Articles

A well-run documentation system will support your business processes and improvements, not hold them back. How do you ensure that this is the case?
System Analysis (1) – Document Creation A well-run documentation system will support your business processes and improvements, not hold them back.  How do you ensure that this is the case? Let’s look first at what is required of a good documentation control system: 1.       Documents must be version-controlled, with traceability on all changes.  You have to be able to demonstrate which version you were using on a particular date, and, essentially, ensure that everyone is using the correct version. 2.       Review and approval cycles need to be well-managed.  This is a h…

PowderMed has submitted an application to UK regulators seeking to conduct human trials of its avian influenza vaccine. Developing an effective vaccine against the next influenza pandemic is a challenging task, but one many companies are taking on. However, until a virus able to cause a pandemic emerges, no one knows for certain which product will be most effective.
PowderMed: flying ahead in avian flu PowderMed has submitted an application to regulators seeking to conduct human trials of its avian influenza vaccine. Developing an effective vaccine against the next influenza pandemic is a challenging task, but one many companies are taking on. However, until a virus able to cause a pandemic emerges, no one knows for certain which product will be most effective. PowderMed has applied to…

Treatment of chronic kidney disease (CKD) is focussing increasingly on prevention of cardiovascular complications with the aim of reducing the cardiovascular mortality and morbidity to which many patients currently succumb.
Role of Arenesp and cinacalcet in protecting hearts of renal patients Treatment of chronic kidney disease (CKD) is focussing increasingly on prevention of cardiovascular complications with the aim of reducing the cardiovascular mortality and morbidity to which many patients currently succumb. Recognition of the fact that it is heart disease rather than renal failure that kills most CKD patients, and that the risks start early in the disease process, was reinforced a couple of years ago when an analysis of the Kaiser Permanente Renal Registry of 1.1 million patients was…

Hints and Tips: Survive in the Work Place Part Two
It’s good to talkPeople like it when you take time to call. A five minute phone call can do the work of several emails because you can hear someone’s tone of voice and gauge reaction.Plan to talkJust because the phone is an informal medium you can still plan an agenda of the points you need to cover and decide what information you need from the other person.Be politeIf your mobile rings during a land-line call, forward it to voicemail. Taking the call is equivalent to looking over someone’s shoulder while they are talking with you.Record itWhen you’ve had an important call, commit to paper what’s been said and agreed.Writing a one page overviewAn executive summary is all most people want or have time to read to make an informed decision o…

'Drug In Focus' is written by Leighton Howard, a patent information expert with extensive generics experience. He has worked within the professional patent information industry and major generic pharmaceutical firms and now provides consultancy services to the generics industry and government organisations via his company XIP Pty Ltd. He is also the founder of GenericsWeb and remains instrumental in maintaining the high quality and accuracy of data contained in Pipeline Patent Intelligence.
As a provider of comprehensive patent intelligence to generic pharmaceutical companies in over 25 countries, GenericsWeb frequently fields questions about how we identify and select relevant patents for inclusion in our Pipeline Patent Intelligence. This article is not intended to explain exactly how we…

Hints and tips to survive in the work place
Get a head startAsk for information to be sent in advance of your start day about the company, products and projects you’ll be working on.What to wearPlan what you're going to wear during the first week so you don’t have to think about it.Plan your journeyPlan the journey you'll take and alternative routes in case of traffic problems or delays.Best behaviourOnce you’ve made it to your new workplace, take a deep breath, walk in with a smile and make gentle eye contact, be upbeat, polite and friendly to everyone you meet.Use your RadarThe main weapon in the fight against office politics is good communication. The more everyone shares the same information, the more difficult it is to play politics with it.Be good at your jobPeople play politics beca…

Hints and tips for job hunting
Self AssessmentThink about how you and others see you - be honest about strengths and weaknessesDefine what you think you have to offer a prospective employerIdentify your achievements in your career to dateSet your Career and Life GoalsThink about where you want to be in the short, medium and long termPlan the steps you need to take you closer to your goalDon’t just concentrate only on career objectives but also your personal onesMarket YourselfUpdate your CV and prepare a template covering letter as your personal advertIf you need help – ask a Recruitment ConsultantStart to apply for suitable rolesAdvertisements / The InternetJobs are traditionally advertised in specific trade publications and Pharma pressThe Internet is faster and you can search for what su…

