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April 10, 2020

Big Pharmas continue to inch potential COVID-19 treatments through clinical testing—with many hopes pinned to their readouts. Gilead revved up remdesivir production and quadrupled its study enrollment, while AstraZeneca set a date for its antibody trial. Meanwhile, Novartis and Incyte plan to put Jakafi up against the coronavirus’ deadly cytokine storms. And as U.S. cases top 450,000, nearly a third of the planet’s 1.5 million, the FDA greenlit its first blood test for COVID-19 antibodies—but Oxford researchers say the serological tests they’ve evaluated so far don’t quite measure up. Those stories and more follow below.

Featured Story

Bill Gates is able—and willing—to lose big money funding factories for COVID-19 vaccines

Wealthy individuals typically don't set out to waste billions of dollars, but amid the COVID-19 pandemic, that’s exactly what Bill Gates is willing to do. The Gates Foundation will help fund factories for seven promising vaccines, even though most of them won't pan out.

Top Stories Of The Week

Trump orders 'genius' biotechs to British PM's bedside

President Donald Trump has asked “leading” U.S. pharmaceutical companies working on experimental COVID-19 treatments to “contact London” and offer help to U.K. Prime Minister Boris Johnson, who is in intensive care after testing positive for the novel coronavirus last month.

FDA officially authorizes its first serological antibody blood test for COVID-19

The FDA granted its first emergency authorization for a rapid antibody blood test for COVID-19, developed by Cellex, allowing people to gauge a person’s immune response to the novel coronavirus.

Special Report—Top biotech money raisers of 2019

At first glance, venture investment for biotech slumped in 2019. By the raw numbers, 2019 lost on every metric compared to 2018. Total investment dollars dropped by $4 billion, from $17.9 billion in 2018 to $13.9 billion in 2019, and the average round size decreased too, from $40.2 million to $36.7 million. But that’s not the full story.

Gilead turbocharges production of COVID-19 hopeful remdesivir

Gilead Sciences' remdesivir has courted high hopes as a potential treatment for COVID-19—so high, in fact, that the company previously had to shut down emergency access to the drug. Now, Gilead's manufacturing of remdesivir is operating at light speed, and free doses of the drug are getting ready to ship. 

AstraZeneca targets summer start for COVID-19 antibody trial

AstraZeneca has outlined its multipronged approach to the development of antibodies against the pandemic SARS-CoV-2 virus. The Big Pharma is applying its own discovery capabilities to the task and helping to evaluate candidates identified by academic partners in China and the U.S. 

Novartis, Incyte set to roll JAK inhibitor Jakafi into COVID-19 clinical trial

Drugmakers across the board are rolling already approved drugs into late-stage clinical trials in an effort to find a speedy therapy for COVID-19. Now, two more are joining the party, with Swiss drugmaker Novartis and partner Incyte set to test their blockbuster JAK inhibitor.

Current COVID-19 antibody tests aren't accurate enough for mass screening, say Oxford researchers

“None of the tests we have validated would meet the criteria for a good test," said the University of Oxford's Sir John Bell, citing many false positive and false negative results, and describing an accurate test as potentially weeks away.

Sanofi CEO: Amid COVID-19 supply push, one fever means 'maybe a half dozen' workers off the job

Sanofi, the maker of a branded hydroxychloroquine drug called Plaquenil, is producing as much drug as it can, CEO Paul Hudson told Reuters. But there are limits amid a pandemic. Some employees are having to step aside if they show symptoms, he said.

Researchers harness new technology for rapid COVID-19 vaccine development

A Massachusetts General Hospital spinoff has developed a self-assembling vaccine for COVID-19 that will enter animal studies this month. It's one of several coronavirus vaccine candidates that's emerging from partnerships between technology developers and biology researchers aiming to speed up solutions to the pandemic.

COVID-19 is bad news for new drug launches. Which will suffer most?

Amid the COVID-19 pandemic new drug rollouts, especially for chronic diseases, face an uphill fight, analysts figure. Bristol Myers has already postponed a big new rollout, and Novartis, Gilead Sciences and Roche could see their closely watched prospects held up by regulatory delays.

Resources

[Whitepaper] Successful BYOD in Any Phase

This white paper includes a Phase III case study and discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations.

[Whitepaper] A Fast Way to Curb Your R&D Spend: Make Failure a Strategy

Turn your drug failures into competitive advantage.

[Whitepaper] Payers’ Perspectives on Digital Therapeutics In-Depth Interviews Reveal What Manufacturers Can Expect

How will US payers evaluate and manage digital therapeutics? Get insights and recommendations on successful market access considerations.

[eBook] 9 Ways to Enhance Healthcare Customer Experiences

Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing.

[Whitepaper] Data Integration and the R&D Organization

Despite advances in content aggregation and search, silos still limit the free flow of data and analytics. So, what can be done, and how can you get more value from the data you already have?

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow

This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future.

[Whitepaper] Ensuring the Greatest Return From Your Poorly Soluble Molecule

Poorly soluble molecules hindering your workflow?

[On Demand] Tufts-eClinical Solutions Data & Analytics Survey Results

Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor.

[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.

[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.

[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.

[Executive Summary] Strategies for Flexible Manufacturing

This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market.

[Case Study] Precision Analytics for Product Launch and Growth

Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights.