

UK Explains New Reliance Routes To Approval Based On EU Dossiers

Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.

Topic Brexit Pharma-Brexit

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Pink Sheet

UK BIA To Push For Post-Brexit Regulatory Agreement With EU

There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.

Topic Regulation Brexit Pharma-Brexit

View article
Pink Sheet

Pink Sheet – US Election and New Administration Coverage

Stay informed of the latest news from the recent US election and understand how the shift in power will affect pharma regulatory and policy issues both within the United States and abroad. Pink Sheet takes you behind the US election headlines for analysis on the real impact you can expect to see on your business.

Topic US Election 2020

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Pink Sheet

Biden Regulatory Freeze May Pause Sunset Rule, Medicare Rebate, Medicaid Line Extension Regs

Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.

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Pink Sheet

2020 Sees Sharp Rise In EU New Drug Approvals

The number of new drugs containing new active substances approved in the EU rose significantly in 2020, underpinned by a strong showing for orphan-designated products and a string of novel medicines for cancer and infectious diseases. Notable among the new clutch of approvals was the first ever COVID-19 vaccine, Pfizer/BioNTech's Comirnaty.

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Pink Sheet

With US Senate Wins In Georgia, Democrats Gain Path For Rx Price Reform, But It May Be Lower Priority

Razor-thin majorities in both chambers of Congress mean Democrats can’t enact a bold agenda, and the pandemic and attendant recession mean that the initial legislative focus won’t be on Rx issues.

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Pink Sheet

UK Vaunts 'New Era' In Drug Approvals

The UK regulator, the MHRA, has published guidance on its new integrated pathway for innovative drug approvals, which it says is intended to bring together partners including health technology assessment agencies, health care bodies and patient organizations to offer “sustained collaboration” with drug developers.

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Pink Sheet

US FDA's COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

Topic Coronavirus FDA

View article
Pink Sheet

Vaccine Distribution Priorities To Rely On Governors, Not ACIP, HHS Secretary Azar Says

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated

Topic Vaccines Coronavirus Distribution

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Generics Bulletin

EU Reforms Must Heed Pandemic Lessons

Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged.

Topic Coronavirus EU Policy & Regulation

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HBW Insight

UK Researchers Seek Commercial Partner For Nasal Spray Shown To 'Prevent' COVID-19

A nasal spray formulated using compounds already approved by regulatory bodies in Europe and the US can “prevent and slow” transmission of COVID-19, according to UK researchers who are now seeking a partner to commercialize the product.

Topic Coronavirus Research & Development Vaccines OTC Drugs

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HBW Insight

Merz Consumer Care Optimistic About Future As German Lockdown Continues

Will the second wave of coronavirus lockdown have the same impact on the European consumer health industry? Speaking exclusively to HBW Insight from Germany, Merz Consumer Care CEO Frank Baldauf thinks not. Recently investing in premium beard care brand Brooklyn Soap and launching its tetesept Formula range in the Netherlands, Merz's Baldauf suggest that there will be less panic buying this time round and the CHC supply chain will hold up under pressure.

Topic Coronavirus OTC Drugs EU

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