A new class of drug for tophaceous gout, the first to be developed in 40 years, is generating hope for patients currently unable to tolerate or respond to standard therapies.
A new class of drug for tophaceous gout, the first to be developed in 40 years, is generating hope for patients currently unable to tolerate or respond to standard therapies. Puricase (PEG-Uricase), currently in phase III trials is being developed by Savient Pharmaceuticals Inc. a small company based in . Puricase is a polyethylene-glycolated recombinant version of the porcine enzyme, uricase.  All mammals except humans and primates produce the uricase enzyme which breaks down uric acid leaving very low levels in the circulation with no untoward effects. Uricase converts uric acid to the more water-soluble metabo…

The UK is the only country in Europe where patients with metastatic colorectal cancer (mCRC) do not have routine access to Erbitux (cetuximab) a drug with potential to extend survival and even cure some people, it was revealed recently.
The is the only country in where patients with metastatic colorectal cancer (mCRC) do not have routine access to Erbitux (cetuximab) a drug with potential to extend survival and even cure some people, it was revealed recently. Erbitux approved for treatment of mCRC in countries all over the world, thanks to a British-led study, is able to arrest growth and spread of aggressive tumours and causes cancer cell death. It is approved for use when irinotecan-based chemotherapy has failed.  However, trials of Erbitux used early in mCRC alongside several chem…

Baraclude (entecavir), a new oral drug developed by Bristol-Myers Squibb, recently approved by the European Commission for treatment of chronic hepatitis B viral (HBV) infections, is expected to become available in a few months in some countries of the EU, the Middle East and Africa.
Baraclude (entecavir), a new oral drug developed by Bristol-Myers Squibb, recently approved by the European Commission for treatment of chronic hepatitis B viral (HBV) infections, is expected to become available in a few months in some countries of the EU, the Middle East and . It will provide a much-needed new antiviral therapy in the face of widespread resistance to existing therapies, according to liver specialists who discussed the drug during the 12th International Symposium on Viral Hepatitis and Liver Di…

The FDA has approved Tibotec and Johnson & Johnson's HIV drug Prezista, enabling it to join Boehringer Ingelheim's recently launched Aptivus as one of just two second-generation protease inhibitors currently available. However, competition will be fierce as both drugs target similar patients in a crowded market where small differences in marketing approaches could impact hugely on sales.
The FDA has granted accelerated approval for Tibotec and Johnson & Johnson's anti-HIV protease inhibitor Prezista (darunavir, previously known as TMC114) co-administered with ritonavir for use in combination therapy in treatment-experienced patients who have failed other antiretroviral therapies.  Prezista belongs to a class of antiretrovirals known as protease inhibitors, or PIs. It is the secon…

ROCHE is set to file for a new indication for its oral, targeted cancer drug Xeloda® following impressive new data presented at the American Society of Clinical Oncology conference (ASCO).
ROCHE is set to file for a new indication for its oral, targeted cancer drug Xeloda® following impressive new data presented at the American Society of Clinical Oncology conference (ASCO). Jonathan Dickinson, Life Cycle Leader - Xeloda®, told Pharmiweb: “Roche plans to file in the next few months for a gastric cancer indication for Xeloda in Europe. The label will be for advanced gastric cancer, because that is what the data at this stage supports. Data in the future may support an indication for gastric cancer in the adjuvant setting.” Mr Dickinson predicted that, if granted, a new indication for Xelod…

Pharmaceutical companies are renowned for exhaustive pages of regulatory reports and documentation procedures. An enormous amount of effort goes into creating and maintaining these documentations, usually by people for whom it is only a small part of their job. Another problem is that complexity exists in such documents and may be due to an excess of information or to inappropriate structure. Again, historically there may have been a drive to put every little detail into the procedures, in t
Lean DocumentationDocumentation is the backbone of the pharmaceutical industry – the taken-for-granted support for GLP, GCP, GMP and many other regulations.  We have to document what we do, how we do it, the expected result, the actual result, what went wrong, what we did about what went wrong,…

