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Genzyme granted Priority Review for Cerdelga investigational oral therapy for Gaucher disease

Genzyme, a Sanofi company, announced today that the Food and Drug Administration (FDA) has granted a six-month Priority Review designation to its New Drug Application (NDA) for Cerdelga™ (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1.

11 Dec 2013

Acetylon Pharmaceuticals presents positive preclinical data for selective HDAC1/2 inhibitors at ASH meeting

Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, announced that positive preclinical data for its selective HDAC1/2 inhibitors for the treatment of sickle cell disease (SCD) and β-thalassemia (bT) were presented at the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.

11 Dec 2013

Navidea receives Fast Track designation for Lymphoseek injection

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.

11 Dec 2013

Baxter seeks FDA approval of OBI-1 for adults with acquired hemophilia A

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A.

From Baxter International Inc. 11 Dec 2013

Avanir Pharmaceuticals' AVP-923 phase II trial fails to meet primary efficacy endpoint

Avanir Pharmaceuticals, Inc. today announced that PRIME, its phase II clinical trial of the investigational drug AVP-923 (dextromethorphan / quinidine) for the treatment of central neuropathic pain in patients with multiple sclerosis did not meet the primary efficacy endpoint.

10 Dec 2013

UTHealth starts clinical trial to study two forms of stem cell treatments for children with CP

A first-of-its-kind clinical trial studying two forms of stem cell treatments for children with cerebral palsy has begun at The University of Texas Health Science Center at Houston Medical School.

10 Dec 2013

Takeda presents clinical study results of oral proteasome inhibitor MLN9708 in multiple myeloma patients

Takeda Pharmaceutical Company Limited today announced final Phase 1 and preliminary Phase 2 results of a study combining oral investigational MLN9708 administered twice a week with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma.

10 Dec 2013

Acetylon announces positive preclinical data of ricolinostat (ACY-1215) in models of lymphoma

Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, announced that positive preclinical data of selective HDAC6 inhibitor, ricolinostat (ACY-1215), in models of lymphoma were presented today in an oral presentation by Dr. Jennifer Amengual, Assistant Professor of Medicine & Experimental Therapeutics, Columbia University Medical Center.

10 Dec 2013

European study investigates high blood pressure drug for treating Alzheimer's patients

An extensive European study is currently investigating whether a drug used to treat high blood pressure may also help patients with Alzheimer's disease. The EU is investing almost 6 million euros on the project, in which Sahlgrenska Academy and Sahlgrenska University Hospital are responsible for Sweden's contribution.

10 Dec 2013

ImmunoGen presents Phase I trial results of SAR650984 at ASH annual meeting

ImmunoGen, Inc., a biotechnology company that develops targeted, antibody-based anticancer therapeutics, today announced the first clinical findings with SAR650984 reported in an oral presentation at the ASH annual meeting. The data are from an ongoing Phase I trial assessing this CD38-targeting therapeutic antibody in patients with CD38-positive MM or other hematologic malignancy.

10 Dec 2013

CRAB CTC enrolls first patient into inaugural cancer clinical trial

Cancer Research And Biostatistics today announced enrollment of the first patient into the inaugural clinical trial sponsored by its Clinical Trials Consortium. The CRAB CTC mission is to ensure rapid clinical testing of new and innovative cancer treatments, and is focusing on lung cancer as its first target. By engaging frontline treating oncologists to push the boundaries of patient care, the aim is to improve the standard of care and extend overall survival.

9 Dec 2013

Acetylon Pharmaceuticals presents positive interim data from two ricolinostat clinical trials at ASH 2013

Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase inhibitors for enhanced therapeutic outcomes, today announced that positive interim clinical data from the two proof-of-concept clinical trials with selective HDAC6 inhibitor, ricolinostat (ACY-1215), were presented at the 55th Annual Meeting of the American Society of Hematology in New Orleans, LA.

9 Dec 2013

Arrowhead reports Phase 1 study data on ARC-520 for treatment of chronic hepatitis B infection

Arrowhead Research Corporation, a biopharmaceutical company developing targeted RNAi therapeutics, today announced that COO and Head of R&D, Bruce Given, M.D., presented data on the Phase 1 clinical study of ARC-520, the company's clinical candidate for the treatment of chronic hepatitis B infection, at the HepDART 2013 conference being held on The Big Island, Hawaii.

9 Dec 2013

NOXXON Pharma reports interim data from two phase IIa studies of anti-CXCL12/SDF-1 Spiegelmer NOX-A12

NOXXON Pharma disclosed interim data from two independent clinical phase IIa studies of the anti-CXCL12/SDF-1 Spiegelmer olaptesed pegol (NOX-A12) at the 55th annual meeting of the American Society of Hematology in New Orleans, LA, USA from 7-10 December 2013.

