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Today's Rundown

Featured Story

J&J starts COVID-19 vaccine phase 3, eyes early 2021 approval

Johnson & Johnson has begun a 60,000-subject phase 3 assessment of its COVID-19 vaccine. The trial will enroll participants in the U.S. and other countries with a high incidence of COVID-19 with a view to generating data to support emergency use authorization early next year.

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Top Stories

Roche, AC Immune's tau-blocking drug flops in Alzheimer's as biotech's shares halved

Blocking tau appears to be just as fruitless as clearing amyloid buildup when it comes to helping Alzheimer’s disease patients.

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FDA to set high bar for emergency COVID-19 vaccine approvals

The FDA is set to take a tough line on the evidence required to support emergency use authorization (EUA) of COVID-19 vaccines, according to The Washington Post. The reported requirements suggest a company is unlikely to have the data needed to support an EUA before the election in six weeks.  

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Silverback Therapeutics nets $85M top-up to push lead ADC through phase 1

After banking $78.5 million in March, Silverback Therapeutics is back for more. The company is picking up another $85 million to advance its lead program through the clinic and to develop its earlier-stage pipeline. Unlike other antibody-drug conjugates designed to kill cancer cells, Silverback is working on treatments that ramp up the immune response to cancer.

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4th time's the charm: Longitude Capital raises $585M in its largest-ever fund

The co-founders and co-managing directors of Menlo Park, Greenwich Village and Boston-based healthcare venture capital firm Longitude Capital invest in areas they hope will increase life expectancy and quality of life for patients suffering from cancer, neurodegenerative diseases, orphan diseases, aging and more.

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Childhood cancer-focused Day One snags Gilead alum Bender for CEO

Day One Biopharmaceuticals emerged in May to develop new drugs specifically for children with cancer. Now, as it ramps up its work, the company is making a flurry of new hires and new board appointments, including a new CEO: Jeremy Bender, Ph.D., who previously led corporate development at Gilead Sciences.

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FDA launches digital health-focused center of excellence

The FDA has launched a new center of excellence to oversee digital health products such as smartphone apps, wearable devices and software-based treatments.

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New insights into the coronavirus spike protein could inspire vaccine development

A team led by scientists at the University of California, San Diego focused its COVID-19 research on glycans, which are sugar molecules that shield the virus's spike protein. The researchers revealed an essential role of N-glycans at two sites on SARS-CoV-2 they say offers a novel pathway for vaccine development.

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Resources

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!

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: Leverage Technology to Expedite Master Protocol Trials

This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials.

Whitepaper: The Chronic Microcap Trap: How Launch Is the Escape for True Growth

How independent drug launch and commercialization can lead to higher market capitalization.

Whitepaper: Antibody-Drug Conjugates: Catalysts for Chemistry

Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development.

Whitepaper: How to Successfully Manage Regulatory and Financial Compliance Risk

Avoid severe compliance penalties by staying on top of evolving laws.

Whitepaper: Accelerating the Development of Orphan Drugs for Rare Diseases

This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging. Download now >>

Case Study: QED Therapeutics accelerates launch of rare cancer drug into niche market with analytics-driven insights

In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy.

Whitepaper: A Guide to Improving Your R&D Data Maturity

Life science R&D generates a LOT of data. Learn how to make sense of it and harness its potential with this step-by-step guide.

Whitepaper: How Broadening the Analysis of Compound Factors Allows for Predictive Solubility Solutions

Don’t oversimplify your solubility challenges.

Whitepaper: Reducing Site Workload for Better, Faster, Safer Clinical Trials

Download this free whitepaper to learn how to execute fast, high-quality clinical trials through eSource for studies that boost efficiency for both sponsors and sites.

Whitepaper: Learn How Collaboration (Not Competition) Will Bring Better Pediatric Medicines to Market

Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research.

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.

Whitepaper: Avoid Fallout From Incompatibility Between Your API And Its Formulation

Download the whitepaper to learn more.

Whitepaper: Top 7 Data Points from Medical Claim Forms to Drive Market Development

Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information.

Whitepaper: New data models to gain insight on medication adherence

Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization.

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

Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all.

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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