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Today's Rundown

Featured Story

Perlmutter named CEO of Eikon, a biotech with $148M to apply Nobel-winning tech to undruggable targets

Roger Perlmutter has taken up the CEO post at Eikon Therapeutics. The startup disclosed the hiring of the former president of Merck Research Laboratories alongside news that it has raised a $148 million series A round to apply live-cell super-resolution microscopy to drug discovery.

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Top Stories

ChemoCentryx's stock sinks as FDA flags issues with pivotal data

ChemoCentryx’s stock price almost halved after the FDA raised concerns with a filing for approval of avacopan. The agency raised multiple concerns with ChemoCentryx’s phase 3 clinical trial ahead of an advisory committee meeting to discuss the complement 5a receptor inhibitor this week.

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Adagio's COVID-19 antibody marches on to phase 2/3 after early data suggest 12 months of protection

Adagio Therapeutics’ COVID-19 antibody drug could provide as much as 12 months of protection against infection with the coronavirus, according to an early-stage clinical trial, supporting advancement of the therapy to phase 2/3.

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Sponsored: Mitotech brings novel approach to treating eye disorders

Mitotech focuses its clinical development efforts on ophthalmology, hoping to deliver its mitochondria targeted therapies to patients suffering from age-related as well as rare genetic eye diseases.

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Childhood-cancer-focused Day One banks $130M for pan-RAF inhibitor

It’s been a busy year for Day One Biopharmaceuticals. Just nine months after debuting with $60 million to tackle childhood cancers, the company is topping up its coffers with a $130 million series B financing. The funds will bankroll development and launch plans for its lead program as well as its search for new drug programs to pick up.

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Sponsored: Risk Mitigation in Direct-to-Patient Clinical Trials

The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Use and acceptance of DTP has grown due to the pandemic, and sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes.

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Jaguar snags a CMO after banking $139M to propel its preclinical gene therapies

Jaguar Gene Therapy emerged in February with about $40 million from Deerfield Management and a plan to get its leading assets into the clinic in the next couple of years. Now, having raised another $139 million to fuel that mission, the company is adding a chief medical officer to its team.

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Esker Therapeutics launches with $70M and a focused approach for autoimmune diseases beyond JAKs

There’s a new autoimmune disease player in town: Esker Therapeutics has raised $70 million to work on a new, focused way that can go beyond some of the limitations of JAK1 drugs.

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NIH-backed device is first to offer long-term wireless monitoring of Parkinson's patients' brain activity

In a veritable whirlwind of neurological discovery—a brain storm, if you will—researchers have developed a device with the potential to massively improve our understanding of the effects of Parkinson’s disease on brain activity.

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Expelling cancer by squeezing out rogue cells

Cancer cells multiply out of control because they're able to escape a mechanism known as programed cell death. But scientists at the Massachusetts Institute of Technology and King’s College London have uncovered key functions of another pathway that the body can use to dispose those rogue cells. That mechanism, called "cell extrusion" could inspire new methods for stopping cancer.

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Resources

Guide: How to Establish a Successful Clinical Data Standards Program

Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials.

Whitepaper: Unlocking the True Value of Digital Therapeutics Through Partnerships

As clinical treatment options become more patient-centric, digital therapeutics provide forward-looking biopharma players the opportunity to augment the value of their offerings to stakeholders.

Whitepaper: The Journey to a Global Modular Content Strategy

One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster.

E-Book: 7 Keys to Success in Europe

This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe.

Executive Brief: Seven Secrets to Patient Experience Breakthroughs: Improving the Patient Experience and Study Retention

The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients.

Article: Make the right move at every step of the drug commercialization process

Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success.

eBook: The New Standard: Virtual Study Training in Clinical Trials

The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

Whitepaper: COVID-19 Survey report: The Lasting Impact on Outsourcing Decisions

How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond?

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

Content Hub: How to improve the virtual work you do every day

We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met.

Whitepaper: Roche to pick up GenMark Diagnostics in $1.8B infectious disease testing deal

Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously.

Content Hub: Remarque Systems Resource Hub

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

Whitepaper: New Data: A Better Way to Run CHO Cell Culture Experiments

Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly.

Whitepaper: Overcoming the hurdles of Real-World Data Access through a federated global network

Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Executive Summary: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

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: 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: 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.

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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