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

Pink Sheet

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

By Bridget Silverman 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.

Pink Sheet

Care Needed With Plain Language Summaries Of EU Study Results

By Vibha Sharma 18 Jan 2022

The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.

Generics Bulletin

Multiple Molecules See UK Prices More Than Double In December

By 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.

HBW Insight

US FDA Says White Paper Could Inform Rulemaking For Cosmetic Talc-Asbestos Testing

By Ryan Nelson 14 Jan 2022

Formed by the FDA in fall 2018 and convened in early 2020 for a public meeting, the Interagency Working Group on Asbestos in Consumer Products maintains that electron microscopy should be a first-line method for detecting asbestos in cosmetic talc and talc-containing products, and that labs should report elongate mineral particles beyond those classically understood as asbestos.

Pink Sheet

Download your free accelerated trials article pack for insights into the latest developments

07 Dec 2021

Don’t miss updates on recent news in accelerated trials and its implications for drug development in the United States.

Generics Bulletin

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

By David Wallace 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.

Pink Sheet

Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies

By Brenda Sandburg 01 Dec 2021

In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.

Generics Bulletin

ANI Pharmaceuticals Completes $210m Novitium Acquisition

By Chloe Kent 30 Nov 2021

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ANI Pharmaceuticals has completed its acquisition of niche generics specialist Novitium Pharma, securing access to a pipeline of generics and 505(b)(2) candidates that has expanded further since the deal was announced earlier in the year.

HBW Insight

Like Plan B, Approval For OTC Daily Oral Contraceptives In US Could Be An 'Adventure’

By Malcolm Spicer 19 Nov 2021

It was only after prolonged litigation led a federal judge in 2013 to order FDA not to allow political interference with its science-based decisions that Plan B and generic equivalents became available OTC without age restrictions. “Hopefully, all I can say, it won't happen again,” says reproductive rights advocate Kirsten Moore.

HBW Insight

US EPA Should Eliminate ‘Hazardous’ Chemicals In Cosmetics? Petition Denied

By Ryan Nelson 18 Nov 2021

The Environmental Protection Agency does not have the jurisdiction to grant William D. Bush’s request, even if the petitioner had specified the “chemical mixtures” he wants banned or provided the level of data required to initiate proceedings under the Toxic Substances Control Act.

Pink Sheet

11 Going On 12: CDC Panel Pays Special Attention To Kids Caught In Middle Of Pfizer/BioNTech Vaccine Dose Increase

By Sue Sutter 03 Nov 2021

Whether a child receives the 10 mcg dose of COVID-19 vaccine authorized for 5-11 year-olds or the 30 mcg dose authorized for ≥12 year-olds should be based on age on day of vaccination, CDC says, but FDA is allowing some dosing flexibility for kids who celebrate their 12th birthday in the middle of the primary series.

Generics Bulletin

Teva And Endo Overcome Opioid Claims In California

By Dean Rudge 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.

HBW Insight

NIH Office Of Dietary Supplements Keeps Tabs On What DSHEA Wrought For US Consumers

By Malcolm Spicer 31 Oct 2021

While working to improve the quality of VMS products available in the US and to provide information on the products to consumers, the ODS doesn’t have authority to impose change on the industry or in the marketplace.

Pink Sheet

Moderna COVID-19 Vaccine: Booster Study Hits Only One Of Two Immunogenicity Endpoints

By Sue Sutter 13 Oct 2021

Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.

Generics Bulletin