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Today's Rundown

Featured Story

FDA approves intramuscular version of Biogen MS drug Plegridy

The FDA has approved an intramuscular formulation of Biogen’s multiple sclerosis drug Plegridy. Biogen is framing the formulation as a way for relapsing MS patients to treat their conditions without suffering the injection site reactions associated with subcutaneous administration.

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Top Stories

Arcutis' topical cream hits goal in psoriasis phase 3, setting up FDA filing and market showdown

A pair of phase 3 clinical trials of Arcutis Biotherapeutics’ roflumilast cream have met their primary endpoints, teeing the company up to seek FDA approval in plaque psoriasis in the second half of the year.

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BiomX hails clinical data as first for oral phage delivery

BiomX has reported top-line findings from a phase 1a clinical trial of its orally administered phage therapy candidate BX002. The study provided early evidence BiomX can get the high concentrations of viable phage to the gastrointestinal tract needed to make oral administration a feasible option.

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Tiziana posts clinical COVID-19 data on nasal antibody delivery

Tiziana Life Sciences has reported data from a small clinical trial of a nasally administered antibody in COVID-19 patients. The study provided early evidence that the anti-CD3 human monoclonal antibody can improve outcomes in people infected with the pandemic coronavirus. 

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Novo Nordisk plots $1.3B in spending as it expands API production—and advances new oral meds

Novo Nordisk is off and running with its launch for oral semaglutide, a Type 2 diabetes med carrying blockbuster expectations. But the company also sees potential new uses for its oral delivery platform, and it's bolstering its manufacturing network to support its forays in that direction.

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Resources

eBook: Your Path to Virtualization: Eight parameters to accelerate and optimize your technology strategy

8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook.

Whitepaper: Navigating the Digital Transformation Journey

Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem.

Whitepaper: A Single Source of Truth: Acorn AI's Commercial Data Model

Acorn AI has developed a flexible and scalable Commercial Data Model that provides pharmaceutical companies with the data-driven insights required to respond to the industry’s ever-changing landscape. Download the whitepaper to learn how Acorn AI’s intuitive data model enables launch success and more. 

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.

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.

Events