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62 Total results for product and free and sample content found

Biomedtracker, Datamonitor Healthcare

2020 Deal-Making Roundup

21 Sep 2021

2020 Deal-Making Roundup

Against a backdrop of unprecedented disruption, the biopharma and medtech industries reached incredible heights for deal-making activity during 2020.

Topic Drug Review Coronavirus

Pink Sheet

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

By Brenda Sandburg 17 Nov 2020

FDA Advisory Committee

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.

Topic advisory committees Drug Review FDA

Scrip, Datamonitor Healthcare

Top 10 Best-Selling Drugs of 2019

By Stephanie Yip 23 Oct 2020

Top 10 Best-Selling Drugs of 2019

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

Pink Sheet

US FDA Postmarketing Drug Safety Modernization Plan Will Cut Across Review Disciplines

By Sue Sutter 08 Jan 2020

US_FDA_Postmarketing_Drug_Safety

Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.

Topic Drug Review Quality Control

Biomedtracker

Q3 2019 Catalyst Roundup

16 Oct 2019

Q3 2019 Catalyst Roundup

What were the outcomes of critical catalysts featured in Biomedtracker’s Q3 2019 Outlook Report? Find out in the Catalyst Roundup: A Review of Select Catalysts from Last Quarter’s Outlook Report. This data-rich graphic is available now – for free.

Topic Approvals Drug Review FDA

Biomedtracker, Datamonitor Healthcare

Key potential drug launches 2020

27 Sep 2019

Key potential drug launches 2020

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.

Topic Approvals Drug Review Drug Development Landscape

Scrip

Inclisiran’s Safety Data Suggest Game-Changing Potential In PCSK9 Market

By Joseph Haas 11 Sep 2019

Inclisiran’s Safety Data Suggest Game-Changing Potential In PCSK9 Market

The Medicines Co. unveiled Phase III safety data for inclisiran showing safety and tolerability comparable to placebo and efficacy in line with the PCSK9 inhibitor class – which should be the reassurance it needs for the oral agent. 

Topic Drug Development Landscape Drug Review

QIDP: What have we GAINed?

By Jonathan Slater 02 Sep 2019

QIDP: What have we GAINed?

The Generating Antibiotic Incentives Now (GAIN) Act passed into law on July 9, 2012. Seven years on, we review the drugs that have obtained QIDP status, the companies involved, and the clinical trial landscape.

Topic Drug Development Landscape Drug Review

Scrip

Oncology Market Leaders Maintain Their Upper Hand

By Jessica Merrill 14 Aug 2019

Oncology Market Leaders Maintain Their Upper Hand

Drugs like Ibrance and Lynparza show that in the cancer market, it can be hard for new entrants to catch early standouts. 

Topic Drug Development Landscape Drug Review

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