All About Drugs

Tout sur les médicaments הכל על תרופות كل شيئ عن الأدوية Все о наркотиках 关于药品的一切 డ్రగ్స్ గురించి అన్ని 마약에 관한 모든 것 Όλα για τα Ναρκωτικά Complete Tracking of Drugs Across the World by Dr Anthony Melvin Crasto, Worldpeacepeaker, worlddrugtracker, PH.D (ICT), MUMBAI, INDIA, Worlddrugtracker, Helping millions, 9 million hits on google on all websites, 2.5 lakh connections on all networks, “ALL FOR DRUGS” CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This is a compilation for educational purposes only. P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent

Cempra Provides Guidance on the Clinical Program Required for Regulatory Approval for Solithromycin for Community-Acquired Bacterial Pneumonia (CABP)

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Jun 142013

solithromycin

(3aS,4R,7S,9R,10R,11R,13R,15R,15aR)-1-[4-[4-(3-aminophenyl)-1H-1,2,3-triazol-1-yl]butyl]-4-ethyl-7-fluorooctahydro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-{[3,4,6-trideoxy-3-(dimethylamino)-β-D–xylo-hexopyranosyl]oxy}-2H-Oxacyclotetradecino[4,3-d]oxazole-2,6,8,14(1H,7H,9H)-tetrone

Identifiers

Legal status	Phase III clinical trials, North America, South America, Europe
Routes	oral, intravenous
CAS number	760981-83-7

Cempra Provides Guidance on the Clinical Program Required for Regulatory …
The Herald | HeraldOnline.com
The Phase 3 solithromycin clinical program in CABP will be planned to consist of an oral trial and an intravenous (IV)-to-oral clinical trial. Cempra followed the CABP guidance that the FDA proposed in a November, 2011, meeting of the Anti-Infective …

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http://www.heraldonline.com/2013/06/13/4944834/cempra-provides-guidance-on-the.html

Solithromycin (formerly known as CEM-101 and OP-1068) is a novel ketolide antibiotic undergoing clinical development for the treatment of community-acquired pneumonia (CAP) and other infections.It is expected to be the first macrolide antibiotic available in intravenous, oral, and pediatric suspension formulations in over 20 years.

Solithromycin exhibits excellent in vitro activity against a broad spectrum of Gram-positive respiratory tract pathogens, including macrolide-resistant strains. Solithromycin has activity against a wide variety of pathogens, and further research is being conducted for other infections.

May 2011: Solithromycin is in a Phase 2 clinical trial for serious community-acquired bacterial pneumonia (CABP) and in a Phase 1 clinical trial with an intravenous formulation.

September 2011 : Encouraging results from the phase 2 clinical trial versus levofloxacin were reported.

DRUG SCALEUP AND MANUFACTURING INTERNATIONAL BY DR ANTHONY M CRASTO, WORLD DRUG TRACKER

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Jun 142013

http://drug-scaleup-and-manufacturing.webnode.com/news/my-website-on-scaleup-of-organic-compounds/

Aphios, VivaCell to Develop Cannabinoid-Based Drugs for MS, CNS Disorders

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Jun 132013

Aphios, VivaCell to Develop Cannabinoid-Based Drugs for MS, CNS Disorders
Genetic Engineering News
Aphios and VivaCell have executed research and commercialization agreements to develop these drug candidates through preclinical studies, clinical development, and commercialization in the U.S. and Europe. Researchers at the University of Córdoba and …

http://www.genengnews.com/gen-news-highlights/aphios-vivacell-to-develop-cannabinoid-based-drugs-for-ms-cns-disorders/81248471/

ViroPharma Receives Orphan Drug Designation For Maribavir In Europe

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Jun 122013

Maribavir

ViroPharma Receives Orphan Drug Designation For Maribavir In Europe
The Herald | HeraldOnline.com
We commend the European Commission for providing incentives such as this for the development of drugs for rare and life threatening diseases.” ViroPharma is currently conducting two Phase 2 dose ranging studies of oral maribavir at one of three doses …

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http://www.heraldonline.com/2013/06/11/4934867/viropharma-receives-orphan-drug.html

Maribavir (originally named 1263W94) is an experimental oral antiviral drug candidate licensed by ViroPharma from GlaxoSmithKline in 2003 for the prevention and treatment of human cytomegalovirus (HCMV) disease in hematopoietic stem cell/bone marrow transplant patients. The mechanism by which maribavir inhibits HCMV replication is by inhibition of an HCMV encoded protein kinase enzyme called UL97 or pUL97. Maribavir showed promise in Phase II clinical trials and was granted fast track status, but failed to meet study goals in a Phase III trial. However, the dosage used in the Phase III trial may have been too low to be efficacious.

