Medical Tidbits, J&J Hosts Eating Disorder Leadership Summit

clinical trials for cancer

On January 15, 2016, Johnson & Johnson and Janssen Neuroscience hosted the first-ever leadership summit on eating disorders, a meeting of diverse leaders from the U.S. eating disorder community with the goal of finding ways to unite forces in order to better serve patients and their families.

Eating disorders have the highest mortality of any mental illness, according to the National Association of Anorexia Nervosa and Associated Disorders, due to the strain on the body, the frequent comorbidity with mood disorders, and a high suicide rate. The prevalence of eating disorders has grown in recent years across all social classes and countries, says the NIH. They are more common than Alzheimers’ and autism, more deadly than drunk driving, and more costly than depression and anxiety. Like other mental illnesses, they have an impact beyond the patient to the whole family and to the communities in which they live and the organizations in which they work.

However, stigma and low public awareness around this group of diseases remains a problem, research is poorly funded, and insurance coverage and treatment options are inadequate.

A key factor behind the lack of progress is that the eating disorder community is fragmented and does not speak with a single, commanding voice, nor does it have an agreed-upon common strategy. read more

Novo Nordisk increased operating profit by 43% in 2015 to DKK 49.4 billion

Sales increased by 22% in Danish kroner and by 8% in local currencies to 107.9 billion.

Sales of modern and new-generation insulin increased by 22% (9% in local currencies).

Sales of Victoza® increased by 34% (18% in local currencies).

Sales in North America increased by 32% (11% in local currencies).

Sales in International Operations increased by 19% (15% in local currencies).

Sales in Region China increased by 22% (4% in local currencies).

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TAGRISSO (osimertinib) approved in EU as first-in-class treatment for PATIENTS WITH EGFR T790M mutation-positive metastatic non-small cell lung cancer

AstraZeneca today announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

Osimertinib is indicated for patients with T790M mutation-positive NSCLC, irrespective of previous treatment with an EGFR tyrosine kinase inhibitor (TKI). Eligibility for treatment with osimertinib will be dependent on mutation status, to be determined through a validated diagnostic test based on a tumour tissue sample or plasma. Availability of a blood-based test for circulating tumour DNA (ctDNA) means that physicians and patients have multiple options to test for a T790M mutation. read more

First Patient Treated With LC Bead LUMI™ Radiopaque Embolic Bead Supported by Philips Live Image Guidance

BTG plc (LSE: BTG), a global specialist healthcare company, and Royal Philips (NYSE: PHG; AEX: PHIA), announced today a significant milestone in their collaboration with the treatment of the first liver cancer patient with LC Bead LUMI™ in conjunction with Philips Live Image Guidance, targeting a hypervascular tumor with the goal to block blood flow to achieve tumor necrosis. Liver cancer is the second leading cause of cancer deaths in the world[1], and one of the most challenging to treat. Each year, more than 700,000 patients worldwide are diagnosed with liver cancer.[2] Interventional embolization is an option for some patients with tumors that cannot be removed by surgery.

Woodford Patient Capital Trust joins existing syndicate supporting transition to clinical development

MISSION Therapeutics, a drug discovery and development company focused on selectively targeting deubiquitylating enzymes to treat cancer, neurodegenerative and other diseases, today announced it has raised £60 million. The financing was jointly led by Imperial Innovations Businesses LLP (“Innovations”) and new investor Woodford Patient Capital Trust Plc (“WPCT”), with follow-on investment from existing shareholders Sofinnova Partners, SR One, Roche Venture Fund and Pfizer Venture Investments.

The £60 million will enable MISSION to maximize the potential of its world leading DUB platform and advance a series of first-in-class small molecule drugs candidates targeting specific DUBs into clinical development.

