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

Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims

19 Jan 2022

US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.

Generics Bulletin

Bio-Thera’s Bevacizumab US Action Date Passes Without Approval

01 Dec 2021

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Bio-Thera Solutions had been hoping to become the first Chinese biosimilars developer to win an FDA approval, for its BAT1706 bevacizumab candidate. However, the announced FDA action date for the application has come and gone with no word from the company or regulator.

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.

Woodcock Attributes Aduhelm Approval Controversy To ‘Process Problems’

M. Nielsen Hobbs 23 Jun 2021

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.

Ulta Beauty Will Have New CEO, Target Store Presence In Climb Back To 2019 Top Line

Ryan Nelson 16 Mar 2021

The specialty retailer, entering Target stores in the fall, is aiming for net sales of $7.2bn to $7.3bn in fiscal 2021, compared with $6.15bn in 2020 and $7.4bn in 2019. President Dave Kimbell will be taking the helm in June while CEO Mary Dillon stays on for one year as executive chair of the board.

UK Vaunts 'New Era' In Drug Approvals

04 Jan 2021

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The UK regulator, the MHRA, has published guidance on its new integrated pathway for innovative drug approvals, which it says is intended to bring together partners including health technology assessment agencies, health care bodies and patient organizations to offer “sustained collaboration” with drug developers.

38th Annual J.P. Morgan Healthcare Conference Review

03 Feb 2020

The 38th Annual J.P. Morgan Healthcare Conference has concluded, and Biomedtracker and Meddevicetracker were there to bring you the important outcomes from the largest and most informative annual healthcare investment symposium in the industry.

US FDA Approval Climate: What Do The Oral Testosterone Reviews Tell Us?

Ramsey Baghdadi 27 Jan 2018

Second go-round for oral testosterone could have marked new boundary on how far FDA is willing to go...

Priority Review Voucher Sales Prices Level Off In 2017

26 Nov 2017

BioMarin's sale of voucher earned with approval of rare pediatric disease drug Brineura the fourth publicly disclosed voucher sale.

OMB's Grogan Talks Drug Pricing And Taking On 'Sacred Cows'

16 Nov 2017

Concerns with promoting competition and reducing consumers' 'pain in the pocketbook' are key tenets of the Trump Administration's approach.

South Africa To Tighten Up On Patenting To Promote Innovation, Improve Medicines Access

21 Aug 2017

Reforms proposed in the draft South African policy on intellectual property and public health that has just been put out for consultation have been welcomed.

Gottlieb Distances Himself From Trump's User-Fee Heavy Budget

Michael Cipriano 30 May 2017

New FDA commissioner passes on defending president's budget proposal during House appropriations subcommittee hearing.

Rx Pricing Practices Of US Trading Partners Criticized By Trade Office

Brenda Sandburg 04 May 2017

US Trade Representative also highlights restrictive patentability criteria in Canada, India and Indonesia in its annual Special 301 report.

Cost Sharing Fight: PhRMA Says Insurance Design Is Real Pricing Culprit

31 Mar 2017

New report finds increase in use of deductibles and coinsurance charging members list prices. Cost sharing for more than one-third of specialty drug prescriptions filled in 2015 by members of commercial insurance plans was based on undiscounted list pricing, according to an analysis released by the Pharmaceutical Research and Manufactures of America March 29.

EMA’s Post-Brexit Home ‘Could Be Decided This Year’

01 Mar 2017

The leader of Denmark’s bid to host the European Medicines Agency after the UK leaves the EU says that a rapid decision-making process on the agency’s new location is needed in order to avoid entanglements with the wider Brexit negotiations, and that a decision could be taken sometime in the second half of this year.

Support for fast pharmaceutical regulatory approval

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