FDA questions effectiveness of Parkinson’s drug

As reported by Reuters, the Food and Drug Administration (FDA) is questioning the effectiveness of Teva Pharmaceutical Industries drug Azilect.

Azilect already has approval by the FDA to treat symptoms of the neurological disorder (such as shaking, stiffness, impaired balance). However, Teva are now seeking an extension of Azilect’s label. However, it is being scrutinized by the FDA as they question it’s effectiveness in slowing down the progression of the disease.

Scepticism regarding the drug stems from results from Teva’s latest trial – the disease appeared to deteriorate more slowly in patients who started taking the drug early in the progression of the disease, rather than later. However, whilst the 1mg dose slowed progression, the 2mg dose did not. This has brought questions about the trial results.

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Roche strengthens infectious drugs pipeline

As reported by InPharm, pharmaceutical giant, Roche, has acquired Anadys, a company that specialises in the development of hepatitis C treatments for $230 million.

The acquisition highlights a strategic move by Roche to strengthen it’s infectious drugs pipeline and move outside it’s oncology franchise. Speaking of the acquisition, Jean-Jacques Garaud, Roche’s global head of their research and early development department stated, “This acquisition augments our already strong HCV portfolio.

“Our aim is to offer physicians and hepatitis patients a powerful combination of therapies that bring us closer to a cure, even without the use of interferon.

Anadys’ most advanced infectious drug setrobuvir is currently in Phase II studies with Roche’s inferferon drugs Pegasys and Copegus.

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Amgen’s Bone Drug is Granted Two New Approvals

As reported by Pharma Times, Amgen’s new bone drug, Prolia has received two new indications by the US Food and Drug Administration:

  1. Prolia can how be used to help increase bone mass in women who are at high risk or fracture
  2. The drug has now been approved to increase bone mass in men at high risk of fracture who are receiving ADT for non-metastic prostate cancer.

The drug first received approval in the US in 2010  for the treatment of osteoporosis in post-menopausal women who are at high risk of fractures.

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Innovative New Prostate Cancer Drug Developed

As reported by the BBC, a new treatment for the advanced and aggressive form of prostate cancer has been developed by Scientists at Queen’s University.

The drug will now be tested in a second phase, combines chemotherapy treatments with two doses of a radioactive chemical.

Speaking of the new treatment, Consultant and Senior Lecturer in Clinical Oncology, Dr O’Sullivan stated,

“This is a significant development in the fight against prostate cancer. While this combination treatment still has to go to phase two of trials, to know that this combination is safe and feasible as a treatment is a huge step forward.”

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Senior Clinical Scientist Job in Cambridgeshire

Jim Gleeson at CK Clinical is recruiting for a permanent Senior Clinical Scientist to join a leading pharmaceutical development organisation based in Cambridgeshire, UK.

The role:

As Senior Clinical Development Scientist, you will be joining the development team for a highly promising respiratory product which is currently undergoing clinical trials. You will also work closely with other functions in the business by supporting all areas of clinical development, from design through to data review.

Responsibilities:

  • Preparation of Clinical Development Plans, protocols and Clinical Study Reports
  • Maintenance of the Clinical Development Plan, with particular regard to health outcomes, epidemiology and pharmacogenetics requirements
  • Data review during the trial to ensure the highest ICH – GCP quality standards in conjunction with the project statistician, clinical operations and data management
  • In-study blinded safety review of adverse events and laboratory data
  • Being up to date with clinical and scientific developments in respiratory disease
  • Sourcing and management of third party vendors such as CROs and assay laboratories

 

The ideal candidate:

To be considered for this Senior Clinical Development Scientist position, you will have the following qualifications, skills and experience:

  • Life Science degree, preferably MSc or PhD
  • Extensive experience gained within respiratory clinical research
  • Experience of protocol design and Case Report Form maintenance
  • Very strong scientific background

 

How to apply:

For more information or to apply for this Senior Clinical Development Scientist position, please contact Jim Gleeson on 01438 870027 or email jgleeson@ckclinical.co.uk.  Please quote reference CL22795 in all correspondence.

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Biomarkers to See Huge Growth by 2017

Clinical development is the largest growing section of the global biomarkers market, which is expected to reach $34 billion by 2017, reports pharmatimes.com.

