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FDA approves Parion’s investigational new drug application for treatment of dry eye disease

Parion Sciences, a company dedicated to the development of novel treatments for ocular and pulmonary diseases, announced today that it has received acceptance from the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for P-321 Ophthalmic Solution for the treatment of dry eye disease.

2 May 2014

Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Teva Pharmaceutical Industries Ltd. today announced positive results from a pivotal Phase III study of hydrocodone bitartrate extended-release tablets designed with Teva's proprietary technology providing potential abuse-deterrent properties (CEP-33237).

30 Apr 2014

Boehringer announces first results of Phase III INPULSIS trials at 2014 ATS International Conference

Boehringer Ingelheim announced today that the first results of the two confirmatory Phase III INPULSISTM trials, investigating nintedanib* in the treatment of idiopathic pulmonary fibrosis (IPF), will be presented at the 2014 American Thoracic Society (ATS) International Conference taking place 16 - 21 May in San Diego

30 Apr 2014

Braeburn announces new clinical trial for Probuphine based on clear guidance from FDA

Braeburn Pharmaceuticals announced today the initiation of a new clinical trial for Probuphine® based on clear guidance from the U.S. Food and Drug Administration (FDA). The study, which was submitted for FDA review in mid-March, is expected to begin enrollment by mid-year and to be completed by the middle of 2015.

30 Apr 2014

Synergy reports positive top-line results from plecanatide phase 2b study in patients with IBS-C

Synergy Pharmaceuticals Inc. today announced positive top-line results from a phase 2b dose-ranging study assessing plecanatide's safety and efficacy in 424 patients with irritable bowel syndrome with constipation (IBS-C).

30 Apr 2014

Can-Fite BioPharma submits study protocol to FDA for CF102 Phase II trial for advanced liver cancer

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that it has submitted a study protocol to the U.S. Food and Drug Administration for its Phase II clinical trial of CF102 for the treatment of advanced liver cancer.

29 Apr 2014

Civitas reports positive results from CVT-301 Phase 2b trial for treatment of Parkinson's disease

Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing and commercializing transformative therapeutics using its proprietary ARCUSTM technology, today announced positive results from a Phase 2b clinical trial of CVT-301, an inhaled formulation of levodopa (L-dopa).

29 Apr 2014

Positive results from pivotal clinical trial of Trophos’ olesoxime in SMA patients to be presented at AAN 2014

Trophos and AFM-Telethon today announce that data from the pivotal clinical trial of Trophos’ lead product candidate olesoxime in spinal muscular atrophy (SMA) will be presented during the 66th American Academy of Neurology annual meeting to be held in Philadelphia, PA, USA, from April 26 to May 3 2014.

29 Apr 2014

Highland subsidiary begins enrolment in Phase III study of HLD-200 in pediatric ADHD patients

Highland Therapeutics Inc., an emerging pharmaceutical company, today announced that its wholly owned subsidiary has begun enrolment in a Phase III study of HLD-200, the Company's novel formulation of methylphenidate, in pediatric patients with Attention-Deficit Hyperactivity Disorder ("ADHD").

28 Apr 2014

Genervon completes GM604 Phase 2a clinical trial for amyotrophic lateral sclerosis

Genervon Biopharmaceuticals LLC today announced that it has successfully completed its Phase 2a clinical trial for amyotrophic lateral sclerosis ("ALS") disease modification. A full analysis of the trial's results is expected to be completed in the third quarter of 2014, but preliminary data suggests that Genervon's novel, proprietary, multi-target biological drug candidate, GM604, shows significant promise for treating ALS.

28 Apr 2014

New data from EMD Serono's multiple sclerosis portfolio to be presented at the 66th AAN Annual Meeting

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that new data from the company's multiple sclerosis (MS) portfolio will be presented at the American Academy of Neurology's 66th Annual Meeting, taking place from April 26 – May 3, in Philadelphia, PA.

26 Apr 2014

Concert Pharmaceuticals reports results from CTP-499 Phase 2 trial in patients with diabetic kidney disease

Concert Pharmaceuticals, Inc. today announced 48-week results of its Phase 2 clinical trial of CTP-499 in patients with diabetic kidney disease. CTP-499, when used in addition to the standard of care, is being developed to delay the progression of these patients to end-stage renal failure, which requires dialysis or kidney transplantation.

