GLG News by QT Interval Prolongation Experts (US)
Analysis of:
Kidney Cancer Drug Linked to Higher Rate of Heart Problems (www.washingtonpost.com)
Patients with rare malignancies, especially those with already metastatic diseases, are being treated with novel oncologic agents. However, as is being seen with many drugs, the hemodynamic consequences of these agents, in many cases a rise in blood pressure, may lead to cardiovascular consequences. ...
Analysis of:
Pfizer and Taisho Finalize Agreement for Novel Schizophrenia Drug Candidate (www.pipelinereview.com:80)
Pfizer Inc (NYSE:PFE) and Taisho Pharmaceutical Co., Ltd. (OTC:TSOPF.PK) announced the signing of a definitive agreement for worldwide collaboration to research, develop and commercialize TS-032. TS-032 is a metabotropic glutamate receptor (mGluR) agonist, a novel drug candidate for the...
Analysis of:
Addex and Merck & Co., Inc. Enter License Agreement to Develop a Drug Candidate for Schizophrenia (www.pipelinereview.com:80)
Addex Pharmaceuticals (Swiss:ADXN.SW) announced on January 3, 2008 an exclusive worldwide license agreement with Merck & Co., Inc. (NYSE:MRK) to develop ADX63365, a potent and selective positive allosteric modulator of the metabotropic glutamate receptor subtype 5 (mGluR5) with potential for the...
Analysis of:
Ablynx Reports Positive Phase I Results for Its Anti-Thrombotic Nanobody(R), ALX-0081 (www.pipelinereview.com)
vWF is one of a number of attractive antiplatelet targets which include P2Y112, GIIb/IIIa, to name a few. Currently Medicines Company's Cangrelor, a small molecule against P2Y12 is quite far along in development. In addition, Archemix just published results of its Phase I trial with its anti-vWF...
Analysis of:
EPIX Pharmaceuticals Reports Compelling Clinical Results for PRX-03140 in Alzheimer's Disease (www.pipelinereview.com)
1. The results of this study demonstrtae a treatment in development, PRX-03140, which may provide stronger pro-cognitive effects than those currently available for Alzheimer's disease. 2. PRX-03140 may be a disease altering alternative to other treatments currently in development. 3. The mechanism...
Analysis of:
AstraZeneca Files Patent Infringement Actions in Response to Crestor(TM) ANDAs (www.pipelinereview.com)
Challenges to pharmaceutical patents prior to the "official" expiration of the patent are proliferating; if they are allowed to stand, that is, if the "original" patent is successfully voided one of the crucial financial incentives to novel pharmaceutical research will be abridged and the "profit" motive...
December 7, 2007
Does The FDA Acceptance of The NDA for Asenapine Signal A Good Outlook for Schering-Plough (NYSE: SGP)?
Analysis of:
Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA (www.pipelinereview.com)
Does The FDA Acceptance of The NDA for Asenapine Signal A Good Outlook for Schering-Plough (NYSE: SGP)?
On November 26 Schering-Plough Corporation (NYSE: SGP) announced the acceptance of the New Drug Application (NDA) for asenapine by the U.S. Food and Drug Administration (FDA). Schering-Plough is seeking marketing approval from the FDA for the treatment of schizophrenia and acute mania or mixed episodes...
Analysis of:
Study Shows Weight-Loss Drug Rimonabant is Associated with Severe Adverse Psychiatric Events (pharmalive.com)
The meta-analysis of the rimonabant trials points to an increase in psychiatric diagnoses. What is missing in this report is the numberical and statistical significance of the findings. This debate needs more rigor; the type of rigor that is applied to cardiac endpoints, needs to be applied here. ...
Analysis of:
NicOx' Naproxcinod ABPM Data Presented At American Heart Association (www.medicalnewstoday.com)
1. The results are intriguing, but the clinical relevance for the large number of patients who could be exposed in the real-life clinical situation is uncertain. 2. The hypotheses for thsi program early-on seem to be supported by the phase 3 data to date, i.e., the nitro-comopounds may have actions...
Analysis of:
SNTA: Patients Treated in Ph III Trial of Elesclomol for Metastatic Melanoma (www.therapeuticsdaily.com)
1. Metastatic melanoma in Stage IV is difficutl to treat. 2. Previous interventions have proven almost worthless 3. The succesful SPA agreement is an important regulatory step for the program. 4. Data will take years to develop, validate, and translate into an approved product.
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