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Today's Rundown

Featured Story

Hits, but mostly misses for Roche’s 4 late-stage trials of GI drug hopeful etrolizumab

Roche’s batch of phase 3 tests of its experimental GI drug etrolizumab has not gone to plan, with “mixed results” highlighting a murky picture for its ulcerative colitis program.

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Top Stories

Battered and bruised Seres Therapeutics see shares skyrocket on phase 3 win

Seres Therapeutics has endured a tough few years of trials setbacks, cuts and new management, but the GI biotech is hoping with its new set of broadly positive late-stage data it can finally file for an approval.

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AbbVie infectious disease exec jumps ship to COVID antiviral biotech

AbbVie and Roche alum Janet Hammond, M.D., Ph.D., Sc.M., F.C.P. has nabbed the chief development officer role at infectious disease biotech Atea Pharmaceuticals.

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WCLC: Xcovery's Xalkori challenger shines in phase 3 lung cancer showdown

Xcovery pitted its ALK inhibitor against Pfizer’s Xalkori—the first FDA-approved drug of that class—and came out on top. The drug, ensartinib, shrank tumors in three-quarters of lung cancer patients, compared to Xalkori’s 67%, and staved off cancer for two years, more than double the time Xalkori logged.

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Dyne Therapeutics grabs $115M to ramp up muscle disease pipeline

Dyne Therapeutics is back at the VC well—this time, it’s raising $115 million to bankroll a pipeline of treatments for muscle diseases including its lead programs for Duchenne muscular dystrophy and two other muscle-wasting diseases. The company is looking at cardiac and metabolic muscle diseases in its discovery-stage work.

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Don't forget to nominate 2020's fiercest women in life sciences

There’s still time to send us your nominations for this year’s Fiercest Women in Life Sciences! We’re looking for women in biotech, pharma and medtech who, in spite of challenges both unique to the industry and to being female, stand out as leaders, innovators and mentors. Submissions close next Monday.

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GigaGen’s polyclonal antibody against COVID-19 outperforms plasma in lab tests

San Francisco startup GigaGen team took plasma from 50 COVID-19 survivors in Louisiana and used it to quickly create a polyclonal antibody to fight the disease. The antibody was 100 times more protective against the disease than convalescent plasma in lab tests and is headed to clinical trials early next year.

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FDA approves Guardant’s tumor-sequencing blood test as a Tagrisso lung cancer diagnostic

Guardant Health received a milestone approval from the FDA for its cancer test, as the first liquid biopsy able to genetically profile solid tumors anywhere in the body through a single blood draw.

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Enrollment Showcase

Bioscience Certificate Pathways Advancing Knowledge, Skills, & Careers

Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more.

Resources

Webcast: DRUG ABUSE LIABILITY ASSESSMENT: Are you taking an integrated approach?

Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment

Executive Summary: Keys to a Successful Rapid Commercial Launch

Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better.

Whitepaper: More Powerful Analytics Capabilities

Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI.

eBook: Navigating the Insulin Affordability Act

Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all.

Whitepaper: Reducing the Complexity and Costs of Channel Planning and Logistics

Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Whitepaper: Learn How Collaboration (Not Competition) Will Bring Better Pediatric Medicines to Market

Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research.

Whitepaper: High-Loaded Dosage Forms: Novel Platform Expands Spray-Dried Dispersion Utility

A novel spray-dried dispersion platform has been developed to faciliate high drug load applications

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.

Events