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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

Following reports that AstraZeneca struck a vaccine deal with four European countries, Johnson & Johnson has begun negotiations with the European Commission to supply its own candidate, if it proves its worth, with plans to launch an early phase trial next month under an accelerated timeline. Across the pond, analysts are betting that the FDA will approve “at least one" vaccine by the end of the year—and before Election Day, specifically. But Commissioner Stephen Hahn went on record saying the agency won’t approve a shot for political reasons. Those stories plus our top reads for the week follow below.

Featured Story

Johnson & Johnson in talks to supply COVID-19 vaccine in Europe: reports

After AstraZeneca struck a deal to supply COVID-19 vaccine to four European countries, another pharma giant is reportedly in talks to earmark hundreds of millions of vaccine doses for Europe should its candidate prove safe and effective. 

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Top Stories Of The Week

Giving highly funded but secretive Moderna a run for its money, Juno-lite Sana raises $700M

Sana Biotechnology has got some major backing after coming out with a huge $700 million initial funding round and the ex-financial and research team from Juno Therapeutics.

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FDA could approve 'at least one' COVID-19 vaccine before election: analyst

About 6 months into the pandemic and about 130 days until the U.S. presidential election, COVID-19 vaccines are moving ahead at record speeds. Now, a group of analysts predict “at least one” vaccine will be approved before November 3.

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Roche, BioNTech post 'low' response rate in cancer vaccine trial

A phase 1b trial of a personalized cancer vaccine in development at Roche and BioNTech has chalked up a “low” response rate. Nine of the 108 evaluable solid tumor patients responded when given the vaccine in combination with Tecentriq, although researchers pointed to immune response results to support continued study in other populations.

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Former Bristol Myers Squibb site marketed as the new home for an 'onshoring' drugmaker

As pandemic lockdowns begin to ease, the U.S. government has shown some interest—and deep pockets—in bringing drugmakers' supply chains stateside to bolster supplies during a future health emergency. Now, a New Jersey site recently owned by a Big Pharma could be the site of one drugmaker's "onshoring" dreams. 

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Gilead pens $1.5B buyout option deal for Pionyr

As it continues with its small to medium-sized biotech deals, Gilead has put down $275 million for a 49.9% share in immuno-oncology biotech Pionyr with the option to buy it out completely should it pass muster in early clinical tests.

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Merck's next-gen pneumococcal vaccine puts the heat on Pfizer with phase 3 wins

Merck and Pfizer are racing their next-gen pneumococcal vaccines to the finish line in a multibillion-dollar field. But while Merck this week posted two trial wins, they won't be enough to secure it a lead in the market-share battle to come, one analyst predicts.

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AACR: Attacking pancreatic cancer by thwarting its survival strategies

At this week’s virtual meeting of the American Association for Cancer Research (AACR), several research groups are presenting new therapeutic tactics aimed at interrupting survival pathways in pancreatic cancer. They include combining CD40 and PD-L1 blockade to improve the immune attack, and disrupting metabolic processes cancer cells need to thrive.

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Pfizer's blockbuster-to-be Vyndaqel is too costly for heart patients, study suggests

Pfizer’s tafamidis arrived in the U.S. in 2019 with a discounted list price over rival transthyretin amyloidosis drugs. But its $225,000-a-year tag still seems too much for many heart patients, a new JAMA Cardiology study found. And it's not the first time experts have questioned the price.

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ArcherDX drops IPO plans in favor of a $1.4B takeover by Invitae

Personalized cancer test developer ArcherDX is walking away from plans to take itself public and into the arms of genetic testing company Invitae.

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Enrollment Showcase

Webinar, July 8: Oncology in the Era of Precision Medicine

University of Florida precision medicine leaders highlight current knowledge and trends to advance the future of health care in this quarterly webinar series. Register today.

Resources

Webinar: Blockchain Innovations that Connect & Protect Merck's Supply Chain

Get an inside look… Merck shares its next-generation approach to supply chain protection with new digital platforms, including Blockchain.

eBook: SUPERCHARGE INNOVATION: UNLEASH THE FULL FORCE OF LIFE SCIENCES

Built on advances in Artificial Intelligence (AI), data mining, and information integration into various systems at 100% accuracy, the new era of intelligent automation is integral to life sciences for devising new treatments faster and at a lower expense.

Case Study: Pharma Sponsor Enlists Cenduit to Rescue a Multi-Country, Multi-Site Oncology Study

Download this case study to read how Cenduit helped one client successfully navigate mid-study changes to medication management.

Whitepaper: 4 Ways to Keep Pace with Big Pharma, Even On a Start-Up Budget

Learn four ways to squeeze more value from your limited R&D resources.

eBook: Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies

Download this eBook and Learn the Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies

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: 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.

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.

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.