FDA approves intramuscular version of Biogen MS drug Plegridy Arcutis' topical cream hits goal in psoriasis phase 3, setting up FDA filing and market showdown BiomX hails clinical data as first for oral phage delivery Tiziana posts clinical COVID-19 data on nasal antibody delivery Novo Nordisk plots $1.3B in spending as it expands API production—and advances new oral meds Featured Story | By Nick Paul Taylor 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. read more |
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Top Stories By Nick Paul Taylor 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. read more By Nick Paul Taylor 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. read more By Nick Paul Taylor 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. read more By Eric Sagonowsky 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. read more Resources Sponsored By: Medidata, a Dassault Systèmes company 8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook. Sponsored By: LabVantage Solutions Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored By: Acorn AI, a Medidata Company 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. Sponsored by: Catalent 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. Sponsored by: Catalent 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. Learn how therapeutics are successfully launched and commercialized March 24-25, 2021 | 9am-3:30pm EST Latin America Healthcare Compliance Certificate Program April 19, 2021 Learn core elements: pricing, competitive assessments and epidemiology April 28-29, 2021 | 9:00am-3:30pm PST
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