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April 14, 2020___

Today's Rundown

Featured Story

Moderna's COVID-19 vaccine trial starts enrolling high-dose arm

A phase 1 trial of Moderna’s COVID-19 vaccine candidate has begun enrolling subjects at the highest dose. Moderna shared the update on the COVID-19 study alongside news that people in another trial had anti-Zika antibodies after receiving the biotech’s vaccine against that virus.

Top Stories

Sanofi, GSK tie up for COVID-19 vaccine work with eyes on possible 2021 rollout

Sanofi and GlaxoSmithKline, two of the world’s biggest vaccine players, may be competitors, but the COVID-19 pandemic has now made them partners. The pharma giants are teaming up to develop a coronavirus shot—and to scale up manufacturing lickety-split.

Biogen Alzheimer's filing likely hit by pandemic, as drugs against the disease set for delay

It’s a pretty grim story in Alzheimer’s research, with years of flops and setbacks against the memory-wasting disease.

Five Prime taps Genentech vet Civik to take the helm

Five Prime Therapeutics has had bumpy few years, losing a couple of CEOs, facing layoffs and coming up empty on a pancreatic cancer trial. Now, it’s recruited a new CEO to steady the ship: Thomas Civik, who spent more than a decade at Genentech commercializing cancer meds.

Alnylam's vutrisiran gets fast-track treatment at the FDA

FDA has put Alnylam’s RNAi treatment for the polyneuropathy of hereditary transthyretin-mediated amyloidosis on its regulatory fast track. Alnylam secured the designation for the candidate, vutrisiran, ahead of the anticipated readout from a phase 3 trial early next year.

MEI Pharma nabs $100M upfront and weighty biobucks in upgraded Kyowa Kirin cancer drug deal

San Diego biotech MEI Pharma has upped its pact with Tokyo, Japan-based Kyowa Kirin in a cost-sharing deal centered on MEI’s experimental oncology asset.

Gates, GV chip into $45M round for CNS biotech Cerevance

Four months after inking its first Big Pharma partnership, Cerevance is topping up its coffers with a $45 million raise. The proceeds will push the company’s lead Parkinson’s disease program through phase 2 and move several earlier-stage prospects into the clinic.

Rutgers' saliva-based test nets FDA green light for COVID-19

Clinical genomics researchers at Rutgers University have received the FDA’s first emergency authorization for a COVID-19 diagnostic test that uses easy-to-collect saliva samples instead of the more difficult deep nose swabs.

Alzheimer's researchers link glucose metabolism to disease pathology, uncovering new drug targets

Researchers led by the Emory School of Medicine discovered proteins that govern how cells derive energy from glucose are elevated in the brains and cerebral spinal fluid of patients with Alzheimer's disease. The findings could be used to define new drug targets and develop diagnostics for early detection of the disease.

The top 10 drugs by sales increase in 2020

Some drugmakers work for years to take one of their meds from launch to blockbuster status—a journey defined by competition, market, branding and a dash of luck. But even for pharma's biggest whales, growth-minded executives have a question: What have you done for me lately? 

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