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

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Pink Sheet

Global Regulatory Harmonization Discussions Ongoing About COVID-19 Vaccine Boosters

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.

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HBW Insight

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

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.

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HBW Insight

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

“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.

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Generics Bulletin

Indian Leaders Begin Unique Collaboration On Molnupiravir

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

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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Pink Sheet

Woodcock Attributes Aduhelm Approval Controversy To ‘Process Problems’

US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.

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Generics Bulletin

Aspen Faces Vaccine Setback In South Africa As Strides Explores Oral COVID Treatment

After a production setback, Aspen and Johnson & Johnson announce a donation of 300,000 vaccines to South African teachers. Strides partners with Ennaid for an oral COVID drug, while Dr Reddy’s, Lupin, Cipla and Sun Pharma Partner with Eli Lilly for baricitinib in India and Formycon receives approval for early action for its COVID-19 drug.

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Pink Sheet

US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion

CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.

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Generics Bulletin

Overseas API Manufacturing Identified As Key Vulnerability In US Supply Chain

After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.

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HBW Insight

Bayer Leads Push For Self-Care In India As Local Business Launches

Bayer has launched a dedicated Consumer Health business in India to market products in key OTC categories. The company is also working to bring different stakeholders together through the creation of a new organization dedicated to promoting self-care in the South Asian country.

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Generics Bulletin

New COVID-19 Vaccine Patent Database Launched

As part of its drive to maximize global access to coronavirus vaccines, the Medicines Patent Pool has developed a publicly accessible resource giving information on the patent status of approved and candidate vaccines.

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HBW Insight

New York’s Age Restrictions On Weight Loss, Sports Supplement Sales Fail To Fly

New York legislation to restrict sales of weight loss and sports nutrition supplements to minors failed without reaching a vote before the end of the session. But the proposal will continue to be a challenge for industry in New York as well as around the country.

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Generics Bulletin

Celltrion Opens Up Canadian Market For Remsima SC

Celltrion has pushed into another new market with its Remsima SC subcutaneous version of infliximab, launching the innovative biosimilar in Canada.

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Pink Sheet

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

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HBW Insight

US FDA’s Preferred Special Treatment For Cannabinoids Points To Mistreating Industry

Senate bill provision allowing FDA to develop unique labeling and packaging for cannabinoid supplements and foods is unnecessary, as the products should following existing labeling regulations, says CRN chief Steve Mister.

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