Pharmacodynamics News and Research

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Simulations Plus launches Version 7.0 of GastroPlus software for pharmaceutical industry

Simulations Plus, Inc.,a leading provider of simulation and modeling software for pharmaceutical discovery and development, has announced the launch of Version 7.0 of GastroPlus, the industry's gold standard software for the simulation of drug absorption, pharmacokinetics, and pharmacodynamics.

25 Aug 2010

Raptor Pharmaceutical updates on cysteamine bitartrate Phase 3 clinical trial in cystinosis patients

Raptor Pharmaceutical Corp.,provides updates on timelines related to its clinical programs including the pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

24 Aug 2010

Array BioPharma fiscal 2010 revenue increases to $53.9 million

Array BioPharma Inc. today reported financial results for the fourth quarter and full year of fiscal 2010.

10 Aug 2010

MAP Pharmaceuticals reports net loss of $12.5M for second-quarter 2010

MAP Pharmaceuticals, Inc. today announced financial results for the second quarter ended June 30, 2010.

3 Aug 2010

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump out unwanted or toxic substances, will announce new results from human trials of its lead compound, LIM-0705, at the 23rd International Congress of the Transplantation Society in Vancouver, Canada, in an oral presentation on August 19, 2010.

29 Jul 2010

AMRI initiates enrollment for Phase I study of ALB-127158 for obesity

AMRI has commenced enrollment for a Phase I study of ALB-127158(a), a novel MCH1 receptor antagonist offering a potential new approach for the treatment of obesity. The announcement was made yesterday during a presentation by AMRI's Dr. Peter Guzzo, director, discovery research and development, at the 6th Obesity and Diabetes Drug Development Summit in Arlington, VA. Preclinical data were also reported.

21 Jul 2010

BioInvent reports net revenues of SEK 63.1M for January - June 2010 period

BioInvent reached an important milestone when the results of a phase II trial of TB-402 following orthopaedic surgery, were reported in May. The data showed that TB-402 is statistically better at preventing thrombosis than enoxaparin, the current standard treatment. Supported by these good results, BioInvent and the company's partner, ThromboGenics, will now prioritise securing a development partner for the programme to ensure that the necessary resources is in place to take the product candidate to the market.

14 Jul 2010

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

NOXXON Pharma AG announced today that it has permission to commence a multiple ascending dose study of its Monocyte Chemoattractant Protein-1 (MCP-1) targeting anti-inflammatory Spiegelmer®, NOX-E36. NOXXON plans to develop NOX-E36 for the treatment of diabetic nephropathy and other diabetes related complications.

7 Jul 2010

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Studies of a more-rapid-acting injectable human insulin formulation (VIAject®) in the treatment of type 1 and type 2 diabetes and of a novel insulin analog formulation (Vialog™) in an animal model of diabetes were reported this week in three poster presentations at the 70th Scientific Sessions of the American Diabetes Association in Orlando, Florida. The findings are based upon results from recent clinical and preclinical studies sponsored by Biodel Inc..

1 Jul 2010

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

Astellas Pharma Inc. announced that the company presented results from a Japanese Phase 2 study conducted with ASP1941, a selective SGLT2 inhibitor, at the 70th Scientific Sessions of the American Diabetes Association (ADA) on June 26, 2010 (EST). ASP1941 is designed to block the re-absorption of glucose in the kidney and excrete glucose in the urine.

29 Jun 2010

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Raptor Pharmaceutical Corp. announced that it has enrolled the first patient in a pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

28 Jun 2010

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Ardea Biosciences, Inc. announced that additional positive data from its Phase 2 program for RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, are being presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Rome, Italy. RDEA594, a first-in-class selective inhibitor of the URAT1 transporter, treats the underlying cause of gout by increasing the excretion of uric acid in order to bring the body's levels of uric acid into a normal range.

18 Jun 2010

Updated Phase 1 trial results of blinatumomab in patients with relapsed NHL presented at EHA 2010

Micromet, Inc. today announced the presentation of updated results from a Phase 1 trial of the Company's lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin's lymphoma. A high objective response rate was maintained among patients treated with blinatumomab using an adapted schedule, comparable to that previously reported in patients receiving constant dosing.

