Pharmaceutical Regulatory Approval

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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

Biomedtracker, Meddevicetracker

Q3 2021 Outlook Report

27 Aug 2021

What major drug catalysts and events can you expect to see in the months ahead? Download your free extract from the Q3 2021 Outlook Report and infographic to find out. Shape your strategy with your inside look at what’s to come.

Topic Drug Review

Single report
Generics Bulletin

India Biosimilars Landscape

19 Aug 2021

India leads the ways with the highest number of approved biosimilars.

Topic Clinical Trials Biosimilars

View infographic
HBW Insight

US FDA Focused On Vulnerable Populations As Cosmetic Risk Assessment Protocol Develops

By Ryan Nelson 17 Aug 2021

The agency’s recent request for contractor quotes cites infants and children, people of color, and immunosuppressed individuals among users whose “unique biological characteristics” could require special consideration in the evaluation of cosmetic ingredients. The FDA also is interested in accounting for unique physicochemical aspects of ingredients such as engineered nanomaterials.

View article
Pink Sheet

AVEO’s Fotivda: US FDA Concerns About Overall Survival Put To Rest By TIVO-3 Final Analysis

By Sue Sutter 16 Aug 2021

After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.

View article
HBW Insight

After US FDA Objects To CBD Safety As NDIs, Supplement Industry Responds, What Else Is New?

By Malcolm Spicer 13 Aug 2021

Rejection of two firms’ proposals for using hemp-derived CBD in supplement isn’t stirring US businesses selling CBD supplements to pull products from market. For one firm that filed an unsuccessful NDI notification for full-spectrum hemp extract CBD, FDA rejection was agenda item with numerous other business, regulatory and legislative developments in its latest quarter.

View article
HBW Insight

Beiersdorf Plans To Reboot Coppertone, Strengthen China Position With Anti-Dark Spot Innovations

By Lauren Nardella 12 Aug 2021

The Germany-based firm exceeded pre-pandemic sales levels in the fiscal 2021 second half, but rising costs could slow its momentum. Coppertone was a key growth driver in the second quarter, and Beiersdorf aims to capitalize with fresh innovation, new packaging and other updates to the brand.

View article
Datamonitor Healthcare, Biomedtracker, Scrip

2021 Post-ASCO Insights and Analysis

11 Aug 2021

The American Society of Clinical Oncology (ASCO) hosted its annual meeting from June 4-8 2021 and our team has the exclusive insights and analysis you can access today.

Topic Cancer

Single report
Pink Sheet

Expectations Are High But What Precisely Will England’s New IMF Deliver?

By Leela Barham 03 Aug 2021

The Innovative Medicines Fund, due for launch in England later this year, may provide industry with an opportunity to hold key public bodies to account.

View article
Pink Sheet

Merck, Pfizer Pneumococcal Vaccines: More Serotype Protection Vs. Pneumonia Indication

By Brenda Sandburg 03 Aug 2021

Ahead of CDC advisory committee this fall, Merck highlights additional bacteria serotypes its Vaxneuvance protects against while Pfizer touts Prevnar 13’s indication for pneumonia.

View article
Generics Bulletin

Dr Reddy’s Gears For Sputnik Light In India, Jab For Adolescents

By Anju Ghangurde 30 Jul 2021

Dr Reddy’s is to press ahead with India filing plans for single-dose COVID-19 vaccine Sputnik Light and also expects to “build on” the Russian partner’s trial in adolescents of the two-dose Sputnik V. The company also pilots a partnered first-of-its-kind cashless digital health offering.

View article
Pink Sheet

Global Regulatory Harmonization Discussions Ongoing About COVID-19 Vaccine Boosters

By Derrick Gingery 14 Jul 2021

US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.

View article
HBW Insight

With VMS Product Registration 'Inevitable' In US, CRN's OWL Moves 'In Right Direction'

By Malcolm Spicer 09 Jul 2021

Supplement OWL advisory board members Guru Ramanathan and Russ Michelson answer HBW Insight questions about the site’s progress and the potential for mandatory registration for dietary supplements sold in the US.

View article
HBW Insight

Perrigo Targets Recyclable Blister Packs In Push To Become 'Genuinely Sustainable'

By David Ridley 05 Jul 2021

“We are actively researching how to be the first OTC pharmaceutical firm to have a blister strip that satisfies regulations that is also recyclable,” reveals Perrigo's sustainability chief Steve Ramus in an exclusive interview with HBW Insight. Ramus also talks about the importance of being genuine when approaching ESG strategy.

View article
Generics Bulletin

Indian Leaders Begin Unique Collaboration On Molnupiravir

By Akriti Seth 01 Jul 2021

Major Indian pharmaceutical companies including Cipla, Dr Reddy’s, Emcure, Sun and Torrent have entered into a first-of-its-kind collaboration to jointly sponsor, supervise and monitor the clinical trial of the investigational oral anti-viral drug molnupiravir to fight against COVID-19 in India.

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Pink Sheet

COVID-19 Causes Further Delay To Canada’s Controversial Pricing Reforms

By Francesca Bruce 30 Jun 2021

A delay to implementing drug pricing reforms is an opportunity for Canadian authorities to come up with better proposals, say industry representatives, while authorities remain adamant that action is necessary to lower prices.

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