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Today's Rundown

Featured Story

AstraZeneca posts phase 3 data on once-weekly diabetes drug in adolescents

A phase 3 clinical trial of AstraZeneca’s extended-release diabetes drug Bydureon in adolescents has met its primary endpoint. The study tested a once-weekly formulation of the glucagon-like peptide-1 receptor agonist exenatide to support a planned filing for approval with the FDA.

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Top Stories

FDA accepts Roche's 6-month Lucentis implant for priority review

The FDA has accepted Roche’s Port Delivery System with ranibizumab (PDS) for priority review. Roche is seeking approval for the drug delivery implant to free patients with wet age-related macular degeneration from the need to undergo frequent eye injections.

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GSK puts long-acting injectables at heart of HIV growth plans, downplays threat of oral rival from Gilead and Merck 

GlaxoSmithKline has put long-acting injectables at the heart of plans to grow its HIV business. GSK is looking to transition to a portfolio built around cabotegravir to mitigate the loss of patent protection on dolutegravir and hold off a challenge from Gilead and Merck.

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Roche wins European approval for subcutaneous NMOSD drug

The European Commission has approved Roche’s Enspryng in neuromyelitis optica spectrum disorder. Roche is looking to subcutaneous administration, which could support dosing at home, to differentiate Enspryng from Alexion’s Soliris in the EU.

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Viatris scores a win in long-running EpiPen antitrust lawsuit, but patent settlement charge heads to trial

Viatris, the newly-formed company that combined Mylan and Pfizer's Upjohn unit late last year, said it's "pleased" with the Kansas federal court's decision to dismiss all claims related to the Racketeer Influenced and Corrupt Organizations Act, including charges against the company's former CEO Heather Bresch, in an ongoing class action case.

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Resources

Whitepaper: To De-Risk Your Next Trial, Seek Outside Expertise

Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions.

Report: Cell & Gene Therapy in 2040: Seizing the moment to propel the industry forward

What does the future of Cell & Gene Therapy look like?

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