Breakthrough Therapy Designation
Market Access/ News/ News/ News/ R&D/ R&D/ US
Zogenix gains Breakthrough status, but GW Pharma still ahead in Dravet syndrome
Andrew McConaghie
Breakthrough Therapy Designation, Dravet syndrome, Zogenix
0 Comment
The FDA has granted Zogenix a Breakthrough Therapy Designation for its pipeline product, ZX008 for the treatment of seizures associated with Dravet syndrome.
Novartis adds Promacta to breakthrough status roll-call
Richard Staines
Breakthrough Therapy Designation, GlaxoSmithKline, Haematology, Novartis, Promacta, regulation
0 Comment
Drug could get new indication based on NIH research
Breakthrough status for nephropathy drug lifts Omeros
Andrew McConaghie
Breakthrough Therapy Designation, Omeros, Rare diseases
0 Comment
Enzyvant gains double fast-track for rare disease drug
Andrew McConaghie
Breakthrough Therapy Designation, Enzyvant, Rare diseases, Regenerative Medicine Advanced Therapy, Vivek Ramaswamy
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Rebiotix microbiome drug success against C diff infection
Andrew McConaghie
Breakthrough Therapy Designation, C diff infection, microbiome, Rebiotix
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Patients suffering from a recurrent C diff infection have benefited from Rebiotix’s microbiome treatment.
New breakthrough designations for Roche’s Alecensa and Actemra
Richard Staines
Breakthrough Therapy Designation, cancer, fda, lung cancer, regulation
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Alecensa and Roactemra are breakthroughs, says FDA.
Janssen’s depression drug gains second breakthrough status
Andrew McConaghie
Breakthrough Therapy Designation, depression, fda, Janssen
0 Comment
Drug could help prevent some of the 41,000 suicides every year in US
New Breakthrough status for Darzalex in earlier myeloma treatment
Andrew McConaghie
Breakthrough Therapy Designation, Darzalex, multiple myeloma
0 Comment
Janssen’s drug looking to gain bigger share in crowded myeloma market