Drug Development
In this episode we dive into regulation, real-time management, and AI’s various applications and how it can streamline different processes with guests from Microsoft and IQVIA.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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THE LATEST
Covalent biologic company Enlaza launches with $61M in seed financing.
Lilly digs deeper into metabolic diseases via GPCR partnership with Sosei.
Third Harmonic Bio drops its Phase 1b asset.
While showing early promise, Senolytics is a new field and most of the research is still in academic centers – most notably, the Mayo Clinic.
Vertex is kicking off a Phase I trial assessing VX-522, an mRNA therapy designed to treat the underlying cause of cystic fibrosis lung disease, while SpliSense is targeting a specific mutation.
Kymera and Sanofi shared positive results for an IRAK4 degrader for hidradenitis suppurativa and atopic dermatitis.
Shares of Avidity Biosciences are soaring following reported early signs of clinical activity and improvement in patients with myotonic dystrophy type 1 (DM1) treated with its RNA-based therapeutic.
In a comparison trial, BeiGene’s Brukinsa bested Janssen’s Imbruvica in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
An investigational mRNA cancer vaccine developed by Moderna and Merck reached its primary efficacy endpoint, inducing a clinically meaningful improvement in recurrence-free survival.
Developed initially to deliver cytotoxic payloads to tumors, antibody therapeutics are evolving to provide new, next-generation conjugates and treat various diseases beyond cancer.