26 Apr 2014

CPX-351 treatment leads to higher chances of remission in AML patients, says study

Moffitt Cancer Center researchers say clinical trials for a new experimental drug to treat acute myeloid leukemia (AML) are very promising. Patients treated with CPX-351, a combination of the chemotherapeutic drugs cytarabine and daunorubicin, are showing better responses than patients treated with the standard drug formulation.

25 Apr 2014

TB Alliance advances first-ever TB drug regimen to global Phase 3 clinical trial

Based on positive results from earlier clinical studies, TB Alliance is advancing the first-ever drug regimen designed to treat both drug-sensitive and some forms of multi-drug resistant tuberculosis (TB) to a global Phase 3 clinical trial.

25 Apr 2014

Captisol-enabled Melphalan meets primary end points in phase 2 pivotal trial

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced that its pivotal trial of Captisol-enabled (propylene glycol-free) Melphalan met its primary end points.

23 Apr 2014

Symposium focused on Surefire Medical's COSY clinical trial to be held at ECIO meeting

Surefire Medical, Inc. announced that a symposium focused on the Coiling vs. Surefire Infusion System in Y90 (COSY) clinical trial will be held during the European Conference on Interventional Oncology (ECIO) meeting taking place in Berlin, Germany April 23-26. T

23 Apr 2014

Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

Pfizer Inc. announced today top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials (OPT) Program, OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079), evaluating the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis.

23 Apr 2014

Cedars-Sinai researchers to receive $8M grant to fund Phase II clinical trial of experimental drug for stroke

Cedars-Sinai stroke intervention researchers have been informed that the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, will award an $8 million grant to fund a multicenter Phase II clinical trial of an experimental drug for stroke.

22 Apr 2014

IV-administered ketamine effective in patients with chronic PTSD

For the first time, evidence that a single dose of IV-administered ketamine was associated with the rapid reduction of symptoms of post-traumatic stress disorder in patients with chronic PTSD was demonstrated in a proof-of-concept, randomized, double blind crossover study, undertaken by researchers at the Icahn School of Medicine at Mount Sinai in New York City. These findings, according to Mount Sinai researchers, could be the first step toward developing new interventions for PTSD.

21 Apr 2014

ARCA biopharma announces genetic screening of first patient in GENETIC-AF Phase 2B/3 clinical trial

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the first patient has been genetically screened in GENETIC-AF, its Phase 2B/3 adaptive design clinical trial.

From Medtronic 18 Apr 2014

Drug Trial News

FDA approves Parion’s investigational new drug application for treatment of dry eye disease

Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Boehringer announces first results of Phase III INPULSIS trials at 2014 ATS International Conference

Braeburn announces new clinical trial for Probuphine based on clear guidance from FDA

Synergy reports positive top-line results from plecanatide phase 2b study in patients with IBS-C

Can-Fite BioPharma submits study protocol to FDA for CF102 Phase II trial for advanced liver cancer

Civitas reports positive results from CVT-301 Phase 2b trial for treatment of Parkinson's disease

Positive results from pivotal clinical trial of Trophos’ olesoxime in SMA patients to be presented at AAN 2014

Highland subsidiary begins enrolment in Phase III study of HLD-200 in pediatric ADHD patients

Genervon completes GM604 Phase 2a clinical trial for amyotrophic lateral sclerosis

New data from EMD Serono's multiple sclerosis portfolio to be presented at the 66th AAN Annual Meeting

Concert Pharmaceuticals reports results from CTP-499 Phase 2 trial in patients with diabetic kidney disease

CPX-351 treatment leads to higher chances of remission in AML patients, says study

TB Alliance advances first-ever TB drug regimen to global Phase 3 clinical trial

Captisol-enabled Melphalan meets primary end points in phase 2 pivotal trial

Symposium focused on Surefire Medical's COSY clinical trial to be held at ECIO meeting

Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

Cedars-Sinai researchers to receive $8M grant to fund Phase II clinical trial of experimental drug for stroke

IV-administered ketamine effective in patients with chronic PTSD

ARCA biopharma announces genetic screening of first patient in GENETIC-AF Phase 2B/3 clinical trial

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