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Today's Rundown

Featured Story

Roche halts Huntington's phase 3 of Ionis-partnered antisense drug as blockbuster hopes fade

Roche has stopped a phase 3 Huntington’s disease clinical trial after an interim review of the data. The preplanned review found no new safety signals associated with Ionis Pharmaceuticals-partnered antisense drug tominersen, suggesting lack of efficacy may have driven the decision to stop the trial.

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Top Stories

Gilead's virology lead and remdesivir developer Brainard jumps ship to run AlloVir

After she helped Gilead Sciences repurpose its old Ebola drug remdesivir into the first antiviral for COVID-19, AlloVir is hoping Diana Brainard, M.D., can repeat that same magic as its new CEO.

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Novartis' radioligand hits goal in phase 3 prostate cancer trial

A phase 3 prostate cancer clinical trial of Novaris’ targeted radioligand therapy 177Lu-PSMA-617 has met both its primary endpoints. The result tees Novartis up to seek approval for a drug it picked up in its $2.1 billion acquisition of Endocyte.

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Sponsored: NK Cells are Now Better Serial Killers

Could native, non-functioning NK cells in cancer patients be rescued and revived by a novel, off-the-shelf immuno-oncology therapeutic that is also a pervasive serial cancer killer? The Data Says Yes.

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EpimAb reels in $120M to propel 3 clinical-stage bispecifics, including dual checkpoint inhibitor

Nearly two years after a $74 million raise, EpimAb Therapeutics is adding another $120 million to its coffers to bankroll the development of its bispecific antibodies. The capital will fuel the journey of three programs through the clinic, including a dual checkpoint inhibitor and a T-cell engager that targets CD3 and BCMA.

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Sponsored: Avoiding Gene Therapy CMC and Clinical Supply Issues

Gene therapy manufacturing and clinical supply strategies should be in place early to avoid potential late-stage development delays.

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Asher Bio sets out with $55M to deliver the pros of cytokines, other immunotherapies without the cons

Cytokines have long held promise as cancer treatments, but their use has been limited as they affect many different cells. That’s because they interact with receptors on multiple cell types. Asher Bio launches with $55 million to advance a suite of immunotherapies, including cytokine treatments, that only activate a targeted cell type.

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Frequency Therapeutics regroups as hearing loss med falls short in phase 2

Frequency Therapeutics is going back to the drawing board. After showing promise in phase 1, four dosing regimens of its hearing loss treatment did no better than placebo in a phase 2a study. The company will press ahead with a single-dose regimen and is waiting on final results from this study as well as readouts from two more phase 1b studies to plot its next steps.

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DaVita, Fresenius team up to bring dialysis care out of their clinics and into the home

The two largest dialysis providers in the U.S. are teaming up to pursue a business proposition that might seem antithetical in nearly any other field or at any other time outside of a worldwide pandemic. They aim to help get patients out of their respective clinics and have them access treatment from inside their own homes.

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AstraZeneca scrambles to update COVID-19 vaccine data after NIH flags 'concerns' about Monday's triumphant release

AstraZeneca’s vaccine prospects were looking up Monday when the company reported solid results from a new phase 3 trial it needed to win U.S. approval. Then, sometime after midnight, U.S. officials took the rare step of publicly questioning whether those data were actually complete.

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Resources

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.

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.

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: Emerging Biotech Resource Center

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

Annual Report: Clinical Trial Landscape In Russia and Eastern Europe, 2020.

Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical.

Report: State of the Industry Report: Embracing Trial Change and Elevating IRT Systems

This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty.

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. 

Guide: How to maximize your drug commercialization investments

Unlock product potential by making the most of your commercialization investments. 

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.

eBook: Optimize Trial Performance with AI-enabled Technology & Advanced Analytics

Unlock competitive advantage with AI and advanced analytics.

Whitepaper: The Crush: How COVID-19 Is Impacting Mature Brand Revenue & Long-Term Value

Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How.

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.

Free Infographic: The Future of Vaccine Development

Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain.

Whitepaper: 2021 Outlook for Cell-Based Therapies in Oncology: CAR-T Expansion & Beyond

A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones.

Whitepaper: Seasonal Vaccine Manufacturing

While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery.

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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