To view this email as a web page, click here

Today's Rundown

Featured Story

As Urovant gears up for vibegron FDA decision, the biotech gets snapped up by Sumitovant Biopharma

Urovant began life as an offshoot of Vivek Ramaswamy’s Roivant goliath, but is now firmly a part of the Sumitovant Biopharma family after the life science company bought up the rest of its shares in the biotech.

read more

Top Stories

Synairgen stock climbs on COVID-19 treatment results

Synairgen has shared more data from the COVID-19 clinical trial that sent its stock up 300% earlier this year. The latest update, which triggered a 30% jump in Synairgen’s shares, contains a closer look at the effect of inhaled nebulised interferon beta-1a SNG001 on hospitalized COVID-19 patients.

read more

AHA: Amgen heart failure med meets phase 3 goal—but doesn’t help patients live longer

Amgen and Cytokinetics did not impress when they unveiled topline data for their heart failure drug last month. Now, the duo are sharing a deeper look at a treatment that met its goal in a phase 3 study but did not help patients with heart failure live longer.

read more

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.

read more

Sanofi pumps €50M into rising French VC shop Jeito

Sanofi has invested €50 million ($59 million) in French VC firm Jeito Capital. The investment, Sanofi’s first in a private French fund, boosts Rafaèle Tordjman’s efforts to establish Jeito as an emerging force in the European biotech VC scene.

read more

Roche ditches EGFR drug pact with C4 Therapeutics

Roche has handed back the rights to one of its C4 Therapeutics targets as it tweaks a four-year research pact.

read more

Cleveland Clinic team draws a link between COVID-19 protection and the sleep aid melatonin

Scientists are continuing to try to repurpose existing medicines as a fast approach to containing COVID-19. After analyzing a large patient registry, researchers at the Cleveland Clinic suggested that a popular over-the-counter sleep aid melatonin may be a possible option for the disease.

read more

AstraZeneca, looking for clarity, snags ImpediMed sensors for heart, kidney failure trials

To capture a clearer picture of patients’ progress in its clinical trials for heart failure and chronic kidney disease, AstraZeneca has tapped the Australian developer ImpediMed and its devices that can measure the fluid status of a person’s tissues in 30 seconds.

read more

FiercePharmaAsia—10 Chinese biotechs to know; RemeGen's $515M IPO; Sinovac COVD vax trial halt

We list 10 biotech leaders in China, most of which have attracted Big Pharma companies to invest in their R&D. Antibody-drug conjugate developer RemeGene raised $515 million in one of the world's largest biotech IPOs. Sinovac's COVID vaccine hit a temporary trial halt in Brazil. And more.

read more

Chutes & Ladders—Proxy brawler Denner joins board at Ironwood Pharmaceuticals

Ironwood has added activist investor Denner to board; Shah ends long run at Eli Lilly; Korro brings on Aiyar as CEO.

read more

Resources

Whitepaper: How sites can navigate the COVID bandwidth crunch

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

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.

eBook: Mass Spectrometry-based Host Cell Protein Analysis in Biologics Development

Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics.

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: 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