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Today's Rundown

Featured Story

Novo Nordisk lays out $1.8B for Emisphere and its oral delivery tech

Novo Nordisk snagged Emisphere Technologies for $1.8 billion, aiming to use the company's tablet formulation technology to beef up its oral-drug offerings in diabetes and beyond. And it knows the Emisphere tech well—it's what made the oral GLP-1 med Rybelsus possible.

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Top Stories

GlaxoSmithKline's HIV PrEP challenge looms as ViiV's long-acting drug tops Gilead's Truvada in women

GlaxoSmithKline’s ViiV Healthcare has been hoping to bring its long-acting PrEP challenger cabotegravir to help both men and women prevent HIV. But that plan depended on very optimistic expectations for results from a head-to-head clinical trial against Gilead’s Truvada in women. Now, it has those data—one year ahead of schedule.

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Shrimp-shell nanoparticle could cut cancer drug side effects and improve durability, mouse study shows

In the hunt for safer and more effective delivery methods for cancer drugs, scientists are taking a cue from the natural armor that surrounds shrimp, insects and and other chitinous critters. A nanoparticle derived from those shells showed promise at cutting side effects and improving durability in a mouse study.

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AstraZeneca targets severe COVID-19 patients for antibody therapy despite Regeneron, Lilly setbacks

AstraZeneca has talked up the prospects of its anti-SARS-CoV-2 antibody working in severe COVID-19 patients despite rival assets from Eli Lilly and Regeneron failing in that population. Mene Pangalos, an AstraZeneca EVP, made the comments while sharing news the antibody is set to start a prophylaxis study next week. 

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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

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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.

Whitepaper: Defining A New Standard of Care: Leading Change from the Front Line

With COVID-19 as the catalyst, empowered clinician leaders are creating solutions to challenges they face every day. Get white paper.

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.

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: 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.

Events