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Bayer nets speedy US review for regorafenib in liver cancer

Priority review in HCC boosts hopes for rejuvenation of Stivarga to combat declining sales

Biogen Idec building

FDA approves Biogen’s Spinraza for spinal muscular atrophy

Analysts predict blockbuster sales as drug is priced at $750,000 for first year of treatment

Roche Basel Switzerland

FDA delays verdict on Roche’s MS drug Ocrevus

Additional manufacturing data postpones US verdict until 28 March 2017

- PMLiVE

FDA okays Clovis’ Lynparza rival rucaparib

Analysts predict Rubraca could become a $1.5bn-plus product by 2020

- PMLiVE

Making a list and checking it twice…

The promise of mobile health lies not in recording information but in promoting behaviour change

- PMLiVE

FDA green light for Pfizer’s eczema drug

Blockbuster-hopeful Eucrisa expected to launch early next year at $580 per 60mg tube

- PMLiVE

FDA starts speedy review of Merck/Pfizer’s PD-L1 inhibitor

If approved avelumab would be first approved cancer immunotherapy for metastatic MCC

Sanofi reception

FDA clears rival diabetes combos from Sanofi and Novo Nordisk

Xultophy set to launch in first half of 2017 while Soliqua is intended for January roll-out

AstraZeneca AZ

Trials of AZ’s durvalumab restart as FDA hold is relaxed

Bleeding side effects in two head and neck cancer studies not attributed to the PD-L1 inhibitor

- PMLiVE

GSK files first application for triple COPD therapy

Submits combo in the US one year early to coincide with EU marketing application

Novartis building

Novartis gets speedy FDA review for midostaurin

Leukaemia treatment could become first targeted therapy for 25 years

- PMLiVE

A rock and a hard place

When insurance companies exclude drugs from their coverage

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