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Today's Rundown

Featured Story

China's Sinovac hit by late-stage COVID-19 vaccine halt after reports of a death in Brazilian trial

Sinovac Biotech has seen a phase 3 trial of its pandemic vaccine hopeful Coronavac stopped in Brazil after reports of a serious safety concern, with one report stating a death is involved but was not in the vaccine arm.

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Top Stories

Amgen, AstraZeneca's tezepelumab hits goal in asthma phase 3  

A phase 3 trial of Amgen and AstraZeneca’s tezepelumab in severe asthma patients has met its primary endpoint. The thymic stromal lymphopoietin inhibitor drove reductions in exacerbations in patients with low levels of eosinophils, teeing the partners up to target a large, underserved portion of the asthma market.

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CureVac climbs on vaccine data despite tolerability questions 

CureVac has presented more clinical data on its COVID-19 vaccine candidate. The results strengthen the impression that the vaccine triggers potentially protective immune responses while leaving scope to question whether CureVac can clear the bar set by its more advanced rivals. 

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Best Practices for Research Sites: Effectively Using Patient Recruitment Advertising Dollars

Are you looking to optimize your site’s patient recruitment advertising dollars? WCG’s experienced team of patient recruitment experts can help your site efficiently use your advertising funds by creating customized recruitment campaigns for any of your studies, and we’ve also curated a list of best practices to ensure your spend sees the best ROI.

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Adagio, 'firing on all cylinders,' grabs $80M for COVID-19 antibody

In a time when speed is of the essence, Adagio Therapeutics is gathering steam. It picked up $80 million to propel its COVID-19 antibody into the clinic next year, just four months after launching with $50 million and a plan to go after multiple members of the coronavirus family.

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TCR2 taps ElevateBio to manufacture T-cell therapy for phase 2

TCR2 Therapeutics’ endgame was always to manufacture its T-cell therapies in-house. But while it works on its own commercial facilities, it’s getting a little help from Boston-area neighbor ElevateBio. The duo inked a manufacturing deal under which TCR2 will use ElevateBio’s centralized R&D and manufacturing site to produce TC-210, its mesothelin-targeting T-cell treatment, for a phase 2 study.

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After Pfizer's vaccine data, analysts say COVID-19 drugmakers face questions about long-term sales prospects

While much of the world focused on Pfizer and BioNTech’s positive COVID-19 vaccine news on Monday, analysts started gaming out potential ripple effects, namely for companies making coronavirus therapeutics.

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FDA greenlights first diagnostic test for COVID-19 antibodies that block the virus from entering cells

The diagnostic developed by GenScript is designed to provide a test result within one hour.

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Eli Lilly wins FDA's emergency nod for COVID-19 antibody—but, thanks to mixed data, it's limited

The U.S. just authorized Eli Lilly's AbCellera-partnered COVID-19 antibody drug bamlanivimab for emergency use in mild-to-moderate patients who aren't hospitalized—so long as they're at "high risk" of serious disease. But just what is high-risk? That could confuse physicians, one analyst figures.

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10 biotechs to know in China

China has witnessed a biotech boom over the past decade, and the first crop just started to bear fruit. Here, we spotlight 10 companies that we think everyone who takes an interest in China’s biotech industry should know about since they'll likely compete on the global stage one day. What sets them apart is that all but one of them have attracted foreign Big Pharma companies buying into their R&D.

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Resources

Research Report: 2020 North America Customer Reference Data Survey

One sentence that will be displayed in the newsletter and should be written to grab the interest of your audience to want to read more.

Webinar: Using SPOT™ & CHO-BC® During Cell Line Development for Titers up to 9 g/L

Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards.

Research: Premier Research Resource Hub

Browse the latest learnings and insights from our clinical development professionals.

eBook: THE NEED FOR TRIAL VIRTUALIZATION

Responding to site challenges. Approaching virtualization. Leveraging real-time data. Medidata shares 8 parameters to implement your virtualization strategy during COVID-19 and beyond. Download Now.

Infographic: Reducing Time to Clinic for Your Biomedical Applications

This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments.

Whitepaper: Liquid-Filled Capsules for Highly Potent Drug Compounds

Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives.

Whitepaper: 6 API Challenges That Could Slow Your Development & How to Avoid Them

One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline.

Whitepaper: Rapid BYOD Build Timelines

This white paper covers a Phase III case study; BYOD advantages and misconceptions; and regulatory, copyright, and equivalency considerations.

Whitepaper: CRCs Equip Sites to Navigate the New Normal

Need additional site resources for your current or upcoming clinical trial?

Whitepaper: Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

Anticipate early development challenges to avoid rework and costs.

Article: Strategies to address the viral vector manufacturing shortage

Accelerating the production of viral-vector based therapy requires both understanding of strategies to address viral vector manufacturing and how to select the most cost-effective solution for your therapeutic. Read more in this article.

Whitepaper: How to Leverage IDN Data – Everything You Need to Know

Get insights into healthcare decision-makers networks.

Webinar: Elevate Your Digital Events Strategy

Learn how to plan immersive digital event experiences

Whitepaper: Gene and Cell Therapy: Planning for Manufacturing Success Early

Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience.

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

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

Whitepaper: Companies Need An Effective Remote Workforce Cloud Strategy To Survive

A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely.

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.

Whitepaper: Go from Process R&D to Clinical APIs Quickly and Effectively

Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success.

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.

Whitepaper: Why Your Business Needs a Ransomware Strategy To Avoid Being Hacked!

Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now!

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

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