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Psychotic depression: the reason for treatment failure with antidepressants

A new study shows that patients with depression who also have psychotic-like symptoms, feelings of being persecuted, or believing others are plotting against them or hearing voices are less likely to respond to antidepressants. The study also showed that bipolar disorder does not appear to be associated with treatment resistance in patients with depression as believed earlier.

7 Dec 2010

StemCells receives Swissmedic authorization to initiate HuCNS-SC Phase I/II clinical trial in spinal cord injury

StemCells, Inc. announced today that is has received authorization from Swissmedic, the Swiss regulatory agency for therapeutic products, to initiate a Phase I/II clinical trial in Switzerland of the Company's proprietary HuCNS-SC® product candidate (purified human neural stem cells) in chronic spinal cord injury. The trial is designed to assess both safety and preliminary efficacy in patients with varying degrees of paralysis who are three to 12 months post-injury, and will progressively enroll patients based upon the severity of injury.

7 Dec 2010

John Theurer Cancer Center presents research findings at ASH meeting

The John Theurer Cancer Center at Hackensack University Medical Center announced today important research findings presented at the annual meeting of the American Society of Hematology taking place December 4-7, 2010 in Orlando, Florida. The ASH meeting is the world's leading scientific gathering of hematologists and hematology researchers.

7 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

Micromet announces presentation of updated results from MT103 Phase 2 trial in MRD positive ALL patients

Micromet, Inc. today announced the presentation of updated results from a Phase 2 trial of the Company's lead product candidate blinatumomab (MT103) in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL). An analysis of long-term efficacy data demonstrated that blinatumomab produced prolonged remissions in patients with ALL. As of November 2010, the hematologic disease free survival (DFS) was 60%, with a follow-up of up to 27.5 months.

7 Dec 2010

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced interim results from a Phase I clinical trial of its investigational drug candidate, recombinant human Interleukin-7 (CYT107), in the treatment of post-transplant patients with T-cell depleted (TCD) bone marrow or peripheral blood stem cell transplants.

7 Dec 2010

Epratuzumab-rituximab combination therapy effective against previously untreated follicular lymphoma

Immunomedics, Inc., a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that combination therapy with epratuzumab and rituximab was effective, with durable complete responses in one-third of evaluable patients, and was very well tolerated by patients with previously untreated follicular lymphoma (FL).

7 Dec 2010

Clinicians should specify subtypes of depression and combine antidepressants and psychotherapy

It is unlikely that different types of depression can be combined to one single disease called Major Depression. When testing the efficacy of antidepressants or psychotherapy, clinicians should make an attempt to specify the subtypes of depression and to combine antidepressants and psychotherapy in a sequential approach.

7 Dec 2010

WHO to create an evidence base for traditional medicine

WHO will develop, for the first time, a classification of traditional medicine, paving the way for the objective evaluation of its benefits.

7 Dec 2010

Expansion of newborn screening throws some families on a journey of great uncertainty

Mandatory genetic screening of newborns for rare diseases is creating unexpected upheaval for families whose infants test positive for risk factors but show no immediate signs of the diseases, a new UCLA study warns.

7 Dec 2010

Medication and blood transfusion reduce risk of recurrent strokes in young patients with sickle cell anemia

St. Jude Children's Research Hospital investigators discuss results of research into managing iron overload associated with stroke prevention in young sickle cell patients and the search for genetic predictors of stroke risk.

7 Dec 2010

IMO-4200 dual agonist increases antitumor activity in lymphoma models: Study

Idera Pharmaceuticals, Inc. today presented data showing that IMO-4200, a dual agonist of Toll-like receptor (TLR) 7 and TLR8, in combination with approved cancer treatments, rituximab or bortezomib, significantly increased antitumor activity in several preclinical lymphoma models. The presentation, entitled "Antitumor Activity of an RNA-Based Agonist of TLR7 and 8 in Preclinical Models of Hematological Malignancies," was made at the 52nd Annual Meeting of the American Society for Hematology in Orlando, Florida by Idera scientists.

7 Dec 2010

Encouraging data from perifosine Phase 2 studies in advanced leukemia, Hodgkin's lymphoma

Aeterna Zentaris Inc. today announced Phase 2 data presented for the first time on perifosine, its lead novel oral anti-cancer compound, showing promising clinical activity, safety and tolerability in patients with advanced chronic lymphocytic leukemia (CLL) and Hodgkin's lymphoma (HL). The data were presented over the weekend at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.

