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FDA: Cybersecurity is an ever-present risk for medical devices

US regulator issues new guidance for manufacturers

- PMLiVE

Sanofi and Merck & Co finalise vaccine alliance split

Dissolve Sanofi Pasteur MSD after poor sales growth

Bayer symbol

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

Keytruda closes in on Opdivo’s lead in Hodgkin lymphoma

KEYNOTE-087 trial shows an overall response rate of 69 percent

- PMLiVE

NICE green lights Keytruda for second-line lung cancer

Merck & Co's oncology treatment backed in draft guidance for NSCLC

- PMLiVE

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

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

- PMLiVE

Keytruda gets priority FDA review for biomarker-positive tumours

Merck & Co’s immuno-oncology drug used for colorectal cancer

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