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Daily Brief: Gottlieb sets out cell and gene pathway, NICE says no to Chiesi ultra-rare treatment and more

News from the frontline of pharma, biotech and healthcare

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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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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

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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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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Health on instalment

Can US-style financial engineering underwrite ultra-expensive gene therapies?

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Seattle Genetics claims key US approval for Adcetris

Becomes the first new treatment for advanced Hl in more than 40 years

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FDA approves another home genetic testing service

23andMe’s kit will check for an increased risk of certain cancers developing

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AbbVie’s uterine fibroids drug aces second phase III trial

An FDA verdict is expected in the US in the coming weeks

Bristol-Myers Squibb (BMS) building

BMS gets OK for monthly Opdivo dosing

Analysts predict the new dosing schedule could see the pharma giant win market share

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