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TxCell’s pilot manufacturing facility activities put on temporary partial hold

TxCell SA, a biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells for severe chronic inflammatory and autoimmune diseases, announces today that it has temporarily put its pilot manufacturing facility activities at Besançon, France on partial hold.

24 Jun 2015

Novogen’s chemotherapy drug Anisina proves as effective anti-cancer agent in animals

US-Australian drug discovery company, Novogen Limited announced today that its candidate cytotoxic chemotherapy drug, Anisina, has proved an effective anti-cancer agent in animals, the result of which it now has been fast-tracked by the Company to come into the clinic.

24 Jun 2015

Alnylam presents positive Phase 1 ALN-AT3 trial results in hemophilia at ISTH 2015 Congress

Additional study results from 12 hemophilia A and B subjects demonstrated that subcutaneous administration of ALN-AT3 achieved potent and dose-dependent knockdown of AT of up to 86%. AT knockdown was highly durable, with effects lasting over two months after the last dose, supporting further evaluation of a once-monthly subcutaneous dose regimen.

24 Jun 2015

Understanding of tumor biology opens new opportunities to conduct clinical trial for thoracic tumors

Our understanding of tumor biology has improved and continues to expand at a rapid pace, and this has opened new opportunities for cancer clinical trials, particularly for thoracic tumors. The identification and molecular alterations in the cancer and the possibility to specifically and selectively target them, has dramatically improved the treatment efficacy in patients with lung cancer.

24 Jun 2015

Perle Bioscience announces enrollment for Phase 3 trial of combination therapy in type 1 diabetics

Perle Bioscience, Inc. announces enrollment for the Insulin Independence Trial (IIT). This trial is the first and only Phase 3 trial to test a combination therapy in type 1 diabetics.

24 Jun 2015

Statins benefit patients undergoing major lung resection, lower major complications

Statins have been shown to reduce complications from cardiovascular surgery. To determine whether statins might also help those undergoing major lung surgeries, a team at Memorial Sloan Kettering Cancer Center conducted a well-designed study that randomized patients to receive either a statin or placebo before and after surgery.

23 Jun 2015

Researchers looking to enroll patients in groundbreaking NIH diabetes study

Maria Gaona has been battling diabetes for eight years. Coupled with a family history of the disease, poor eating habits and no exercise regimen, the 64-year-old faces a lifetime of daily medications to control her disease. Fortunately, in 2014, she enrolled in a groundbreaking national research study that has already helped her control her glucose level, lose 16 pounds and regulate her daily medications.

23 Jun 2015

Isis Pharmaceuticals provides update on ISIS-SMN Rx Phase 2 study in children with SMA

Isis Pharmaceuticals, Inc. today provided an update on children with spinal muscular atrophy (SMA) who have completed the open-label, Phase 2 multiple-dose study of ISIS-SMN Rx and are continuing to receive treatment in an open-label extension (OLE) study.

22 Jun 2015

ImmunoCellular, Pure MHC partner to develop new assay for ICT-107 phase 3 registrational clinical program

ImmunoCellular Therapeutics, Ltd. announced an agreement with Pure MHC, an Emergent Technologies portfolio company, for development of a novel assay for quality control that will be an important component of ImmunoCellular's ICT-107 phase 3 registrational clinical program in newly diagnosed glioblastoma, anticipated to begin in the second half of 2015.

22 Jun 2015

Planning for first clinical trial of MERS-CoV vaccine candidate now underway

Researchers from Ludwig-Maximilians-Universitaet in Munich have demonstrated, in a preclinical setting, the protective effect of a candidate vaccine directed against the coronavirus that causes Middle East Respiratory Syndrome. Planning for the first clinical trial is now underway.

22 Jun 2015

Celimmune to provide oral presentation on AMG 714 antibody at 16th International Coeliac Disease Symposium

Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing autoimmune diseases, announced today that Dr. Francisco Leon, CEO and Chief Medical Officer, will provide an oral presentation on an abstract related to the company's lead product candidate, AMG 714, at the 16th International Coeliac Disease Symposium, June 24, 2015, in Prague, Czech Republic.

22 Jun 2015

The Lancet Oncology publishes results of CYRAMZA (ramucirumab) Phase III trial for HCC treatment

Eli Lilly and Company announced that The Lancet Oncology has published results of the Phase III REACH trial that evaluated CYRAMZA (ramucirumab) as a second-line treatment for people with hepatocellular carcinoma (HCC), also known as liver cancer. While the REACH trial's primary endpoint of overall survival favored the CYRAMZA arm, it was not statistically significant.

