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Latest From Mandy Jackson
Bristol-Myers R&D leaders Brian Gavin and Sean Connolly offered insight into the company's immunology focus for autoimmune diseases, which increasingly is driven by a search for biomarkers that point to the best use of the big pharma's drugs.
Roche's Genentech reported positive top-line Phase III results for Hemlibra in a second hemophilia A population – patients without inhibitors – just four days after its approval for patients with inhibitors, which will broaden the product's market and may improve its competitive position.
US initial public offerings by biopharma firms in 2017 have outpaced the number of IPOs completed in the previous year and as investors continue to see big returns the pace isn't likely to slow in 2018.
Genentech/Roche's Hemlibra, now FDA-approved for hemophilia A patients with inhibitors, offers a once-weekly injection, impressive efficacy with a safety concern that appears to be manageable, and a price that's at least half the cost of the established prophylaxis regimen.
FDA has approved Abilify MyCite, a treatment for some psychiatric conditions that integrates a drug with a sensor that records when the medication is taken. The goal is to track medication compliance. It is an important regulatory milestone for the nascent field of digital medicine, but many questions about the market remain.
Otsuka plans a slow, measured launch of Abilify MyCite, developed with Proteus Health. The product includes an ingested sensor that sends a signal to a wearable patch and an app that tracks ingestion, activity and mood to potentially improve management of psychiatric care.