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May 22, 2020

The ball is rolling: Gilead said its donation of 1.5 million worldwide remdesivir doses will run out by early summer, and the company will begin charging for the antiviral after that. Meanwhile, Moderna posted early data showing its vaccine prompted antibodies hostile to the coronavirus in eight people at low doses. Its share price soared—inflating the holdings of Moncef Slaoui, the former GSK vaccine head tapped to lead the Trump administration’s “Warp Speed” R&D efforts. This week, Slaoui said he would sell his $12.4 million in Moderna stock, and donate the most recent gains to cancer research.

Featured Story

Gilead to start selling remdesivir in coming weeks, expects 'multi-year commercial opportunity'

Gilead Sciences’ initial donation of remdesivir will be exhausted by early summer. The biotech will start charging for the drug in COVID-19 after that, and it could become a "multi-year commercial opportunity" rather than just a year or two of revenue flow, Gilead CFO Andrew Dickinson told an analyst.

Top Stories Of The Week

Moderna posts 'positive' early data for COVID-19 vaccine

Moderna’s COVID-19 prompted an immune response similar to those seen in patients who have recovered from infection. Eight patients who received the two lowest dose levels—25 micrograms and 100 micrograms—developed neutralizing antibodies against the virus two weeks after receiving their second dose.

After sneak peak at early data, Operation Warp Speed head Slaoui 'confident' in COVID-19 vaccine by year's end

President Donald Trump officially unveiled the "Operation Warp Speed" program and its leaders on Friday. The group aims to develop a COVID-19 vaccine by the end of the year, and its newly appointed head—GSK veteran and former Moderna board member Moncef Slaoui—said Friday he's "confident" the team can deliver.

'Warp Speed' head Slaoui, challenged for 'huge conflict of interest,' sells off $12.4M in Moderna stock

As the Operation Warp Speed program races ahead with COVID-19 vaccine candidates, one of its leaders, former GSK exec Moncef Slaoui, kept millions of dollars of stock in Moderna, the biotech leading the pack. But now, after an influential senator challenged that ownership interest, he's planning to sell.

It's too soon to assume success for Moderna's COVID-19 vaccine: analyst

Evercore ISI analyst Umer Raffat analyzed the data Moderna released earlier this week on its experimental COVID-19 mRNA vaccine and found some shortcomings that he believes the company will have to address in phase 3 trials. They include questions about the validity of comparators the company used and the durability of protection the vaccine offers.

CureVac ramps up COVID-19 mRNA vaccine effort as Moderna analysts raise questions about animal data

CureVac announced that its lead COVID-19 mRNA vaccine candidate generated “high levels” of virus-neutralizing titers in animal models and that it will launch a phase 1/2a clinical trial next month. But with Moderna's equally optimistic statements about a mouse trial of its mRNA vaccine candidate, some analysts are raising questions about what the preclinical data really means.

AstraZeneca signed up to deliver U.K. shots first. Now it aims to supply COVID-19 vaccine worldwide: report

U.K.-based AstraZeneca, partnered with the University of Oxford on a leading COVID-19 vaccine candidate, already inked a deal to supply millions of doses to its home country. Now, the drugmaker is scouting for partnerships to make the potential vaccine available worldwide.

More threat to Gilead's HIV business? GlaxoSmithKline touts long-acting injectable PrEP win against Truvada

Just as GlaxoSmithKline launches an assault on Gilead Sciences’ HIV business in the treatment realm, it’s also targeting the prevention market with new data backing twice-monthly cabotegravir as a more convenient PrEP alternative to Gilead Sciences' Truvada.

What pandemic? With ADC's $233M listing, biotech IPOs keep on rolling

After pulling the plug on its first IPO attempt, ADC Therapeutics tried its luck during a pandemic. That gamble has paid off—the cancer drug developer reeled in $233 million in its Wall Street debut, outraising its original goal by more than $80 million. The proceeds will push the company’s lead programs through pivotal phase 2 studies.

Allergan receives FDA warning over recalled breast implant safety studies

The FDA issued two warning letters to breast implant manufacturers this week, including Allergan for failing to complete postmarket safety studies documenting the risks of two implant models the company took off the worldwide market last year.

Enrollment Showcase

Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

Resources

[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

[Presentation] Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

[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] 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.

[Whitepaper] The great data transition: Making the move from claims to EHR data

The immediacy of EHR data availability can be significantly impactful, particularly as the health care system works to address COVID-19. Download this whitepaper to learn more.

[Report] Decentralized Trials - Where Does the Industry Stand?

Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual."

[Whitepaper] Continuous Manufacturing vs Batch: Deciding on the Best Solution for your Oral Solid Dose Product

Continuous Manufacturing vs. Batch for Oral Solid Dose

[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. 

[Whitepaper] Flexible Design for Novel Trials

Download this case study to read about how Cenduit navigated these challenges, and successfully supports the trial sponsor to execute the umbrella trial with agility.

[Whitepaper] Critical API Attributes and the Major Impact They Can Have on Drug Product Development

Download this whitepaper to learn more about the importance of an integrated approach to formulation.

[Case Study] More Powerful Analytics Capabilities

Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI.

[Whitepaper] Is Wurster Processing the Right Choice for My Multiparticulate Modified Release Dosage Form?

Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. Read this whitepaper to determine whether Wurster processing is the right option for your project.

[Webinar] Chemistry Through Biology: Translating Molecular Biology Technologies into Practical Processes for API Production

In this webinar, the featured speaker will explore the key advances and critical hurdles for translating these emerging molecular biology technologies into real-world applications and commercial processes.

[Whitepaper] Assessing the Financial Impact of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug. Download the whitepaper.

[Whitepaper] New Lonza Whitepaper on Modulating lgG Effector Function

This whitepaper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies.

[GUIDE] Managing Clinical Trial Patient & Site Engagement During COVID-19

Leverage strategic solutions to respond to immediate challenges to patient and site engagement from COVID-19, and learn to maximize the FDA guidance on the conduct of clinical trials during a pandemic.

[Magazine] Perspective: the patient edition

Report: Think you’re patient-centric? Think again. Find out how patients really feel about patient-centricity. Learn what they would like to experience along with tools and tips for maximising patient engagement across the product life cycle¬ – from clinical trials to service design and creative campaigns.