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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

GSK initiates rhACE2 phase IIa study for Acute Lung Injury

APEIRON Biologics AG announced today that GlaxoSmithKline, exclusive, worldwide licensee for Apeiron's new investigational recombinant human Angiotensin Converting Enzyme 2 (rhACE2, name: GSK2586881, formerly APN01), has initiated a phase IIa study in patients suffering from Acute Lung Injury.

19 Dec 2011

Zalicus commences Z944 Phase 1 clinical trial for treatment of acute and inflammatory pain

Zalicus Inc. a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced the initiation of a Phase 1 clinical trial evaluating the pharmacokinetics and safety of Z944, a novel oral T-type calcium channel blocker with demonstrated preclinical potential for the treatment of acute and inflammatory pain.

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

Combination of bevacizumab and chemoradiation safe, effective for nasopharyngeal carcinoma

The trial conducted by the Radiation Therapy Oncology Group (RTOG) shows the feasibility to deliver bevacizumab to the current chemoradiation standard without any apparent increased adverse side effects.

17 Dec 2011

Enrollment complete in ThromboGenics, BioInvent TB-402 Phase IIb trial on VTE

ThromboGenics NV and co-development partner BioInvent International announce today that they have completed the enrolment of a 632-patient Phase IIb trial with their novel long-acting anticoagulant TB-402 for the prophylaxis of venous thromboembolism (VTE) after total hip surgery. The trial has recruited patients from 36 centers across Europe.

17 Dec 2011

Immediate ART appears preferable to deferring treatment among recently infected HIV patients

Among people recently infected with HIV, immediate antiretroviral therapy (ART) appears preferable to deferring treatment, according to a new study published in The Journal of Infectious Diseases and now available online.

17 Dec 2011

Positive results from Hatchtech's DeOvo Phase 2b trial on head lice

Specialty pharmaceutical company Hatchtech Pty Ltd today announced positive results for its Phase 2b clinical trial in subjects with head lice infestation. The results confirmed that DeOvo, a topical head lice treatment, is both safe and highly effective following a single application.

15 Dec 2011

Cereblon protein now holds hope in fight against multiple myeloma

Research on the same protein that was a primary mediator of the birth defects caused by thalidomide now holds hope in the battle against multiple myeloma, say Mayo Clinic researchers who presented results of several clinical trials at the 53nd annual meeting of the American Society of Hematology Dec. 10-13 in San Diego.

15 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

Vaginal progesterone reduces rate of preterm birth and neonatal complications

A team of investigators of the National Institutes of Health housed at the Detroit Medical Center (DMC) and Wayne State University (WSU) published today that performing a cervical ultrasound in all pregnant women and treating those with a short cervix with vaginal progesterone reduces the rate of preterm birth and neonatal complications.

15 Dec 2011

AtheroNova establishes clear development plan for AHRO-001 after positive FDA feedback

AtheroNova Inc., a biotech company focused on the research and development of compounds to regress atherosclerotic plaque has established a clear development plan, including Phase I and Phase II protocol outlines, based on the recently finalized minutes of its pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its AHRO-001, a compound for the treatment of atherosclerosis.

15 Dec 2011

JHN to initiate new Phase I immunotherapy trial in glioblastoma

Physicians at the Jefferson Hospital for Neuroscience (JHN), the region's only dedicated hospital for neuroscience, are tackling a particularly aggressive brain cancer that even surgery, chemotherapy and radiation often fail to treat with a promising new immunotherapy to attack a patient's tumor with their own cancer cells.

15 Dec 2011

Isis announces addition of three new drug development candidates

Isis Pharmaceuticals, Inc. announced today that it has added three new drugs to its development pipeline, ISIS-APOARx, ISIS-DGAT2Rx and ISIS-FVIIRx.

15 Dec 2011

Ganitumab shows promise in early-phase trials for metastatic pancreatic cancer

Over 17,000 patients will have been diagnosed with locally-advanced pancreatic cancer in the United States in 2011. Surgery is not a treatment option for these patients whose tumor has grown beyond the pancreas to surrounding vital structures.

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

Positive data from Nektar's NKTR-181 Phase 1 clinical study for chronic pain

Nektar Therapeutics today announced positive data from a Phase 1 clinical study of NKTR-181 evaluating multiple ascending oral doses of NKTR-181 over an 8-day treatment period in healthy subjects.

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

Maraviroc reduces incidence of GvHD in blood cancer patients after ASCT

An HIV drug that redirects immune cell traffic appears to significantly reduce the dangerous complication graft-versus-host disease (GvHD) in blood cancer patients following allogeneic stem cell transplantation (ASCT), according to new research from the Perelman School of Medicine at the University of Pennsylvania that will be presented today at the 53rd American Society of Hematology Annual Meeting.

14 Dec 2011

CTI, Chroma announce final results from tosedostat phase II study on AML

Cell Therapeutics, Inc. and Chroma Therapeutics Ltd. announced that final results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) were presented by Jorge Cortes, M.D. of the University of Texas M.D. Anderson Cancer Center during the Acute Myeloid Leukemia - Therapy, excluding Transplantation: Clinical Studies session at the American Society of Hematology Annual Meeting.

14 Dec 2011