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June 04, 2020___

Today's Rundown

Featured Story

Gilead shows durability of filgotinib ahead of face-off with AbbVie

Gilead and Galapagos have released 52-week clinical trial data showing the durability of filgotinib in rheumatoid arthritis patients. The update comes as the partners close in on a FDA approval that will position them to compete with rival JAK inhibitors sold by AbbVie, Eli Lilly and Pfizer.

Top Stories

Safety issues for Pfizer's Dupixent rival may 'give prescribers pause'

Pfizer’s eczema hopeful has posted promising efficacy results from multiple phase 3 studies, building its case to challenge Sanofi and Regeneron’s Dupixent. But there’s a little something that could stand in its way: safety. New data show that patients taking abrocitinib had reductions in platelet counts, as well as a higher risk of serious infection.

GSK's cell therapy R&D lead jumps ship to partner Immatics

Just a few months after GlaxoSmithKline penned a $50 million deal with biotech Immatics for its T-cell work, the executive running the Big Pharma’s cancer cell therapy unit is upping sticks to join the U.S.-European startup.

Accent, AstraZeneca take aim at RNA modifiers in $55M cancer pact

Since it launched in 2018, Accent Therapeutics has busied itself discovering new targets for cancer drugs in the space of RNA-modifying proteins. But the time for lying low is over—just weeks after the biotech raised a $63 million round, it’s striking its first Big Pharma partnership with AstraZeneca.

Pfizer, Merck, AZ, J&J and Moderna selected as 'Warp Speed' finalists: NYT

The Trump administration has selected its COVID-19 vaccine finalists for Operation Warp Speed, which aims to deliver safe and effective coronavirus vaccines to Americans by the end of the year, The New York Times reports. 

Spectrum Pharma nabs Five Prime, Gilead veteran as new clinical lead

After swinging the ax on staffers last year and gaining a new CEO a few months back, Five Prime Therapeutics’ clinical development lead is hoping for a more stable time at new employer Spectrum Pharma.

Athira reels in $85M for phase 2/3 Alzheimer's study

Athira Pharma changed its name last year to reflect its focus on regenerative medicine. Now, it’s snagged $85 million to advance those medicines, which includes bankrolling a phase 2/3 trial in Alzheimer’s for its lead asset, designed to restore the lost neural connections in the brain or spur the growth of new ones.

Daiichi Sankyo taps CRO Syneos Health to help run ADC cancer drug work, including Enhertu

Japanese pharma company Daiichi has penned a new deal with Syneos Health to launch a “coalition” that sees the CRO work on its big-name antibody-drug conjugate targets.

Gene-edited T cells to treat diabetes inch closer to clinical trials

Scientists at Seattle Children’s Research Institute and the Benaroya Research Institute have engineered T cells that mimic the immunosuppressive properties of regulatory T cells—an approach that they say could potentially be used to treat autoimmune diseases such as Type 1 diabetes.

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Resources

[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.

[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.

[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] Covid-19 Requires a Cloud Strategy to Succeed in the “New Normal”

Covid-19 has forever changed the paradigm of “go to the office” business operations. Learn how an effective Cloud Strategy can position your company for success in these unprecedented times.

[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.

[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.

[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