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GLG News by Physicians who Treat Insomnia (US)

Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
May 13, 2008
Abbott 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)
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...
May 5, 2008
TNF worked in dogs but not humans
By a GLG Expert Contributor
Analysis of: Can biologic drugs tackle antibiotic resistance? (www.pharmaceutical-business-review.com)
Immunomodulation especially with antibodies is difficult.  Proteins are not as easily given and distributed through the body as low molecular weight compounds.  I believe that the first drug to be effective will pave the way for many others
Dipti Doshi, MD, Rheumatologist
HEALTHCARE PARTNERS MEDICAL GROUP
May 1, 2008
TRU-015 and SBI-087 both trubion's product both strong products with Different MOA , B cell depletion.
Analysis of: Trubion Announces Initiation of Phase 1 Study of SBI-087 for the Treatment of Rheumatoid Arthritis (www.pipelinereview.com)
Drug therapies for RA include (NSAIDS), DMARDS, and, most recently, biologics. Biologics currently on the market for RA target immune messengers called cytokines, which promote the damaging inflammatory process, and include anti-tumor necrosis factor (TNF) drugs – infliximab , etanercept,adalimumab,...
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
April 28, 2008
Glaxo Decision Moves Drug Development Forward Again
Analysis of: Federal Court Sides With GlaxoSmithKline, Strikes Down Rules Issued by Patent Office (biz.yahoo.com)
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...
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
April 24, 2008
Corcept 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)
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...
Daniel Wynn, MD, Director, Clinical Research
Daniel Wynn, MD, Director, Clinical Research
Consultants In Neurology Ltd.
April 24, 2008
COPAXONE from the START of MS
Analysis of: Teva Seeks Approval for the Extension of its Indication to Include the Treatment of Patients with a First Clinical Event Suggestive of MS (www.pipelinereview.com)
Copaxone has become the leading treatment for relapsing remitting MS in the US.  The results of the PRECISE trial will likely add to TEVA's sales momentum and boost sales further.
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
April 17, 2008
Another Casualty in Antidepressant Development
Analysis of: EPIX Pharmaceuticals Announces Discontinuation of PRX-00023 Clinical Development Program (biz.yahoo.com)
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 7, 2008
Taranabant--To Be or Not To Be
By a GLG Expert Contributor
Analysis of: Taranabant looks promising (www.taranabant-health.com)
Although the concept is exciting--an inverse agonist at the cannabinoid-1 (CB-1) receptor to reduce appetite, this medicine has a lot of bad press from rimonabant to overcome.  The major problem with rimonabant was psychopathological reactions in patients.  We do not yet know whether this...
David Engler, MD, Physician
David Engler, MD, Physician
The Allergy Clinic
April 4, 2008
Xyzal--Just overpriced Zyrtec
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) (www.therapeuticsdaily.com)
 A bottle of 30 Generic Zyrtec can be purchased for $15.  No one is going to get Xyzal that inexpensively. There are no head to head studies showing Xyzal to be better than Zyrtec.  Even though Xyzal claims a 6% sedation rate compared to Zyrtec's 14% rate, it's not apples to apples. ...
David Engler, MD, Physician
David Engler, MD, Physician
The Allergy Clinic
April 4, 2008
Slowly but surely, Primary Care gets the message about preventing asthma
Analysis of: FDA Approves ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11 (www.pipelinereview.com)
Use of Asmanex will continue to increase with this approval down to age 4. Its dose counter tells you exactly how many doses are left in the device.  Pulmicort uses a system that counts down 120---90---60---30---0. A lot of patients on Pulmicort complain to me about this "approximate" dose...

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