To view this email as a web page, click here

Today's Rundown

Featured Story

Gilead stops 3 filgotinib trials pending FDA feedback on faltering JAK1 inhibitor

Gilead has paused enrollment in clinical trials of filgotinib in three indications pending feedback from the FDA. The cessation of enrollment follows the FDA’s decision to reject a filing for approval of the JAK1 inhibitor in rheumatoid arthritis due to toxicity concerns.

read more

Top Stories

Regeneron's COVID-19 antibody cuts medical visits in phase 2/3 trial

Regeneron’s anti-SARS-CoV-2 antibody cocktail has significantly reduced medical visits in ambulatory COVID-19 patients. The phase 2/3 clinical trial linked REGN-COV2 to a 57% decline in medical visits associated with COVID-19 in the 29 days after treatment.

read more

Cancer combos are king as Sanofi-Merck and AstraZeneca-Arcus team up for next-gen trials

Sanofi is teaming up with Merck while AstraZeneca taps Arcus as the future of cancer work is very much made together.

read more

Novartis sharpens focus on vision-restoring gene therapy with $150M Vedere buyout

Vedere Bio didn’t stand a chance. The Atlas Venture gene therapy startup was working under the radar on its vision loss candidates and contemplating another venture round when it got an offer from Novartis it couldn’t refuse: $150 million up front, plus $130 million more if it hit certain goals.

read more

Q32 Bio banks $60M as it ramps up 'immune rebalancing' programs

Just five months after coming out of stealth, Q32 Bio is back for round two. The autoimmune player raised $60 million from the likes of OrbiMed, Atlas Venture and Abingworth to push its lead antibody through the clinic and bolster its pipeline and the technology behind it.

read more

LianBio nets $310M to bring medicines to Asia

Drug companies often face steep challenges when entering new markets for the first time, and certain markets struggle to access much-needed drugs in a timely fashion. That’s where LianBio comes in.

read more

Syneos Health snaps up late-stage CRO Synteract, aims to 'drive growth' among emerging biopharmas

Syneos Health is buying out midsized, late-stage focused contract research organization Synteract to help bolster its research services footprint.

read more

Takeda digital transformation continues with trial data platform pact through Seqster

Shortly after announcing plans to transform itself into a digital, “cloud-first” drugmaker, Takeda has extended its agreements with Seqster—a company whose founder describes it as the Mint.com of patient healthcare data.

read more

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.

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