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Today's Rundown

Featured Story

Regeneron hit by 'safety signal' for COVID-19 cocktail as data board tells pharma to stop enrolling sicker patients

The saga of COVID-19 antibody R&D continues as the REGN-COV2 antibody cocktail used by President Donald Trump and touted as a cure has been hit by safety worries as it continues to push for an FDA emergency authorization.

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Top Stories

Bellicum shares nose-dive on poor CAR-T data, program pause—company axes 79% of staffers

Bellicum’s shares are being routed after it announced a full house of horrors: poor data, a paused program and slashing the vast majority of its staff as it looks to save cash.

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Novo Nordisk scraps Type 1 diabetes drug after phase 2 trial

Novo Nordisk has scrapped development of anti-IL-21 antibody NN9828 in combination with Victoza after getting a look at phase 2 data in Type 1 diabetics. The news is another setback for a drug that has underwhelmed in multiple indications over the past decade. 

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Astellas cuts Potenza anti-TIGIT asset in quarterly cull

In 2018, Astellas spent $405 million to buy out long-term biotech partner Potenza and its small group of early-stage cancer drugs.

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SQZ Biotech, breaking convention, hits the NYSE with $71M IPO

When it’s time to go public, most biotech companies for the Nasdaq. Not so for cell therapy-focused SQZ Biotech, which raised $71 million in its New York Stock Exchange debut. The proceeds will bankroll a pipeline of cell therapies based on a platform that squeezes cells through a microfluidic chip, disrupting their membranes to get materials into them.

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Golumbeski, Hasnain join Vertex Ventures as executive advisers

Vertex Ventures has named George Golumbeski and Faheem Hasnain as executive advisers. The appointments position the VC fund to benefit from the input of industry veterans who, respectively, turned Celgene into one of the most active deal-makers in biotech and ran companies including Receptos.

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C2N debuts Alzheimer's blood test for predicting amyloid plaque deposits in the brain

C2N Diagnostics is launching a simple blood test the company says can identify the state of amyloid plaque in the brain, one of the hallmarks of the neurodegenerative condition.

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Training the innate immune system to fight cancer

Existing immuno-oncology therapies primarily leverage adaptive immunity to fight cancer. A research team led by scientists at the Icahn School of Medicine at Mount Sinai has discovered a possible way to tap the innate immune system, using a nanobiologic to boost the effectiveness of checkpoint inhibitors in mice.

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FiercePharmaAsia—Takeda-Moderna COVID vaccine deal; CStone-EQRx PD-1/L1 pact; Korea flu shot woe

Takeda has inked a deal to help bring Moderna's COVID-19 vaccine to Japan. China's CStone Pharmaceuticals out-licensed its PD-1 and PD-L1 inhibitors to EQRx in a potential $1.3 billion deal. Singapore halted two flu shots amid rising post-vaccination deaths in Korea. And more.

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Chutes & Ladders—Bayer adds Roche veteran Rommel as research head

Roche veteran Rommel joins Bayer as head of research; Cogent names Robbins as CEO; Fox takes over CFO role at Nuvation.

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Resources

White Paper: How Patient Affordability Legislation May Shape Your Business

In this case study on the Alec Smith Insulin Affordability Act, you will learn not just about the law but about the portal platform designed to change the entire process for manufacturers, pharmacists, and patients.

Webinar: Elevate Your Digital Events Strategy

Learn how to plan immersive digital event experiences

Whitepaper: Gene and Cell Therapy: Planning for Manufacturing Success Early

Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience.

Whitepaper: COVID-19 Vaccine Clinical Trials in Children: Challenges on the Horizon

Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper

Whitepaper: Companies Need An Effective Remote Workforce Cloud Strategy To Survive

A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely.

Whitepaper: Exploring the patient dynamic from different perspectives

The culture of clinical research is evolving from one directed by researchers to one driven by the needs of patients and those who care for them.

Whitepaper: High Content Screening in 3D: Faster 3D Image & Multi-Parametric Data Analysis

Creating integrated HCS workflows in a single platform increases accuracy; reduces time and helps to identify the most appropriate hits or drug candidates. Learn more about a reliable method for creating a more efficient, faster, 3D image and multi-parametric data analysis workflow.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Whitepaper: Go from Process R&D to Clinical APIs Quickly and Effectively

Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success.

Whitepaper: COMPLIANCE –THE COMPETITIVE DIFFERENTIATOR TO COMMERCIALIZATION: An Integrated Model Setting the New Global Standard

An integrated compliance model can be the competitive differentiator to commercialization and move the needle from cost center to value. Learn How.

Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.

eBook: CMC Considerations for Successful Early Drug Development

This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success.

Webinar: Phase Appropriate Expertise and Technologies to Accelerate Product Development to Commercialization

In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site.

Whitepaper: How to Achieve Time and Cost Reductions in Clinical Trial Design and Build

Learn how to save time and reduce costs and complexity by streamlining the clinical trial process.

Whitepaper: Position Your Pharmaceutical Lab for Success

Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions.

Whitepaper: Technology Transfers: Reaping Rewards, Reducing Risks

Learn how to safeguard supply, improve distribution and reduce program costs and risks

Whitepaper: Making Data Central to Your CNS and Pain Trials

Learn how the right data capture solution can prompt the patient to follow the correct procedures and automatically sort the responses, according to protocol.

Whitepaper: Research Reveals New Launch Standards for First-to-launch Pharma and Biotech Companies

While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products.

Whitepaper: 16 Biopharma Leaders Tell How COVID-19 Will Change Customer Engagement

Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers.

Report: State of Life Sciences | 2020 Trends Report

A complete Life Science Industry Snapshot in One Report

Whitepaper: Why Your Business Needs a Ransomware Strategy To Avoid Being Hacked!

Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now!

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

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: 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.

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