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Today's Rundown

Featured Story

Eli Lilly bets $135M on neuro biotech Disarm Therapeutics, with up to $1.2B to come

Eli Lilly is snapping up Disarm Therapeutics, a biotech working to “disarm” the SARM1 protein, which plays a key role in neurodegeneration. The deal is worth $135 million upfront but Disarm investors could reap as much as $1.225 billion down the line if Lilly translates its preclinical work to marketed products.

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Top Stories

Vertex's big move beyond cystic fibrosis hits a wall with lung drug failure

Vertex is pulling the plug on a treatment for a rare, inherited lung disease after the prospect caused abnormally high levels of liver enzymes in a phase 2 study. The company will continue developing a “structurally distinct drug” for the same disorder.

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Sage shares data on retreatment with depression drug zuranolone

Sage Therapeutics has shared data from an open-label trial of zuranolone as it starts to remake the case for the drug following its phase 3 failure. The study found around half of major depressive disorder patients who respond to zuranolone require retreatment and that outcomes for subsequent courses are comparable to the initial treatment.

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Otsuka's guadecitabine flunks 2 more late-phase cancer trials

Otsuka’s guadecitabine has failed to improve overall survival in two phase 3 blood cancer clinical trials. Guadecitabine has now failed three late-phase trials, leaving Otsuka to weigh up the next steps for a hypomethylating agent it acquired in its $886 million takeover of Astex Pharmaceuticals.

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Dewpoint, fresh off a $77M round, snags former Sanofi CMO as its new chief

In February, Sanofi CEO Paul Hudson cut four top executives as part of a bid to simplify the company’s management structure. Among them was Ameet Nathwani, M.D., its chief medical officer and chief digital officer, who—like many a colleague before him—made the leap from Big Pharma to small biotech.

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COVID-19 mRNA vaccine candidate from Sanofi and Translate protects mice, monkeys: study

Sanofi and its partner Translate Bio tested their mRNA COVID-19 vaccine candidate MRT5500 in mice and macaques and found that the animals developed neutralizing antibodies and a favorable T-cell response, they reported. A phase 1/2 trial is expected to start this quarter.

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Regeneron, in the thick of COVID-19 fight, snags historic FDA approval for Ebola treatment

With the world focused on the fight against COVID-19, the scientific community just scored a big win in another infectious disease. The FDA approved the first treatment—Inmazeb from Regeneron—to treat Ebola in adults and children.

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Resources

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

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

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.

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.

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