Pharma RD Annual Review 2020 Whitepaper

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

Pink Sheet

What Did US FDA Do Wrong In Its Review Of Aducanumab AdCom Members Have A List

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

Top 10 Best-Selling Drugs of 2019

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.

Biomedtracker

The Race to Find a COVID-19 Treatment - Infographic

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.

HBW Insight

OTC Drug Oversight By US FDA Split Among Two Divisions In Reorganization

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.

Pink Sheet

Sharfstein: US FDA Incentives Not Broke, But Fix Them

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

Amarin's Vascepa: US FDA Panel To Scrutinize Breadth Of CV Risk Reduction

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.

Pink Sheet

Pink Sheet Performance Trackers: Navigate a complex world with the regulatory performance trackers from Pink Sheet

16 Oct 2019

Keep track of compliance, legislation, policy regulations, and industry developments with the expertise of our worldwide network of expert analysts and journalists on the ground in key global regions.

Biomedtracker, Datamonitor Healthcare

Key potential drug launches 2020

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.