7 Dec 2010

Clinical trial results of ACY-1215 in multiple myeloma published in scientific journal of ASH

Acetylon Pharmaceuticals today announced the publication of favorable results of preclinical safety and efficacy testing of its oral selective HDAC6 inhibitor drug candidate, ACY-1215, in multiple myeloma.

7 Dec 2010

NIH scientists consider prospects for universal influenza vaccine

The costly, time-consuming process of making, distributing and administering millions of seasonal flu vaccines would become obsolete if researchers could design a vaccine that confers decades-long protection from any flu virus strain. Making such a universal influenza vaccine is feasible but licensing it may require innovation on several fronts, including finding new ways to evaluate the efficacy of vaccine candidates in clinical trials, conclude scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

7 Dec 2010

Positive interim data from Phase I/II trial of CYT387 in myelofibrosis presented at ASH Annual Meeting

YM BioSciences Inc. today announced positive interim data from the first 60 patients enrolled in the Phase I/II trial for its JAK1/JAK2 inhibitor, CYT387, in myelofibrosis. The results were reported today in an oral presentation at the 52nd American Society of Hematology Annual Meeting being held in Orlando, Florida.

7 Dec 2010

Drug prescribed for Parkinson's disease may also treat restless leg syndrome: MCG researchers

A drug prescribed for Parkinson's disease may also treat restless leg syndrome without the adverse side effects of current therapies, Medical College of Georgia researchers say.

7 Dec 2010

New analysis of Soliris in patients with PNH presented at ASH Annual Meeting

Independent investigators reported today that patients with paroxysmal nocturnal hemoglobinuria who were treated long-term with Soliris (eculizumab) achieved survival comparable to that of an age- and gender-matched normal population. Findings from this investigator-led analysis were reported in an oral presentation today at the 52nd American Society of Hematology Annual Meeting and Exposition in Orlando.

7 Dec 2010

FDA accepts for review Bristol-Myers Squibb's ORENCIA sBLA for severe RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA® (abatacept), a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) administered through an injection into the skin. Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.

7 Dec 2010

VIVUS reports positive results from avanafil phase 3 study in erectile dysfunction

VIVUS, Inc. today announced positive results from TA-314, a phase 3 pivotal open-label safety study of avanafil, an investigational drug for the treatment of erectile dysfunction (ED). The study met all primary endpoints by demonstrating improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP2 and SEP3) and improvements in the International Index of Erectile Function (IIEF).

7 Dec 2010

Efficacy News and Research

Psychotic depression: the reason for treatment failure with antidepressants

StemCells receives Swissmedic authorization to initiate HuCNS-SC Phase I/II clinical trial in spinal cord injury

John Theurer Cancer Center presents research findings at ASH meeting

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Micromet announces presentation of updated results from MT103 Phase 2 trial in MRD positive ALL patients

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

Epratuzumab-rituximab combination therapy effective against previously untreated follicular lymphoma

Clinicians should specify subtypes of depression and combine antidepressants and psychotherapy

WHO to create an evidence base for traditional medicine

Expansion of newborn screening throws some families on a journey of great uncertainty

Medication and blood transfusion reduce risk of recurrent strokes in young patients with sickle cell anemia

IMO-4200 dual agonist increases antitumor activity in lymphoma models: Study

Encouraging data from perifosine Phase 2 studies in advanced leukemia, Hodgkin's lymphoma

Clinical trial results of ACY-1215 in multiple myeloma published in scientific journal of ASH

NIH scientists consider prospects for universal influenza vaccine

Positive interim data from Phase I/II trial of CYT387 in myelofibrosis presented at ASH Annual Meeting

Drug prescribed for Parkinson's disease may also treat restless leg syndrome: MCG researchers

New analysis of Soliris in patients with PNH presented at ASH Annual Meeting

FDA accepts for review Bristol-Myers Squibb's ORENCIA sBLA for severe RA

VIVUS reports positive results from avanafil phase 3 study in erectile dysfunction

Industry Focus eBook - Analytical Chemistry (2nd Edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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