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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

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

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

Generics Bulletin

Global Industry Hails Bioequivalence Progress

By Aidan Fry 11 Dec 2019

For the first time, a working group within the International Council for Harmonization has started work on a regulatory topic specifically tailored to the global generics and biosimilars industry.

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HBW Insight

US Senate Passes First Monograph Reform Bill After House Passed Three

By Malcolm Spicer 11 Dec 2019

Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.

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HBW Insight

Fragrance Creators Association Readies New Consumer Website To Cap 'Year For The Public'

By Ryan Nelson 11 Dec 2019

Farah Ahmed, president and CEO of the Fragrance Creators Association, discusses the trade group’s expansion in recent years beyond immediate regulatory and legislative concerns to a platform for robust member collaboration in the name of positively impacting the world.

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Pink Sheet

Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation With DOJ

By Brenda Sandburg 06 Dec 2019

Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.

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HBW Insight

Future of CBD In Supplements: NDI Notification Looms As Regulatory Path

By Malcolm Spicer 06 Dec 2019

Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.

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HBW Insight

GSK Launches OTC Fluticasone In Japan Following Switch

By Tom Gallen 06 Dec 2019

GSK has launched Flunase in Japan following the switch of fluticasone propionate. JSMI’s Toshi Tominaga gives his assessment of the product’s prospects as an OTC drug.

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Generics Bulletin

Ophthalmics Are Next Frontier For Teligent

By Aidan Fry 06 Dec 2019

US niche generics player Teligent intends to use its expertise in topical and injectable drugs manufacturing to push into the North American ophthalmics sector.

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Pink Sheet

Former FDA Commissioner Frank Young Passes Away At 88

By Michael Cipriano 28 Nov 2019

From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.

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HBW Insight

Sunscreen Industry Faces Major Challenge In GRASE Push That OTC Monograph Reform Would Solve

By Ryan Nelson 28 Nov 2019

Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.

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Generics Bulletin

Celltrion's Remsima SC Ready For Early 2020 Launch

By David Wallace 28 Nov 2019

Celltrion says it is ready to roll out its Remsima SC subcutaneous infliximab in Europe in the first quarter of 2020, after receiving a formal pan-European marketing authorization from the European Commission.

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HBW Insight

Complicated Regulatory Odyssey Steers FDA Toward Rule On CBD In Supplements

By Malcolm Spicer 27 Nov 2019

Before Congress de-scheduled hemp at end of 2018 and forced agency's hand on considering lawful use of ingredients derived from the plant in supplements and food, the floodgate for sales of the products was opened in 2013 by a DoJ policy change to de-emphasize enforcement of most federal marijuana laws.

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HBW Insight

Aspirational Products Driving Growth In Developed OTC Markets

By Tom Gallen 22 Nov 2019

Aspirational OTC products such as probiotics are outstripping demand for traditional symptom relievers, IQVIA's Andy Tisman told the recent Ceuta International Conference. Consumer health players must adapt their portfolios to cater for the more health conscious, informed, and digitally-connected consumer, Tisman advises

Topic Business Strategies

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Pink Sheet

How Sustainable Is England's Cancer Drugs Fund?

By Francesca Bruce 20 Nov 2019

The Cancer Drugs Fund has improved access to oncology drugs, but if it is to remain fit for purpose it will need to evolve.

Topic Cancer

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Generics Bulletin

Amneal Starts Seeking International Partners

By Aidan Fry 20 Nov 2019

In a bid to make better use of Amneal’s US portfolio and pipeline, the company is looking for international licensing partners, especially in Eastern Europe and China, as its new management team looks to restore growth and revive profit margins.

Topic Business strategies

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Generics Bulletin

Accord Strikes Thiotepa Deal With Adienne

By Aidan Fry 20 Nov 2019

Accord Healthcare has secured commercial rights to Adienne’s novel lyophilized formulation of thiotepa in Europe, extending its portfolio of cancer treatments.

Topic Business strategies Cancer

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