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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

Biomedtracker, Datamonitor Healthcare

Key Potential Drug Launches in 2021

Valuable insight and expert analyst commentary 2021’s expected drug launches, their indications, commercial potential, regulatory catalysts and more.

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HBW Insight

Nestlé To Enter Europe's CBD Market With UK Launch

Nestlé Health Science is expanding its CBD offering outside the US with the UK launch of a dietary supplement formulated by cannabis development firm Geocann.

Topic Consumer EU

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Generics Bulletin

EMA Endorses Dexamethasone For COVID-19

Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.

Topic Coronavirus Policy & Regulation

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Generics Bulletin

AAM Ramps Up US Election Lobbying

The AAM has published a timely guide highlighting various voter issues of concern in the run-up to the US elections, including anti-competitive tactics building on monopoly pricing and weak patent laws. The AAM has also called for policies to encourage generic and biosimilar entry in the market while the guide also focuses on policies around the US supply chain.

Topic US Election 2020 Policy & Regulation

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Pink Sheet

Six Pharma CEOs To Testify In House as Democrats, Trump Compete For Attention On Drug Pricing

While neither party is likely to make any big policy changes this year, the action from both sides of the aisle indicates politicians still see going after pharma as a winning issue with voters even as polls show voters are focused elsewhere.

Topic US Election 2020 Drug Pricing

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Pink Sheet

'March In' Plan Unveiled By Democratic Think Tank: A Battle Biopharma Would Welcome?

In sign of how much has changed in four years, industry might be better off if Biden takes CAP’s advice and launches ‘march-in’ actions to address pricing of COVID products.

Topic US Election 2020 Drug Pricing

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Pink Sheet

Biden's Drug Pricing Administrative Actions Could Focus On Medicare Demos

Center for American Progress suggests pricing reforms for the 'next Administration' in lieu of legislation.

Topic US Election 2020 Drug Pricing

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Pink Sheet

What Justice Ginsburg's Death Means For Pharma

A more conservative US Supreme Court may mean a less authoritative FDA, and drug pricing won’t get as much attention in the presidential campaign, which is a good thing.

Topic US Election 2020 FDA

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Pink Sheet

Germany Sets Direction Of Travel With New Biosimilar Guidelines

Germany is for the first time to adopt national guidelines on prescribing biologics and biosimilars in move towards increasing biosimilar uptake.

Topic EU Biosimilars

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Pink Sheet

US FDA Expects COVID-19 Vaccines To Meet 'EUA Plus' Standards, Marks Says

CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.

Topic Coronavirus Vaccines

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Pink Sheet

Trump Halt To US Funding For WHO: Making Global Health, Government Organization Potent Issues

Selling government efficiency as a campaign issue has not been an easy task for Democrats. COVID-19 – and especially support for international responses – may present a new opportunity.

Topic US Election 2020 Coronavirus

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Pink Sheet

Global Supply Chain Security Meets US Presidential Politics

Joe Biden’s presidential campaign now has a plan to address supply chains and encourage US-based manufacturing of prescription drugs. That affirms the unlikely national prominence of the issue – and reduces the chances of meaningful legislation this year.

Topic US Election 2020 Manufacturing

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Pink Sheet

Biopharma Needs A Deal On Drug Pricing As Shield Against Possible Democrat Wins - BIO's Greenwood

Outgoing Biotechnology Innovation Organization CEO suggests consideration of price inflation caps instead of 'big discounts' in Medicare Part D and says that industry should fund a cap on beneficiary out-of-pocket costs in the program.

Topic US Election 2020 Drug Pricing Legislation

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Pink Sheet

US Presidential Field Narrows, But Ranking The Candidates For Pharma Is Still Complicated

It is easy to see why Sen. Bernie Sanders would be the least popular pick for biopharma executives among the contenders in the Presidential race. But for industry lobbyists, it might not be the worst outcome – at least in terms of clarifying positions.

Topic US Election 2020

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Pink Sheet

Biopharma, the White House And Getting Drug Pricing 'Off The Table'

Industry balks at President Trump’s latest effort to force biopharma to negotiate a drug pricing solution, but investors may be pushing for concessions that could head off more onerous policies supported by a Biden White House.

Topic US Election 2020 Drug Pricing Regulation

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