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April 17, 2020___

Today's Rundown

Featured Story

Gilead's remdesivir looks promising in leaked early results, but don't jump to conclusions: analysts

The world is watching and waiting for data to see whether Gilead's investigational antiviral remdesivir can help fight COVID-19. And while some leaked early results suggest that it can, industry watchers will need to wait for data from Gilead's own controlled phase 3 study to know for sure.

Top Stories

BARDA promises Moderna up to $483M to shepherd COVID-19 vaccine to approval

Last month, Moderna became the first company to test a COVID-19 vaccine in humans, and, now, the Biomedical Advanced Research and Development Authority is stepping up to pay its way to approval. The agency is committing up to $483 million to bankroll late-stage clinical trials and scale up manufacturing for the vaccine.

MD Anderson research freeze stops production of Bellicum drugs

The cessation of research at MD Anderson Cancer Center has put a stop to production of Bellicum Pharmaceuticals’ clinical development candidates. 

Lantern files for IPO to study 5-time phase 3 cancer failure

Lantern Pharma has filed IPO paperwork to raise money to test a failed cancer prospect. The drug, LP-300, failed five phase 3 trials between 2006 and 2013, but retrospective analyses of data from two of the studies have convinced Lantern it has a future in a subset of lung cancer patients.

PTC Therapeutics elevates biotech buyout CEO to chief development officer

Late last year, PTC Therapeutics bought up California-based BioElectron Technology in a small deal, nabbing its leading drug, EPI-743, for metabolic and mitochondrial disorders.

Designing precision antibiotics with inspiration from bacteria's survival strategy

A team led by scientists at UCLA, with help from Bay area biotech Pylum Biosciences, described the key structural mechanism of action for a class of naturally occurring bacteria-killing proteins called R-type pyocins. The findings could aid in the development of more precise antibacterial agents, they say.

Roche slates COVID-19 antibody blood test for early May

Roche announced plans to launch its own COVID-19 antibody blood test early next month as a complement to its previous high-throughput test for active infections authorized by the FDA in March.

EuroBiotech Report—Witty joins WHO project, Arix cuts, Galapagos, Leo and Novartis

In this week's EuroBiotech Report, WHO taps Witty for COVID-19 project, Arix cuts costs and Galapagos hooks up with Ryvu.

FiercePharmaAsia—Gilead’s nixed remdesivir trials; Indian pharmas’ site nods; CanSino’s COVID-19 vaccine

Two remdesivir trials in China have been suspended due to low enrollment. The FDA has cleared a trio of Indian Pharmas' production sites this month. CanSino's recombinant shot became the first COVID-19 vaccine to enter phase 2 trial. And more.

Chutes & Ladders—Mylan's Coury steps into exec chairman role

Mylan elevates Coury to executive chairman role; Cardurion names ArQule vet Lawrence to CEO post; Civik takes helm at Five Prime.

Biopharma's no-holds-barred fight to find a COVID-19 vaccine: The full list

The hunt is well underway for medicines to combat COVID-19, but it will be longer for vaccines than it will be for drug treatments. Here’s a guide to the vaccines in development against COVID-19, including Moderna Therapeutics' phase 1 RNA shot, Pfizer and BioNTech's candidate hard on its heels and a host of preclinical prospects.

Resources

[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.

[Whitepaper] Navigating the Changing Clinical Trial Landscape

The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need.

[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?

[Webinar] Model-Based Approach to Design Bispecific Modalities in Early Discovery

Learn how we used a tiered model-based approach of a bispecific antibody to appropriately cover multiple antigen pairs to help teams with informed antibody design, prioritization of experiments, and triaging of challenging antigen pairs

[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.

[Guide] Pandemic Survival Guide --- IT Solutions for Business Continuity

To survive in these challenging conditions, companies need to promptly address business continuity issues - especially the remote delivery of data and voice solutions. See how Outer Edge can help.

[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.

[Presentation] Flexible Manufacturing Strategies

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

[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.

[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. 

Events