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.
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Real-time tracking and analysis of the drug development pipeline
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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.
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Generics Bulletin
By David Wallace 25 Oct 2022
Chirag Patel and Chintu Patel have returned to being co-CEOs of Amneal, just over a year after the firm completed its merger with Impax. Rob Stewart – who was president and CEO of Amneal – and executive chairman Paul Bisaro have resigned from the roles.
Topic Company Analysis
Pink Sheet
21 Oct 2022
As biopharma continues to make progress developing novel and more targeted cancer therapies, regulators are responding with innovative and collaborative approaches to reviewing cancer products, aiming to resolve questions earlier and review products more quickly. Pink Sheet closely covers these programs, helping readers understand the expectations, challenges and opportunities, as well as lessons from companies putting policy into practice. This ebook takes some of our recent articles on special review mechanisms and regulators’ data expectations.
Biomedtracker, Meddevicetracker
23 May 2022
In this report, we cover catalysts from 31 drugs, devices, diagnostics, and deals expected to occur in the second quarter of 2022.
Topic Outlook
Biomedtracker, Meddevicetracker
08 Feb 2022
In pharma’s fast paced and continually evolving world, accurately anticipating the impact of events on the horizon is critical to your success.
Topic Business Strategies
Pink Sheet
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.
Generics Bulletin
By Chloe Kent 18 Jan 2022
Medicines for Ireland has appointed Accord Healthcare Ireland managing director Padraic O’Brien as chairperson and Teva Ireland director of generic products Paul Neill as vice chairperson of the Irish industry association. The changes come just a few weeks after Ireland implemented its new framework agreement on off-patent pricing.
Pink Sheet
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
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
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
06 Dec 2021
Don’t miss updates on recent news in accelerated trials and its implications for drug development in the United States.
Topic Business Strategies
Generics Bulletin
By David Wallace 01 Dec 2021
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
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
By Chloe Kent 30 Nov 2021
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
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
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
08 Jun 2023
Pink Sheet
08 Jun 2023
Pink Sheet
08 Jun 2023
HBW Insight
08 Jun 2023
Generics Bulletin
08 Jun 2023
Pink Sheet
07 Jun 2023
Pink Sheet
07 Jun 2023
HBW Insight
07 Jun 2023
Pink Sheet
07 Jun 2023
Generics Bulletin
07 Jun 2023
Pink Sheet
07 Jun 2023
Pink Sheet
07 Jun 2023
HBW Insight
07 Jun 2023
HBW Insight
07 Jun 2023
HBW Insight
07 Jun 2023
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