Annual growth of over a quarter leading up to 2017 is expected in biomarker applications in clinical drug development, though the high costs of the trials hampers the overall market growth, which means smaller businesses aren’t involving themselves in the sector. Despite this, the biomarker applications sector is growing quickly, particularly as 90% of drugs fail in clinical trials.

Biomarkers allow detection of reasons drugs may fail, such as toxicity, in early stage trials which allows for significant savings in the long term. Oncology and cardiology are expected to be the two areas in which biomarkers are most extensively used as drugs fail in clinical trials more often for these therapy types. They can also be used to assess patient’s susceptibility to illness, such as the risk of a stable patient suffering coronary issues, for example a stroke.

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GSK Breast Cancer Trial Scaled Back

Inpharm.com has reported that GlaxoSmithKline is to scale back a phase III clinical trial looking into potential breast cancer treatments.

The trial, which has been running since 2007, is evaluating the effectiveness of the breast cancer drug Tyverb in four different combinations, following surgery. The patients in the trial receive either Tyverb, Roche’s established drug Herceptin, Herceptin followed by Tyverb or both drugs.

An interim report has indicated that the patients only receiving Tyverb are not demonstrating any improvement compared to Herceptin, so that arm of the trial has been discontinued. Those who are halting their treatment are to discuss other options with trial physicians. 8,400 patients are taking part in the study, and the remaining three trials are to continue as normal.

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Director of Health Outcomes Job in London

Jonathan Hart-Smith at CK Clinical is looking for a Director of Health Outcomes to join his client based in London.

The job:

As Director of Health Outcomes you will play a pivotal role in guiding the organisation, providing a strategic insight and understanding of theirs client’s and stakeholders needs.

As Director of Health Outcomes you will also be responsible for developing important relationships with instrument authors and key opinion leaders and make recommendations on instrument selection and validation. You will support the Sales and Operations streams and participate in bed defences.

In addition, you will represent the company at scientific conferences, webinars and be recognized as an authority in the industry.

 

The ideal candidate:

To be considered for this Director of Health Outcomes position, you will possess comprehensive knowledge of the regulatory requirements in the EU and US for patient reported outcomes. In addition, this role demands candidates with a broad and diverse understanding of many different therapeutic areas.

How to apply:

For more information or to apply for this Health Outcomes Director role, please contact Jonathan on 01438 743 047 or email jhartsmith@ckclinical.co.uk.

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CK Clinical Launch ClinicalJobs app for iPhone!

CK Clinical is proud to announce that our ClinicalJobs app for iPhone is now available to download from iTunes!

CK Clinical is always looking for new and innovative ways to make the job hunting experience as easy and as enjoyable as possible for our candidates. We would therefore like to introduce to our new free ClinicalJobs iPhone app.

The ClinicalJobs app for iPhone will help take the hassle out of searching for your next job in science.  By simply downloading the app you can search, shortlist and apply for the latest science jobs directly from your mobile – anytime, anywhere.

Features of the ClinicalJobs app include:

  • Search and apply for jobs 24/7
  • Real time updates of jobs.
  • Find jobs across different disciplines including: Clinical/Clinical QA, Clinical R&D, Clinical Operations, Nurses, Data management, SAS, Biostatistics, Regulatory Affairs, Pharmacovigilance, Drug Safety, Medical Information, Medical Affairs, Health Outcomes, Pharmaceutical Medics, Medical Writing
  • Search for jobs near you.
  • Add selected jobs to your shortlist and apply at a time that suits you.
  • Access the latest industry news and careers advice
  • Contact CK Clinical instantly.

 

Click here to download  directly from iTunes now.

For more information, please contact Catherine Gutsell at CK Clinical or email cgutsell@ckclinical.co.uk.

Screen Shots of the Clinical Jobs app for iPhone

Compatible with iPhone, iPod touch and iPad. Requires iOS 3.1 or later

Apple, iPad, iPhone, iPhone touch, and iTunes are trademarks of Apple Inc

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Candidate of the Week: Principal Data Manager

Priya Mukherjee presents CK Clinical’s Candidate of the Week – a Principal Data Manager looking for a new position in the South East of England.

This excellent candidate specialises in Clinical Data Management, with 12 years experience of working within Pharmaceutical, CRO’s and Not for Profit Organisations.

This candidate has proven leadership skills and has mentored, lead and supported a team of staff.

For more information, please contact Priya Mukherjee at CK Clinical on 01438 743 047 or email pmukherjee@ckclinical.co.uk.

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