High-dose Spinraza inches closer to EU approval despite FDA setback
A high-dose version of Biogen’s Spinraza (nusinersen) could soon be available in Europe, after a panel recommended the formulation’s approval.…
Central Nervous System
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Modulight secures $12m to shine precise light on neurological diseases
Modulight Biotherapeutics has raised $12.2m in seed financing to advance its optogenetic technology being developed for neurological disorders. The seed…
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J&J’s Caplyta wins MDD approval to extend revenue horizon
Caplyta (lumateperone) has scored a label extension into the depression setting, underscoring the belief Johnson & Johnson (J&J) saw in…
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Lundbeck and Contera partner for oligonucleotide-based medicines
H Lundbeck and Contera Pharma have announced a research partnership aimed at expediting the discovery as well as development of…
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Oragenics partners Receptor.AI for brain health candidate portfolio
Clinical-stage biotechnology company Oragenics has announced a strategic collaboration with the US-based tech bio firm Receptor.AI to expedite the development…
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FDA lifts clinical hold on Neurizon’s ALS drug
The US Food and Drug Administration (FDA) has released its clinical hold on Neurizon Therapeutics’ NUZ‑001, paving the way for…
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NMPA approves Eisai and Biogen for Leqembi IV maintenance dosing
China's National Medical Products Administration (NMPA) has granted approval for four-weekly intravenous (IV) maintenance dosing of Eisai and Biogen’s Leqembi…
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Roche bids to broaden MS pipeline and strengthen Ocrevus influence
Roche plans to present data at a major multiple sclerosis (MS) conference indicating the continued efficacy of its investigational Bruton…
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FDA delays approval decision for Sanofi’s MS treatment tolebrutinib
There’s been another detour in tolebrutinib’s path to market, with developer Sanofi revealing that the US Food and Drug Administration…
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Reunion Neuroscience expands Series A to $133m after positive trial milestones
The success of Reunion Neuroscience’s lead psychedelic candidate in a postpartum depression (PPD) trial has provided a last minute boost…
