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Insmed receives FDA clinical hold order for ARIKACE phase 3 trials in CF and NTM

Insmed Incorporated, a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the agency has placed a clinical hold on Insmed's phase 3 clinical trials for ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas lung infections and patients with non-tuberculous mycobacterial (NTM) lung disease.

2 Aug 2011

Ursodeoxycholic acid could help prevent disturbances in heart's normal rhythm

A synthesised compound which is also found in bear bile could help prevent disturbances in the heart's normal rhythm, according to research published today in the journal Hepatology by a team from Imperial College London.

2 Aug 2011

Can-Fite commences CF101 phase 2/3 trial for treatment of Psoriasis

Can-Fite BioPharma Ltd, a biotechnology company developing small molecule drugs for the treatment of inflammatory, ophthalmic, and liver diseases, traded on the Tel Aviv Stock Exchange announced today that it has commenced patient enrolment in a phase 2/3 clinical trial of CF101 for the treatment of Psoriasis.

2 Aug 2011

Alnylam second quarter revenue decreases to $20.6 million

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today reported its consolidated financial results for the second quarter 2011, and company highlights.

From Precision NanoSystems Inc. 2 Aug 2011

Spiritual retreat can help heart patients return to psycho-spiritual well-being

Attending a non-denominational spiritual retreat can help patients with severe heart trouble feel less depressed and more hopeful about the future, a University of Michigan Health System study has found.

1 Aug 2011

FDA approves Medtronic's IDE for Advisa DR MRI SureScan pacing system

Medtronic, Inc. today announced U.S. Food and Drug Administration approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating Advisa DR MRI SureScan pacing system.

From Medtronic 1 Aug 2011

First cardiac ablation procedure using Thermocool SmartTOUCH catheter performed at Mount Sinai

The Mount Sinai Medical Center has become the first hospital on the east coast to perform a cardiac ablation procedure using the Thermocool Smarttouch Contact Force-Sensing Catheter for the treatment of symptomatic, paroxysmal atrial fibrillation (AF), or periodic rapid and irregular heartbeats.

30 Jul 2011

Humira defect lawyers file lawsuit against Abbott in Texas state court

Humira defect lawyers filed a lawsuit against Abbott Laboratories in Texas state court claiming Abbott's blockbuster drug, Humira, caused a life-threatening disease, leukemia.

30 Jul 2011

UH Case Medical Center to commence Phase 1 clinical trial on TMC207

University Hospitals Case Medical Center will begin a Phase 1 clinical trial on a new experimental anti-tuberculosis drug called TMC207.

30 Jul 2011

ORENCIA SC formulation receives FDA approval for treatment of adults with RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a subcutaneous formulation of ORENCIA (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis.

30 Jul 2011

Study shows fall in blood pressure during dialysis for patients increases risk of blood clotting

A sudden drop in blood pressure while undergoing dialysis has long vexed many kidney patients. Side effects associated with this situation over the long term range from stroke to seizure to heart damage to death.

30 Jul 2011

EGT transfers clinical grade lentiviral vector to MSKCC

Errant Gene Therapeutics, LLC, a pioneering boutique drug development firm specializing in Rare Diseases, announced the transfer of its clinical grade lentiviral vector, TNS 9.55.3, to Memorial Sloan Kettering Cancer Center.

29 Jul 2011

Amgen reports 8% increase in second quarter total product sales to $3,893 million

Amgen reported total revenue increased 4 percent during the second quarter of 2011 to $3,959 million versus $3,804 million in the second quarter of 2010. Total product sales increased 8 percent in the second quarter of 2011 to $3,893 million versus $3,613 million in the second quarter of 2010. The increase in total revenue in the second quarter of 2011 included a decline in other revenue due to certain milestone payments earned in the second quarter of 2010.

29 Jul 2011

Book examines impact of new racial science

In 2005, the Food and Drug Administration approved a drug called BiDil as a therapy for heart failure specifically for African-American patients, claiming in a press release that this was a step toward personalized medicine.

29 Jul 2011

Polaris initiates ADI-PEG 20 Phase 3 trial in hepatocellular carcinoma

Polaris Group today announced that it has dosed the first patient in a pivotal Phase 3 clinical trial evaluating its lead cancer therapeutic, pegylated arginine deiminase (ADI-PEG 20), in hepatocellular carcinoma (HCC) patients.

29 Jul 2011

Sigma-Tau, Soligenix expand partnership to develop and commercialize orBec in Europe

Soligenix, Inc., a late-stage biopharmaceutical company, announces the expansion and amendment of its North American licensing partnership with Sigma-Tau Pharmaceuticals, Inc. for the development and commercialization of orBec into the European territory.

29 Jul 2011

RegeneRx to initiate enrollment in RGN-259 Phase 2 trial for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. has announced that it is set to begin a Phase 2 clinical trial in 72 patients with dry eye syndrome.

29 Jul 2011

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

28 Jul 2011

Curis second quarter net loss increases to $4.9 million

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today reported its financial results for the second quarter ended June 30, 2011.

28 Jul 2011

Inspiration presents OBI-1 pivotal study data on hemophilia at 23rd ISTH congress

Ipsen today announced that its partner Inspiration Biopharmaceuticals, Inc. presented data from its clinical development program for OBI-1, an intravenous (IV) recombinant porcine factor VIII product (rpFVIII), intended for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia.

28 Jul 2011

Clinical Trial News and Research

Insmed receives FDA clinical hold order for ARIKACE phase 3 trials in CF and NTM

Ursodeoxycholic acid could help prevent disturbances in heart's normal rhythm

Can-Fite commences CF101 phase 2/3 trial for treatment of Psoriasis

Alnylam second quarter revenue decreases to $20.6 million

Spiritual retreat can help heart patients return to psycho-spiritual well-being

FDA approves Medtronic's IDE for Advisa DR MRI SureScan pacing system

First cardiac ablation procedure using Thermocool SmartTOUCH catheter performed at Mount Sinai

Humira defect lawyers file lawsuit against Abbott in Texas state court

UH Case Medical Center to commence Phase 1 clinical trial on TMC207

ORENCIA SC formulation receives FDA approval for treatment of adults with RA

Study shows fall in blood pressure during dialysis for patients increases risk of blood clotting

EGT transfers clinical grade lentiviral vector to MSKCC

Amgen reports 8% increase in second quarter total product sales to $3,893 million

Book examines impact of new racial science

Polaris initiates ADI-PEG 20 Phase 3 trial in hepatocellular carcinoma

Sigma-Tau, Soligenix expand partnership to develop and commercialize orBec in Europe

RegeneRx to initiate enrollment in RGN-259 Phase 2 trial for dry eye syndrome

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Curis second quarter net loss increases to $4.9 million

Inspiration presents OBI-1 pivotal study data on hemophilia at 23rd ISTH congress

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