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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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
28 Jul 2022
What's on the horizon for pharma in 2018? Find out with Biomedtracker's Early 2018 Outlook Report extract. Download free extracts from this essential report, which investigates the catalysts expected to occur in the first part of the year for 21 different drugs.
Pink Sheet
By Michael McCaughan 16 Jun 2022
The latest flurry of Executive Order activity on drug pricing reinforces the message that the President wants to own the headlines for being tough on the drug industry as Election Day looms. Looking for substance beyond that goal is a fool’s errand – but the headlines could still have significant consequences no matter who wins in November.
Topic US Election 2020
Pink Sheet
By Brian Yang 16 Jun 2022
Given the ongoing election challenges in the US, China has yet to officially congratulate Joe Biden as the next US president, although many world leaders are already hailing a reset in US foreign policy. Many are wondering if this and other moves indicate a quiet internal shift for China's high tech and life sciences sectors, just days after Beijing concluded a high-level plenary meeting outlining its priorities for the next five years.
Topic US Election 2020 China
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
07 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.
HBW Insight
31 Jan 2023
HBW Insight
31 Jan 2023
HBW Insight
31 Jan 2023
Generics Bulletin
31 Jan 2023
Generics Bulletin
31 Jan 2023
Pink Sheet
31 Jan 2023
Pink Sheet
31 Jan 2023
Pink Sheet
31 Jan 2023
Pink Sheet
31 Jan 2023
Generics Bulletin
31 Jan 2023
Generics Bulletin
31 Jan 2023
HBW Insight
31 Jan 2023
HBW Insight
31 Jan 2023
Generics Bulletin
31 Jan 2023
Generics Bulletin
31 Jan 2023
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