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Potentially preventable deficiencies account for significant delays in approval of new drugs by FDA

Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable outcome measures for a study, accounted for significant delays in the approval of new drugs by the Food and Drug Administration (FDA), according to a study in the January 22/29 issue of JAMA.

22 Jan 2014

Kolltan Pharmaceuticals announces treatment of first cancer patient with KTN3379

Kolltan Pharmaceuticals, a privately held biopharmaceutical company, today announced treatment of the first cancer patient with Kolltan's lead drug candidate, KTN3379, as part of a Phase 1 clinical study evaluating safety, preliminary evidence of antitumor activity, and pharmacokinetics. KTN3379 is a human monoclonal antibody that blocks the activity of ErbB3, a member of the ErbB family of receptor tyrosine kinases.

21 Jan 2014

Population Council gets USAID cooperative agreement to develop non-ARV microbicides that block HIV, STI

The Population Council today announced it was awarded a cooperative agreement from the US Agency for International Development's (USAID) Office of HIV and AIDS: "Non-ARV Based Combination Microbicide that Blocks HIV and Other STIs."

6 Jan 2014

Astellas, ClearPath announce strategic partnership to develop vaccine for infectious diseases

Astellas Pharma Inc. (Astellas) and ClearPath Development Company (ClearPath) announced today a strategic partnership to form a portfolio of development companies focused on vaccines targeting infectious diseases.

6 Jan 2014

New tools for neglected diseases: an interview with Dr. BT Slingsby, CEO, GHIT Fund

Nearly 3.3 billion people, a little less than half of our world’s population, are at risk of malaria, TB and what we call “neglected tropical diseases”—diseases caused by worms, parasites, viruses and bacteria like Chagas disease, river blindness, elephantiasis, sleeping sickness, etc.

24 Dec 2013

Sorrento Therapeutics acquires Concortis Biosystems

Sorrento Therapeutics, Inc. announced today that it has completed its acquisition of Concortis Biosystems, Corp., providing Sorrento with a comprehensive technology platform to create a new generation of homogenous antibody drug conjugates with site-specific toxin conjugation and consistent drug-antibody ratios. With the close of the deal, Sorrento has issued an aggregate of 1,331,978 shares of its common stock to the Concortis shareholders. Based on the closing share price on December 18, 2013, the transaction is valued at $11.3 million.

19 Dec 2013

New projects advance treatments for radiation syndrome, cardiac arrest-induced brain injury and rare blood disorder

The National Institutes of Health today has launched three pre-clinical projects to advance potential new treatments for acute radiation syndrome, brain injury following cardiac arrest and a rare blood disorder called beta thalassemia.

17 Dec 2013

Circulating nucleosomes and colorectal cancer diagnostics: an interview with Dr. Stefan Holdenrieder, University Hospital Bonn

For my MD thesis I modified and evaluated an immunological assay that detected the cell death products “nucleosomes” as a new blood-based cancer biomarker. As cell death processes are enhanced or suppressed during different stages of tumor development, it was assumed that they may enable stage-dependent detection of cancer disease.

12 Dec 2013

CRAB CTC enrolls first patient into inaugural cancer clinical trial

Cancer Research And Biostatistics today announced enrollment of the first patient into the inaugural clinical trial sponsored by its Clinical Trials Consortium. The CRAB CTC mission is to ensure rapid clinical testing of new and innovative cancer treatments, and is focusing on lung cancer as its first target. By engaging frontline treating oncologists to push the boundaries of patient care, the aim is to improve the standard of care and extend overall survival.

9 Dec 2013

EMD Serono's TocopheRx to focus on development of oral FSH agonists for infertility treatment

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today the creation of TocopheRx, a Boston-based spin-off company resulting from the Entrepreneur Partnership Program launched by Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, in April 2012.

3 Dec 2013

Researchers identify protein in malaria that is inhibited by newly discovered anti-malarial compounds

Researchers have identified the protein in malaria-causing Plasmodium parasites that is inhibited by a newly discovered class of anti-malarial compounds known as imidazopyrazines.

28 Nov 2013

Bioxodes completes seed funding round to bring Ir-CPI product into pre-clinical development

Bioxodes SA, a company developing products derived from natural sources, has completed a EUR 2.6 million (USD 3.5 million) first seed funding round with a consortium of business angels and Belgian investment funds. EUR 1.6 million is from the European Regional Development Fund and the Walloon Region in Belgium via the Retech program for Research and Technology. It will be used to bring the company’s lead product Ir-CPI into pre-clinical development over the next 18 months.

27 Nov 2013

Study suggests novel approach for treatment of advanced metastatic prostate cancers

New study suggests that selective blockade of CRM1-dependent nuclear export represents a completely novel, tumour metastasis-selective approach for the treatment of advanced metastatic prostate cancers.

16 Nov 2013

Clinical testing expanded for vaccine against latent TB

Statens Serum Institut and Aeras today announced the initiation of a Phase I/IIa clinical trial for a candidate tuberculosis vaccine designed to protect people, especially those latently infected with TB, from developing active TB disease.

8 Nov 2013

ImmunoGen starts clinical testing with its EGFR-targeting ADC, IMGN289 for several types of cancers

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops novel anticancer therapeutics using its ADC technology, today announced the start of clinical testing with its EGFR-targeting ADC, IMGN289.

6 Nov 2013

ImmunoGen decides to stop IMGN901 Phase II SCLC study

ImmunoGen, Inc., a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate technology, announced today the decision to stop the IMGN901 Phase II SCLC study, following the recommendation of the trial's independent Data Monitoring Committee.

6 Nov 2013

Research roundup: States struggling with Medicaid expansion "complex issues"

We conducted a secondary analysis of data (2005 to 2010) from the Medical Expenditure Panel Survey. ... Comparisons were made between 2 groups to reflect likely movements in insurance status after the Patient Protection and Affordable Care Act implementation: (1) the uninsured who will be Medicaid eligible afterward versus Medicaid insured, and (2) the uninsured who will be Medicaid ineligible afterward versus the privately insured. ...

4 Nov 2013

New therapeutic approach for treating type 2 diabetes

Scientists from the Helmholtz Zentrum München (HMGU) and the Technische Universität München (TUM), together with scientists in the USA, have developed a new therapeutic approach for treatment of type 2 diabetes.

31 Oct 2013

Scientists develop new therapeutic approach for treatment of type 2 diabetes

Scientists from the Helmholtz Zentrum Muenchen and the Technische Universitaet Muenchen, together with scientists in the USA, have developed a new therapeutic approach for treatment of Type 2 diabetes. A novel single molecule hormone, which acts equally on the receptors of the insulin-stimulating hormones GLP-1 and GIP, was observed to reduce weight and improve blood sugar.