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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

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

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

View all content

Pink Sheet

Brexit: New Rules Will Hit Parallel Trade From UK to EU

From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries.

Topic EU Pharma-Brexit Brexit

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Pink Sheet

Brexit Issues Lead NICE To Delay Methods Review

England’s health technology appraisal body, NICE, and the UK medicines regulator, the MHRA, are working together to align their process timelines so that access to medicines is “maintained and enhanced.”

Topic Brexit Pharma-Brexit EU

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Pink Sheet

Brexit: UK Joining US-Led Project Orbis To Speed Cancer Drug Approvals

Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.

Topic Pharma-Brexit Brexit

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Pink Sheet

UK Firms Face Thousands Of Variations To Update Safety Information

With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.

Topic Pharma-Brexit Safety Brexit

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Pink Sheet

Act Quickly On Converted EU Product Approvals GB Firms Urged

The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year.

Topic Pharma-Brexit Brexit Approvals

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Pink Sheet

US Drug Pricing Reform Post-Election: Scenarios To Consider And Lessons Learned

Regardless of the outcomes of the US elections, drug pricing is likely to take a back seat to COVID as policy focus. But the pandemic does offer pharma an opportunity for partnerships with payers on health outcomes. Commonwealth Fund’s Liz Fowler, South Capitol’s John O’Brien and ICER’s Steve Pearson discuss where drug pricing stands in public opinion, whether policies embraced by President Trump will have staying power, and the conditions needed in the policy environment for major change.

Topic US Election 2020 Policy & Regulation Drug Pricing

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Pink Sheet

Biden Administration May Push Rx Pricing To Back Burner With Senate That Stays Pharma Friendly

A Biden Administration with near-term priorities other than drug pricing and a Republican-controlled Senate dedicated to blocking any legislation that would enact government price controls is a relatively positive outcome for industry

Topic US Election 2020 Drug Pricing

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Pink Sheet

China-US Relationship Hinges On Changing Internal, External Forces

Given the ongoing election challenges in the US, China has yet to officially congratulate Joe Biden as the next US president, although many world leaders are already hailing a reset in US foreign policy. Many are wondering if this and other moves indicate a quiet internal shift for China's high tech and life sciences sectors, just days after Beijing concluded a high-level plenary meeting outlining its priorities for the next five years.

Topic US Election 2020 China

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Pink Sheet

Biden's COVID-19 Advisory Board Bodes Well For Science-Driven FDA

Two prominent former US FDA officials are a part of the president-elect’s new COVID-19 advisory board. Biden’s emphasis on scientific independence, including a commitment to publicly release vaccine trial data, could help restore public confidence in the agency and coming COVID-19 vaccines.

Topic US Election 2020 Coronavirus FDA

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Biomedtracker, Meddevicetracker

Q4 Outlook Report 2020

The world-class data contained in this report extract will keep you up to speed on the drug development landscape for better decision-making

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Pink Sheet

NICE Reform Plans Aim To Help Make Post-Brexit UK A 'First Launch' Country

Following a Brexit-induced delay over the summer, England's HTA body NICE has come up with a concrete set of proposals that it says will help it “robustly and efficiently” evaluate innovative technologies such as advanced therapies, histology-independent cancer treatments, and technologies for rare diseases. Industry bodies have welcomed the plans, which have just been put out for consultation.

Topic Brexit EU

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Pink Sheet

What Did US FDA Do Wrong In Its Review Of Aducanumab AdCom Members Have A List

Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.

Topic advisory committees Drug Review FDA

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Generics Bulletin

Pfizer Reports 80% Biosimilars Growth In Q3

Pfizer has reported 80% growth in its global biosimilars business for the third quarter of 2020, on the back of recent oncology launches. Though the company’s sterile injectables saw a slight drop in business, Pfizer’s biopharma business saw 4% growth.

Topic Coronavirus Biosimilars Deals

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HBW Insight

Sanofi's New Consumer Chief Identifies 'Untapped Potential' In Digital

Sanofi's recently-appointed Consumer Healthcare head Julie Van Ongevalle says she has identified "untapped potential" for the business to utilize "cutting edge digital platforms." Van Ongevalle revealed her early plans for Sanofi as it reported a drop in Q3 sales.

Topic Sales Earnings Digital Health

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Pink Sheet

Biden, Germany And Bringing A National Drug Pricing Negotiation Process To US

Germany uses government facilitated price negotiations between publicly funded insurers and manufacturers that are based on an independent assessment of how much added value a drug provides.

Topic US Election 2020 Drug Pricing

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