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bluebird bags breakthrough status for CALD gene therapy

News comes after impressive data from a phase II/III trial

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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

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Morning brief: Gilead partners with Verily, Roche expands 4DMT partnership and more

A rapid round up of pharma, biotech and healthcare news

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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Morning brief: Allergan’s migraine results, Biktarvy approved in Europe and more

A rapid run-down of news in pharma, biotech and healthcare

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Allergan’s oral migraine drug closer to US filing

New data keeps Allergan ahead of rival Biohaven

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Shaping healthcare

Bayer’s Lars Bruening talks about moving to the UK as the market works its way through a series of seismic changes

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Otsuka finally gets FDA OK for kidney disease drug

Approval at last for rare disease treatment

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Shire rebuffs Takeda bids, as Allergan bows out

Allergan doesn’t intend to make a formal offer following a dip in its share prices

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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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