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Italian Medicines Agency grants marketing authorization to ILUVIEN for chronic DME treatment

pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

23 Jun 2014

XenoPort initiates XP23829 Phase 2 clinical trial in patients with psoriasis

XenoPort, Inc. announced today that it has initiated a Phase 2 clinical trial of XP23829, its proprietary investigational next-generation fumaric acid product candidate. The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of XP23829 as a potential treatment of patients with moderate-to-severe chronic plaque-type psoriasis.

23 Jun 2014

Denosumab increases bone density for postmenopausal women with osteoporosis

Postmenopausal women with osteoporosis who take denosumab long-term have increased bone density, sustained low rate of fractures, and a favorable benefit/risk profile, a new multinational study finds.

23 Jun 2014

Aradigm begins Pulmaquin Phase III study for treatment of non-CF BE

Aradigm Corporation ("Aradigm" or the "Company") today announced the dosing of the first patient in the ORBIT-4 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) Phase III pivotal clinical trial of Aradigm's proprietary formulation of inhaled ciprofloxacin (Pulmaquin®) for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE).

23 Jun 2014

PSI CRO presents the changing dynamic of clinical trial feasibility at PCMG meeting

PSI CRO, a full-service contract research organization, announced today that Kasia Moscicka, Director Feasibility Research and Patient Recruitment Services, presented on the changing dynamic of clinical trial feasibility at recent PCMG meeting held in Lisbon, Portugal.

23 Jun 2014

Trevena reports positive results from TRV734 Phase 1 trial for treating acute/chronic pain

Trevena, Inc. (NASDAQ:TRVN) today announced positive results from its Phase 1 trial of TRV734, which Trevena is developing with the goal of providing improved analgesia while avoiding gastrointestinal and respiratory side effects typically associated with opioids.

23 Jun 2014

Bayer, Dimension Therapeutics partner to develop new gene therapy for hemophilia A

Dimension Therapeutics, a company focused on developing novel adeno-associated virus (AAV) gene therapy treatments for rare diseases, today announced it has entered into a collaboration with Bayer HealthCare (Bayer) for the development and commercialization of a novel gene therapy for the treatment of hemophilia A.

23 Jun 2014

Chinese FDA accepts Lee's IND for Phase 2 dry eye study

RegeneRx Biopharmaceuticals, Inc. and Lee's Pharmaceutical Holdings Ltd. today jointly announced that the Chinese FDA has accepted a Phase II IND for RGN-259 (thymosin beta 4-based, preservative-free eye drops) to be tested in patients with moderate to severe dry eye syndrome in China.

23 Jun 2014

Celsion acquires all assets of EGEN

Celsion Corporation, an oncology drug development company, today announced the completion of the acquisition by Celsion of substantially all of the assets of EGEN, Inc., a privately-held biopharmaceutical company focused on the development of nucleic acid-based therapeutics for the treatment of cancer and other difficult to treat diseases.

21 Jun 2014

Arthritis drug promotes hair growth in hairless man

A man with almost no hair on his body has grown a full head of it after a novel treatment by doctors at Yale University.

20 Jun 2014

Clinical trial shows that selumetinib drug can delay progression of metastatic uveal melanoma

For the first time, a therapy has been found that can delay progression of metastatic uveal melanoma, a rare and deadly form of melanoma of the eye.

20 Jun 2014

New treatment for ovarian cancer can improve response rates

Doctors at the University of Arizona Cancer Center at St. Joseph's Hospital and Medical Center in Phoenix reported today in Lancet Oncology that a new treatment for ovarian cancer can improve response rates (increase the rate of tumor shrinkage) and prolong the time until cancers recur.

20 Jun 2014

Alkermes reports data from aripiprazole lauroxil phase 3 clinical trial for treatment of schizophrenia

Alkermes plc today announced the presentation of data from its phase 3 clinical trial of aripiprazole lauroxil, an investigational drug candidate in development for schizophrenia, at the American Society of Clinical Psychopharmacology Annual Meeting in Hollywood, Fla.

18 Jun 2014

Animas' predictive algorithm technology maintains glucose above hypoglycemic levels

Animas Corporation today shared encouraging results from its predictive hypoglycemia-minimizing algorithm in development.

18 Jun 2014

Scottsdale Healthcare, TGen initiate AG-120 clinical trial in patients with solid tumors

The Virginia G. Piper Cancer Center at Scottsdale Healthcare and the Translational Genomics Research Institute are studying the safety and effectiveness of a new drug, AG-120, for treatment of patients with solid tumors, especially those with brain tumors and gallbladder bile duct cancer.

18 Jun 2014

Single dose restores normal cellular signaling in mouse model of autism

In a further test of a novel theory that suggests autism is the consequence of abnormal cell communication, researchers at the University of California, San Diego School of Medicine report that an almost century-old drug approved for treating sleeping sickness also restores normal cellular signaling in a mouse model of autism, reversing symptoms of the neurological disorder in animals that were the human biological age equivalent of 30 years old.

18 Jun 2014

BIPI, Lilly announce resubmission of empagliflozin NDA to FDA for treatment of type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the resubmission of a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes (T2D) to the U.S. Food and Drug Administration (FDA).

17 Jun 2014

OHS performs clinical drug trial to reduce cholesterol levels with just one injection

Research One, Inc., an affiliate of Orlando Heart Specialists (OHS), is seeking candidates for a clinical drug trial that could reduce cholesterol levels with just one injection, twice a month.

17 Jun 2014

Lowering systolic blood pressure below 120 does not appear to provide additional benefit

For decades, common medical wisdom has been "the lower the better" in treating the approximately one in three people in this country who have high blood pressure.

17 Jun 2014

BioClinica announces acquisition of Blueprint Clinical to drive RBM strategies for clinical trials

BioClinica®, Inc., a leading provider of eClinical Solutions for the Pharmaceutical Industry, has announced the acquisition of Blueprint Clinical, a fast-growing company offering ground-breaking technology and extensive expertise to drive successful Risk-Based Monitoring (RBM) strategies for clinical trials.

From Clario 16 Jun 2014

Clinical Trial News and Research

Italian Medicines Agency grants marketing authorization to ILUVIEN for chronic DME treatment

XenoPort initiates XP23829 Phase 2 clinical trial in patients with psoriasis

Denosumab increases bone density for postmenopausal women with osteoporosis

Aradigm begins Pulmaquin Phase III study for treatment of non-CF BE

PSI CRO presents the changing dynamic of clinical trial feasibility at PCMG meeting

Trevena reports positive results from TRV734 Phase 1 trial for treating acute/chronic pain

Bayer, Dimension Therapeutics partner to develop new gene therapy for hemophilia A

Chinese FDA accepts Lee's IND for Phase 2 dry eye study

Celsion acquires all assets of EGEN

Arthritis drug promotes hair growth in hairless man

Clinical trial shows that selumetinib drug can delay progression of metastatic uveal melanoma

New treatment for ovarian cancer can improve response rates

Alkermes reports data from aripiprazole lauroxil phase 3 clinical trial for treatment of schizophrenia

Animas' predictive algorithm technology maintains glucose above hypoglycemic levels

Scottsdale Healthcare, TGen initiate AG-120 clinical trial in patients with solid tumors

Single dose restores normal cellular signaling in mouse model of autism

BIPI, Lilly announce resubmission of empagliflozin NDA to FDA for treatment of type 2 diabetes

OHS performs clinical drug trial to reduce cholesterol levels with just one injection

Lowering systolic blood pressure below 120 does not appear to provide additional benefit

BioClinica announces acquisition of Blueprint Clinical to drive RBM strategies for clinical trials

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