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Daily Brief

A rapid round-up of the top pharma, biotech and healthcare news

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FDA looks to regulate digital tools

US regulator adds new components to digital health plan

Sanofi reception

Sanofi’s latecomer PD-1 gets date for FDA verdict

While Keytruda extends its lead, Sanofi makes a late bid to enter PD-1 space

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Novartis launches remote clinical trial app

FocalView will allow patients to participate in ophthalmology trials

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Otsuka finally gets FDA OK for kidney disease drug

Approval at last for rare disease treatment

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Rigel and Ultragenyx claim approvals for rare drugs

Tavalisse and Crysvita are set to treat patients with chronic ITP and XLH, respectively

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Amgen and Novartis migraine drug hits the mark again

Aimovig will become the first CGRP receptor-targeting drug if it reaches market

Bristol-Myers Squibb (BMS) building

BMS claims rapid FDA nod for Opdivo plus Yervoy in kidney cancer

Data shows the combo can improve survival compared to Pfizer’s Sutent

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Novartis buys gene therapy firm AveXis for $8.7bn

Lead candidate AVXS-101 could potentially replace regular drug treatment for SMA with a one-off intervention

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Alkermes slumps as FDA turns down depression drug

The drug needs to be supported with additional trials and a bioavailability study, says US regulator

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GSK buys Novartis out of consumer health JV after ditching Pfizer bid

Will pay $13bn for the 36.5% stake owned by the Swiss drug maker

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Can value-based healthcare take off and reach for the skies?

Are companies willing to contribute to the change in the healthcare system?

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