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Biogen/Ionis’s Spinraza Approved; Second Antisense Drug For Neurodegeneration In 2016

 
• By Mandy Jackson

Analysts expect strong uptake for the antisense oligonucleotide (ASO) given the high unmet need in SMA and positive data in multiple studies, while the first ASO approved this year – Sarepta’s Exondys 51 – has seen some pushback from payers despite the lack of DMD therapies.

Biogen and partner Ionis Pharmaceuticals Inc. are ending 2016 with US FDA approval for Spinraza (nusinersen) in the treatment of spinal muscular atrophy (SMA), marking the second antisense drug approved this year to treat a rare neurodegenerative disease.

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Japan Market Entry: Consortium’s One-Stop Shop To Support Foreign Entrants

 
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Japanese CDMO Bushu talks about a consortium designed to provide a broad range of development services to smaller foreign firms looking to bring high-need drugs to the Japanese market.

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Japan Market Entry: Consortium’s One-Stop Shop To Support Foreign Entrants

 
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Bristol’s Growth Plans Take A Hit As Cobenfy Fails As A Schizophrenia Add-On

 
• By Mandy Jackson

Cobenfy is approved as a monotherapy, but failed in the adjunctive setting when combined with generic atypical antipsychotics, giving BMS a second Phase III failure in two weeks.

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• By Alaric DeArment

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