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Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

Aeterna Zentaris Inc. today announced that it has reached an agreement with the U.S. Food and Drug Administration ("FDA") on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission.

29 Dec 2012

Juxtapid receives FDA approval for treatment of rare cholesterol disorder

On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments.

27 Dec 2012

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

BCPR, Orexigen partner to accelerate patient enrollment for Contrave obesity Light Study

Blue Chip Patient Recruitment, a division of Blue Chip Marketing Worldwide, a full-service integrated marketing agency, has successfully partnered with Orexigen Therapeutics to accelerate patient enrollment of The Light Study, Orexigen's cardiovascular outcomes trial evaluating Contrave (naltrexone sustained release (SR)/bupropion SR).

21 Dec 2012

Halozyme grants Pfizer worldwide license to develop products combining Enhanze with biologics

Halozyme Therapeutics, Inc. announced today that it has entered into a worldwide Collaboration and License Agreement with Pfizer Inc. for the purpose of developing and commercializing products combining proprietary Pfizer biologics with Halozyme's Enhanze technology.

21 Dec 2012

Gene therapy shows promise for severe coronary artery disease

Diagnosed with severe coronary artery disease, a group of patients too ill for or not responding to other treatment options decided to take part in a clinical trial testing angiogenic gene therapy to help rebuild their damaged blood vessels.

21 Dec 2012

OncoMed commences dosing in OMP-52M51 Phase 1 clinical trial for hematologic cancers

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that patient dosing has begun in a Phase 1 clinical trial of OMP-52M51 in patients with hematologic cancers.

21 Dec 2012

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval for the use of ENTEREG® (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease.

21 Dec 2012

Pergamum’s DPK-060 Phase II trial on acute external otitis meets primary end-point

Pergamum AB announced today that the primary end-point was met in the randomized Phase II trial of DPK-060 for treatment of acute external otitis.

21 Dec 2012

UCLA study assesses prevalence of various types of study partners in Alzheimer's trials

For Alzheimer's disease researchers who conduct clinical trials, enrolling enough patients to make a trial meaningful is always a challenge. To enroll a single patient in a study requires not one but two participants - the patient and what's known as a study partner. Study partners provide the patient with support and update researchers about the patient's progress.

21 Dec 2012

Merck’s TREDAPTIVE clinical study on high-risk CVD patients does not meet primary endpoint

Merck, known outside the United States and Canada as MSD, today announced that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of TREDAPTIVE(extended-release niacin/laropiprant) did not meet its primary endpoint.

20 Dec 2012

Antibiotic amoxicillin ineffective for treating cough according to European trial

The antibiotic amoxicillin, that doctors typically prescribe for common lower respiratory tract infections (LRTI) such as cough and bronchitis, is no more effective at relieving symptoms than the use of no medication, even in older patients. The findings from the largest randomised placebo controlled trial of antibiotics for acute uncomplicated LRTI to date are published Online First in The Lancet Infectious Diseases.

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

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

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

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

e-Therapeutics’ ETS2101 cancer trials on track

e-Therapeutics plc today provides an update on the clinical trials of its cancer drug ETS2101. Two phase I studies, one in patients with primary or secondary brain cancer and the other in patients with various solid tumours, remain on track to report final data in Q4 2013 and Q1 2014, respectively. Interim data from the trials are expected in H1 2013.

18 Dec 2012

Drug Trial News

Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

Juxtapid receives FDA approval for treatment of rare cholesterol disorder

AMAG seeks FDA sNDA approval for Feraheme Injection

BCPR, Orexigen partner to accelerate patient enrollment for Contrave obesity Light Study

Halozyme grants Pfizer worldwide license to develop products combining Enhanze with biologics

Gene therapy shows promise for severe coronary artery disease

OncoMed commences dosing in OMP-52M51 Phase 1 clinical trial for hematologic cancers

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Pergamum’s DPK-060 Phase II trial on acute external otitis meets primary end-point

UCLA study assesses prevalence of various types of study partners in Alzheimer's trials

Merck’s TREDAPTIVE clinical study on high-risk CVD patients does not meet primary endpoint

Antibiotic amoxicillin ineffective for treating cough according to European trial

Lancet reports on global efforts to develop malaria vaccine

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

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

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

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

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

Pharmalink commences Nefecon Phase IIb study in primary IgA nephropathy

e-Therapeutics’ ETS2101 cancer trials on track

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Bioprocess Efficiency with Cell Density Monitoring

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