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58 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

Pharma RD Annual Review 2020 Whitepaper

By Ian Lloyd 27 Nov 2020

Pharma RD Annual Review 2020 Whitepaper

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

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

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

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

Biomedtracker

Biomedtracker Q3 2019 Outlook Report Extract

29 Jul 2019

Biomedtracker Q3 2019 Outlook Report Extract

In this report, we cover catalysts from 27 drugs, devices and diagnostics expected to occur in Q3 2019. For each drug, the likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided. These data points were provided using a combination of Pharmapremia, Informa’s drug development benchmarking product utilizing Biomedtracker’s LOA data to assist in informed decisions about drug pipeline prioritization, partnerships, and acquisitions, and drug approval data from Biomedtracker.   

Topic Drug Development Landscape Drug Review Research & Development Strategy

Meddevicetracker

MeddeviceTracker Q3 2019 Outlook Report

24 Jul 2019

MeddeviceTracker Q3 2019 Outlook Report

In this report, we cover catalysts from 27 drugs, devices and diagnostics expected to occur in Q3 2019. For each drug, the likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided.

Topic Strategy Research & Development Drug Development Landscape Drug Review

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