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Latest From John Davis
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for centralized EU marketing authorization. Here’s a summary of their March 2017 recommendations.
Targeting the age-dependent decline in immune function is the aim of a new PureTech Health subsidiary, resTORbio, that has licensed two clinical-stage mTORC1 inhibitors from Novartis.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
CSL Behring’s long-acting subcutaneous C1 inhibitor formulation, CSL830, has confirmed its efficacy for the prevention of hereditary angioedema (HAE) attacks, and is expected to be introduced this year, giving it initial traction in what could become a crowded sector.
Newron’s new Parkinson’s disease therapy, Xadago, approved in the US after a regulatory delay, is expected to be the first of several new products to be introduced in this long-neglected therapeutic sector.
The first large real-world evidence study has found SGLT2 inhibitors cut the rate of hospitalizations for heart failure and all-cause mortality in patients at low risk of cardiovascular events, but the results of CV outcomes studies are awaited to confirm the findings.