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- PMLiVE

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FDA’s Gottlieb lambasts industry’s biosimilar-blocking tactics

Speech coincides with Biosimilars Action Plan

- PMLiVE

Sage surges after depression drug gets rapid path to approval

Will be able to file a marketing application based on its phase II trial

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AbbVie, Roche get FDA OK for broader use of Venclexta

The drug is tipped to become a $2.5bn product by 2024

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Europe’s public-private alliance targets pain management

Innovative Medicines Initiative (IMI) brings pharma together with academia and patient groups in underserved area

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Pfizer drug gets speedy FDA review for rare heart failure complication

Tafamidis chalked up a comprehensive win in its phase III trials programme

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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

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

- PMLiVE

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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