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November 10, 2008Astra Zeneca Seeking to Widen Indications, Markets for Seroquel XR
Analysis of: AstraZeneca Announces European SEROQUEL XR Submission for the Treatment of Generalised Anxiety Disorder | www.pharmalive.com
Author: Louis Sanfilippo, President, LCS Group, LLC
Astra Zeneca is pursuing important medical and, of course, commercial goals by seeking the expanded clinical indications of major depression and generalized anxiety disorder for Seroquel XR, heir to blockbuster Seroquel (quetiapine). This latest EU submission culminates regulatory submissions...
July 21, 2008A Small Company, A Big Idea
Analysis of: TheraGenetics Licenses Intellectual Property Related To Predicting Patient Response To Antidepressant Therapy | www.medicalnewstoday.com
Author: Louis Sanfilippo, President, LCS Group, LLC
“Personalized medical diagnositics” looks to be evolving as a high impact area in neuropsychiatric drug development. Such ‘genetic biomarker’ platforms, based on either pharmacogenetic profiles coming from DNA blueprints or gene products from a simple blood draw, aim to identify patients who are...
July 3, 2008One Drug, Many Uses -- Mostly a Very Good Idea
Analysis of: One drug, many uses. Good idea? | www.indystar.com
Author: Louis Sanfilippo, President, LCS Group, LLC
‘One drug, many uses’ can make lots of sense clinically and commercially. Seeking additional FDA indications for a specific drug has obvious business benefits: greater revenue stream, improved branding, potentially longer market exclusivity, greater franchising potential of the drug...
June 30, 2008Lundbeck Reveals Mechanism of Action of its “Mixed Serotonin Modulator and Stimulator” Antidepressant LuAA21004
Analysis of: Interim report for the first quarter of 2008 - strong growth in sales and profits | www.lundbeck.com
Author: Louis Sanfilippo, President, LCS Group, LLC
Lundbeck has now disclosed the mechanism of action of its “mixed serotonin modulator and stimulator,” albeit buried in a first quarter report. Data on LuAA21004, Lundbeck’s lead antidepressant jointly in development with Takeda, was released at the Scandinavian College of Neuro-Psychopharmacology...
May 21, 2008BrainCells Novel Antidepressant: Targeting Neurogenesis but not Serotonin?
Analysis of: BrainCells Inc. Initiates Phase 2 Clinical Trial With BCI-540 For Depression With Anxiety | www.medicalnewstoday.com
Author: Louis Sanfilippo, President, LCS Group, LLC
It’s not clear just how BrainCells’ BCI-540 works but the company claims the drug acts by way of promoting neurogenesis without an effect on serotonin neurotransmission. While SSRI’s also promote neurogenesis, a downstream effect believed to favorably impact mood and anxiety, they obviously...
May 13, 2008Abbott Targets Adult ADHD with Nicotinic Drug, Shows Strong CNS Pipeline
Analysis of: Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com
Author: Louis Sanfilippo, President, LCS Group, LLC
Abbott’s Neuronal Nicotinic Receptor (NNR) partial agonist platform is an innovative target for ADHD and potentially other CNS disorders. The Phase II data on ABT-089 suggests efficacy for adult ADHD with good safety/tolerability. NNRs will not have the kind of effect size seen with stimulants...
April 28, 2008Glaxo Decision Moves Drug Development Forward Again
Analysis of: Federal Court Sides With GlaxoSmithKline, Strikes Down Rules Issued by Patent Office | biz.yahoo.com
Author: Louis Sanfilippo, President, LCS Group, LLC
The USPTO’s proposed rule changes, struck down in this important Glaxo federal court decision, would have added significant burdens to pharmaceutical companies in developing their IP portfolios and ultimately their drug treatments. The proposed changes were seemingly motivated to make the...
April 24, 2008Corcept Therapeutics Takes Yet Another Shot at Psychotic Depression
Analysis of: Corcept Therapeutics Announces Commencement Of Next Phase 3 Study With CORLUX(R) For The Treatment Of Psychotic Depression | www.biospace.com
Author: Louis Sanfilippo, President, LCS Group, LLC
Corcept Therapeutics is at it again with yet another clinical trial for its lead candidate mifeprisotone (Corlux), a GR-II (glucocorticoid) receptor antagonist, hoping to show efficacy on the psychotic features of psychotic major depression (PMD). Corlux clearly offers a potentially novel...
April 17, 2008Another Casualty in Antidepressant Development
Analysis of: EPIX Pharmaceuticals Announces Discontinuation of PRX-00023 Clinical Development Program | biz.yahoo.com
Author: Louis Sanfilippo, President, LCS Group, LLC
The development of a new generation of serortinin 5HT1a agonists for major depression and anxiety disorders has met yet another failure, now from EPIX Pharmaceuticals’ PRX-00023. Gepirone ER (GlaxoSmithKline), another 5HT1a partial agonist, suffered the same fate last November when...
April 9, 2008
ROTARIX(R) Rotavirus Vaccine Will Give Pediatricians Another Vaccination Option
Analysis of: FDA Approves ROTARIX(R) Rotavirus Vaccine | www.pipelinereview.com
Author: GLG Expert Contributor
ROTARIX(R) Rotavirus Vaccine Will Give Pediatricians Another Vaccination OptionAnalysis of: FDA Approves ROTARIX(R) Rotavirus Vaccine | www.pipelinereview.com
Author: GLG Expert Contributor
Clinical trials have shown very similar efficacy and safety with both GSK's Rotarix and Merck's Rotateq. With only two doses needed for Rotarix, pediatricians may opt for a simpler schedule. Financial consideration will likely play the largest role in adopting the new vaccine.
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