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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

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In Vivo, Pink Sheet

Manufacturing and Distribution: Challenges and Opportunities

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

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Pink Sheet

US COVID Vaccine Patent Waiver Is Big, Symbolic Blow For Pharma, But The Fight Is Just Beginning

Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It's also not clear whether it’s an ominous sign for other industry battles in the US, including the drug pricing debate.

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HBW Insight

Germany's OTC Market Struggling To Recover To Pre-Pandemic Levels

As Germany remains in lockdown, sales in its OTC market struggle to return to pre-pandemic levels, according to new data from Sempora Consulting. Meanwhile, COVID-related trends for wellness and online shopping endure, indicating some strategic priorities for OTC firms operating in the country.

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Citeline, Biomedtracker, Pharma Consulting, Datamonitor Heal...

COVID-19 24 hour webinar recordings

Catch up on any missed COVID-19 24 hour webinar sessions

Topic Cardiovascular Coronavirus

Full video
Generics Bulletin

Industry Steps Up To Help India Through Second Wave

As India sees a consistent rise in daily cases and deaths due to COVID-19, the off-patent industry is stepping up to make drugs affordable and available. Zydus Cadila is seeking approval for virafin, while Natco has applied for molnupiravir approval. Vaccine production and availability has also come under focus.

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Generics Bulletin

European Biosimilars Can Benefit From Sharing Experiences

Attendees to Medicines for Europe’s virtual summit on biosimilars heard how learning from experiences across Europe can allow individual countries to build a toolbox of policies to help create a sustainable biosimilars market.

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Pink Sheet

Long-Awaited EU Clinical Trials Portal Meets Major Milestone

A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.

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Biomedtracker

Biopharma Partnering and Financing Trends, H1 2020 Whitepaper

Get an inside view into the trends powering COVID-era deal making in the life sciences with your free copy of “Biopharma Partnering and Financing Trends, H1 2020”. Informa Pharma Intelligence takes you inside the forces shaping the industry

Topic BIO-Europe

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HBW Insight

NIH, CDC Distributing OTC COVID-19 Tests In US Study On Reducing Community Transmission

NIH pays for 2m of Quidel's QuickVue tests in a program it’s conducting with CDC to determine whether frequent self-administered testing helps reduce community transmission of SARS-CoV-2.

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Pink Sheet

Sputnik V COVID-19 Vaccine Causing A Stir In The EU

The team behind Sputnik V has attacked what it calls “fake news and provocations” in the EU as political arguments over the vaccine claim another ministerial scalp.

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Generics Bulletin

FDA Guides On Generic Development During COVID-19

Guidance published by the US FDA in the form of a question-and-answer document addresses questions from ANDA applicants about generic drug development during the COVID-19 pandemic.

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HBW Insight

Is The Tide Turning For EU Prebiotics And Probiotics Regulation?

More EU countries than you might think allow the terms "prebiotic" and "probiotic" on food supplement labels, suggests a survey from consultancy firm Sandwalk Bioventures. HBW Insight speaks to Sandwalk's managing director, Luis Gosalbez, about a possible move towards liberalization in the region among member states, as well as a way forward for EU regulators lagging behind this localized movement.

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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.

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Generics Bulletin

Pfizer Breaks With Biosimilars In China Through WuXi Bio Deal

Pfizer has announced plans to put a lid on its biosimilars programs in China, while agreeing the sale of its manufacturing site in Hangzhou.

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Pink Sheet

Real-World Evidence On COVID 19 Vaccines Coming Into US FDA

Peter Marks says agency is getting first RWE readouts of vaccine safety; AstraZeneca’s vaccine has no expiration date, so stockpile is not currently at risk of being thrown out, the CBER director tells a House hearing.

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