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Latest From John Davis
A potential near-blockbuster drug, AstraZeneca’s Lokelma (ZS-9), has received a positive opinion from Europe’s CHMP and, if approved, will soon have to justify best-in-class plaudits and a hefty acquisition price.
The long-acting eye insert Dextenza has been accepted for review by the US FDA, a piece of good news for Ocular Therapeutix that had previously received a complete response letter on manufacturing issues and a mixed bag of late-stage clinical trial results.
The setting up of the Rosalind Franklin Institute to link up with one of the world’s largest electron microscopy centers in Harwell, Oxford, could bolster company sentiment towards UK R&D investment in a post-Brexit world.
Instead of helping raise a Series A, the Teva chairman and others acquire the preclinical company, convinced of its synthetic nanotech promise in immuno-oncology. Vifor and ChemoCentryx expand their orphan and renal disease collaboration, while Gilead out-licenses an addiction drug candidate.
Two-year-old biotech Mereo BioPharma Group plc is planning to start a pivotal Phase IIb study in osteogenesis imperfecta patients in the first-half of this year with its anti-sclerostin antibody, BPS-804, and if the results are promising, EU patients could gain early access through the region’s adaptive pathways program.
Pipeline Watch has been updated to bring greater depth and detail to a potential therapeutic product’s progress through the R&D pipeline. The table brings you a snapshot of selected late-stage clinical trial events in the pharma and biotech industries.