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Today's Rundown

Featured Story

Merck tips implant to give yearly HIV protection, plans phase 2

A phase 1 trial has found an implantable formulation of Merck’s islatravir could protect against HIV for at least one year. Merck is now preparing to start a phase 2 study of the subdermal implant. 

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Top Stories

Capricor touts exosomes as better mRNA delivery vehicle

Capricor Therapeutics has shared early data on the exosome-mediated delivery of COVD-19 vaccines. The preclinical work furthers Capricor’s efforts to show its exosomes are a better delivery vehicle for mRNA than the currently used lipid nanoparticles.

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Intellia advances CRISPR/Cas9 delivery to treat sickle cell

Intellia Therapeutics has presented preclinical data on its bone marrow-tropic delivery system for in vivo genome editing. The study moves Intellia a step closer to its goal of systemically delivering CRISPR/Cas9 to treat diseases such as sickle cell.

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FDA rejects rare disease drug, asks for prefilled syringe info

The FDA has rejected PharmaEssentia’s request for approval of a treatment for a rare blood cancer. PharmaEssentia needs to provide more information about the instructions for the prefilled syringes used to administer the pegylated interferon.

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Fierce Biotech’s top 10 data readouts in 2021

The first two entries in our 2021 clinical readouts list cover clinical trials of vaccines and therapeutics in COVID-19. Out list also covers familiar ground, featuring emerging drug candidates for cancer, diabetes, central nervous system disease, rare disorders and immunological conditions.

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Resources

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. 

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.

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.

Webinar: Patient-Focused Drug Design: Through the Lens of Real-World Case Studies, Clinical Evidence and Advanced Delivery Solutions

Discover the current state of patient-focused dose design through clinical evidence, real-world case studies and patient preference-driven drug design solutions that can help develop better treatments and successful real-world outcomes.

eBook: Drug Design and the Patient Journey

This eBook features insights from experts in the industry on patient-centric drug development challenges and strategies on advancing drug design and development effectively.

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.

Webinar: Phase Appropriate Expertise and Technologies to Accelerate Product Development to Commercialization

In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site.

Events