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Impax commences IPX159 Phase IIb trial in Restless Legs Syndrome

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., announced that it has initiated a Phase IIb trial of its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome.

20 Dec 2011

Phase I clinical study of Selexys SelG1 for sickle cell disease completed

Selexys Pharmaceuticals announced today that it has completed a Phase I clinical study of its lead compound SelG1, an antibody specific for the pro-inflammatory cell adhesion molecule P-selectin.

19 Dec 2011

Alkermes commences ALKS 9070 phase 3 clinical trial for schizophrenia

Alkermes plc today announced the initiation of a phase 3 clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes molecule, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY for the treatment of a number of central nervous system disorders.

19 Dec 2011

Diseases of the Colon & Rectum publishes results from Pacira's EXPAREL Phase 3 trial

Pacira Pharmaceuticals, Inc. today announced the publication of data from a placebo-controlled, pivotal Phase 3 trial of EXPAREL (bupivacaine liposome injectable suspension), a non-opioid local analgesic that was recently approved by the U.S. Food and Drug Administration (FDA) for administration into the surgical site to produce postsurgical analgesia.

19 Dec 2011

FDA accepts Vertex KALYDECO NDA for six-month Priority Review

Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KALYDECOTM (ivacaftor) and granted the company's request for six-month Priority Review.

16 Dec 2011

Vaginal progesterone safe and effective in preventing preterm birth

Women with a short cervix should be treated with vaginal progesterone to prevent preterm birth, according to a landmark study by leading obstetricians around the world. Vaginal progesterone decreased the rate of preterm birth by 42%, and significantly reduced the rate of respiratory distress syndrome and the need for mechanical ventilation, as well as a composite of several complications of premature newborns.

15 Dec 2011

$Celgene reports final results from REVLIMID-rituximab combination phase II study for relapsed/refractory CLL$

Celgene reports final results from REVLIMID-rituximab combination phase II study for relapsed/refractory CLL

Celgene International Sàrl, a subsidiary of Celgene Corporation, (NASDAQ: CELG), announced final results from a phase II investigational study evaluating the combination of REVLIMID® (lenalidomide) and rituximab in 59 patients with relapsed or refractory chronic lymphocytic leukemia (CLL). These data were presented at the 53rd Annual Meeting of the American Society of Hematology in San Diego, CA.

14 Dec 2011

Celgene announces data from REVLIMID Phase III study on high-risk asymptomatic smoldering MM

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that updated data evaluating continuous treatment with REVLIMID (lenalidomide) in patients with high-risk asymptomatic smoldering multiple myeloma were presented at the 53rd Annual Meeting of the American Society of Hematology.

14 Dec 2011

JDRF initiates enrollment in metformin clinical study for type 1 diabetes

JDRF-funded researchers have begun enrolling adult patients with type 1 diabetes (T1D) in the REMOVAL study, to test whether metformin-a drug commonly used to treat type 2 diabetes-could help prevent or reduce the risk of cardiovascular complications in people with T1D.

14 Dec 2011

Positive results from Aestus' ATx08-001 Phase II study on post-herpetic neuralgia

Aestus Therapeutics, Inc. today reported positive results from a Phase II clinical study evaluating the efficacy of its novel neuropathic pain therapeutic, ATx08-001, in the treatment of post-herpetic neuralgia.

14 Dec 2011

U.S. DoD awards $11M to study two different ways to treat PTSD in war veterans

A team of researchers who have pioneered novel treatments for post-traumatic stress disorder (PTSD) has been awarded an $11 million, four-year grant from the U.S. Department of Defense to investigate the differences between virtual reality and traditional prolonged exposure therapy.

14 Dec 2011

Incyte announces further analyses from Jakafi Phase III trial on myelofibrosis

Incyte Corporation today announced that further analyses from the global, pivotal Phase III clinical program of Jakafi (ruxolitinib or INC424) are being presented at the 2011 American Society of Hematology (ASH) Annual Meeting.

13 Dec 2011

Ruxolinitib reduces spleen size by 35% in patients with myelofibrosis

In a major advance in treatment, a multicenter study found that ruxolinitib did a better job than off-label chemotherapy drugs reducing the terrible symptoms associated with myelofibrosis, including pain, enlarged spleen, anemia, fever, chills, fatigue, and weight loss.

13 Dec 2011

ISIS-FXIRx reduces Factor XI activity without bleeding in healthy volunteers

Isis Pharmaceuticals, Inc. announced today positive results from a Phase 1 study with ISIS-FXIRx. The results demonstrated that treatment with ISIS-FXIRx produced dose-dependent statistically significant reductions of up to 78 percent in Factor XI activity.

13 Dec 2011

Celgene reports final results from REVLIMID plus VIDAZA phase II study on higher-risk MDS

Celgene International Sàrl, a subsidiary of Celgene Corporation, today reported final results from the phase II portion of a multi-center phase I/II study evaluating combination therapy with REVLIMID (lenalidomide) and VIDAZA (azacitidine) in patients with higher-risk myelodysplastic syndromes (MDS) not previously treated with either drug.

13 Dec 2011

Soligenix reports results from orBec Phase 2 trial on acute GVHD

Soligenix, Inc., a development stage biopharmaceutical company, announced the publication of results from its investigator-initiated Phase 2 "proof-of-concept" exploratory clinical trial of orBec for the prevention of acute Graft-versus-Host disease (GVHD) in patients undergoing myeloablative conditioning regimens with initiation of dosing prior to hematopoietic cell transplantation (HCT) and continuing through the post-transplantation period.

12 Dec 2011

Celgene announces interim results of REVLIMID study on CLL

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced interim results of CLL-009, a study evaluating three starting doses of REVLIMID (lenalidomide), followed by step-wise dose escalation as tolerated in patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

12 Dec 2011

Research assesses safety and efficacy of pre-operative transfusions, hydroxyurea therapy for SCD

Research assessing the safety and efficacy of hydroxyurea therapy in pediatric patients with sickle cell disease (SCD) and the use of pre-operative transfusions for patients with SCD who undergo low- and moderate-risk elective surgery will be presented today at the 53rd Annual Meeting of the American Society of Hematology.

12 Dec 2011

Research examines novel treatment techniques for hemophilia B, VTE

Bleeding and clotting disorders affect a large number of patients annually and, while accurate diagnosis is important, timely and effective treatment for these disorders is key, as they have the potential to quickly become life-threatening. Research examining novel treatment techniques for bleeding and clotting disorders will be presented today at the 53rd Annual Meeting of the American Society of Hematology.

12 Dec 2011

BioInvent announces new BI-505 preclinical data on multiple myeloma

BioInvent International AB announced today that new preclinical data has been presented on its BI-505 programme that demonstrates anti-cancer activity in multiple myeloma and beneficial effect on bone density.

12 Dec 2011