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Biotest receives FDA approval for BIVIGAM to treat primary humoral immunodeficiency

Biotest AG announced today that Biotest Pharmaceuticals Corporation received approval for BIVIGAM for the treatment of patients with Primary Humoral Immunodeficiency (PI) from the U.S. Food and Drug Administration (FDA).

20 Dec 2012

French method successful for clubfoot

Researchers have demonstrated the efficacy of the “French” functional method for correcting congenital idiopathic clubfoot, with the majority of patients achieving a good result, often without surgery.

20 Dec 2012

CBT boosts response in medication-resistant depression

Patients with depression who have not responded to pharmacologic treatment should be offered cognitive behavioral therapy, suggest the results of a randomized trial conducted in a primary care setting.

20 Dec 2012

Lancet reports on global efforts to develop malaria vaccine

The Lancet reports on global efforts to develop a malaria vaccine, writing, "Since the mid-1980s, various malaria vaccine candidates have been tested in the hope of finding a molecule that can provide long-lasting immune protection against the disease that still kills 600,000 to 1.2 million people in sub-Saharan Africa each year. However, none has yet made it into routine use."

20 Dec 2012

Positive top-line results from Idera’s IMO-3100 Phase 2a trial on plaque psoriasis

Idera Pharmaceuticals today announced that 48% of patients with moderate-to-severe plaque psoriasis (12 of 25) treated with IMO-3100, a selective antagonist of Toll-like Receptors (TLRs) 7 and 9, demonstrated improvements in Psoriasis Area Severity Index (PASI) scores of 35% to 90% from baseline at the completion of a randomized, double-blind, placebo-controlled Phase 2a clinical trial of two dose levels of IMO-3100 administered for four weeks, with a four-week follow-up period.

20 Dec 2012

Top-line results from Medivir's simeprevir phase III trials on genotype 1 HCV infection

Medivir AB today announced top-line results from three pivotal phase III trials examining the one pill, once-daily, investigational protease inhibitor, simeprevir (TMC435), administered with pegylated interferon and ribavirin.

20 Dec 2012

AAV-based gene therapy cocktail may help extend lives of children with Canavan disease

Results of a clinical trial that began in 2001 show that a gene therapy cocktail conveyed into the brain by a molecular special delivery vehicle may help extend the lives of children with Canavan disease, a rare and fatal neurodegenerative disorder.

20 Dec 2012

Investigators assess efficacy of ORC vs. robotic-assisted laparoscopic radical cystectomy

About 30 percent of the more than 70,000 bladder cancer cases expected in 2012 are muscle invasive. In such cases, radical cystectomy is the preferred treatment. In a pilot trial, a team of investigators assessed the efficacy of open radical cystectomy (ORC) vs. robotic-assisted laparoscopic radical cystectomy (RARC).

20 Dec 2012

US FDA approves raxibacumab for treating inhalational anthrax

The US Food and Drug Administration have approved the monoclonal antibody raxibacumab for treatment of inhalational anthrax, caused by breathing in spores of Bacillus anthracis.

19 Dec 2012

Umbilical cord stem cell therapy shows promise in infant BPD

Researchers have successfully used human umbilical cord stem cells to partially prevent damage and restore lung structure and function in an experimental animal model of bronchopulmonary dysplasia.

19 Dec 2012

Tumor cells manipulate unfolded protein response

Researchers at the University of California, San Diego School of Medicine report that tumor cells use stress signals to subvert responding immune cells, exploiting them to actually boost conditions beneficial to cancer growth.

19 Dec 2012

Infectex initiates enrollment in SQ109 Phase IIb-III trial for MDR-TB

Infectex, a Russian biotech company in Maxwell Biotech Venture Fund's portfolio, announced today enrollment of the first patients in its Phase IIb-III clinical trial of SQ109 for MDR-TB. Infectex was founded in 2011 to develop and commercialize innovative products for the treatment of TB.

19 Dec 2012

Clopidogrel pretreatment for PCI does not reduce risk of overall mortality

Among patients scheduled for a percutaneous coronary intervention (PCI; procedures such as balloon angioplasty or stent placement used to open narrowed coronary arteries), pretreatment with the antiplatelet agent clopidogrel was not associated with a lower risk of overall mortality but was associated with a significantly lower risk of major coronary events, according to a review and meta-analysis of previous studies published in the December 19 issue of JAMA.

19 Dec 2012

EMD Serono's L-BLP25 Phase III NSCLC trial does not meet primary endpoint

EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that the Phase III STARTa trial of its investigational product L-BLP25 (formerly referred to as Stimuvax) in patients with unresectable, locally advanced stage IIIA or IIIB non-small cell lung cancer (NSCLC) did not meet its primary endpoint to demonstrate a statistically significant improvement in overall survival (OS).

19 Dec 2012

HAL Allergy completes enrollment in SUBLIVAC FIX Phleum pratense Phase II trial

HAL Allergy B.V. today announced that it has successfully completed patient enrollment in its Phase II trial with SUBLIVAC FIX Phleum pratense.

19 Dec 2012

New once-daily dual bronchodilator effective in COPD

A once-daily, inhaled, fixed-dose dual bronchodilator combination has greater efficacy than twice-daily salmeterol plus fluticasone for the treatment of chronic obstructive pulmonary disease, results of the phase III ILLUMINATE trial show.

18 Dec 2012

Pharmalink commences Nefecon Phase IIb study in primary IgA nephropathy

Pharmalink AB, a Swedish specialty pharma company, today announces it has initiated a Phase IIb study with Nefecon (Nefigan) in patients with primary IgA nephropathy at risk of developing end-stage renal disease.

18 Dec 2012

AHA/ASA identify top cardiovascular and stroke research advances for 2012

Resuscitation, cell regeneration, a new high blood pressure treatment and developments in devices for treating stroke are among the key scientific findings that make up this year's top cardiovascular and stroke research identified by the American Heart Association and American Stroke Association.

18 Dec 2012

IRMA, Population Council and MTN release Rectal Revolution video project

International Rectal Microbicide Advocates (IRMA), the Population Council, and the Microbicide Trials Network (MTN) today released a collaborative video project called "The Rectal Revolution Is Here: An Introduction to Rectal Microbicide Clinical Trials." The jointly produced video, the first of its kind, is designed to educate communities affected by HIV about rectal microbicide development and the importance of participating in clinical trials to help speed the search for new HIV prevention options.

18 Dec 2012

Maryland researchers launch groundbreaking study into spread of drug-resistant malaria in Burma

University of Maryland School of Medicine researchers have launched groundbreaking research into the spread of potentially deadly drug-resistant malaria in the developing Southeast Asian nation of Myanmar, also known as Burma.

17 Dec 2012