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Today's Rundown

Featured Story

Biogen reveals gene therapy trial failure as investors remain laser-focused on aducanumab drama

Biogen revealed that a gene therapy failed to improve vision in patients with X-linked retinitis pigmentosa, a disease area that has become ripe for the company’s rivals. The company had hoped the gene therapy would become a one-time treatment for these patients, who currently have no other treatment options.

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Top Stories

With a new CMO and phase 3 data to hand, Humanigen eyes COVID-19 drug emergency filing by June

Humanigen is prepping its COVID-19 drug lenzilumab for an emergency use authorization with the FDA before the month’s end.

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Foresite, Arch fuel $92M round for Interline Therapeutics, a biotech taking aim at protein communities

We often think of proteins as isolated targets for drugs, says Zach Sweeney, Ph.D., a biopharma veteran who most recently was chief scientific officer at Denali Therapeutics. But it's more complicated than that. Enter Interline Therapeutics, which launches with $92 million to develop drugs that alter protein communities to treat disease.

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Kinnate, OrbiMed team up to target Chinese lung cancer market

Kinnate Biopharma and investors including OrbiMed Asia Partners have created a Chinese joint venture. The new company will develop Kinnate’s RAF inhibitor KIN-2787 for the Chinese market.

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Compass inks Trigr takeover to land clinical-phase bispecific

Compass Therapeutics has struck a deal to acquire a clinical-phase bispecific antibody. The deal will see Compass buy Trigr Therapeutics for a DLL4xVEGF-A candidate that is being studied in patients with solid tumors. 

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Novartis taps Ada Health's AI diagnosis platform for tracking rare, immunological conditions

To start, Novartis will use Ada’s AI-based surveys to speed up the diagnosis of axial spondyloarthritis, psoriatic arthritis and familial Mediterranean fever.

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Fierce Pharma Asia—BioNTech's Asia expansions; Takeda's debt plans; AZ-Daiichi ADC's breast cancer data

BioNTech is investing in Asia as part of its ambition to become a "global immunotherapy powerhouse." Takeda eyes top-line growth as it moves beyond its cost-cutting and divestiture stage. AstraZeneca and Daiichi Sankyo reported encouraging data for their second antibody-drug conjugate program. And more.

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Chutes & Ladders—Gossamer vet Salter-Cid dons CSO mantle at Flagship's new Pioneering Medicines unit

Former Bristol Myers Squibb compatriots are reuniting at Flagship Pioneering. Natural killer cell biotech Acepodia has enlisted AbbVie oncology exec Thorsten Graef as its chief medical officer. And Centessa has called upon a former AstraZeneca heavyweight as its new CMO.

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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