Moderate Improvements in Blood Glucose Levels Could Deliver Significant Benefits for People With Diabetes in the UK and the NHS  

– Almost a million serious medical complications could be avoided, potentially avoiding billions in future NHS costs(1)

Sanofi, Diabetes UK and JDRF today announce the publication of IMPACT 2 in the journal Diabetic Medicine. This new study shows that, if sustained, even modest improvement in blood glucose(*) levels can provide significantly improved outcomes for the 3.5 million(2) people diagnosed with diabetes in the UK. As a result, if applied to the whole diabetes population, almost a million serious medical complications, such as blindness, amputation and kidney failure could be avoided over 25 years, improving the lives of people with diabetes.(1) Better management of blood glucose levels over the same period could equate to a cost avoidance of £5.5 billion for the NHS.(1

FDA centers and researchers gain access to QIAGEN’s enhanced solutions for applications including microbial and microbiome analysis

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced new partnerships to enhance the profile and expand the use of its market leading bioinformatics solutions for microbiome, metagenomics and other applications.

QIAGEN Bioinformatics signed an agreement with genomics big data company CosmosID, Inc. to allow users of QIAGEN’s CLC Genomics Workbench to access and integrate CosmosID’s metagenomics analysis platform into their QIAGEN bioinformatics platform. CosmosID’s platform allows users to identify and characterize microbial communities from whole genome shotgun data and to determine their relative abundance. The new plug-in expands the range of metagenomic and microbiome applications supported by QIAGEN’s microbial genomics solution enabling researchers in fields such as infectious disease, animal health, agriculture, environmental and food safety to use shotgun metagenomics analysis for routine testing employing next-generation sequencing.

 Bristol-Myers Squibb and Pfizer Sign Collaboration with Portola Pharmaceuticals to Develop and Commercialize Investigational Andexanet Alfa in Japan

PRINCETON, N.J. & NEW YORK–(BUSINESS WIRE (link is external))–Bristol-Myers Squibb Company (link is external) (NYSE:BMY) and Pfizer Inc. (NSYE:PFE) today announced that the companies have entered into a collaboration agreement with Portola Pharmaceuticals Inc. (Nasdaq: PTLA) to develop and commercialize the investigational agent andexanet alfa in Japan. Andexanet alfa, which is in Phase 3 clinical development in the U.S. and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, includingEliquis (apixaban). read more

LCT Receives Ethics Approval for Phase IIb Parkinson’s Trial

SYDNEY & AUCKLAND, New Zealand–(BUSINESS WIRE)–Living Cell Technologies (ASX: LCT) (OTCQX: LVCLY) has received approval from the Northern A Health and Disability Ethics Committee for the Phase IIb clinical trial of NTCELL® for Parkinson’s disease. The New Zealand Minister of Health authorised the application to conduct the trial on 12 November 2015.

The Phase IIb trial follows the successful Phase I/IIa trial, which showed excellent safety data and clinically and statistically significant efficacy data in patients with Parkinson’s disease one year after NTCELL treatment.

The Phase IIb trial aims to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson’s disease patient sub group. The company plans to initiate the trial on 24 February 2016.

If the trial is successful the company will apply for provisional consent and launch NTCELL as the first disease modifying treatment for Parkinson’s disease in 2017.

For further information:

 Imagined ugliness, or body dysmorphic disorder (BDD) as it is known, can be treated with internet-based CBT, according to a recent randomised study, the first of its kind ever conducted. The new treatment, which is published in the   British Medical Journal (BMJ) has been developed by researchers at Sweden’s Karolinska Institutet and has the potential to increase access to care for sufferers of BDD.

People suffering from BDD have a preoccupation with perceived flaws in one’s physical appearance, despite looking normal. However, even though the diagnosis is associated with an elevated risk of suicide, higher rate of sick leave and considerable distress, BDD has long been neglected by the care services, leaving sufferers struggling to find the help they need.

In order to increase access to therapy, a new type of internet-based cognitive behavioural therapy (CBT) has been developed and tested in the largest treatment study to date. After twelve weeks’ of treatment, one in every three patients no longer met criteria for a diagnosis of BDD. read more

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