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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

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Pink Sheet: global policy and regulatory coverage

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Biomedtracker: follow the drug development process

Track and assess key events that will impact a drug’s probability of technical success and approval.

Key benefits:

Stay up to date
Get ahead of the competition
Conference coverage

View all content

Biomedtracker, Meddevicetracker

Q4 2019 Outlook Report Extract

16 Oct 2019

What major drug catalysts and events can you expect to see this quarter? Get a view of what's to come with an extract from the full report.

Topic Clinical trials Drug development landscape

Single report
Biomedtracker

Q3 2019 Catalyst Roundup

16 Oct 2019

What were the outcomes of critical catalysts featured in Biomedtracker’s Q3 2019 Outlook Report? Find out in the Catalyst Roundup: A Review of Select Catalysts from Last Quarter’s Outlook Report. This data-rich graphic is available now – for free.

Topic Drug approval Drug review FDA

View infographic
Pink Sheet

Pink Sheet Sample Article Pack: The Hottest Topics in Pharma Regulatory Compliance

16 Oct 2019

When you look at newly approved drugs, the latest product reviews and the decisions made during the process, you can gain critical insights to inform your own strategic decisions. That’s what Pink Sheet delivers, and now you can try it for free.

Topic Drug approval Drug development landscape

View article
Pink Sheet

Pink Sheet Performance Trackers: Navigate a complex world with the regulatory performance trackers from Pink Sheet

16 Oct 2019

Keep track of compliance, legislation, policy regulations, and industry developments with the expertise of our worldwide network of expert analysts and journalists on the ground in key global regions.

Topic Drug development landscape Drug review FDA

View article
Pink Sheet

The Opioids Crisis Regulatory Response to an Epidemic

14 Oct 2019

With the opioid crisis in full swing in the US, government and regulatory agencies are announcing changes to guidance and legislation related to both new and existing drugs. Keep abreast of these critical changes with essential coverage from Pink Sheet.

Topic Drug approval FDA

View article
Scrip, Pink Sheet, Generics Bulletin

Mega Mergers

30 Sep 2019

When it comes to M&A, Informa Pharma Insights has got it covered. Our readers benefit from exclusive executive interviews with industry leaders and expert analysts on business, pipeline and M&A strategy, broad and detailed coverage on implications of deal-making from antitrust to quality compliance, commercial and R&D infrastructure, regional repercussions and the impact on existing partners. 2019 has already been notable for major deals, from the closing of the $62bn Takeda/Shire acquisition to the agreed purchases of Celgene for $74bn by Bristol-Myers Squibb and of Allergan for $63bn by AbbVie, to Pfizer’s plan to merge its Upjohn generics business with Mylan.

Topic Business strategies

View article
Biomedtracker, Datamonitor Healthcare

Key potential drug launches 2020

27 Sep 2019

Take a longer-term look at key late-stage drugs projected to hit the market in 2020, including new drug classes, major changes to standards of care, and/or large market opportunities across the wide range of indications covered by Biomedtracker and Datamonitor Healthcare.

Topic Drug approval Drug review Drug development landscape

View infographic
Citeline, Pink Sheet

Clinical Trial Design Report

26 Sep 2019

Rising costs, patient recruitment issues, shifting regulations, and more are making bringing new drugs to market more difficult than ever. Explore changes in clinical trial design being adopted in response to these challenges with reporting from Pink Sheet.

Topic Drug development landscape

Single report
Generics Bulletin

Corporate Strategies of the biggest Generics and Biosimilar players

17 Sep 2019

Understand the latest Corporate Strategies of the biggest Generics and Biosimilar players.

Topic Business strategies

Single report
Biomedtracker

Biomedtracker: Improved Custom Company Portfolio Feature

04 Sep 2019

Discover how creating custom company portfolios can help you overcome your toughest business challenges.

Topic Business strategies

Single report
Generics Bulletin

Executive and market moves interviews for exclusive insider knowledge

04 Sep 2019

Get in the side track on the Generics market with executive and market-moves interviews for exclusive insider knowledge.

Topic Business strategies

Single report
Generics Bulletin

Hikma Snaps Up Insys Sprays As Part Of US Drive Towards Differentiation

By Aidan Fry 15 Aug 2019

By acquiring global rights to epinephrine and naloxone nasal spray candidates from Insys, Hikma is following its strategy of moving its non-injectable Generics business segment in the US towards differentiated products.

Topic Business strategies

View article
Pink Sheet

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

By Derrick Gingery 14 Aug 2019

Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.

Topic FDA Company analysis

View article
Generics Bulletin

Chirag Patel And Chintu Patel Return As Co-CEOs Of Amneal

By David Wallace 14 Aug 2019

Chirag Patel and Chintu Patel have returned to being co-CEOs of Amneal, just over a year after the firm completed its merger with Impax. Rob Stewart – who was president and CEO of Amneal – and executive chairman Paul Bisaro have resigned from the roles.

Topic Company analysis

View article
Pink Sheet

The Stakes Are High So Get It Right: CHMP Oral Explanations & FDA AdComs

By Neena Brizmohun 09 Aug 2019

The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. How they perform is critical. Consultant Kate Dion has a raft of helpful tips for companies facing this daunting situation. Neena Brizmohun reports.

Topic Drug approval

View article