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Today's Rundown

Featured Story

FDA approves Chimerix's oral suspension smallpox antiviral, giving treatment option to dysphagic patients  

Chimerix has received FDA approval for tablet and oral suspension formulations of its smallpox drug Tembexa. The approval makes Tembexa the first smallpox antiviral authorized for use in infants and people who have difficulty swallowing. 

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Top Stories

Noveome posts clinical data on nose-to-brain delivery device

Noveome Biotherapeutics has presented phase 1 data on its nasally delivered glaucoma candidate ST266. The safety and tolerability data tee Noveome up to advance into efficacy clinical trials in a range of neurological and ophthalmological indications.

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LianBio bags Chinese rights to Lyra's nasal implantable matrix

LianBio has licensed exclusive rights to Lyra Therapeutics’ nasally administered treatment for chronic rhinosinusitis (CRS) in China and other Asian markets. Lyra is receiving $12 million upfront in return for the regional rights to the clinical-phase, mometasone furoate-eluting implantable matrix.

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PharmaTher, TSRL ally to create microneedle patches to deliver psychedelics and antivirals

PharmaTher and TSRL have teamed up to co-develop microneedle patches. The collaboration sets the partners up to pool resources to create intradermal delivery devices for use in their respective therapeutic areas of focus.

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Regeneron leaps ahead in COVID-19 antibody race, scoring FDA nod for lower dose and subcutaneous injection

The FDA has adjusted its emergency use authorization for Regeneron's COVID-19 antibody cocktail, allowing it to be administered in a smaller dose and by subcutaneous injection. The action gives the company another leg up in its antibody battle with Eli Lilly.

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Resources

Whitepaper: How to Launch a Successful BYOD Strategy in Any Phase

For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink.

eBook: Improving Diversity and Inclusion in Clinical Trials

Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them.

Whitepaper: Closed Cell Processing System Benefits for Cell & Gene Therapy

Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process.

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.

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

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. 

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.

Events