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FDA approves Ascenta's IND for AT-406 multi-IAP antagonist

Ascenta Therapeutics announced today that following the approval by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) Application for AT-406, an orally-active, small molecule, multi-IAP antagonist, the company will initiate a Phase I clinical trial in patients with advanced cancer during the fourth quarter of 2009.

10 Sep 2009

arGEN-X BV announces first closing of its Series A equity financing round

arGEN-X BV, a biopharmaceutical company focused on the discovery and development of human antibodies using its proprietary SIMPLE Antibody platform, today announced the successful first closing of its Series A equity financing round. The Company raised EUR 9.5million (~ USD 13.6 million) from a syndicate of leading life science investors. The financing round is one of the largest of its kind in the last 12 months.

10 Sep 2009

Roche Group and ImmunoCellular Therapeutics sign research agreement regarding ICT-69 antibody

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a clinical-stage biotechnology company that is developing immune based therapies for the treatment of brain and other cancers, announced today that it has entered into a research and license option agreement regarding its ICT-69 antibody with Roche Group (SWX: ROG.VX; RO.S, OTCQX: RHHBY), one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics.

10 Sep 2009

Oral GLP-1 Analog approved for human clinical trial

Oramed Pharmaceticals, Inc., a developer of oral drug delivery systems, announced today that it has received approval from the Institutional Review Board (IRB) to commence human clinical trials of an oral GLP-1 Analog.

10 Sep 2009

Phase II trial of ANA598 commenced by Anadys Pharmaceuticals

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that dosing has begun in a Phase II trial of ANA598 in patients chronically infected with hepatitis C virus (HCV). The study will evaluate ANA598 over 12 weeks, taken in combination with pegylated interferon-alpha and ribavirin, in treatment naive HCV patients. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor.

9 Sep 2009

Ceragenix awarded $2.87M NIH grant to develop a drug for treating Clostrdium difficile and Shigella

Ceragenix Pharmaceuticals, Inc. (“Ceragenix”) (OTCBB:CGXP), a medical device company focused on infectious disease and dermatology, today announced that the National Institutes of Health (“NIH”) has awarded a $2.87 million grant to fund the pre clinical development of a Ceragenin™based oral drug to treat two common and potentially deadly gastrointestinal infections: Clostrdium difficile and Shigella.

9 Sep 2009

Bayer submits an IND for its MN-IC antibody-drug conjugate to the FDA

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Bayer Schering Pharma AG, Germany. The milestone was triggered by Bayer’s submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for MN-IC, an ADC for solid tumors.

9 Sep 2009

AST scientific conference to emphasize on immunosuppression and tolerance

The American Society of Transplantation (AST) will present a scientific conference this winter that offers an in-depth, up-to-date look at immunosuppression and tolerance -- but with a brand new vibe. Called the Annual Scientific Exchange (ASE), slated for December 2-6, 2009, at the Marriott World Center in Orlando, Florida, it will differ from the typical conference in its format, which is specifically designed to be relaxed yet focused.

9 Sep 2009

Phase 3 clinical trials of BHR-100 infusion to be initiated by BHR Pharma

BHR Pharma, LLC (BHR) announced today that it will initiate a global, Phase 3, multi-center pivotal trial (www.synapse-trial.com) to evaluate the effectiveness of its proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective agent for treating severe traumatic brain injury (TBI) patients in early 2010.

9 Sep 2009

NanoViricides' drug pipeline to be discussed at NanoBusiness2009

NanoViricides, Inc. (the "Company"), announced today that Anil Diwan, PhD, President of the Company has been asked to present a talk at NanoBusiness2009 - the 8th annual NanoBusiness Conference.

8 Sep 2009

Early schizophrenia symptoms include unusually high CA1 subfield activity

In the first functional magnetic resonance imaging (fMRI) study of its kind, neurologists and psychiatrists at Columbia University have identified an area of the brain involved in the earliest stages of schizophrenia and related psychotic disorders.

7 Sep 2009

Nanoparticle-delivered suicide gene therapy effectively reduces ovarian tumor burden in mice

Nanoparticle delivery of diphtheria toxin-encoding DNA that expresses selectively in ovarian cancer cells reduced the burden of ovarian tumors in mice, and researchers expect that this therapy could be tested in humans with advanced ovarian cancer within 18 to 24 months, according to a report in Cancer Research. If additional tests are successful, these finding could lead to a new treatment for ovarian cancer, which now causes more than 15,000 deaths each year in the United States. Because it is usually diagnosed at a relatively late stage, ovarian cancer is one of the most deadly forms of the disease.

7 Sep 2009

Identifying a specific molecular signature can help customize cancer treatment

A molecular signature that helps account for the aggressive behavior of a variety of cancers such as pancreatic, breast and melanoma may also predict the likelihood of successful treatment with a particular anti-cancer drug. The finding, which could lead to a personalized approach to treatment for a variety of solid tumors that are currently resistant to therapies, will be published September 6 in the advance online edition of Nature Medicine.

7 Sep 2009

Ipsen grants license to Debiopharm for developing and commercialising cancer treatment

Ipsen (Euronext:IPN), an innovation-driven global specialty pharmaceutical Group and Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, announced today the signature of an agreement under which Debiopharm is granted an exclusive worldwide license to develop and commercialise Ipsen's first-in-class inhibitor of the CDC25 phosphatase enzyme (now Debio 0931), for the treatment of various human cancers.

7 Sep 2009

Debiopharm granted license to develop and commercialise CDC25

Ipsen, an innovation-driven global specialty pharmaceutical Group and Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, announced today the signature of an agreement under which Debiopharm is granted an exclusive worldwide license to develop and commercialise Ipsen’s first-in-class inhibitor of the CDC25 phosphatase enzyme (now Debio 0931), for the treatment of various human cancers.

7 Sep 2009

Shire receives FDA approval for INTUNIV extended release tablets

Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

4 Sep 2009

StemCells’ novel neuroprotective approach for treating neurodegenerative diseases

StemCells, Inc. today announced the publication of preclinical data demonstrating for the first time that transplantation of its proprietary, purified human neural stem cells delays the loss of motor function in a mouse model of infantile neuronal ceroid lipofuscinosis (NCL).

4 Sep 2009

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV- (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

4 Sep 2009

IND for Cytopia's CYT387 clears the FDA review

Cytopia Limited's Investigational New Drug Application (IND) for CYT387 has passed US Food and Drug Administration (FDA) review. CYT387 is a small-molecule oral JAK1/JAK2 kinase inhibitor designed to treat various haematological disorders.

4 Sep 2009

Germany’s BMBF awards NOXXON grant for developing Spiegelmer NOX-A12

NOXXON Pharma AG (NOXXON), clinical-stage developer of L-RNA based scaffolds (Spiegelmers®) that bind their targets conceptually similar to antibodies, announced today that the company was awarded a research grant from Germany’s Federal Ministry of Education and Research (BMBF) under the ministry’s small and medium enterprise innovation initiative (“KMU-Innovativ”).

3 Sep 2009