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Today's Rundown

Featured Story

Johnson & Johnson aims to beef up schizophrenia offerings with new 6-month Invega formula

Johnson & Johnson has had little trouble keeping sales from its Invega portfolio of long-acting antipsychotic injectables in the billions. Now, it's angling for approval of an even more durable formulation that could further hone the drug's convenience edge over competitors. 

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Top Stories

Johns Hopkins scientists create parasite-inspired microdevice to gradually deliver drugs in the GI tract

Scientists at Johns Hopkins say they've developed a parasite-inspired microdevice that changes shape inside the body to attach to the inside of the GI tract. Paired with an anti-inflammatory drug and tested in rats, the "theragripper" remained inside the animals' colons for 24 hours, leading to higher drug exposure and durability.

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Kala Pharma staffs up in sales to roll out newly minted dry-eye med Eysuvis

Kala Pharmaceuticals' Eysuvis—delivered by drop four times daily for up to two weeks—is the first prescription drug approved specifically for short-term treatment of dry eye disease, and the only corticosteroid with an FDA indication in the field.

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Xeris Pharma's auto-injector-friendly diazepam wins FDA fast-track tag in cluster seizures

Xeris Pharmaceuticals last year snared approval for its first drug, a shelf-stable glucagon injector for hypoglycemia. Now it's deploying its formulation tech to hit another target—epilepsy—and the FDA has taken notice.

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Resources

Whitepaper: CRCs Equip Sites to Navigate the New Normal

Need additional site resources for your current or upcoming clinical trial?

Q&A: The Road to a COVID 19 Treatment Launch

How pharma's supply chain partners are paving the way for coronavirus therapies.

Whitepaper: Liquid-Filled Capsules for Highly Potent Drug Compounds

Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives.

Whitepaper: Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

Anticipate early development challenges to avoid rework and costs.

Article: Strategies to address the viral vector manufacturing shortage

Accelerating the production of viral-vector based therapy requires both understanding of strategies to address viral vector manufacturing and how to select the most cost-effective solution for your therapeutic. Read more in this article.

Whitepaper: How to Leverage IDN Data – Everything You Need to Know

Get insights into healthcare decision-makers networks.

Webinar: Elevate Your Digital Events Strategy

Learn how to plan immersive digital event experiences

Whitepaper: Gene and Cell Therapy: Planning for Manufacturing Success Early

Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience.

Whitepaper: COVID-19 Vaccine Clinical Trials in Children: Challenges on the Horizon

Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper

Whitepaper: Companies Need An Effective Remote Workforce Cloud Strategy To Survive

A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely.

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.

Whitepaper: Go from Process R&D to Clinical APIs Quickly and Effectively

Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success.

Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.

eBook: CMC Considerations for Successful Early Drug Development

This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success.

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.

Whitepaper: How to Achieve Time and Cost Reductions in Clinical Trial Design and Build

Learn how to save time and reduce costs and complexity by streamlining the clinical trial process.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Executive Summary: Keys to a Successful Rapid Commercial Launch

Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Events