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Today's Rundown

Featured Story

Eli Lilly rushes to FDA with its COVID-19 antibody for emergency green light, reveals new cocktail therapy data

Eli Lilly is hustling to the FDA with its antibody therapy for a speedy emergency use authorization as it also reveals new data for a combo therapy.

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Top Stories

Nobel Prize in chemistry goes to CRISPR pioneers Doudna, Charpentier

The 2020 Nobel Prize in chemistry was awarded to Jennifer Doudna and Emmanuelle Charpentier for their 2012 discovery of the genome-editing tool CRISPR-Cas9. It was the first time two women have won a science Nobel Prize. CRISPR-Cas9 comprises a guide RNA that zeroes in on a DNA target and the Cas9 enzyme that cuts the DNA.

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Chinese COVID-19 vaccine trial reports falling antibody titers

The Chinese Academy of Medical Sciences has presented phase 1 data on its inactivated SARS-CoV-2 vaccine. The readout suggests the vaccine is safe and triggers an immune response, although a drop in neutralizing antibody titers from Day 14 to Day 28 is a potential cause for concern.

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Sponsored: Xevinapant’s 3-year data make waves in head and neck cancer at ESMO 2020

Xevinapant in combination with standard cisplatin-based chemoradiation therapy (CRT) reduces the risk of death in high-risk patients with locally advanced head and neck cancer by 50%.. This first-in-class molecule showed it could improve long-term outcomes in hard-to-treat patients, becoming the first in decades to demonstrate a survival benefit in this group.

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With clinical focus elsewhere, Germany's Merck sells off osteoarthritis drug to Novartis

Germany’s Merck is pretty busy with its focus on cancer (notably its Pfizer-partnered Bavencio) and neurology, so it's decided to make a quick buck turfing out an unwanted bone drug to Novartis.

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Roche targets cystic fibrosis with deal for TMEM16A potentiator

Roche has bought a phase 1 pan-genotype cystic fibrosis program from Enterprise Therapeutics. The deal, which is worth £75 million ($97 million) upfront to Enterprise’s shareholders, gives Roche a TMEM16A potentiator designed to restore lung function in all cystic fibrosis patients.

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Scribe Therapeutics emerges with $20M, Biogen pact to clear CRISPR hurdles

Bacteria evolved CRISPR as a form of “genetic vandalism" to fend off pathogens, so it works very well in bacteria but runs into various obstacles when researchers try to put it to work in humans. Jennifer Doudna’s latest CRISPR company plans to surmount those hurdles with an entirely new platform that does not rely on molecules found in nature.

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Medtech CEOs discuss returning procedure volumes, V-shaped recoveries and 'the new normal' after COVID-19

It’s an urgent question not only for the medtech community and its patients, but one described as “top of mind" for the healthcare industry at large: How will surgical procedures recover and evolve as the country continues to navigate the COVID-19 pandemic?

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Designing a universal flu vaccine by refocusing the immune system

A group of researchers led by MIT and Bristol Myers Squibb has shed light on a possible strategy for developing a universal flu vaccine by targeting a more stable region of the influenza virus that’s normally not targeted by the immune system.

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Resources

Webinar: Streamline your Clinical Research Organization's processes on the Salesforce Platform

Join this webinar to learn first hand why executing clinical research trials end-to-end on a single platform is the best way to successfully meet the needs of today’s market.

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: Five Imperatives for Becoming More Patient-Centric

Achieving patient centricity depends on evolving how evidence is generated.

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: Leverage Technology to Expedite Master Protocol Trials

This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials.

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.

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.

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