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Today's Rundown

Featured Story

Daiichi Sankyo, AstraZeneca's $5B Enhertu follow-up shows early signs of success in breast cancer

Daiichi Sankyo and partner AstraZeneca’s next-gen antibody-drug conjugate datopotamab deruxtecan has show glimmers of efficacy and a reasonable safety profile in its first data release in breast cancer.

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Top Stories

Abingworth raises $582M clinical co-development fund amid rising biotech interest

Abingworth has raised $582 million for its second clinical co-development fund. The fund, ACCD 2, equips Abingworth to make triple-digit million investments in late-stage clinical programs.

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KRAS biotech Mirati delivers so-so news for investors closely watching Amgen battle

Mirati Therapeutics investors waiting to hear the latest in the KRAS inhibitor story were disappointed Thursday evening, as the biotech reported that a few key clinical developments have slipped into 2022.

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Centessa's new chief medical officer has AstraZeneca's Tagrisso, Lynparza on his resume

The resume of Antoine Yver, M.D., includes several of AstraZeneca’s most well-known approved cancer drugs including Tagrisso. He will now bring that expertise to Centessa Pharmaceuticals as chief medical officer.

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Drug licenser LianBio poaches Lilly's COVID-19 antibody leader to fill CEO role

As LianBio strikes more deals to bring new drugs to China, the company is installing a new CEO: Yizhe Wang, Ph.D., who will arrive next Monday after leading the team that brought Eli Lilly’s COVID-19 antibody, bamlanivimab, to an emergency nod. Wang fills a vacuum left by LianBio’s founding CEO Bing Li, who departed quietly earlier this year.

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Bayer's near-approval Farxiga rival meets goal in 2nd phase 3

Bayer’s finerenone has met the primary endpoint in another phase 3 clinical trial. The study, which linked the mineralocorticoid receptor antagonist to a significant reduction over placebo against a composite cardiovascular event endpoint, has met the primary endpoint in another phase 3 clinical trial.

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Flagship debuts Laronde to develop RNA-based meds that could turn cells into protein factories

Antibodies and other protein therapeutics can treat a wide range of diseases, but they come with various challenges that have limited their reach. Laronde is using an RNA-based approach that could surmount these hurdles and yield medicines that give patients the ability to express therapeutic proteins in their own body instead of passively receiving those proteins through an injection.

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BioNTech, Fosun Pharma eye 1B doses of COVID-19 vaccine capacity with new China JV

As BioNTech makes inroads with its COVID-19 vaccine in Western countries under a partnership with Pfizer, the German biotech is bringing its work in China to the next level with a joint venture with licensing partner Fosun Pharma. The goal is to have manufacturing capacity of up to 1 billion doses a year.

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Resources

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