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Sorafenib does not improve overall survival among patients with NSCLC

Treatment with the drug sorafenib as a third or fourth line therapy does not result in improved overall survival among patients with advanced non-small cell lung cancer (NSCLC), according to findings released at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna. However, a post-hoc biomarker analysis of the trial data that was also presented suggests that patients with EGFR-mutant tumors may benefit.

29 Sep 2012

Drug combinations show promise against metastatic melanoma

Promising new data on drug combinations to treat metastatic melanoma are presented at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna.

29 Sep 2012

Synta announces results from ganetespib Phase 2b trial on NSCLC

Synta Pharmaceuticals Corp. today announced results from an interim analysis of the Phase 2b portion of the GALAXY trial, a global, randomized, multi-center Phase 2b/3 study designed to evaluate the efficacy and safety of the Company's lead Hsp90 inhibitor, ganetespib, as second-line treatment for advanced non-small cell lung cancer (NSCLC).

29 Sep 2012

New trial data shows improvements in treatment of esophageal and gastrointestinal cancers

New trial data showing improvements in the treatment of esophageal and gastrointestinal cancers were released today at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna.

29 Sep 2012

Cardiac Dimensions commences commercialization of CARILLON mitral contour system in Europe

Cardiac Dimensions, Inc. today announced that it has initiated its commercial efforts in Europe, treating the first patients with its CARILLON Mitral Contour System under its Conformite Europeenne (CE) Mark approval.

29 Sep 2012

MicroDose completes third and final MDT-637 Phase 1 study on RSV infection

MicroDose Therapeutx, Inc., announced today the completion of its third and final Phase 1 clinical study for MDT-637 with its novel inhaled antiviral fusion inhibitor, MDT-637, for the treatment of RSV infection.

29 Sep 2012

AVEO submits tivozanib NDA with FDA for treatment of advanced renal cell carcinoma

AVEO Oncology and Astellas Pharma Inc. today announced that AVEO has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC).

29 Sep 2012

U.S. Pharmacopeial announces winners of 2012-13 Global Fellowship awards

Since the program's inception more than thirty years ago, USP has invested nearly $4 million in over 200 fellowship awards.

28 Sep 2012

Researchers discover way to detect and eliminate troublemaking stem cells

Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells.

28 Sep 2012

Provectus amends and expands protocol for PV-10 Phase 1 hepatocellular carcinoma study

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced that it has amended and expanded the scope of the protocol PV-10-LC-01, "A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma not Amenable to Resection or Transplant."

28 Sep 2012

EC approves Janssen’s DACOGEN for treatment of de novo acute myeloid leukaemia

Janssen-Cilag International NV announced today that the European Commission has approved the marketing authorisation for DACOGEN(decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

28 Sep 2012

Conditionally reprogrammed cells help identify effective therapy for HPV-positive RRP

Using a newly discovered cell technology, Georgetown University Medical Center researchers were able to identify an effective therapy for a patient with a rare type of lung tumor. The single case study, reported in the September 27 issue of New England Journal of Medicine, provides a snapshot of the new technology's promising potential; however, researchers strongly caution that it could be years before validation studies are completed and regulatory approval received for its broader use.

28 Sep 2012

UNMCC to investigate R-ketorolac use against ovarian cancer cells

Most drugs take ten years-and frequently, more-to go from concept to FDA approval. One way to reduce this time investment is to look for already-approved drugs that could be put to new uses. And that's just what Angela Wandinger-Ness, PhD, UNM Professor of Pathology, and Laurie Hudson, PhD, UNM Professor of Pharmaceutical Sciences, have done.

28 Sep 2012

BioLineRx’s BL-1020 safe and effective in treating schizophrenia

BioLineRx, a biopharmaceutical development company, announced today the publication of results from the Phase II EAGLE clinical trial for BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, showing that BL-1020 is safe and effective in improving schizophrenia, in addition to improving cognitive impairment associated with this condition.

28 Sep 2012

Japanese MHLW approves Sosei’s Seebri inhalation capsules to treat COPD

Sosei Group Corporation confirms the information released today by Novartis that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Seebri (glycopyrronium bromide) Inhalation Capsules 50 mcg administered through the Breezhaler device, as a once-daily, long-term, inhaled maintenance bronchodilator treatment for the relief of various symptoms due to airway obstructive disease in chronic obstructive pulmonary disease.

28 Sep 2012

OncoGenex commences custirsen Phase 3 trial in non-small cell lung cancer

OncoGenex Pharmaceuticals, Inc. announced today the initiation of ENSPIRIT, a Phase 3 trial evaluating custirsen for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have progressed after initial chemotherapy treatment has failed.

28 Sep 2012

Report illustrates safety and efficacy of transoral robotic surgery for supraglottic laryngectomy

Robotic surgery though the mouth is a safe and effective way to remove tumors of the throat and voice box, according to a study by head and neck cancer surgeons at the Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

27 Sep 2012

Amakem commences AMA0076 Phase 2a study in glaucoma and ocular hypertension

Amakem NV, a kinase platform company focusing on ophthalmology, today announces that it has initiated a Phase 2a proof of concept study of its novel Rho Kinase (ROCK) inhibitor, AMA0076, in patients with glaucoma and ocular hypertension.

27 Sep 2012

Forest submits levomilnacipran NDA with FDA for treatment of major depressive disorder

Forest Laboratories, Inc. and Pierre Fabre Laboratories todayannounced that Forest has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for levomilnacipran, a serotonin norepinephrine reuptake inhibitor (SNRI) for the treatment of Major Depressive Disorder (MDD) in adults.

27 Sep 2012

Enrollment complete in Boehringer Ingelheim’s nintedanib phase III studies for IPF

Boehringer Ingelheim Pharmaceuticals, Inc. announced that clinical trial enrollment has completed for two phase III studies evaluating the safety and efficacy of nintedanib (BIBF 1120), an investigational compound, in patients with idiopathic pulmonary fibrosis (IPF), being studied at a twice-daily oral dose.

27 Sep 2012

Efficacy News and Research

Sorafenib does not improve overall survival among patients with NSCLC

Drug combinations show promise against metastatic melanoma

Synta announces results from ganetespib Phase 2b trial on NSCLC

New trial data shows improvements in treatment of esophageal and gastrointestinal cancers

Cardiac Dimensions commences commercialization of CARILLON mitral contour system in Europe

MicroDose completes third and final MDT-637 Phase 1 study on RSV infection

AVEO submits tivozanib NDA with FDA for treatment of advanced renal cell carcinoma

U.S. Pharmacopeial announces winners of 2012-13 Global Fellowship awards

Researchers discover way to detect and eliminate troublemaking stem cells

Provectus amends and expands protocol for PV-10 Phase 1 hepatocellular carcinoma study

EC approves Janssen’s DACOGEN for treatment of de novo acute myeloid leukaemia

Conditionally reprogrammed cells help identify effective therapy for HPV-positive RRP

UNMCC to investigate R-ketorolac use against ovarian cancer cells

BioLineRx’s BL-1020 safe and effective in treating schizophrenia

Japanese MHLW approves Sosei’s Seebri inhalation capsules to treat COPD

OncoGenex commences custirsen Phase 3 trial in non-small cell lung cancer

Report illustrates safety and efficacy of transoral robotic surgery for supraglottic laryngectomy

Amakem commences AMA0076 Phase 2a study in glaucoma and ocular hypertension

Forest submits levomilnacipran NDA with FDA for treatment of major depressive disorder

Enrollment complete in Boehringer Ingelheim’s nintedanib phase III studies for IPF

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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