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Today's Rundown

Featured Story

Moderna finalizes design of phase 3 COVID-19 vaccine trial ahead of July start

Moderna has finalized the design and dosage of its phase 3 COVID-19 vaccine trial, keeping it on track to start the pivotal test next month. Work to get the 30,000-subject phase 3 trial underway is advancing in parallel to ongoing enrollment in earlier phases of development.

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Top Stories

Juno-WuXi AppTec JV JW Therapeutics nabs $100M for cell therapy push

Back in 2016, Juno Therapeutics (now owned by Celgene, now owned by Bristol Myers) and WuXi AppTec joined forces to create a new CAR-T biotech and in 2018 got off a meaty $90 million series A.

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BIO: Kura Oncology CEO Wilson on the power of biotech in the quest beyond KRAS

Troy Wilson’s company, Wellspring Biosciences, was working on a KRAS inhibitor with Johnson & Johnson when a thought struck him: Are there other ways to modulate the same pathway KRAS does? After spending “nights and weekends” poring over literature, he stumbled across a drug that his partner, despite all its resources, couldn’t take forward.

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New gene therapy technique shows promise in stem cell model of retinitis pigmentosa

Scientists at Trinity College Dublin and University College London “mini retinas” with mutations in the RP2 gene that cause some forms of retinitis pigmentosa. Delivering a functional RP2 gene to the model eyes rescued the rod photoreceptor cells needed for proper vision, they reported.

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Pfizer partner BioNTech scores €100M debt financing to fund COVID-19 vaccine production in Europe

BioNTech and Pfizer are among the front-runners in the closely watched COVID-19 vaccine race, and as they simultaneously work through development and scale up manufacturing, BioNTech has scored a €100 million financing agreement to help fund production in Europe.

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Doctors don't think Biogen Alzheimer's drug should be approved, but they'd still prescribe it: survey

When Biogen disclosed a filing delay for its closely watched Alzheimer’s disease drug candidate aducanumab back in April, analysts were puzzled and pushed for answers. But no matter when the drug makes its way to regulators, controversy will follow, J.P. Morgan analysts wrote in a recent note, pointing to results from a survey of experts. 

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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.

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FiercePharmaAsia—Roche-Innovent deal; Lilly-Junshi COVID pact; Fujifilm, WuXi Biologics expansions

Roche is licensing out part of its cancer platform to Chinese biotech Innovent Biologics. Eli Lilly taps Junshi Biosciences' candidate as its second COVID-19 antibody program. Two Asian CDMO giants, Fujifilm and WuXi Biologics, are busy expanding their presence in Western countries. And more.

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Chutes & Ladders—Lonza poaches Roche vet Ruffieux as newest CEO

Lonza taps Roche veteran Ruffieux as newest CEO; Altasciences brings in Morelli as CMO: FDA expert Marks bolts from Operation Warp Speed.

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Resources

Whitepaper: Pandemic respiratory vaccine clinical trials: a departure from business as usual

Download this whitepaper to learn more about the success factors that are required to keep a pandemic respiratory vaccine trial running at optimal speed and efficiency.

Whitepaper: Brand Revitalization with RP Scherer Softgel Solutions for Analgesics

In a series of innovation sessions, Catalent RP Scherer softgel capsules were quickly identified as the ideal solution to drive incremental growth. Learn more.

Whitepaper: 7 Keys to Success in Europe

White paper describing 7 keys to success for any biopharma company that is entering (or thinking about entering) Europe.

Whitepaper: Rapid BYOD Build Timelines

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

Whitepaper: Keep Your GI Trials Moving During COVID-19

Learn how GI specific data capture solutions can support virtual and hybrid trials during COVID-19.

Whitepaper: The Evolution and Importance of Biomedical Ontologies for Scientific Literature

Dive into the history of biomedical classification and how these systems have evolved to address new technology and use cases.

Whitepaper: Pandemic respiratory vaccine clinical trials: a departure from business as usual

Download this whitepaper to learn more about the success factors that are required to keep a pandemic respiratory vaccine trial running at optimal speed and efficiency.

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.

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. 

Podcast: Developing residual HCPs ELISA assay for biopharmaceutical products

Listen to our brand-new Frontage Laboratories podcast where you’ll take home tips for developing residual host cell proteins ELISA assay for biopharmaceutical products using commercial kits.

Virtual Event: Cardiac Safety London Online

Join us for a day of discovery as global experts in Cardiology, Pharmacology and Diabetes discuss state of the art methods in early phase clinical research.

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: Why Your Business Needs An Effective Cloud Strategy To Survive Now

Businesses must maintain pre-pandemic levels of productivity with smaller IT budgets. Learn why an effective Cloud Strategy is imperative for success in these unprecedented times.

Events