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.

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

Multiple Molecules See UK Prices More Than Double In December

David Wallace 18 Jan 2022

WaveData’s compilation of the fastest-rising UK generics prices in December showed several products across multiple presentations more than doubling their average trade prices to independent pharmacists.

Teva And Endo Overcome Opioid Claims In California

02 Nov 2021

Following a recent settlement in Louisiana, Teva has been told by a court in California it is not liable for the state’s opioid crisis, avoiding for now the potential for significant damages.

Pink Sheet

CureVac Pulls Covid Vaccine From European Review Process

12 Oct 2021

The company behind the CVnCOV COVID-19 vaccine candidate says the decision to withdraw from regulatory review is strategic. The EMA says outstanding issues affecting the benefit-risk balance remained to be answered at the time of withdrawal.

Influencer Biz Getting Dicier; Instagram Celeb, His Manager And Attorney Talk Shop

08 Oct 2021

At NAD 2021, Adam Waheed, an award-winning content creator with more than 17m social media followers, addressed challenges and legal risks that have escalated in recent years as influencer marketing opportunity exploded in the US and abroad.

2020 Deal-Making Roundup

21 Sep 2021

Against a backdrop of unprecedented disruption, the biopharma and medtech industries reached incredible heights for deal-making activity during 2020.

Alkem Delivers Strong Quarter With Domestic Recovery

Akriti Seth 14 Sep 2021

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India’s Alkem has delivered a strong quarter with a boost in its domestic business on the back of “strong volume-led growth in the acute therapies and faster than market growth in chronic therapies.” However, the company saw a slight YoY decline in the US.

Amazon-Exclusive And Hybrid Selling Strategies Deliver Success For German Wellness Brands

David Ridley 13 Sep 2021

Amazon is becoming an increasingly important retail channel for the German wellness market. An analysis of best-selling categories, Omega 3, vitamin B and probiotic supplements, by Sempora Consulting suggests a mixture of exclusive and hybrid selling strategies can deliver results.

Indian Leaders Begin Unique Collaboration On Molnupiravir

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.

Pink Sheet

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

By Sarah Karlin-Smith 16 Jun 2021

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.

Pink Sheet

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

By Sue Sutter 08 Jun 2021

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.

Long-Awaited EU Clinical Trials Portal Meets Major Milestone

Vibha Sharma 22 Apr 2021

A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.

UK Explains New Reliance Routes To Approval Based On EU Dossiers

27 Jan 2021

Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.