A Phase II study with maribavir demonstrated that prophylaxis with maribavir displayed strong antiviral activity, as measured by statistically significant reduction in the rate of reactivation of CMV in recipients of hematopoietic stem cell/bone marrow transplants. In an intent-to-treat analysis of the first 100 days after the transplant, the number of subjects who required pre-emptive anti-CMV therapy was statistically significantly reduced with maribavir compared to placebo.

ViroPharma conducted a Phase III clinical study to evaluate the prophylactic use for the prevention of cytomegalovirus disease in recipients of allogeneic stem cell transplant patients. In February 2009, ViroPharma announced that the Phase III study failed to achieve its goal, showing no significant difference between maribavir and a placebo at reducing the rate at which CMV DNA levels were detected in patients.

Promising Results in Clinical Study for Acne Drug Candidate

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Jun 122013

Promising Results in Clinical Study for Acne Drug Candidate
SkinInc.com
Novan Therapeutics,announced results from a recent clinical trial demonstrating that nitric oxide releasing drug candidate SB204 reduces colonization of the acne causing bacteria Propionibacterium acnes (P. acnes) in the skin of healthy volunteers. This study in combination with Novan’s earlier findings regarding sebum production, suggests the formulation may be capable of targeting multiple factors in acne.

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http://www.skininc.com/skinscience/ingredients/Promising-Results-in-Clinical-Study-for-Acne-Drug-Candidate-211007471.html

Ariad begins Phase 2 trial of Iclusig to treat GI tumors

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Jun 122013

Ponatinib

Ariad begins Phase 2 trial of Iclusig to treat GI tumors

Boston Business Journal (blog)

Ariad Pharmaceuticals, Inc. has launched a Phase 2 trial to test its approved leukemia drug Iclusig as a potential treatment for gastrointestinal stromal tumors (GIST).

The Cambridge, Mass-based company’s drug was approved by the U.S. Food and Drug Administration in December 2012. It’s approved to treat certain patients chronic myeloid leukemia (CML) that is resistant or intolerant to other drugs and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

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http://www.bizjournals.com/boston/blog/bioflash/2013/06/ariad-trial-cancer-drug.html

Isis Pharmaceuticals, Inc.announced that data from the Phase 1 study of ISIS-STAT3Rx in patients with cancer were presented today at the American Society of Clinical Oncology in Chicago

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Jun 042013

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced that data from the Phase 1 study of ISIS-STAT3Rx in patients with cancer were presented today at the American Society of Clinical Oncology in Chicago. Results of the initial dose escalation study in patients with metastatic cancer showed that ISIS-STAT3Rx treatment resulted in partial responses that were durable and prolonged in two out of three patients with diffuse large B-cell lymphoma (DLBCL) who were refractory to prior chemotherapy treatments. Isis and AstraZeneca are currently evaluating ISIS-STAT3Rx, in two clinical studies in patients with advanced lymphoma and metastatic liver cancer.

Chinese researchers have developed the world’s first ever vaccine against a strain of enterovirus that can cause hand, foot and mouth disease,

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Jun 032013

AsianScientist (Jun. 3, 2013) – By Sunanda Creagh – Chinese researchers have developed the world’s first ever vaccine against a strain of enterovirus that can cause hand, foot and mouth disease, a condition commonly affecting small children that can lead to deadly infection of the brain and spinal cord membranes.

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http://www.asianscientist.com/health-medicine/world-hand-foot-mouth-vaccine-developed-2013/

GSK, Genmab announce positive results from Phase III study of Arzerra (ofatumumab)

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Jun 012013

may30,2013–GlaxoSmithKline (GSK) and Genmab (GEN) have announced positive results from Phase III study of Arzerra (ofatumumab) in combination with chlorambucil for the treatment of chronic lymphocytic leukaemia (CLL) patients.