19 Jun 2015

MedDay announces additional positive results from MD1003 Phase III trial in patients with progressive MS

MedDay, a biotechnology company focused on the treatment of nervous system disorders, reports additional positive data from its pivotal Phase III clinical trial, MS-SPI, with MD1003, a highly-concentrated pharmaceutical grade biotin, in patients with Progressive Multiple Sclerosis.

19 Jun 2015

Lilly announces positive results from LY2951742 Phase 2b study in patients with episodic migraine

Eli Lilly and Company announced today that its investigational medicine for prevention of migraine (LY2951742, a CGRP neutralizing antibody) met the primary endpoint in a Phase 2b study in episodic migraine.

19 Jun 2015

Mayo Clinic, TGen researchers help launch national clinical trial to treat advanced skin cancer patients

Mayo Clinic and the Translational Genomics Research Institute are helping launch a national clinical trial that will apply the latest in precision medicine to treat advanced melanoma skin cancer.

19 Jun 2015

$Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC$

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone.

19 Jun 2015

Injectable drug ocriplasmin improves vision in patients with symptomatic vitreomacular adhesion

In two ancillary studies of two multi-center international clinical trials led by the University of Southern California Eye Institute, the injectable drug ocriplasmin appears to improve vision among patients suffering from symptomatic vitreomacular adhesion (VMA), a condition related to the aging eye that could cause permanent vision loss if left untreated.

18 Jun 2015

CGRP monoclonal antibodies show promise in treating migraine

Migraine researchers and clinicians are growing excited about a new class of drugs called Calcitonin Gene-Related Peptide (CGRP) monoclonal antibodies, which are showing promise in treating high-frequency episodic migraine and chronic migraine.

17 Jun 2015

Phase I study: Idarucizumab reverses anticoagulant effect of dabigatran in healthy volunteers

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that The Lancet published results from a phase I study investigating the effects of idarucizumab, an investigational agent, in reversing the anticoagulant effect of dabigatran in healthy volunteers. The data demonstrate that complete reversal was achieved following administration of idarucizumab.

17 Jun 2015

Genticel’s GTL001 phase 1 clinical study of HPV therapeutic vaccine granted FDA clearance

Genticel, a French biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus, today announces that the US Food and Drug Administration (FDA) has cleared Genticel’s Investigational New Drug application to conduct in the US a phase 1 clinical study of GTL001 in patients infected with HPV 16 and/or 18, the two HPV types responsible for 70% of cervical cancer cases.

16 Jun 2015

Drug Trial News

TxCell’s pilot manufacturing facility activities put on temporary partial hold

Novogen’s chemotherapy drug Anisina proves as effective anti-cancer agent in animals

Alnylam presents positive Phase 1 ALN-AT3 trial results in hemophilia at ISTH 2015 Congress

Understanding of tumor biology opens new opportunities to conduct clinical trial for thoracic tumors

Perle Bioscience announces enrollment for Phase 3 trial of combination therapy in type 1 diabetics

Statins benefit patients undergoing major lung resection, lower major complications

Researchers looking to enroll patients in groundbreaking NIH diabetes study

Isis Pharmaceuticals provides update on ISIS-SMN Rx Phase 2 study in children with SMA

ImmunoCellular, Pure MHC partner to develop new assay for ICT-107 phase 3 registrational clinical program

Planning for first clinical trial of MERS-CoV vaccine candidate now underway

Celimmune to provide oral presentation on AMG 714 antibody at 16th International Coeliac Disease Symposium

The Lancet Oncology publishes results of CYRAMZA (ramucirumab) Phase III trial for HCC treatment

MedDay announces additional positive results from MD1003 Phase III trial in patients with progressive MS

Lilly announces positive results from LY2951742 Phase 2b study in patients with episodic migraine

Mayo Clinic, TGen researchers help launch national clinical trial to treat advanced skin cancer patients

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Injectable drug ocriplasmin improves vision in patients with symptomatic vitreomacular adhesion

CGRP monoclonal antibodies show promise in treating migraine

Phase I study: Idarucizumab reverses anticoagulant effect of dabigatran in healthy volunteers

Genticel’s GTL001 phase 1 clinical study of HPV therapeutic vaccine granted FDA clearance

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