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Today's Rundown

Featured Story

Amgen, AstraZeneca's tezepelumab is looking for a slice of blockbuster asthma market dominated by Sanofi's Dupixent

After seeking approval for tezepelumab in severe asthma on Monday, Amgen and collaborator AstraZeneca are laying all their cards on the table with hopes of eating up portions of the market left behind by Sanofi’s Dupixent and other monoclonal antibodies for inflammatory conditions.

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Top Stories

MSD Partners, Panacea's biotech SPAC hits the Street with $200M IPO

Orion Biotech Opportunities Corp., a SPAC formed by MSD Partners and Panacea Venture, pulled off a $200 million IPO. Now, it is on the hunt for biotech or life sciences companies to acquire in North America, Europe or Asia.

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Autolus' CD19 CAR-T posts 100% complete response rate, zero grade 3 CRS in small lymphoma trial

Autolus Therapeutics has linked its CD19 CAR-T to a 100% complete response rate in a small indolent B-cell lymphoma trial. AUTO1 drove the responses without causing any grade 3 or worse cytokine release syndrome, sending shares in the biotech up 35%.

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NEA-backed Allay exits stealth with clinical pain data, plans to reduce need for opioids

Allay Therapeutics has exited stealth armed with clinical pain data, cash from backers including NEA and plans to move its lead candidate into phase 2b this year.

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With a new approach, startup Flare Therapeutics may solve the transcription factor puzzle

With $82 million series A financing, Third Rock Ventures launches Flare Therapeutics, which has developed a unique "switch site" approach to targeting elusive transcription factors.

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How a genetic 'CopyCatcher' could open the door to CRISPR-based precision gene therapy

Using a technology called “CopyCatcher” to detect and quantify CRISPR-based gene editing, researchers at the University of California, San Diego demonstrated high rates of gene copying in fruit flies. The team said the findings lay the groundwork for developing a CRISPR-based gene therapy for humans.

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Medtronic issues 3rd Class I recall of the year related to HeartWare blood pump

They say bad things come in threes and that’s certainly proving to be the case for Medtronic’s long-troubled HeartWare Ventricular Assist Device system.

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Resources

Guide: Your Guide to Overcome Inconsistent Clinical Data Standards

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: 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

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.

Events