14 Jun 2010

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

Biodel Inc. announced today that the following oral and poster presentations describing results from studies of the company's product candidates will be presented during the 70th Scientific Sessions of the American Diabetes Association this month in Orlando, Florida:

14 Jun 2010

Chiasma successfully completes Phase I clinical study of Octreolin

Chiasma, Inc., a privately held biopharma company, announced that it has successfully completed a Phase I clinical study evaluating the safety and pharmacokinetics (PK) of its proprietary product Octreolin, which contains the active ingredient octreotide actetate and is administered orally

14 Jun 2010

Extensive usage of antibiotic linezolid associated with ICU outbreak of LRSA

An outbreak of infection due to linezolid and methicillin-resistant Staphylococcus aureus (LRSA) in 12 intensive care unit patients in Spain was associated with transmission within the hospital and extensive usage of the antibiotic linezolid, often used for the treatment of serious infections, with reductions in linezolid use and infection-control measures associated with resolution of the outbreak, according to a study in the June 9 issue of JAMA.

10 Jun 2010

Important milestone in development of ORMD-0801 published in DOM journal

Oramed Pharmaceuticals Inc., a developer of alternative drug delivery systems, announced today that the paper entitled, "Open-label study to assess the safety and pharmacodynamics of five oral insulin formulations in healthy subjects," authored by Dr. Roy Eldor, Dr. Miriam Kidron and Dr. Ehud Arbit, was accepted and published in the Diabetes, Obesity and Metabolism journal.

26 May 2010

Cytochroma reports positive Phase 1/2 results for CTAP101 Capsules in non-dialysis CKD patients

Cytochroma today announced positive Phase 1/2 results for CTAP101 Capsules, a product being developed to treat secondary hyperparathyroidism (SHPT) associated with vitamin D insufficiency in non-dialysis chronic kidney disease (CKD) patients. The study demonstrated that a single dose of CTAP101 Capsules was safe, effective and well tolerated.

25 May 2010

Spectrum Pharmaceuticals to present clinical data on belinostat at ASCO 2010

Spectrum Pharmaceuticals, Inc., a commercial stage biotechnology company with a primary focus in hematology and oncology, today announced that clinical data on belinostat will be presented at the 2010 Annual Meeting of the American Society of Clinical Oncology, to be held June 4-8, 2010 at the McCormick Place Convention Center in Chicago, Illinois.

25 May 2010

Infinity to present data from Hsp90 chaperone and Hedgehog pathway inhibitor programs at 2010 ASCO

Infinity Pharmaceuticals, Inc., an innovative drug discovery and development company, today announced that data from its Hsp90 chaperone and Hedgehog pathway inhibitor programs will be presented during the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Ill. from June 4 through June 8, 2010.

21 May 2010

Pharmacodynamics News and Research

Simulations Plus launches Version 7.0 of GastroPlus software for pharmaceutical industry

Raptor Pharmaceutical updates on cysteamine bitartrate Phase 3 clinical trial in cystinosis patients

Array BioPharma fiscal 2010 revenue increases to $53.9 million

MAP Pharmaceuticals reports net loss of $12.5M for second-quarter 2010

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

AMRI initiates enrollment for Phase I study of ALB-127158 for obesity

BioInvent reports net revenues of SEK 63.1M for January - June 2010 period

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Updated Phase 1 trial results of blinatumomab in patients with relapsed NHL presented at EHA 2010

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

Chiasma successfully completes Phase I clinical study of Octreolin

Extensive usage of antibiotic linezolid associated with ICU outbreak of LRSA

Important milestone in development of ORMD-0801 published in DOM journal

Cytochroma reports positive Phase 1/2 results for CTAP101 Capsules in non-dialysis CKD patients

Spectrum Pharmaceuticals to present clinical data on belinostat at ASCO 2010

Infinity to present data from Hsp90 chaperone and Hedgehog pathway inhibitor programs at 2010 ASCO

Pittcon Highlights: Pharmaceutical & Biologic eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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