Todays Headlines from across the DailyUpdates network (July 7th, 2006) - In today's edition we highlight Biomarin's development of the novel antihypertensive 6R-BH4 and new research describing a promising molecular target for future sepsis therapeutics.
Todays Headlines from across the DailyUpdates network (July 7th, 2006) - In today's edition we highlight Biomarin's development of the novel antihypertensive 6R-BH4 and new research describing a promising molecular target for future sepsis therapeutics.  Summaries of this content can be seen below or click here for today's edition of DailyUpdates Breaking News (from DailyUpdates-Cardiovascular Diseases): Biomarin advance novel antihypertensive: Effective blood pressure control for all hypertensive patients remains an elusive goal. Th…

Todays Headlines from across the DailyUpdates network (from DailyUpdates 5th July)- Although press releases are quite thin on the ground today because of the July 4th holiday in the US, Abiogen have released important information regarding the start of phase 2 testing of the company's anxiolytic, ABIO 08/01. In addition we feature a review describing a potentially groundbreaking drug delivery technology. This technology harnesses protein transduction domains (PTDs), endogenous peptide sequences
Todays Headlines from across the DailyUpdates network (from DailyUpdates 5th July)- Although press releases are quite thin on the ground today because of the July 4th holiday in the US, Abiogen have released important information regarding the start of phase 2 testing of the company's anxiolytic, AB…

A recent Department of Health study showed that healthcare associated infection (HCAI) affects 8 per cent of acute admissions to hospitals. These infections can delay discharge home by up to 11 days. For the NHS in England this represents a loss of 3.6 million bed days, with a projected cost of £1 billion a year.
Maureen Bott, Product and Development Manager, Kalamazoo Security Print, comments on the MRSA and solutions to combat the spread of it. “A recent Department of Health study showed that healthcare associated infection (HCAI) affects 8 per cent of acute admissions to hospitals. These infections can delay discharge home by up to 11 days. For the NHS in this represents a loss of 3.6 million bed days, with a projected cost of £1 billion a year. It is well documented that transmission…

Clinical Professionals offers clients a unique ‘suite’ of candidate attraction tools that are proven to be invaluable to employers in the highly competitive clinical recruitment market with a specialist headhunting team, which proactively searches for the rarest talent in the marketplace on an ongoing basis.
Clinical Professionals Limited is an innovative company addressing clinical research in a unique fashion.  Our management team incorporates industry experience, in-depth clinical knowledge coupled with over 10 years pharmaceutical recruitment expertise to focus on attracting the highest calibre clinical research professionals to selected opportunities within the pharmaceutical industry. We will always work ethically, and consultatively to ensure that the service is customer focused…

The leading pharmaceutical companies have historically focused on developing small molecules to drive their bottom line growth. However, this is set to change, with around 60% of revenue growth for 'Big Pharma' companies forecast to come from biologic products. In fact by 2010, annual sales of biologics will have increased by $26 billion, compared to a $13 billion increase for small molecules.
The leading pharmaceutical companies have historically focused on developing small molecules to drive their bottom line growth. However, this is set to change, with around 60% of revenue growth for 'Big Pharma' companies forecast to come from biologic products. In fact by 2010, annual sales of biologics will have increased by $26 billion, compared to a $13 billion increase for small molecules. Datamo…

Todays Headlines from across the DailyUpdates network - Today we feature news from Vasogen on their candidate treatment of chronic heart failure plus new data from Johnson & Johnson on a new integrin antagonist that may underly a future treatment of asthma
Todays Headlines from across the DailyUpdates network (June 27th) Breaking News (from DailyUpdates-Cardiovascular Disease): New phase III data on heart failure candidate, Velacade: There is a clear need for new treatments for heart failure, as associated mortality and morbidity rates are high. Nearly 5 million Americans and 6.5 million Europeans have heart failure and each year, in the alone, 550,000 new cases of heart failure are diagnosed and nearly 300,000 deaths are registered. The five-year survival rate for patients with heart fail…

While the number of individuals with major depressive disorder (MDD) is set to grow only minimally in next two decades, the condition still represents a key health risk, for both society and the individual. For example, MDD is a leading cause of disability and under-diagnosis remains a problem. Furthermore, the leading classes of MDD drugs have been linked to increased suicidality.
It's estimated that 34 million people suffer from MDD in the western world, but new research estimates that the number of individuals with MDD will grow only minimally in the next two decades, to 37 million by 2025. Unlike a number of other global health issues such as cancer and Parkinson's disease, the aging nature of the world's population won't significantly increase the number of those suffering from MDD.…