67 Total results for product and free and sample content found
Datamonitor Healthcare
14 Nov 2022
This essential whitepaper looks at how increased drug spending and a rising desire for expenditure controls are influencing access dynamics across key markets. It is available to you now, for free.
By Ian Lloyd 27 Nov 2020
Using the new, granular datapoints in Pharmaprojects, Senior Director Ian Lloyd presents his expert insights into pharma’s R&D activities over the past year and what they may mean for the pipeline during the year to come. The 27th instalment of the Annual Review, this version takes advantage of improvements to Pharmaprojects’ data granularity to bring you details on pharma R&D trends
Topic Drug Development Landscape Drug Review Research & Development
Pink Sheet
By Brenda Sandburg 17 Nov 2020
Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.
Scrip, Datamonitor Healthcare
By Stephanie Yip 23 Oct 2020
In 2019, the 10 most lucrative medicines generated combined global sales of $92.5B. Scrip provides insight into these top sellers and the companies behind them, as well US dynamics, global sales forecasts and lifecycle data, with complementary market analysis from Datamonitor Healthcare on diseases targeted, indications, and more.
Topic Drug Review Diseases
Biomedtracker
29 Apr 2020
Access this infographic which focuses on Gilead’s drug Remdesivir which currently shows the greatest promise for the likelihood of approval as a possible treatment to effectively treat the virus. The infographic highlights the drug summary and profile, the number of patients in each trial phase, and the history of events that have moved this product through the development process.
Topic Coronavirus FDA Drug Review
HBW Insight
By Malcolm Spicer 27 Jan 2020
CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.
Topic Drug Review FDA OTC Drugs
Pink Sheet
By Derrick Gingery 15 Jan 2020
The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.
Pink Sheet
By Sue Sutter 13 Nov 2019
REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.
Topic Drug Review FDA
Biomedtracker, Datamonitor Healthcare
27 Sep 2019
Take a longer-term look at key late-stage drugs projected to hit the market in 2020, including new drug classes, major changes to standards of care, and/or large market opportunities across the wide range of indications covered by Biomedtracker and Datamonitor Healthcare.
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