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BioLineRx commences BCM CE Mark registration trial for prevention of cardiac remodeling following AMI

BioLineRx, a biopharmaceutical development company, announced today the commencement of the PRESERVATION I clinical trial, a CE Mark registration trial of BCM (BL-1040), a novel medical device intended for the prevention of cardiac remodeling following an acute myocardial infarction (AMI).

4 Jan 2012

Arena, Eisai collaborate in response to FDA's lorcaserin Complete Response Letter

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that Arena has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) following review of the lorcaserin New Drug Application (NDA).

4 Jan 2012

$Yakult Honsha commences perifosine Phase 1/2 trial for refractory advanced colorectal cancer in Japan$

Yakult Honsha commences perifosine Phase 1/2 trial for refractory advanced colorectal cancer in Japan

Aeterna Zentaris Inc. today announced that its Japanese partner, Yakult Honsha, has initiated a Phase 1/2 trial in Japan to assess the safety and efficacy of the Company's PI3K/Akt inhibitor, perifosine, in combination with chemotherapeutic agent, capecitabine, in patients with refractory advanced colorectal cancer ("CRC").

4 Jan 2012

Positive results from Can-Fite BioPharma's CF102 Phase 1/2 study on HCC

Can-Fite BioPharma Ltd, a biotechnology company developing small molecule drugs for the treatment of inflammatory, and liver diseases, traded on the Tel Aviv Stock Exchange announced today the successful results of the Phase 1/2 study of its drug candidate CF102 in the treatment of hepatocellular carcinoma.

4 Jan 2012

Ampio completes enrollment phase of Australian Ampion In Knee trials

Ampio Pharmaceuticals, Inc., a company that discovers and develops new uses for previously approved drugs and new molecular entities, today announced that it is has completed the expanded patient enrollment phase of its Ampion In Knee (AIK) trials in Australia.

3 Jan 2012

Astellas, AVEO announce results of tivozanib and sorafenib comparison trial on RCC

AVEO Pharmaceuticals, Inc. and Astellas Pharma Inc. today announced that tivozanib demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase 3 clinical trial evaluating the efficacy and safety of investigational drug tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma.

3 Jan 2012

Additional financing to fund Advaxis' cervical cancer trials

Advaxis, Inc.,, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has entered into a definitive Convertible Notes Purchase Agreement (Agreement) with certain accredited investors, for the purchase of the aggregate principal value of approximately $1.2 million of Convertible Promissory Notes (Notes) for an aggregate purchase price of approximately $1.0 million.

31 Dec 2011

FDA invites Amgen for ODAC meeting on XGEVA sBLA to treat castration-resistant prostate cancer

Amgen today announced the U.S. Food and Drug Administration has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

30 Dec 2011

GOG targeted therapy phase 3 clinical trial delays progression of advanced ovarian cancer

Targeted drugs, which block or disrupt particular molecules involved in the growth of tumors, have been shown to be effective treatments against many types of cancer.

29 Dec 2011

Bevacizumab delays disease progression in ovarian cancer

Treating ovarian cancer with the drug bevacizumab ("Avastin") delays the disease and may also improve survival, show the results of an international clinical trial co-led by Drs. Amit Oza of the Princess Margaret Cancer Program, University Health Network and Timothy Perren, St James's Institute of Oncology, Leeds, UK.

29 Dec 2011

Emergent commences Phase 2 combination trial of TRUw-016 with bendamustine in relapsed CLL

Emergent BioSolutions Inc. today announced the initiation of a Phase 2 study (protocol 16201) of TRU-016 in combination with bendamustine for patients with relapsed chronic lymphocytic leukemia (CLL).

29 Dec 2011

Critical considerations for adenovirus-based HIV vaccine trials

A clinical trial testing a candidate HIV vaccine known as the STEP study was halted in September 2007 after interim analysis indicated that the vaccine did not work. Moreover, subsequent analyses indicated that the vaccine made some individuals more susceptible to HIV, in particular individuals who had pre-existing immune effectors (antibodies) that recognized a component of the vaccine (adenovirus serotype 5 [Ad5]).

