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Stemedica receives FDA's IND approval for itMSC Phase IIa clinical trial to treat Alzheimer's disease

Stemedica Cell Technologies, Inc. received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with mild to moderate dementia due to Alzheimer's disease (AD), the sixth leading cause of death in the United States.

9 Jun 2015

Duration of antibiotic treatment can be cut by half for complicated abdominal infections

In a finding important for preventing the development of antibiotic-resistant superbugs, researchers at the University of Virginia School of Medicine and 22 other institutions have determined that the duration of antibiotic treatment for complicated abdominal infections can be cut by half and remain equally effective.

9 Jun 2015

Phase II clinical trial of Linsitinib launched in patients with advanced Ewing sarcoma

EUROSARC, European Clinical trials in Rare Sarcomas within an integrated translational trial network, has launched a phase II trial of Linsitinib for patients with relapsed and/or refractory Ewing Sarcoma. The trial, EORTC 1225 / OCTO 038, aims to establish pharmacodynamic responses in Ewing sarcoma tumors to Linsitinib using functional imaging and biopsies, and toxicity and clinical outcomes.

9 Jun 2015

Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Sanofi announced today the presentation of full results of the Phase IIIb ELIXA study, which was designed to assess the cardiovascular (CV) safety of Lyxumia (lixisenatide) in adults with type 2 diabetes and high CV risk.

8 Jun 2015

Jazz enrolls first patients in JZP-110 Phase 3 study for treatment of EDS in patients with narcolepsy or OSA

Jazz Pharmaceuticals plc announced today that the first patients have been enrolled in a Phase 3 clinical development program evaluating the safety and efficacy of its investigational drug candidate, JZP-110, as a wake-promoting agent in the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy or with obstructive sleep apnea (OSA).

8 Jun 2015

Results from Intarcia's two phase 3 clinical trials of ITCA 650 to be presented at ADA's Scientific Session

Intarcia Therapeutics, Inc. today announced the presentation of results from its first two phase 3 clinical trials (FREEDOM-1 and FREEDOM-1 HBL) of its late-stage investigational candidate ITCA 650 (exenatide delivered continuously via a small matchstick-size subcutaneous osmotic mini-pump just once or twice yearly) at the 75th Scientific Sessions of the American Diabetes Association.

8 Jun 2015

Celtaxsys closes $40M Series D financing and receives $5M CFFT grant to conduct CTX-4430 Phase 2 trial

Celtaxsys, Inc., a clinical stage drug development company focused on developing novel therapies for inflammatory diseases, today announced the successful completion of a $40M Series D financing led by Domain Partners VIII. Additional investors in the financing include Lumira Capital, RMI Partners, Masters Capital Management and the Georgia Research Alliance Venture Fund.

8 Jun 2015

DalCor, MHI partner to conduct Phase III clinical trial of investigational cardiovascular drug

DalCor Pharmaceuticals and the Montreal Heart Institute announced today a collaboration in principle to conduct an international Phase III clinical trial which could result in a major clinical advance in cardiovascular personalised medicine.

8 Jun 2015

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Braeburn Pharmaceuticals, an Apple Tree Partners company, today reported positive topline results from the Phase 3 double-blind, double-dummy clinical study of Probuphine, the investigational subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction.

8 Jun 2015

Nuvo obtains Health Canada approval to conduct WF10 Phase 2 trial for treatment of allergic rhinitis

Nuvo Research Inc., a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced it has received Health Canada approval to conduct a new Phase 2 clinical trial (the 2015 WF10 Trial) to assess WF10 for the treatment of allergic rhinitis.

8 Jun 2015

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza 0.9 mg after 52 weeks of treatment. Eli Lilly and Company will present these data at the 75th American Diabetes Association Scientific Sessions in Boston.

