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Today's Rundown

Featured Story

Regeneron's Praluent sidekick nabs speedy FDA review, with February PDUFA date

Regeneron has taken a step closer to getting a green light for its experimental high cholesterol drug as the FDA allows a swift review of evicanumab.

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Top Stories

Researchers call out Gilead over diversity of remdesivir trials

Researchers have called for sponsors of COVID-19 clinical trials to run more diverse studies. The call follows an analysis of Gilead’s remdesivir clinical trials that found the studies “failed to provide equal representation of Black, Latinx and Native Americans.”

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Roche offloads clinical-phase cancer drug to Celleron

Roche has offloaded its anti-CSF1R monoclonal antibody emactuzumab to Celleron Therapeutics. The licensing deal comes almost two years after Roche dropped the tumor microenvironment modulator after putting it through a clutch of early-phase studies in solid tumor patients.

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F2G raises $61M for late-phase antifungal R&D

F2G has raised $60.8 million to fund late-phase clinical development of its antifungal agent olorofim and prepare for commercialization. The Cowen Healthcare Investments-led round comes four years after F2G raised a similar sum to take the dihydroorotate dehydrogenase inhibitor into phase 2b.

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Life science incubator Paragon Biosciences grabs new CEO for investment arm

Biotech, digital health and medtech incubator Paragon Biosciences has hired Kerensa Jimenez as the new CEO of its capital markets group Paragon Health Capital (PHC).

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Alphabet’s Verily opens own lab to speed up COVID testing

The buzzy life sciences company Verily is looking to speed up COVID testing with a new lab based at its native South San Francisco.

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How a protein implicated in Alzheimer’s could enhance cancer immunotherapy

Variants of TREM2, a receptor expressed by immune cells, have been linked to the development of Alzheimer’s disease. Now scientists at Washington University School of Medicine have demonstrated that targeting the protein could be a potential new way to enhance the power of immuno-oncology drugs.

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Enrollment Showcase

Bioscience Certificate Pathways Advancing Knowledge, Skills, & Careers

Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more.

Resources

Whitepaper: Quality by Design: A Holistic Approach to Drug Development

Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker.

Whitepaper: Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs

How to select the right dosage form for your Phase I clinical supply.

Webcast: DRUG ABUSE LIABILITY ASSESSMENT: Are you taking an integrated approach?

Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment

Executive Summary: Keys to a Successful Rapid Commercial Launch

Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better.

Whitepaper: More Powerful Analytics Capabilities

Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI.

eBook: Navigating the Insulin Affordability Act

Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all.

Whitepaper: Reducing the Complexity and Costs of Channel Planning and Logistics

Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Whitepaper: Learn How Collaboration (Not Competition) Will Bring Better Pediatric Medicines to Market

Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research.

Whitepaper: High-Loaded Dosage Forms: Novel Platform Expands Spray-Dried Dispersion Utility

A novel spray-dried dispersion platform has been developed to faciliate high drug load applications

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study.

eBook: Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study.

Events