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- PMLiVE

Roche gains EU PRIME status for Spinraza rival

Oral treatment joins Novartis' gene therapy challenger

- PMLiVE

FDA takes aim at pharma’s biosimilar-delaying tactics

Ever-rising cost of insulins also to be targeted

- PMLiVE

FDA clears Sandoz and Pear’s Opioid Use Disorder app

The app incorporates CBT to improve high relapse rates

- PMLiVE

Orphan drugs from Biogen and Amicus win UK Prix Galien

New medical technology category added for the first time

- PMLiVE

Pfizer claims rapid FDA nod for Lorbrena

Green light is latest in a string of cancer drug approvals

- PMLiVE

Spinraza lifts Biogen ahead of Alzheimer’s data

Continued strong growth for Biogen’s spinal muscular atrophy therapy Spinraza helped the company exceed revenue expectations in the third quarter, but pipeline disappointments kept its shares largely static.Spinraza (nusinersen) was...

- PMLiVE

AcelRX’s potent opioid tablets set to win FDA backing for pain relief

Panel voted 10 to 3 in favour of the treatment

- PMLiVE

Insmed claims first FDA okay for limited population antibiotic

Arikayce is cleared to treat lung disease caused by MAC

- PMLiVE

Alnylam seeks fast-track filing with biomarker data

Early filing reflects FDA desire for faster approvals

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