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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

Datamonitor Healthcare, Biomedtracker

COVID-19 and the impact on the clinical trial space

The effect of COVID-19 on clinical trials, the industry response, and the return to full operations

Topic Coronavirus Clinical Trials

View white paper
HBW Insight

Health, Beauty and Wellness Coronavirus Coverage

The COVID-19 pandemic has impacted the consumer health and beauty products industries in different ways, and HBW Insight covers it all. We deliver all the latest regulatory, legislative, legal and commercial developments across the over-the-counter medicine, dietary supplement and the cosmetics sectors to keep you informed and strategically on target.

Topic Coronavirus

Single report
Pink Sheet

New Leader & Reorgs at Key Regulatory Agencies

Pink Sheet invites you to go inside the recent personnel changes at key regulatory agencies around the globe – including US FDA, EMA, and England’s NICE – and how these new appointments will likely influence future regulation of the biopharma industry.

Topic Regulation

Single report
Generics Bulletin

Glenmark Debuts Favipiravir For COVID-19 In India

Glenmark has received the go-ahead in India for and launched its low-priced favipiravir product for mild to moderate COVID-19 under an accelerated approval process.

Topic Coronavirus Drug Review

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HBW Insight

US COVID-19 Fraud: Licorice Promoted As Treatment, Unapproved Tests Offered OTC

FDA and FTC continue adding to total each has made during novel coronavirus pandemic. FTC's latest include peroxide gel and licorice as treatments; FDA’s emphasizes in warnings that three businesses' tests were not approved for OTC sales or for home use.

Topic Coronavirus Dietary Supplements

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Pink Sheet

Patient-Reported Data In COVID-Impacted Trials: US FDA Cautions Against Missing Data, Potential Bias

Considerations for switching from in-person to remote collection of patient- and observer-reported outcomes addressed in latest update to Q&A guidance, which also discusses Part 11 compliance requirements in the context of the pandemic and electronic collection of informed consent through MyStudies app.

Topic Coronavirus Clinical Trials

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Pink Sheet

What The Pandemic Can Teach Us About Running Clinical Trials

Participants in a recent webinar looked at how the coronavirus is changing the way we look at clinical trials and whether new EU COVID-19 guidance might hold lessons for future approaches to study design.

Topic Coronavirus

View article
Generics Bulletin

Dr Reddys Joins Remdesivir Licensees

Dr Reddy’s has become the latest firm to strike a licensing deal with Gilead for its remdesivir potential treatment for COVID-19.

Topic Coronavirus

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HBW Insight

DuPont Sees Immune Health Probiotic Sales Opening Window On More Microbial Use In Nutrition

While stockpiling for immune health support drove early sales growth in response to the pandemic, probiotic sales likely will continue increasing, says DuPont Nutrition probiotic marketing head Vanessa Bailey. “My gut tells me I think we could see some sustained increase. There’s going to be some difference in how we behave.”

Topic Coronavirus

View article
Generics Bulletin

WHO Launches COVID-19 Technology Access Pool

C-TAP, the voluntary initiative aimed at making vaccines, tests, treatments and other health technologies to fight COVID-19 accessible to all, has been launched by the WHO, in partnership with Costa Rica.

Topic Coronavirus

View article
Generics Bulletin

Teva, Sandoz And Accord Take COVID-19 Action

While Teva has helped to mitigate a Canadian shortage of salbutamol inhalers, Accord has struck a deal with the UK government to supply hydroxychloroquine. Sandoz is bolstering its inventory to meet demand and Apotex is donating critical medicines, while MedPharm’s new testing model will screen drugs for therapeutic eﬀectiveness and Beximco is focusing on manufacturing hydroxychloroquine, favipiravir and ivermectin.

Topic Coronavirus

View article
HBW Insight

COVID Who? CBD Leader Charlotte’s Web Maintains FY 2020 Guidance Of Growth Up To 20%

Charlotte’s Web is strengthening its DTC lead while growing its brick-and-mortar retail business, accelerating its pet product distribution and working to close its Abacus Health acquisition announced in March. The Boulder, CO-based CBD product manufacturer posted a 1% decline in net sales for the first quarter, but expects a rapid escalation in the second half of the year.

Topic Coronavirus

View article
Pink Sheet

For COVID, Consensus On Value Of Platform Trials, But A Confusion Of Consortia

The coronavirus pandemic could be a turning point for master protocol and platform trial designs, but clear guidance and coordination are still needed.

Topic Coronavirus

View article
Generics Bulletin

Hikma Outlines Strategy For Coping With COVID-19 Demand

As Hikma launches propofol vials in three presentations in the US to address a local shortage, CEO Siggi Olafsson explains how the company is more broadly keeping on top of the higher demand generated by the coronavirus pandemic.

Topic Coronavirus

View article
Generics Bulletin

Teva, Sandoz And Accord Take COVID-19 Action

While Teva has helped to mitigate a Canadian shortage of salbutamol inhalers, Accord has struck a deal with the UK government to supply hydroxychloroquine. Sandoz is bolstering its inventory to meet demand and Apotex is donating critical medicines, while MedPharm’s new testing model will screen drugs for therapeutic eﬀectiveness and Beximco is focusing on manufacturing hydroxychloroquine, favipiravir and ivermectin.

Topic Coronavirus

View article