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Today's Rundown

Featured Story

FDA starts pilot after AstraZeneca, J&J make case for novel drug delivery excipients

Academic literature features a steady stream of papers on novel excipients with the potential to improve drug delivery, but they rarely show up in newly approved drugs because companies shy away from the additional risk they entail. Recognizing that, the FDA has created a Novel Excipient Review Pilot Program to clear the logjam. 

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Top Stories

Cingulate, gunning for pharma majors, seeks $58M to develop extended-release ADHD drugs

Can drug delivery technology equip Cingulate to win market share from Johnson & Johnson, Novartis and Takeda? That is the question facing investors as they weigh up whether to back Cingulate’s pitch to raise up to $58 million to bankroll its attack on the attention deficit hyperactivity disorder (ADHD) market.

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Windgap bags $17M to advance smaller, longer-life autoinjectors

Does size matter in the autoinjector market? Windgap is betting that delivering smaller devices with longer shelf lives will give it an edge—and has parted investors from $17 million to realize its vision. 

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Ultrasound unlocks blood-brain barrier in cancer clinical trial

Researchers have advanced the age-old effort to overcome the blood-brain barrier with clinical trial data suggesting ultrasound can temporarily enable molecules past the blockade.

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Citius buys out license to Ontak replacement from Dr. Reddy's for $40M

Citius Pharmaceuticals is paying $40 million to acquire the license to a phase 3 asset meant to replace Ontak, the FDA-approved cancer drug that was withdrawn from the market in 2014 due to manufacturing issues. 

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As gene therapy safety faces scrutiny, Broad Institute proposes a safer and more efficient delivery tool

A team led by scientists at the Broad Institute has developed adeno-associated viruses as gene therapy vectors. The vehicles can target muscle tissue, and therapies based them are effective in animals at low doses, potentially reducing the risk of liver damage, they said.

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Resources

Whitepaper: Applications of Digital Twins in Clinical Trials for Alzheimer’s Disease

Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes.

Whitepaper: Evaluating current manufacturing platforms for recombinant AAV production

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

Whitepaper: The Value of Precision Medicine Informatics Initiatives Research Findings

Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives.

Whitepaper: Challenging Tradition: The Argument for Integrated Commercialization to Improve Operational Agility

Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how.

Whitepaper: High-yield NK cell culture for allogeneic cell therapy applications

Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications.

Whitepaper: Five Trends to Watch in the European Market Access Environment

This white paper provides a concise overview of the trends currently shaping the market access environment in Europe, as well as the implications for biopharma companies.

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.

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