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November 17, 2008"Tamper-Proof" -- A Significant Gain to Whom??
Analysis of: FDA Asks if Pain Pill Is Tamper-Proof | online.wsj.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
Abuse resistant long acting narcotics offer benefit as they are less desirable to those who might wish a quick high via snorting, injecting crushed time-release narcotic.
Unfortunately, given the higher cost than long acting generics and increased pressure on physicians to prescribe generics, expect...
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...
October 6, 2008
cold medications overdose- med fault or Dr. fault?
Analysis of: FDA urged to recall cold medicines for youngsters | news.yahoo.com
Author: GLG Expert Contributor
cold medications overdose- med fault or Dr. fault?Analysis of: FDA urged to recall cold medicines for youngsters | news.yahoo.com
Author: GLG Expert Contributor
There is a alot of information in the media about the dangers of givng OTC cough medication to young children . Many children have ended up in the emergency room after "over-ingesting" "cold remedy products that include OTC antihistamines, decongestants and cough suppressants. Also when...
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...
June 5, 2008Novartis and Multiple Sclerosis: A Major Commitment
Analysis of: Extavia® approved in E.U for treatment of multiple sclerosis, first in planned portfolio of therapies from Novartis | www.asia-manufacturing.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
Extavia, Novartis' brand of interferon beta 1b, has been approved for the treatment of multiple sclerosis by the European Union. With FTY72, Fingolimod, Novartis has the eye on filing NDA by the end of 2009. While essentially identical to Bayer's Betaferon interferon beta 1b,...
June 2, 2008Abbott's ABT-089 --Much More than a Treatment for ADHD
Analysis of: Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
The data on ABT-089 in adults has been released with positive results, whereas the adolescent/childhood trial is on-going for this novel compound for ADHD. The key difference is the potential to improve learning, not simply regain attention and lessen hyperactivity.
May 27, 2008
Aliskiren the good, bad and the quest.
Analysis of: New data show Tekturna HCT® is twice as effective at reducing blood pressure than the diuretic HCT alone | www.novartis.com
Author: GLG Expert Contributor
Aliskiren the good, bad and the quest.Analysis of: New data show Tekturna HCT® is twice as effective at reducing blood pressure than the diuretic HCT alone | www.novartis.com
Author: GLG Expert Contributor
I think the long affect of Aliskiren (3-4 days ) after the last pill is both a benefit and a risk; it is good in the setting on noncompliance but quite a challenge when trying to reverse the hypotensive effects in emergency situation. It is interesting that it is more effective...
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...
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