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CTI completes recruitment in PERSIST-1 clinical trial of pacritinib for treatment of myelofibrosis

CTI BioPharma Corp. announced today that it has completed recruitment in the PERSIST-1 pivotal Phase 3 clinical trial of pacritinib, a novel oral JAK2/FLT3 inhibitor that is being evaluated for the treatment of myelofibrosis.

From Baxter International Inc. 1 Jul 2014

Ipsen submits Supplemental New Drug Application to FDA for Somatuline Depot 120mg injection

Ipsen today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration for Somatuline Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

1 Jul 2014

New approach may help develop more effective immunotherapy for metastatic melanoma

A new approach demonstrated that the recognition of unique cancer mutations appeared to be responsible for complete cancer regressions in two metastatic melanoma patients treated with a type of immunotherapy called adoptive T-cell therapy.

1 Jul 2014

Aclaris Therapeutics reports positive results from A-101 Phase 2 trial for removing SK lesions

Aclaris Therapeutics, Inc. today announced positive results from a Phase 2 clinical trial of the Company's lead drug, A-101. In the trial, A-101 demonstrated clinically and statistically significant improvements in clearing seborrheic keratoses (SK), one of the most common types of skin tumors.

1 Jul 2014

UCSF researchers complete first Internet-based clinical trial for children with autism

UC San Francisco researchers have completed the first Internet-based clinical trial for children with autism, establishing it as a viable and cost effective method of conducting high-quality and rapid clinical trials in this population.

1 Jul 2014

BioLight enrolls first patient in FDA Phase 1/2a clinical trial with Eye-D for treatment of glaucoma

BioLight Israeli Life Sciences Investments Ltd., a firm that invests in, manages and commercializes biomedical innovations grouped into clusters around defined medical conditions, announces that the first patient has been enrolled in the U.S. into a FDA Phase 1/2a clinical trial with Eye-D, the company's controlled-release latanoprost insert for the treatment of glaucoma.

1 Jul 2014

FSC Laboratories acquires exclusive marketing rights for Aciphex Sprinkle in the U.S.

FSC Therapeutics, LLC, today announced that the Company has entered into a transaction with Eisai Inc. to acquire exclusive U.S. marketing rights for AcipHex® Sprinkle™ (rabeprazole sodium), Delayed-Release Capsules, 5 mg and 10 mg, for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.

30 Jun 2014

ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has approved LemtradaTM (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

30 Jun 2014

EMA accepts for review Merck’s pembrolizumab MAA for treatment of advanced melanoma

Merck, known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company's investigational anti-PD-1 antibody, for the treatment of advanced melanoma.

30 Jun 2014

IXICO and VirtualScopics jointly lease office space in New Hope, Pennsylvania

VirtualScopics, Inc., a leading provider of clinical trial imaging solutions, and IXICO plc (AIM: IXI), the brain health company, announced today they are jointly leasing 2,190 sq. ft. of office space in New Hope, Pennsylvania, strategically located within the big pharma corridor that runs through New Jersey and Pennsylvania.

30 Jun 2014

Genervon generates biomarker data for its Phase 2a clinical trial for ALS

Genervon Biopharmaceuticals LLC ("Genervon") today announced that it has analyzed and generated a Biomarker Data Report for its recent Phase 2a clinical trial for ALS disease modification.

30 Jun 2014

Afrezza gets FDA approval to improve glycemic control in adults with diabetes mellitus

The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.

28 Jun 2014

Thoratec commences CE Mark Clinical Trial for HeartMate III chronic left ventricular assist system

Thoratec Corporation, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that its CE Mark Clinical Trial for HeartMate III™ commenced with the first patient implanted with this new device.

27 Jun 2014

Dosing commences in Essentialis’ DCCR clinical study in obese Prader-Willi syndrome patients

Essentialis announced today the dosing of the first patient in clinical study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome patients.

27 Jun 2014

Surgical biopsies can be safely performed on selected patients with late-stage lung cancer

Researchers at UC Davis have determined that surgical biopsies can be safely performed on select patients with late-stage non-small cell lung cancer, which should enhance their access to drugs that target specific genetic mutations such as epidermal growth factor receptor (EGFR).

27 Jun 2014

Blocking enzyme Cdk5 could reduce brain damage after stroke

A drug that blocks the action of the enzyme Cdk5 could substantially reduce brain damage if administered shortly after a stroke, UT Southwestern Medical Center research suggests.

27 Jun 2014

Scientists report first successful step toward vaccine that targets mutation in brain cancer

Astrocytomas and oligodendrogliomas are subtypes of a brain cancer called 'glioma'. These incurable brain tumors arise from glial cells, a type of support cell found in the central nervous system.

26 Jun 2014

Response-adaptive randomization approach can boost patients’ participation in medical studies

It's a classic Catch-22: Medical researchers need to figure out if a promising new treatment is truly better than a current one, by randomly assigning half of a group of patients to get each treatment.

26 Jun 2014

EnGeneIC plans for Phase 2a trial of EGFR-targeted doxorubicin-packaged EDV nanocells for GBM

EnGeneIC, Ltd., an emerging biopharmaceutical company focused on revolutionizing the treatment of cancer through the targeted delivery of therapeutic agents directly to cancer cells, today announced plans to move forward with a Phase 2a clinical trial in the U.S. using its formulation of EGFR-targeted, EDV nanocells packaged with doxorubicin for the treatment of recurrent glioblastoma (GBM), a common and aggressive type of brain tumor.

26 Jun 2014

GW clinical trial aims to identify novel modalities to reduce seizures in MTLE patients

A first-of-its-kind clinical trial at the George Washington University Medical Faculty Associates employs low-frequency deep brain stimulation to potentially help reduce epileptic seizures in patients with mesial temporal lobe epilepsy (MTLE) - the most common type of focal epilepsy that often necessitates surgical resection of the temporal lobe, risking memory function.

26 Jun 2014

Clinical Trial News and Research

CTI completes recruitment in PERSIST-1 clinical trial of pacritinib for treatment of myelofibrosis

Ipsen submits Supplemental New Drug Application to FDA for Somatuline Depot 120mg injection

New approach may help develop more effective immunotherapy for metastatic melanoma

Aclaris Therapeutics reports positive results from A-101 Phase 2 trial for removing SK lesions

UCSF researchers complete first Internet-based clinical trial for children with autism

BioLight enrolls first patient in FDA Phase 1/2a clinical trial with Eye-D for treatment of glaucoma

FSC Laboratories acquires exclusive marketing rights for Aciphex Sprinkle in the U.S.

ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

EMA accepts for review Merck’s pembrolizumab MAA for treatment of advanced melanoma

IXICO and VirtualScopics jointly lease office space in New Hope, Pennsylvania

Genervon generates biomarker data for its Phase 2a clinical trial for ALS

Afrezza gets FDA approval to improve glycemic control in adults with diabetes mellitus

Thoratec commences CE Mark Clinical Trial for HeartMate III chronic left ventricular assist system

Dosing commences in Essentialis’ DCCR clinical study in obese Prader-Willi syndrome patients

Surgical biopsies can be safely performed on selected patients with late-stage lung cancer

Blocking enzyme Cdk5 could reduce brain damage after stroke

Scientists report first successful step toward vaccine that targets mutation in brain cancer

Response-adaptive randomization approach can boost patients’ participation in medical studies

EnGeneIC plans for Phase 2a trial of EGFR-targeted doxorubicin-packaged EDV nanocells for GBM

GW clinical trial aims to identify novel modalities to reduce seizures in MTLE patients

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