Moderna announces positive top line data from phase II/III study of COVID-19 vaccine in children 6 to 11

-Moderna Inc. announced positive interim data from the Phase II/III study, called the KidCOVE study, of mRNA-1273 , the Company’s vaccine candidate against COVID-19, in children 6 to under 12 years of age. This interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile. Moderna plans […]

Phase III ATOM trial of Tymlos shows positive results in osteoporosis – Radius Health

Radius Health announced positive topline results from the ATOM study evaluating Tymlos (abaloparatide) 80mcg subcutaneous (SC) for use in males with osteoporosis. The ATOM study met its primary endpoint – the percentage change in lumbar spine (LS) bone mineral density (BMD) compared to placebo – demonstrating statistical significance after 12 months (p-value < 0.0001). Study participants receiving abaloparatide-SC experienced an […]

NICE (UK) recommends Adakveo as a treatment for preventing recurrent sickle cell crises – Novartis

Novartis is pleased to announce that eligible patients in England and Wales will soon have routine access to Adakveo (crizanlizumab) under a Managed Access Agreement (MAA). The news comes as the National Institute for Health and Care Excellence (NICE), published the Final Appraisal Determination (FAD) recommending crizanlizumab as an option for preventing recurrent sickle cell crises (two or more vaso-occlusive […]

Mirtazapine is ineffective, possibly dangerous, for agitation in dementia

Mirtazapine, an antidepressant often used to treat agitation in patients with dementia, is ineffective, researchers reported on Oct. 21, 2021 in The Lancet. And the investigators found a potentially higher mortality with use of mirtazapine. “Our results indicate that mirtazapine, given with normal clinical care, is not clinically effective compared with placebo for the treatment of clinically significant agitation in […]

FDA Advisory Committee unanimously votes in support of emergency use for a booster dose of Moderna’s COVID-19 Vaccine in the U.S

Moderna, Inc. confirmed that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and […]