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Today's Rundown

Featured Story

Why did J&J hit pause on its COVID-19 vaccine trial? Stay tuned, execs say

Johnson & Johnson put its late-stage COVID-19 vaccine study on hold because a patient has fallen ill. The pause comes just weeks after the company kicked off the 60,000-patient study and about a month after AstraZeneca suspended its own COVID-19 study for similar reasons.

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Top Stories

Gossamer Bio's DP2 inhibitor GB001 fails 2 midphase trials

Gossamer Bio’s GB001 has failed in two midphase trials in asthma and chronic rhinosinusitis. The failures come months after Novartis dumped rival DP2 inhibitor fevipiprant in response to a clutch of phase 3 flops.

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EdiGene raises $67M to take gene-editing therapies into humans

EdiGene has raised around $67 million to advance work on gene-editing therapies. The Beijing-based biotech will use the series B funding to progress a pipeline led by a beta-thalassemia treatment and an allogeneic CAR-T therapy.

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Voyager's Huntington gene therapy faces FDA hold thanks to manufacturing issues

Voyager Therapeutics can’t catch a break—at least, it looks that way for its Huntington disease program. The gene therapy has run into an FDA hold, one year after Sanofi’s Genzyme unit pulled out of a collaboration on that program.

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Could a lasso-shaped drug blend the best of antibodies and small molecules? Lassogen banks $4.5M to get started

Despite the rise of CAR-T and other cell therapies, small molecules and antibody treatments remain the bread and butter of cancer treatment. Lassogen thinks it’s found a way to combine the power of antibodies and small molecules while overcoming their weaknesses—lasso peptides.

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Wasp toxin inspires new antibiotic that overcomes tough-to-treat sepsis in mice

Penn scientists engineered an antibiotic from an ingredient in the venom of the Korean yellow-jacket wasp. In mouse models of sepsis caused by E. coli—an infection that is becoming more and more resistant to marketed antibiotics—the compound was effective and not toxic to healthy cells.

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Takeda-led alliance starts scaling up production of COVID-19 plasma therapy as phase 3 kicks off: report

Takeda, CSL Behring and the rest of the CoVIg Plasma Alliance have started commercial manufacturing of their coronavirus-fighting immunoglobulin drug. But scaling up won't follow the typical pharma process, as Takeda CEO Christophe Weber notes: Because it depends on plasma donations, the company isn't even sure how many doses it can produce.

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Resources

Whitepaper: Exploring the patient dynamic from different perspectives

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.

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

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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.

A complete Life Science Industry Snapshot in One Report

Whitepaper: Five Imperatives for Becoming More Patient-Centric

Achieving patient centricity depends on evolving how evidence is generated.

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

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Whitepaper: Leverage Technology to Expedite Master Protocol Trials

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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.

eBook: Navigating the Insulin Affordability Act

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Whitepaper: Reducing the Complexity and Costs of Channel Planning and Logistics

Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients.

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.

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