SkyePharma's asthma drug Flutiform could face US delay
This article was originally published in Scrip
The US FDA has given SkyePharma a preliminary notice of some potential review issues for its combination asthma drug Flutiform (fluticasone propionate plus formoterol fumarate). Additional clinical work may be required to provide more data on dosing, potentially causing a delay to regulatory approval, the UK company says.
You may also be interested in...
Experimental drugs rarely face setbacks because they are too effective, but Pfizer's novel nerve growth factor antagonist tanezumab might number among the unlucky few. Phase II data presented this week in the NEJM show that the monoclonal antibody relieved osteoarthritic pain, but an accompanying editorial proposed that in doing so the analgesic enables physical activity that can lead to excessive wear and tear on fragile joints.
AstraZeneca has enrolled the first patient in the pivotal programme for the first-in-class Syk kinase inhibitor fostamatinib (previously known as R778). Fostamatinib, which it licensed from Rigel Pharmaceuticals, is being evaluated as a treatment for rheumatoid arthritis (RA) in patients with an inadequate response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX).
The Michael J. Fox foundation has launched a $40 million, 5-year initiative to identify biomarkers of Parkinson's disease progression. The scheme, called the Parkinson's Progression Markers Initiative (PPMI), will be carried out at 18 sites in the US and the EU, and will track 400 patients with newly diagnosed disease as well as 200 who do not have the disease.