9 Dec 2013

Prana completes treatment phase of IMAGINE Alzheimer’s Disease clinical trial

Prana Biotechnology, a developer of best-in-class treatments for neurodegenerative disease, today announced the completion of the treatment phase of its IMAGINE Alzheimer’s Disease clinical trial.

9 Dec 2013

Studies confirm superiority of Tasigna to Glivec at achieving molecular response in Ph+ CML patients

Findings from three large, randomized Phase III studies demonstrate the superiority of Tasigna (nilotinib) compared to Glivec (imatinib) at achieving deeper molecular responses across various Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) patient populations, including newly diagnosed patients, patients with residual disease who switched to Tasigna after long-term treatment with Glivec, and patients who failed to respond to frontline Glivec (as defined by 2013 European LeukemiaNet [ELN] guidelines).

9 Dec 2013

CAR therapy shows potential for advancing treatment of patients with ALL and CLL

Novartis is highlighting new research from members of the faculty at the University of Pennsylvania’s Perelman School of Medicine on the investigational chimeric antigen receptor therapy, CTL019. Several studies being presented at the American Society of Hematology annual meeting add to the scientific understanding of CTL019 in the treatment of acute lymphoblastic leukemia and chronic lymphocytic leukemia and build on earlier research findings.

9 Dec 2013

Heptares starts HTL9936 Phase 1 study for improving cognitive function in Alzheimer's patients

Heptares Therapeutics, the leading GPCR structure-guided drug discovery and development company, announces that it has initiated a Phase 1 clinical study of HTL9936, the first fully selective muscarinic M1 receptor agonist to enter clinical development. HTL9936 is an orally available, small molecule drug candidate discovered using the Heptares GPCR structure-based drug design platform.

9 Dec 2013

Ligand announces data from preclinical studies on small-molecule oral G-CSF receptor agonist

Ligand Pharmaceuticals Incorporated announced that data from preclinical studies on its granulocyte colony stimulating factor (G-CSF) receptor agonist program were featured in a poster presentation today at the 55th Annual Meeting of the American Society of Hematology in New Orleans.

9 Dec 2013

Janssen reports positive pivotal Phase 2 study data of siltuximab for Multicentric Castleman's Disease

Janssen Research & Development, LLC today announced positive results from a pivotal Phase 2 global registration study (MCD2001) suggesting siltuximab, an investigational compound, along with best supportive care, exhibited statistically significant efficacy and a tolerable safety profile compared with placebo and BSC in treating patients with the rare disorder Multicentric Castleman's Disease who are HIV-negative and human herpes virus 8-negative.

8 Dec 2013

Drug Trial News

Genzyme granted Priority Review for Cerdelga investigational oral therapy for Gaucher disease

Acetylon Pharmaceuticals presents positive preclinical data for selective HDAC1/2 inhibitors at ASH meeting

Navidea receives Fast Track designation for Lymphoseek injection

Baxter seeks FDA approval of OBI-1 for adults with acquired hemophilia A

Avanir Pharmaceuticals' AVP-923 phase II trial fails to meet primary efficacy endpoint

UTHealth starts clinical trial to study two forms of stem cell treatments for children with CP

Takeda presents clinical study results of oral proteasome inhibitor MLN9708 in multiple myeloma patients

Acetylon announces positive preclinical data of ricolinostat (ACY-1215) in models of lymphoma

European study investigates high blood pressure drug for treating Alzheimer's patients

ImmunoGen presents Phase I trial results of SAR650984 at ASH annual meeting

CRAB CTC enrolls first patient into inaugural cancer clinical trial

Acetylon Pharmaceuticals presents positive interim data from two ricolinostat clinical trials at ASH 2013

Arrowhead reports Phase 1 study data on ARC-520 for treatment of chronic hepatitis B infection

NOXXON Pharma reports interim data from two phase IIa studies of anti-CXCL12/SDF-1 Spiegelmer NOX-A12

Prana completes treatment phase of IMAGINE Alzheimer’s Disease clinical trial

Studies confirm superiority of Tasigna to Glivec at achieving molecular response in Ph+ CML patients

CAR therapy shows potential for advancing treatment of patients with ALL and CLL

Heptares starts HTL9936 Phase 1 study for improving cognitive function in Alzheimer's patients

Ligand announces data from preclinical studies on small-molecule oral G-CSF receptor agonist

Janssen reports positive pivotal Phase 2 study data of siltuximab for Multicentric Castleman's Disease

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