7 Jun 2015

IDMC recommends continuation of Argos’ ADAPT phase 3 trial of AGS-003 in mRCC patients

Argos Therapeutics Inc., an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis technology platform, today announced an independent data monitoring committee (IDMC) has recommended the continuation of the company’s pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) following the first of three planned interim data analyses.

5 Jun 2015

Seattle Children's opens enrollment for first clinical trial of Tumor Paint BLZ-100 for children with brain tumors

Seattle Children's today announced the opening of patient enrollment for the first clinical research trial of the drug Tumor Paint BLZ-100, which is designed to improve surgical outcomes in children with brain tumors – the most common solid tumor cancer in kids.

5 Jun 2015

Ibrutinib (IMBRUVICA) improves survival in treatment-naïve patients with chronic lymphocytic leukemia

Today, Pharmacyclics LLC, an AbbVie company, announced that ibrutinib (IMBRUVICA) improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival (OS) and overall response rate (ORR) in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL, respectively) in the final analysis of the Phase III RESONATE™-2 (PCYC-1115) trial.

5 Jun 2015

Pivotal Therapeutics enrolls first patient in POMEGA Phase IIa clinical trial of PVT-100

Pivotal Therapeutics Inc., a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease (CVD) and overall health, announced today the enrollment of the first patient in Pivotal's POMEGA Phase IIa clinical trial with PVT-100.

4 Jun 2015

Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

Rhythm announced today the initiation of two Phase 2 clinical trials focused on evaluating the safety and effectiveness of setmelanotide (RM-493), the company's novel melanocortin 4 receptor (MC4R) agonist, for the treatment of Prader-Willi Syndrome (PWS) and POMC-null obesity.

4 Jun 2015

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 ("miR-21").

4 Jun 2015

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that it has filed an application with China's Food and Drug Administration to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076.

4 Jun 2015

Egalet announces top-line results from Egalet-002 study in moderate drinkers

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced top-line results from a randomized, four-way crossover alcohol-interaction study in healthy male and female moderate drinkers with Egalet-002, an abuse-deterrent, extended-release, oral oxycodone-based product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.

4 Jun 2015

ProBioGen initiates clinical trials of Ebola vaccine using AGE1.CR.pIX cell line

Complex biologics development and manufacturing specialist ProBioGen today announced that an investigational vaccine against Ebola virus disease, produced on its proprietary, continuous muscovy duck AGE1.CR.pIX cell line, has proceeded into clinical trials at the Jenner Institute, Oxford University, UK.

3 Jun 2015

Drug Trial News

Stemedica receives FDA's IND approval for itMSC Phase IIa clinical trial to treat Alzheimer's disease

Duration of antibiotic treatment can be cut by half for complicated abdominal infections

Phase II clinical trial of Linsitinib launched in patients with advanced Ewing sarcoma

Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Jazz enrolls first patients in JZP-110 Phase 3 study for treatment of EDS in patients with narcolepsy or OSA

Results from Intarcia's two phase 3 clinical trials of ITCA 650 to be presented at ADA's Scientific Session

Celtaxsys closes $40M Series D financing and receives $5M CFFT grant to conduct CTX-4430 Phase 2 trial

DalCor, MHI partner to conduct Phase III clinical trial of investigational cardiovascular drug

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Nuvo obtains Health Canada approval to conduct WF10 Phase 2 trial for treatment of allergic rhinitis

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

IDMC recommends continuation of Argos’ ADAPT phase 3 trial of AGS-003 in mRCC patients

Seattle Children's opens enrollment for first clinical trial of Tumor Paint BLZ-100 for children with brain tumors

Ibrutinib (IMBRUVICA) improves survival in treatment-naïve patients with chronic lymphocytic leukemia

Pivotal Therapeutics enrolls first patient in POMEGA Phase IIa clinical trial of PVT-100

Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

Egalet announces top-line results from Egalet-002 study in moderate drinkers

ProBioGen initiates clinical trials of Ebola vaccine using AGE1.CR.pIX cell line

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