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Today's Rundown

Featured Story

Amid cold chain blues, Pfizer looks to powder vaccine formula in 2021: report

Promising news Monday on the efficacy of Pfizer and BioNTech's vaccine candidate was met with concerns over access given the shot's stringent cold chain storage requirements. But the drugmaker is already weighing a solution in the form of a powder formulation that would likely only require standard refrigeration, the company's top scientist said.

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Top Stories

Sedor Pharma bags nod for room temp-stable seizure med Sesquient

The FDA this week gave a thumbs-up to Sedor's room temperature-stable Sesquient to treat status epilepticus in adults and children, making it the only FDA-approved fosphenytoin drug that can be stored in point-of-care settings like emergency rooms, ambulances, long-term care facilities and more, the drugmaker said. 

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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.

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CureVac's mRNA coronavirus shot boasts one advantage over Pfizer and Moderna counterparts—refrigerated storage

While Pfizer's COVID-19 vaccine turned in strong efficacy numbers and NIAID director Anthony Fauci said he expects similar figures from Moderna, the new class of mRNA shots mostly comes with stringent storage requirements that raise logistical hurdles to a broad rollout. Except CureVac, which now reports that its candidate is stable for up to three months at refrigerator temperatures.

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2020's Fiercest Women in Life Sciences

More women are climbing to the top of the corporate ladder than ever before. This report recognizes 20 of them: women who lead the charge in life sciences, in everything from research to business development to regulatory to commercial, or have outright built and run their own companies.

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Resources

Research Report: 2020 North America Customer Reference Data Survey

New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress.

Whitepaper: Survey Reveals Demand for Clinical Trial Innovation in the Wake of COVID-19

The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement.

Whitepaper: How sites can navigate the COVID bandwidth crunch

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

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.

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.

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: 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.

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