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Today's Rundown

Featured Story

U.K. set to infect volunteers with coronavirus in world's first COVID-19 challenge study

Researchers in the U.K. are set to deliberately infect young, healthy volunteers with SARS-CoV-2. The challenge study, which has £33.6 million ($43.6 million) in government support, could shed light on how people react to the virus and accelerate development of vaccines.

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Top Stories

Compass aims at $50M IPO to push lead antibody through the clinic

On the heels of a merger and $60 million private offering, immuno-oncology biotech Compass Therapeutics is looking to go public. It filed to raise up to $50 million in its Nasdaq debut. The funds will bankroll clinical trials and manufacturing for its lead program, CTX-471, an antibody that activates CD137, a receptor found on immune cells

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Aptinyx posts phase 2 PTSD win, nearly 2 years after diabetes pain flop

Things are looking up for Aptinyx, whose stock has been down in the dumps since its lead asset flopped in diabetes-linked pain last year. The company’s post-traumatic stress disorder (PTSD) treatment topped placebo on a composite measure of PTSD symptoms, teeing up an FDA meeting and a pivotal trial next year.

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Merck's rival to Pfizer's Prevnar 13 hits goal in phase 3 again

Two more phase 3 trials of Merck’s challenger to Pfizer’s Prevnar 13 have met their immunogenicity endpoints. The results suggest the V114 vaccine provides broader protection from pneumococcal bacteria than Prevnar 13 does, positioning Merck to muscle in on Pfizer’s turf. 

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COVID-19 vaccine biotech Vaccitech nabs Pfizer, Kite vet as full-time CMO

The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new chief medical officer.

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Lab survey illustrates testing delays spreading to non-COVID-19 diagnostic areas

Despite widespread increases in the production of COVID-19 test kits this year, about three out of four surveyed U.S. laboratories still report that they do not have enough supplies to meet the pandemic’s demand.

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Covance to 'transform' into a decentralized CRO

After snapping up contract research organization Covance for $6.5 billion five years ago, LabCorp is now looking to change the makeup of its drug development business.

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Resources

eBook: Navigating the Insulin Affordability Act

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Whitepaper: COVID-19 Vaccine Clinical Trials in Children: Challenges on the Horizon

Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper

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The culture of clinical research is evolving from one directed by researchers to one driven by the needs of patients and those who care for them.

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eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

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Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.

eBook: CMC Considerations for Successful Early Drug Development

This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success.

Webinar: Phase Appropriate Expertise and Technologies to Accelerate Product Development to Commercialization

In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site.

Whitepaper: How to Achieve Time and Cost Reductions in Clinical Trial Design and Build

Learn how to save time and reduce costs and complexity by streamlining the clinical trial process.

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Whitepaper: Technology Transfers: Reaping Rewards, Reducing Risks

Learn how to safeguard supply, improve distribution and reduce program costs and risks

Whitepaper: Making Data Central to Your CNS and Pain Trials

Learn how the right data capture solution can prompt the patient to follow the correct procedures and automatically sort the responses, according to protocol.

Whitepaper: Research Reveals New Launch Standards for First-to-launch Pharma and Biotech Companies

While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products.

Whitepaper: 16 Biopharma Leaders Tell How COVID-19 Will Change Customer Engagement

Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers.

Report: State of Life Sciences | 2020 Trends Report

A complete Life Science Industry Snapshot in One Report

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Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

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: 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.

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

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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.

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