General

Nektar Given Good News on Cancer Drug

Tuesday, July 19th, 2011

Nektar has been given a positive review of its ovarian cancer drug, reports the Pharmaceutical Business Review.

The Committee for Orphan Medicinal Products, a branch of the European Medical Association, has responded positively in relation to Nektar’s attempt to have its ovarian cancer drug granted orphan medicinal product status, which can lead to extended exclusivity. A phase II study is currently recruiting patients with ovarian cancer, whilst the company are looking to begin a phase III study later this year.

Nektar Drug Development and Regulatory Affairs vice president Carlo DiFonzo has said that the news of the positive opinion is welcome following the recent designation of orphan drug status in the US in April.

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Bone Cancer Drug Granted Approval

Monday, July 18th, 2011

Amgen’s bone cancer drug Xgeva has been granted European approval, reports inpharm.com.

The drug, used to prevent serious bone problems in cancer patients, is expected to make $1 billion in oncology and can now be used to help with skeletal issues relating from tumours, such as bone metastases.

The drug was approved after phase III trials on 5,700 patients were positive. Bone metastases occur in 1.5 million cancer patients worldwide, and the “approval makes a real advance” according to professor Ingo J. Diel at the Institute for Gynaecological Oncology in Germany. The trials gave increased protection against skeletal problems and slowed the rate at which pain spread throughout the body of cancer patients.

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New Facebook Page!

Thursday, July 14th, 2011

CK Regulatory has recently launched a new Facebook page for people to stay up to date on all that’s happening in the world of Regulatory Affairs.

If you’re looking to start a career, or looking for someone to fill a role withing your company, then the CK team can help as we have access to some of the best Regulatory jobs in the industry, an enviable track record of providing high quality recruitment to pharmaceutical companies and we aim to make the job hunting process as easy and enjoyable as possible for both clients and candidates.

For regular updates, make sure to ‘like’ us here

New Cancer Drug Granted Patent

Wednesday, July 13th, 2011

Aeterna Zentaris, the Canadian based pharmaceutical company, has secured a European patent for a new cancer drug, reports the Pharmaceutical Business Review.

Perifosine has been granted a patent by the European Patent Office until 28th July 2023 for use in combination with anti-tumour medication as it helps to prepare medication targeting both benign and malignant tumours.

The patent protects Perifosine for use in various cancers, including gastric and breast, and is acquired at the point where Aeterna Zentaris “are looking forward to the completion of pivotal phase III trials,” says CEO Juergen Engel.

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Success for Novartis’ Regulatory Affairs

Thursday, July 7th, 2011

Novartis’ regulatory affairs staff have secured a new treatment for tuberous sclerosis complex in Europe, reports cslrecruitment.com.

The European Medicine Agency’s Committee for Medicinal Products for Human Use reached the decision following phase II trials showing patients who could not undergo surgery improved significantly. If approved, the treatment will be the first in the EU for this condition.

Herve Hoppenot, oncology president at Novartis, believes this “reflects the commitment Novartis has made to develop innovative therapies to help address unmet medical needs”.

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Strict Regulatory Affairs Means EU Could Lose Out to US

Wednesday, July 6th, 2011

Stricter regulatory affairs are making it harder for new pharmaceuticals to gain approval, cslrecruitment.com reports.

There has been a significant decline in the amount of new drugs being approved over the previous two decades. Many new products fail at the phase III clinical trials, with 55 products failing at this stage in 2010. Chris Stirling, head of pharmaceuticals at KPMG, believes this would not have been the case just fifteen years ago.

Whilst this shows an improvement in drug standards, it also worries pharmaceutical bosses, concerned about the amount of drugs they can successfully produce with the new, tighter guidelines.

Added to this the length of time it takes EU to ratify new drugs compared to the US, making it possible for the US to market and sell drugs sooner than EU businesses, there is significant disquiet amongst EU companies that they could lose out financially.

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The Growing Role of Regulatory Affairs

Tuesday, July 5th, 2011

The increased demand by medicine regulators on license holders has led to increased importance being placed on regulatory affairs, reports inpharm.com. Areas such as paediatric requirements and pharmacovigilance have grown over the last decade, and as the science behind medicine evolves, there needs to be people who can understand and manage what is happening.

Lynda Wright, executive director at The Organisation for Professionals in Regulatory Affairs (TOPRA), says that information has to be effectively processed and assimilated, meaning that “you have to be a confident scientist and say, yes, I can get my head around all that information.” Whereas previously regulatory affairs staff were drawn from pharmacy, an increase in biomedical degrees has led to many others becoming involved in RA.

TOPRA is attempting to increase the amount of students joining straight from university, as traditionally it has been necessary to have experience in the RA field. By working with universities and arranging internships, it hopes to help students looking to go into RA.

Lynda Wright also comments that, whilst RA is not free from cuts, those who are found out of work “are not for long” and mentions that those found redundant in other areas of the pharmaceutical industry could find work within regulatory affairs.

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Regulatory Affairs Salary Survey 2011

Monday, May 16th, 2011

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Candidate of the Week: Regulatory Consultant

Thursday, May 5th, 2011
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This candidate has been a Regulatory Consultant for over 10 years. He specialises in Product Life Cycle Management.

This excellent also has a particularly good knowledge of International and European registration procedures regarding clinical trials.

They have substantial experience in the following therapy areas:
- Neurology
- Oncology
- Cardiovascular

This candidate is looking for roles that will involve the development of strategy and is available at short notice.

Want to find out more?

For more information, or to discuss any Regulatory Affairs you are currently recruiting for, please contact Meera Pattni on 01843 870 024 or email mpattni@ckregulatory.com.

Inviting you to…Biocity’s Framework Focus Event

Friday, April 15th, 2011

BioCity  is pleased to invite you to an event that will give you an opportunity to learn first-hand about the opportunities for European R&D funding  in  Healthcare  projects soon to be announced in the 2012 FP7 call.This call has a significant focus on SMEs, with guaranteed EC funding to leading SME partners in successful consortia and a range of more broadly specified topics targeted at SME interests.

During the event there will also be an opportunity to hear about other sources of European Funding for SMEs through the Research for the Benefit of SMEs and Eureka Eurostars programs.

The event, organised in partnership with CK Science and Beta Technologies will also provide details on how to access further support , give attendees a chance  to meet with national support teams, hear from a successful SME participant  and network with potential partners.  A buffet lunch will be provided.

When is the event?

This event will be taking place on Monday 23rd May at Biocity Nottingham’s Boardroom. The event will start at 9.00am and will finish at 13.30pm.

Who should attend?  
The event is targeted at SMEs in the biotech/healthcare sector but will also be of interest to academics and other interested parties working in the following areas of health research;

• Detection and Diagnosis of disease
• Innovative therapeutic approaches and interventions
• Large scale data gathering and processing
• Development and ageing
• Translational research on major infectious diseases, including HIV, TB and malaria
• Translational research on, diabetes/obesity, rare and chronic diseases
• Healthcare systems and public health
• Adverse drug reactions

How to register?

To register your place at the event, or for more information, please contact Liam O’Connell at CK Science on 0114 283 9956 or email loconnell@ckscience.co.uk.