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Today's Rundown

Featured Story

Moderna's COVID-19 vaccine investigator leaves FDA advisory committee over conflict of interest

The FDA’s advisory committee chair has stepped down from reviewing the upcoming pandemic vaccines given her prominent role in Moderna’s late-stage COVID-19 test.

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Top Stories

Poxel posts phase 3 diabetes data ahead of approval decision

Poxel has shared the phase 3 data it hopes will secure approval for Type 2 diabetes drug imeglimin in Japan. The readouts link the oral oxidative phosphorylation blocker imeglimin to near- and long-term improvements when given as a monotherapy and in combination with other drugs.

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Lumen bags U.S. grant for GI-focused COVID-19 antibody cocktail

Lumen Bioscience has received a federal grant to develop a treatment for gastrointestinal infection in COVID-19 patients. The money will support work on a biologic drug cocktail that Lumen thinks can be a scalable, inexpensive fix for the gastrointestinal symptoms that affect many people with COVID-19.

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Versant's Monte Rosa reels in $96M to bankroll 'molecular glue' treatments for cancer, other diseases

Creating drugs that harness the body’s protein-degrading processes is not a new idea; companies like Arvinas are using this approach to destroy disease-causing proteins rather than simply blocking their function. But Monte Rosa Therapeutics wants to take protein degradation in a different direction, and it’s just raised $96 million to do so.

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Novo Nordisk tees up phase 3 trial for once-weekly insulin

People with Type 2 diabetes are no strangers to needles, with some injecting bolus insulin after meals, others injecting basal insulin once or twice a day, and others still doing both. Novo Nordisk is working on a once-weekly basal insulin that could cut down on these injections, and the phase 2 data look promising.

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LabCorp to roll out Resolution Bio's lung cancer liquid biopsy test

Under a partnership inked earlier this year, the clinical testing giant LabCorp will now begin rolling out a blood test for lung cancer developed by Resolution Bioscience.

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Agios helps identify genes that allow cancer to escape the immune system

Scientists at the University of Toronto, in collaboration with Agios Pharmaceuticals, used CRISPR to screen six genetically diverse mouse cancer cell lines. In so doing, they found that genes involved in autophagy—a process where cells recycle damaged components to regenerate themselves—were key for immune evasion.

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Resources

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: The Chronic Microcap Trap: How Launch Is the Escape for True Growth

How independent drug launch and commercialization can lead to higher market capitalization.

Whitepaper: Antibody-Drug Conjugates: Catalysts for Chemistry

Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development.

Whitepaper: How to Successfully Manage Regulatory and Financial Compliance Risk

Avoid severe compliance penalties by staying on top of evolving laws.

Whitepaper: Accelerating the Development of Orphan Drugs for Rare Diseases

This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging. Download now >>

Case Study: QED Therapeutics accelerates launch of rare cancer drug into niche market with analytics-driven insights

In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy.

Whitepaper: A Guide to Improving Your R&D Data Maturity

Life science R&D generates a LOT of data. Learn how to make sense of it and harness its potential with this step-by-step guide.

Whitepaper: How Broadening the Analysis of Compound Factors Allows for Predictive Solubility Solutions

Don’t oversimplify your solubility challenges.

Whitepaper: Reducing Site Workload for Better, Faster, Safer Clinical Trials

Download this free whitepaper to learn how to execute fast, high-quality clinical trials through eSource for studies that boost efficiency for both sponsors and sites.

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: 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.

Whitepaper: Avoid Fallout From Incompatibility Between Your API And Its Formulation

Download the whitepaper to learn more.

Whitepaper: Top 7 Data Points from Medical Claim Forms to Drive Market Development

Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information.

Whitepaper: New data models to gain insight on medication adherence

Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization.

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.

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