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Nuvilex overcomes fundamental challenges faced in stem cell therapy

Nuvilex, Inc., an emerging biotechnology provider of cell and gene therapy solutions, released information today about the company's cell encapsulation technology and the breakthrough in stem cell research which overcomes specific fundamental challenges faced in stem cell therapy—host rejection and migration of implanted cells away from the target site.

5 Mar 2012

Concert commences dosing in CTP-499 Phase 2 clinical trial for diabetic nephropathy

Concert Pharmaceuticals, Inc. today announced the initiation of dosing in a Phase 2 clinical trial evaluating CTP-499, an investigational drug for the treatment of diabetic nephropathy, the leading cause of chronic kidney disease (CKD) in the US.

5 Mar 2012

Repligen seeks EMA marketing approval for SecreFlo for pancreatic imaging

Repligen Corporation announced today that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for SecreFlo to improve detection of pancreatic duct abnormalities in patients with pancreatitis.

5 Mar 2012

Roche selects ICON as technology partner

ICON plc,, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been selected by Roche as its technology partner for storing and managing medical images collected during the company's clinical research programs.

5 Mar 2012

Simulations Plus second quarter revenues increase to record $2.789M

Simulations Plus, Inc., a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported preliminary revenues for its second quarter of fiscal year 2012 ended February 29, 2012 (2QFY12).

5 Mar 2012

Concert, Fast Forward partner to advance new approach to treat spasticity and pain in MS

Concert Pharmaceuticals, Inc. and Fast Forward, LLC, the National Multiple Sclerosis Society's subsidiary devoted to bridging the gap between research and drug development, today announced a new collaboration to fund the preclinical advancement of C-21191, a deuterium-modified subtype-selective GABAA modulator developed by Concert with the therapeutic potential of treating spasticity and pain in multiple sclerosis (MS).

5 Mar 2012

Exelixis initiates cabozantinib and abiraterone phase 1 combination trial in CRPC

Exelixis Inc. today announced the initiation of a phase 1 dose-finding trial of cabozantinib in combination with abiraterone in men with metastatic castration-resistant prostate cancer (CRPC) who have disease progression following treatment with up to two prior chemotherapy regimens.

5 Mar 2012

KYTHERA commences two ATX-101 Phase III trials for reduction of submental fat

KYTHERA Biopharmaceuticals, Inc., a privately-held biotechnology company focused on the development and commercialization of prescription products in aesthetic medicine, today announced the initiation of two pivotal U.S. Phase III trials of ATX-101, a first-in-class injectable drug under clinical investigation for the reduction of submental (under the chin) fat.

5 Mar 2012

Long-term data from Baxter's HyQ clinical study on PI

Baxter International Inc. today announced the presentation of additional long-term data supporting the clinical profile of HyQ, its investigational combination product for use in patients with primary immunodeficiencies.

From Baxter International Inc. 3 Mar 2012

EC grants marketing authorization for Baxter's VEPACEL to treat influenza A

Baxter International Inc. announced today that the European Commission (EC) has granted marketing authorization for VEPACEL in all European Union (EU) Member States, as well as Iceland, Liechtenstein and Norway.

From Baxter International Inc. 2 Mar 2012

Preliminary results from Genentech's ACTEMRA monotherapy study on RA

Genentech, a member of the Roche Group, today announced that preliminary results from the ADACTA (ADalimumab ACTemrA) study showed that patients who received ACTEMRA (tocilizumab) as monotherapy achieved a significantly greater reduction in disease activity after 24 weeks than those given adalimumab monotherapy.

2 Mar 2012

Conference on follow-on versions of complex drugs

On March 9, the New York Academy of Sciences will present "Scientific Considerations for Complex Drugs in Light of Established Regulatory Guidance." This full-day conference will explore current definitions, global scientific and regulatory hurdles, and future challenges for follow-on versions of complex drugs.

2 Mar 2012

New HS44 molecule inhibits lung metastasis

One type of white blood cell, the Natural Killer T Cells, fights against infections and tumours by freeing cytokine proteins which activate the body's immune response and destroy infected or malignant cells. To do so they must receive an activation signal. Specific receptors located on their surface act as switches: they activate the lymphocyte in presence of an antigen, a molecule which triggers alarm signals.

2 Mar 2012

Report highlights benefits of Nuvilex's cell encapsulation technology for diabetes

Nuvilex, Inc., an emerging biotechnology provider of cell and gene therapy solutions, today provided additional details based on the Goldman Small Cap Research report issued February 29, 2012, that highlighted the company's cell encapsulation technology and its benefits for treating chronic diseases such as diabetes.

2 Mar 2012

First clinical assessment of how interferon fights infections in people

A drug once taken by people with HIV/AIDS but long ago shelved after newer, modern antiretroviral therapies became available has now shed light on how the human body uses its natural immunity to fight the virus—work that could help uncover new targets for drugs.

1 Mar 2012

iBio receives U.S. patent for fusion-protein vaccine technology

iBio, Inc. today announced issuance of a US patent covering the use of iBio's proprietary fusion-protein technology in combination with influenza virus antigens for vaccine product applications.

29 Feb 2012

Creabilis initiates CT327 Phase IIb trial in psoriasis vulgaris

Creabilis SA, a European biotechnology company specialising in the development of treatments for dermatology, inflammation and pain, today announced the start of the Phase IIb global clinical trial of its lead product CT327 in patients with psoriasis vulgaris. Recruitment is progressing well.

29 Feb 2012

New research shows how motor neurones are produced

The quest for treatments for motor neurone disease, spinal cord injury and strokes could be helped by new research that shows how key cells are produced.

28 Feb 2012

Biogen Idec receives FDA approval for two separate dosing innovations to treat MS

Today Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has approved two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week AVONEX for relapsing forms of multiple sclerosis (MS).

28 Feb 2012

Baxter commences CD34+ stem cell phase III trial in CMI

Baxter International Inc. announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual's own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).

From Baxter International Inc. 28 Feb 2012