28 Dec 2011

IL-1 gene inactivation may reduce severe clinical complications of atherosclerosis

Atherosclerosis is a disease of the major arterial blood vessels. It is one of the major causes of heart attack and stroke. The proinflammatory molecule IL-1 has been linked to atherosclerosis and a clinical trial has been launched in which an antibody specific for IL-1-beta is being studied for its effects on the severe clinical complications of atherosclerosis.

28 Dec 2011

CEL-SCI to expand Multikine Phase III trial in head and neck cancer

CEL-SCI Corporation is in the process of expanding its Phase III clinical trial of the investigational therapy Multikine (Leukocyte Interleukin, Injection) to 4 additional European countries - Spain, Czech Republic, Slovakia and Croatia.

27 Dec 2011

Initial results from 22nd Century's X-22 Phase II-B smoking cessation trial

22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction products, today announced X-22, a prescription smoking cessation aid in development consisting of very low nicotine (VLN) cigarettes, showed a reduction of smoking from baseline over the 6-week treatment period in the company's Phase II-B clinical trial.

26 Dec 2011

Correcting anemia can preserve kidney function in many transplant recipients

Correcting anemia, a red blood cell deficiency, can preserve kidney function in many kidney transplant recipients, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology.

23 Dec 2011

Top-line results from Noven's LDMP Phase 3 clinical study on menopausal VMS

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced top-line results from the first of two planned Phase 3 clinical studies evaluating low-dose mesylate salt of paroxetine (LDMP, formerly referred to as Mesafem) for the treatment of vasomotor symptoms (VMS) associated with menopause.

23 Dec 2011

Abbott commences Esprit drug eluting BVS trial in peripheral artery disease

Abbott today announced the initiation of ESPRIT I, a first-of-its-kind clinical trial in Europe evaluating the safety and performance of the novel Esprit drug eluting bioresorbable vascular scaffold (BVS) for the treatment of blockages in the superficial femoral arteries (SFA) and iliac arteries that have resulted in claudication.

23 Dec 2011

ViroPharma to acquire Meritage

ViroPharma Incorporated today announced that it has entered into an exclusive option to acquire Meritage Pharma, Inc., a private company based in San Diego, CA focused on developing oral budesonide suspension (OBS) as a treatment for eosinophilic esophagitis (EoE), a chronic inflammatory disorder of the esophagus.

23 Dec 2011

Enrollment complete in two Anacor's tavaborole Phase 3 trials on onychomycosis

Anacor Pharmaceuticals announced today that it has completed the enrollment of approximately 600 patients in the second of its two Phase 3 trials of tavaborole, a topical anti-fungal product candidate for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.

23 Dec 2011

Drug Trial News

BioLineRx commences BCM CE Mark registration trial for prevention of cardiac remodeling following AMI

Arena, Eisai collaborate in response to FDA's lorcaserin Complete Response Letter

Yakult Honsha commences perifosine Phase 1/2 trial for refractory advanced colorectal cancer in Japan

Positive results from Can-Fite BioPharma's CF102 Phase 1/2 study on HCC

Ampio completes enrollment phase of Australian Ampion In Knee trials

Astellas, AVEO announce results of tivozanib and sorafenib comparison trial on RCC

Additional financing to fund Advaxis' cervical cancer trials

FDA invites Amgen for ODAC meeting on XGEVA sBLA to treat castration-resistant prostate cancer

GOG targeted therapy phase 3 clinical trial delays progression of advanced ovarian cancer

Bevacizumab delays disease progression in ovarian cancer

Emergent commences Phase 2 combination trial of TRUw-016 with bendamustine in relapsed CLL

Critical considerations for adenovirus-based HIV vaccine trials

IL-1 gene inactivation may reduce severe clinical complications of atherosclerosis

CEL-SCI to expand Multikine Phase III trial in head and neck cancer

Initial results from 22nd Century's X-22 Phase II-B smoking cessation trial

Correcting anemia can preserve kidney function in many transplant recipients

Top-line results from Noven's LDMP Phase 3 clinical study on menopausal VMS

Abbott commences Esprit drug eluting BVS trial in peripheral artery disease

ViroPharma to acquire Meritage

Enrollment complete in two Anacor's tavaborole Phase 3 trials on onychomycosis

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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