Clinical Trial News and Research

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BrainStorm's phase 2a ALS study meets primary endpoint

BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced positive final results from its phase 2a clinical trial of NurOwn™ in amyotrophic lateral sclerosis (ALS) patients, which enrolled 14 subjects at Hadassah Medical Center in Jerusalem.

6 Jan 2015

Amedica's CASCADE data shows silicon nitride spacers are comparable to hollow-body PEEK spacers

Amedica Corporation, a biomaterial company that develops and commercializes silicon nitride ceramics, today released the results of its CASCADE study, a blinded, randomized clinical trial that compared outcomes of spinal fusion surgery between its composite silicon nitride spacers manufactured with a central core of cancellous structured ceramic (CsC), to the gold standard, i.e., PEEK (polyether ether ketone plastic) spacers filled with bone autograft.

6 Jan 2015

FDA receives Actavis' NDA resubmission for cariprazine

Actavis plc (NYSE: ACT) and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Actavis' New Drug Application (NDA) resubmission for its atypical antipsychotic cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors.

6 Jan 2015

Oncoceutics, MD Anderson partner to develop novel anti-cancer drug

Oncoceutics Inc. and The University of Texas MD Anderson Cancer Center today announced the initiation of a strategic alliance and research collaboration agreement for the clinical development of ONC201, a novel anti-cancer drug.

5 Jan 2015

Clementia secures additional $10 million to support development of palovarotene for treatment of FOP

Clementia Pharmaceuticals, Inc. today announced that it has secured an additional $10 million from current investors to support development of the company's lead compound palovarotene for the treatment of fibrodysplasia ossificans progressive (FOP).

5 Jan 2015

Saatchi Bill: an interview with Dr. David Collingridge, Editor-in-Chief, The Lancet Oncology

The intention of the Medical Innovation Bill is to encourage and support doctors to explore new medicines for their patients when they believe existing options are no longer achieving good outcomes.

4 Jan 2015

Spark Therapeutics files Form S-1 registration statement for initial public offering of common stock

Spark Therapeutics announced today that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission relating to the proposed initial public offering of its common stock.

2 Jan 2015

New treatment approach may improve survival rates for certain patients with stage 4 lung cancer

A clinical trial that combined stereotactic body radiation therapy with a specific chemotherapy regimen more than doubled survival rates for certain stage 4 lung cancer patients, UT Southwestern Medical Center cancer researchers report.

2 Jan 2015

Top cancer research and clinical developments at Dana-Farber Cancer Institute in 2014

Immunotherapy, genomic profiling, and investigating game-changing drug therapies topped the list of most important cancer research and clinical developments at Dana-Farber Cancer Institute in 2014.

1 Jan 2015

Combination of bedaquiline and verapamil reduces side effects, improves outcomes for TB patients

While an effective treatment is available for combating multidrug-resistant tuberculosis, it carries serious side effects for patients.

31 Dec 2014

Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that enrollment has initiated and the first patient was dosed in a Phase 1b clinical trial of SYN-004, an investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

31 Dec 2014

OncoGenex executes initial agreement with Teva to regain rights to custirsen

OncoGenex Pharmaceuticals, Inc. today announced that it has executed an initial agreement with Teva Pharmaceutical Industries Ltd. to regain rights to custirsen, an investigational compound currently being evaluated in Phase 3 clinical development as a treatment for prostate and lung cancers.

31 Dec 2014

FDA receives IDE application for CytoSorbents' CytoSorb cardiac surgery trial

CytoSorbents Corporation, a critical care immunotherapy company commercializing its CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation in critically-ill and cardiac surgery patients, announced today that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to conduct its proposed clinical trial using CytoSorb® intra-operatively in patients undergoing complex cardiac surgery requiring the use of a heart-lung machine.

31 Dec 2014

Early use of heart failure drugs slows cardiac damage in boys, young men with DMD

Early use of available heart failure drugs slows the progressive decline in heart function before symptoms are apparent in boys and young men with Duchenne muscular dystrophy (DMD), according to a new study published online by The Lancet Neurology.

30 Dec 2014

G-treeBNT files IND with MFDS for Phase IIB/III clinical trial of RGN-259 for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. announced that its strategic partner, G-treeBNT Co. Ltd., has filed an IND with the Korean Ministry of Food and Drug Safety for a Phase IIB/III clinical trial with RGN-259 (designated GBT-201 in Korea and the licensed Pan Asia territory) for the treatment of patients with dry eye syndrome.

29 Dec 2014

Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, today announced that it has started its bremelanotide pivotal registration program.

29 Dec 2014

Soligenix closes previously announced registered public offering

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that on December 24, 2014 it closed its previously announced registered public offering.

25 Dec 2014

FDA approves Novo Nordisk’s weight loss injection, Saxenda

Novo Nordisk today announced that the Food and Drug Administration (FDA) has approved the new drug application (NDA) for Saxenda® (liraglutide [rDNA origin] injection), the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management.

25 Dec 2014

Novastem uses Stemedica's stem cell products to treat patient in ischemic stroke study

Novastem, a leader in regenerative medicine, announces the treatment of its first patient in its study for ischemic stroke at Clinica Santa Clarita.

25 Dec 2014

Kinex Pharmaceuticals doses first patient with KX2-361 in ‘A Phase 1’ clinical trial

Kinex Pharmaceuticals announced today that the first patient has been dosed with KX2-361 at Roswell Park Cancer Institute.

25 Dec 2014

Clinical Trial News and Research

BrainStorm's phase 2a ALS study meets primary endpoint

Amedica's CASCADE data shows silicon nitride spacers are comparable to hollow-body PEEK spacers

FDA receives Actavis' NDA resubmission for cariprazine

Oncoceutics, MD Anderson partner to develop novel anti-cancer drug

Clementia secures additional $10 million to support development of palovarotene for treatment of FOP

Saatchi Bill: an interview with Dr. David Collingridge, Editor-in-Chief, The Lancet Oncology

Spark Therapeutics files Form S-1 registration statement for initial public offering of common stock

New treatment approach may improve survival rates for certain patients with stage 4 lung cancer

Top cancer research and clinical developments at Dana-Farber Cancer Institute in 2014

Combination of bedaquiline and verapamil reduces side effects, improves outcomes for TB patients

Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

OncoGenex executes initial agreement with Teva to regain rights to custirsen

FDA receives IDE application for CytoSorbents' CytoSorb cardiac surgery trial

Early use of heart failure drugs slows cardiac damage in boys, young men with DMD

G-treeBNT files IND with MFDS for Phase IIB/III clinical trial of RGN-259 for dry eye syndrome

Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Soligenix closes previously announced registered public offering

FDA approves Novo Nordisk’s weight loss injection, Saxenda

Novastem uses Stemedica's stem cell products to treat patient in ischemic stroke study

Kinex Pharmaceuticals doses first patient with KX2-361 in ‘A Phase 1’ clinical trial

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