Opinion on Central Nervous System

Published within

« | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | ... | » »|

Type Product title / description Pub Price
Expert View
Expert View

Four more years: solanezumab to remain in Phase III

Solanezumab, Eli Lilly's experimental Alzheimer's antibody, is to be tested in another Phase III trial, targeting mild patients only. Discussions with the FDA have dissuaded Lilly from seeking immediate approval, although the path to market for the much-maligned drug now appears relatively straightforward, albeit 4 years later than scheduled.

Published By Datamonitor
13 Dec 2012
Expert View
Expert View

Forest attempts to squeeze cariprazine into the crowded antipsychotic market

Cariprazine is set to become the latest drug to enter the crowded antipsychotic market following its NDA submission for schizophrenia and bipolar mania. Despite consistent efficacy, the drug's side-effect profile will be limiting, especially in a market now dominated by generics. Nevertheless, opportunities for differentiation remain, with Forest already looking toward additional approvals.

Published By Datamonitor
28 Nov 2012
Expert View
Expert View

Merck & Co: suvorexant takes stride towards refreshing the dormant insomnia market

On account of its novel mechanism of action, Merck's suvorexant has the potential to address key unmet needs in the treatment of insomnia. If approved, the drug is expected to grow the insomnia market and become a blockbuster. However, lack of scheduling and demonstration of superiority over the current gold-standard insomnia treatment, zolpidem, will be key in suvorexant attaining this status.

Published By Datamonitor
09 Nov 2012
CommentWire
CommentWire

Sunovion: Latuda poised to expand options in bipolar depression

Following positive data from two Phase III clinical trials of lurasidone HCl in bipolar depression, Sunovion is eager to capture a large patient share by seeking approval for Latuda as both a mono and adjuvant therapy. While Sunovion will be competing with AstraZeneca's Seroquel franchise, Latuda's efficacy in alleviating cognitive symptoms offers potential for differentiation.

Published By Datamonitor
02 Nov 2012
Expert View
Expert View

Eisai: novel Fycompa expands treatment options for refractory epilepsy in US

Eisai's Fycompa has become the first AMPA receptor antagonist to gain FDA approval for the adjunctive treatment of partial-onset seizures. While underwhelming clinical trial data, DEA scheduling, and a boxed warning will hinder revenues, Fycompa's novel class, convenient dosing regimen, and preferable side-effect profile will support its uptake in the drug-resistant patient population.

Published By Datamonitor
25 Oct 2012
Expert View
Expert View

Eli Lilly: EXPEDITION is over but solanezumab should live on

While both EXPEDITION studies missed their primary endpoints, a pooled analysis of solanezumab data has revealed a significant reduction in cognitive decline in mild Alzheimer's disease. The drug's commercial potential in this indication should ensure that Lilly conducts further studies, despite the inherent high risk of failure.

Published By Datamonitor
09 Oct 2012
CommentWire
CommentWire

Sanofi/Genzyme: modest efficacy sees Aubagio compete on price

Following the announcement of positive Phase III data in June 2012, the FDA has granted approval of Aubagio for the oral treatment of relapsing multiple sclerosis (MS). Sanofi is competitively pricing Aubagio in the face of strong competition, but will nevertheless achieve only modest sales for the drug in the MS market.

Published By Datamonitor
14 Sep 2012
Expert View
Expert View

Merck: suvorexant on track to refresh insomnia market

Merck & Co. has announced positive Phase III data for its insomnia candidate suvorexant, renewing hope in the novel orexin receptor antagonist drug class after speculation about class-wide safety issues. Although suvorexant has the potential to address key unmet needs in the treatment of insomnia, demonstration of superiority over zolpidem and lack of scheduling will be key to commercial success.

Published By Datamonitor
12 Sep 2012
Expert View
Expert View

Lilly's antipsychotic axe will shift attention to Roche

Development of Lilly's pipeline glutamate receptor agonist, pomaglumetad methionil, has been discontinued following a confirmed lack of efficacy. Disappointingly, this promising new mechanism fails to translate into a viable drug, although Roche's commitment to its own novel schizophrenia candidate, RG1678, shows that drug developers are not yet ready to move away from psychiatry.

Published By Datamonitor
30 Aug 2012
Expert View
Expert View

Lilly's Phase III data for solanezumab disappoint yet tantalize

Solanezumab has failed to meet its primary endpoints in two pivotal Phase III studies in Alzheimer's disease. Significantly, however, efficacy signals were discovered in prespecified secondary analyses. This suggests that Lilly's drug - widely expected to fail completely - may still have a potential path to market, pending discussions with regulators and further clinical trials.

Published By Datamonitor
28 Aug 2012

« | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | ... | » »|

No help is available.