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Medgenics’ EPODURE receives FDA clearance to proceed into clinical trials

Medgenics, Inc., developer of the novel Biopump technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the U.S. Food and Drug Administration to proceed with a Phase IIb clinical trial of EPODURE for the treatment of anemia in patients undergoing renal dialysis.

18 May 2012

Spectrum initiates ZEVALIN and MGd Phase 2 combination study in NHL

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the initiation of a Phase 2 study evaluating ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use + rituximab in combination with motexafin gadolinium (MGd) in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin's lymphoma.

18 May 2012

Kudzu root components may treat alcoholism and curb binge drinking

An extract of the Chinese herb kudzu dramatically reduces drinking and may be useful in the treatment of alcoholism and curbing binge drinking, according to a new study by McLean Hospital and Harvard Medical School researchers.

18 May 2012

Pfizer outlines vision for Systems-based Pharmaceutics

Leading pharmaceuticals company Pfizer outlined its vision for Systems-based Pharmaceutics, a revolutionary model-based approach linking drug process and product engineering to product quality and performance in the human body, at the recent Advanced Process Modelling Forum in London.

17 May 2012

Hitting the target: IntelliCap provides reliable and accurate regional drug delivery

Medimetrics, recently certified to ISO 13485, has successfully developed the IntelliCap system, specifically designed to target delivery of small molecule drugs and biologics to the gastrointestinal (GI) tract. The technology is capable of achieving controlled release of drugs to specific GI sites in a fast, cost-effective and convenient manner (Shimizu et al., 2008).

16 May 2012

Better understanding of new T-size descriptors on adjuvant chemotherapy effect needed

The most recent research released in June's Journal of Thoracic Oncology indicates there might be a positive correlation between tumor size and adjuvant platinum based chemotherapy in surgically resected patients with node negative non-small cell lung cancer.

16 May 2012

First patient included in the phase II study of Amphinex® in head and neck cancer patients

PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that the first patient has been included in the phase II study of Amphinex in combination with the cytotoxic agent bleomycin in head and neck cancer patients, called the ENHANCE study. The first patient was included at the National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany. NCT is a joint project of the German Cancer Research Center (DKFZ), Heidelberg University Hospital, Thoraxklinik Heidelberg and Deutsche Krebshilfe (German Cancer Aid).

16 May 2012

Micronutrients, early food supplementation during pregnancy improve survival of newborns

Pregnant women in poor communities in Bangladesh who received multiple micronutrients, including iron and folic acid combined with early food supplementation, had substantially improved survival of their newborns, compared to women in a standard program that included usual food supplementation, according to a study in the May 16 issue of JAMA, a theme issue on Global Health.

16 May 2012

Newspapers examine concerns surrounding possible FDA approval of Truvada for PrEP

The New York Times and the Financial Times examine concerns expressed by AIDS activists and members of an FDA panel that last week recommended Gilead Sciences' antiretroviral drug Truvada be approved for pre-exposure prophylaxis (PrEP) to prevent HIV among healthy people at risk of contracting the virus.

16 May 2012

Achaogen’s plazomicin and levofloxacin safe and effective in treating cUTI, acute pyelonephritis

Achaogen, Inc. announced today that all objectives were met in the company's multi-national Phase 2 study of plazomicin compared to levofloxacin for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis in adults.

16 May 2012

Partnership for Patients initiative participants launch sprint program to prevent pressure ulcers

Hospitals participating in the Partnership for Patients initiative have launched a program to prevent pressure ulcers.

16 May 2012

Pfizer fails to meet primary endpoint in TORISEL Phase 3 study for advanced RCC

Pfizer Inc announced that the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL(temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after SUTENT (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib.

16 May 2012

Two specific gene variants speed progression of Parkinson's disease

UCLA researchers may have found a key to determining which Parkinson's disease patients will experience a more rapid decline in motor function, sparking hopes for the development of new therapies and helping identify those who could benefit most from early intervention.

16 May 2012

Galectin Therapeutics commences Phase 1/2 trial of new treatment combination for advanced MM

Galectin Therapeutics, the leader in developing carbohydrate-based therapeutic compounds to inhibit galectin proteins for the therapy of liver fibrosis and cancer, today announced that the first patient has been dosed in a Phase 1/2 trial evaluating the safety and efficacy of a novel treatment combination for the treatment of advanced metastatic melanoma.

16 May 2012

AxioMed’s Freedom Cervical Disc receives CE Mark approval

AxioMed Spine Corporation announces the receipt of CE Mark approval for its Freedom Cervical Disc, an elastomeric total spinal disc replacement device.

16 May 2012

Juventas begins enrollment in JVS-100 Phase IIa study for Rutherford Class 4 or 5 CLI

Juventas Therapeutics, a privately-held, clinical-stage company developing novel regenerative therapies for treatment of cardiovascular disease, is pleased to report that it is actively enrolling patients in a placebo-controlled, randomized double-blinded Phase IIa study evaluating the safety and efficacy for JVS-100 in patients with Rutherford Class 4 or 5 critical limb ischemia.

16 May 2012

InVivo Therapeutics reports net income of $3,150,000 for first quarter 2012

InVivo Therapeutics Holdings Corp., a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today reported the financial results for the three months ended March 31, 2012 and provided a business update.

15 May 2012

Sinovac first quarter sales increase 30.3% to $6.0M

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today its unaudited first quarter financial results for the period ended March 31, 2012.

15 May 2012

CHDI, KineMed partner to investigate turnover rates of huntingtin protein

KineMed, Inc. and CHDI Foundation, Inc. announced today a collaboration to use KineMed's isotopic labeling and dynamic proteomics platform to investigate the turnover rates of huntingtin protein, a mutant form of which plays a central role in the pathogenesis of Huntington's disease (HD).

15 May 2012

SANUWAVE first quarter revenues decrease 5% to $238,540

SANUWAVE Health, Inc. today reported financial results for the three months ended March 31, 2012 and provided a business update.

15 May 2012

Efficacy News and Research

Medgenics’ EPODURE receives FDA clearance to proceed into clinical trials

Spectrum initiates ZEVALIN and MGd Phase 2 combination study in NHL

Kudzu root components may treat alcoholism and curb binge drinking

Pfizer outlines vision for Systems-based Pharmaceutics

Hitting the target: IntelliCap provides reliable and accurate regional drug delivery

Better understanding of new T-size descriptors on adjuvant chemotherapy effect needed

First patient included in the phase II study of Amphinex® in head and neck cancer patients

Micronutrients, early food supplementation during pregnancy improve survival of newborns

Newspapers examine concerns surrounding possible FDA approval of Truvada for PrEP

Achaogen’s plazomicin and levofloxacin safe and effective in treating cUTI, acute pyelonephritis

Partnership for Patients initiative participants launch sprint program to prevent pressure ulcers

Pfizer fails to meet primary endpoint in TORISEL Phase 3 study for advanced RCC

Two specific gene variants speed progression of Parkinson's disease

Galectin Therapeutics commences Phase 1/2 trial of new treatment combination for advanced MM

AxioMed’s Freedom Cervical Disc receives CE Mark approval

Juventas begins enrollment in JVS-100 Phase IIa study for Rutherford Class 4 or 5 CLI

InVivo Therapeutics reports net income of $3,150,000 for first quarter 2012

Sinovac first quarter sales increase 30.3% to $6.0M

CHDI, KineMed partner to investigate turnover rates of huntingtin protein

SANUWAVE first quarter revenues decrease 5% to $238,540

Industry Focus eBook - Neurology/Neuroscience - 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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