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Today's Rundown

Featured Story

AstraZeneca edges out in front of competition with FDA nod for once-weekly diabetes drug in kids

The FDA has approved AstraZeneca’s extended-release Type 2 diabetes drug Bydureon BCise for use in children aged 10 years and older. Securing the FDA approval provides a point of differentiation for AstraZeneca in the competitive GLP-1 market.

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Top Stories

Otsuka’s dispersible TB drug for kids wins CHMP support

Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Otsuka’s 25 mg dispersible tablet formulation of Deltyba. Otsuka developed the new formulation of the pulmonary multidrug resistant tuberculosis (MDR-TB) treatment for use in children.

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Ex-Genzyme CFO takes up exec chair role at subcutaneous delivery specialist

ReForm Biologics has appointed former-Genzyme chief financial officer Jim Sherblom as its executive chairman. The subcutaneous delivery specialist disclosed the appointment alongside news that it raised $10 million and restructured to improve its access to capital markets.

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Stada scores rights to targeted oral steroid under review for an autoimmune kidney disease

Stada has teamed up with Calliditas Therapeutics to market an oral formulation that gets budesonide to the lower small intestine to treat the chronic autoimmune kidney disease IgA nephropathy. The candidate uses a two-step technology to delay absorption of the active ingredient until the lower small intestine.

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CDMO Recipharm continues its rapid expansion with a second fill-finish facility, this time in India

Swedish CDMO Recipharm unveiled plans for a new fill-finish facility in India. The announcement comes less than three weeks after the company said it was building a new plant in Morocco.

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Resources

eBook: Get solutions to market faster

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.

Whitepaper: Strategies for mitigating supply chain risk in clinical trials

Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget.

Whitepaper: Evaluating current manufacturing platforms for recombinant AAV production

Choose the right AAV platform for your viral vector-based therapy

E-Book: Digital Therapeutics 101

E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic.

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?

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

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