Medical comms - Articles

For those new to the industry, a quick round up of the common abbreviations and what they stand for might be useful....
ABPI Association of British Pharmaceutical Industry ADME Absorption, Distribution, Metabolism and Excretion ADR Adverse Drug Reaction AE Adverse Event CPMP Committee for Proprietary Medicinal Products CRF Case Report Form CSM Committee on Safety of Medicines CTC Clinical Trial Certificate CTX Clinical Trial Certificate of Exemption DBDD Double Blind Double Dummy EMEA European Medicines Evaluation Agency FDA Food and Drug Administration GCP Good Clinical Practice GMP Good Manufacturing Practice IDB Investigators’ Drug Brochure IEC Independent Research Ethics Committee MAA Marketing Authorisation Approval MHRA Medicines and Healthcare Produ…

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The prevalence of diabetes, in particular type 2 diabetes, is increasing worldwide. Type 2 diabetes increases with age, but recently has been affecting much younger individuals. In the UK, diabetes prevalence has doubled over the last 12-15 years, and is set to double again over a similar timeframe. The prevalence of diabetes in the UK is now, on average, 3.3%, though many patients are undiagnosed.
The prevalence of diabetes, in particular type 2 diabetes, is increasing worldwide. Type 2 diabetes increases with age, but recently has been affecting much younger individuals. In the UK, diabetes prevalence has doubled over the last 12–15 years, and is set to double again over a similar timeframe. The prevalence of diabetes in the UK is now, on average, 3.3%, though many patients are undiagnose…

On Wednesday 22nd June, PharmiWeb Solutions and Microsoft brought together a senior group of sales and marketing professionals, to discuss how software and e-business based solutions can deliver competitive advantage for the pharmaceutical organisation.
On Wednesday 22nd June, PharmiWeb Solutions and Microsoft brought together a senior group of sales and marketing professionals, to discuss how software and e-business based solutions can deliver competitive advantage for the pharmaceutical organisation.   “In planning for this event, we were keen to avoid the usual traps of either speaking techno-babble, or failing to focus on business issues, and so I hope with our range of speakers that we were able to draw attention to how the practical application of technology-based solutions can…

Pharma Sales World 2005 will provide delegates with a unique opportunity to gain critical business information about how Europe’s leading pharma companies are addressing the challenge of improving sales force effectiveness. The conference will highlight the issues of accessibility, emerging customer bases, market changes in the next decade, sales force size and structure, targeting and segmentation, the new breed of representative, data acquisition, training and development, customer relationshi
Never before has the industry been positioned for such dramatic change as what the pharmaceutical sector is currently facing, creating more uncertainty in an already challenging market. At Pharma Sales World 2005 we have an exceptional programme that will provide creative solutions for the toughe…

Fractures resulting from osteoporosis are widely recognised as a major cause of morbidity and mortality in the elderly population. It has been estimated that approximately 310,000 osteoporotic fractures occur annually in the UK, with a consequent cost to the health service of £1.7 billion.
Fractures resulting from osteoporosis are widely recognised as a major cause of morbidity and mortality in the elderly population. It has been estimated that approximately 310,000 osteoporotic fractures occur annually in the UK, with a consequent cost to the health service of £1.7 billion. Over the past two decades major advances have been made in the management of this disease and a number of pharmacological agents have been approved for the reduction of fracture risk in postmenopausal women with osteopo…

On Friday 16th September, before a glittering audience of local business Champions, Exco was awarded the highly acclaimed prize of Small Business of the Year 2005.
  The Small Business of the Year Award was presented in recognition of Exco’s successful implementation of a strategic business development plan, leading to growth within an increasingly competitive environment. The judges were unanimous in their statement confirming that Exco is ‘Truly Entrepreneurial, this Company is committed to achieving Best Practice in every aspect of its Business’.  The organization has benefited from a strategic approach where objectives are outlined and all staff are encouraged to participate in driving the business forward. This has lead to continued success across every division, a steady gro…

The pharmaceutical industry’s new molecular entity (NME) submissions to the U.S. FDA and new active substance (NAS) submissions to the European Medicines Evaluation Agency (EMEA) rose to five-year highs in 2004, according to PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2005/2006.
The pharmaceutical industry's new molecular entity (NME) submissions to the U.S. FDA and new active substance (NAS) submissions to the European Medicines Evaluation Agency (EMEA) rose to five-year highs in 2004, according to PAREXEL's Pharmaceutical R&D Statistical Sourcebook 2005/2006. The FDA received 31 NME submissions in 2004, while the EMEA received 45 NAS submissions under its centralized registration procedure, through which a drug can gain access to all 25 countries in the European Union via a…

Epilepsy is characterised by a tendency to experience unprovoked seizures and is one of the most common neurological disorders. Over 2% of the population will experience a seizure at some time in their life, and recurrent unprovoked seizures will require treatment in approximately one-in-200 people at any given time. Treatment of epilepsy remains important in helping to reduce the psychological and social sequelae which follow on from uncontrolled seizures.
Epilepsy is characterised by a tendency to experience unprovoked seizures and is one of the most common neurological disorders. Over 2% of the population will experience a seizure at some time in their life, and recurrent unprovoked seizures will require treatment in approximately one-in-200 people at any given time. Treatment of epileps…

It is often forgotten that until the late 1950s there was no treatment for schizophrenia, or for that matter, any other severe enduring mental illness. The majority of patients admitted to asylum care never left: hence the peak occupancy of 150,000 reported in the UK in 1955. As an interesting comparison, this is twice the current UK prison population.
It is often forgotten that until the late 1950s there was no treatment for schizophrenia, or for that matter, any other severe enduring mental illness. The majority of patients admitted to asylum care never left: hence the peak occupancy of 150,000 reported in the UK in 1955. As an interesting comparison, this is twice the current UK prison population. The discovery of conventional (or typical) antipsychotic drugs made a major contribution…

According to LeadDiscovery's recent feature report, Pain Therapeutics 2005, about one and a half billion people suffer from moderate to severe chronic pain worldwide, driving the market for analgesics to nearly $23 billion in 2004. Many companies are investing heavily in the development of new pain therapeutics, even more so now with the recent problems to have hit the Cox-II inhibitors. Calcium channel blockers stepped into the spotlight at the end of last year with the FDA approval of Elan's Z
According to LeadDiscovery's recent feature report, Pain Therapeutics 2005, about one and a half billion people suffer from moderate to severe chronic pain worldwide. The value of the pharmaceutical market for pain relief reflects this seeming worldwide epidemic of pain, with the overall value reach…

Worth an estimated $35 billion in 2003, analysts predict that the sale of oncology therapeutics will grow to $60 billion by 2010. Targeted therapeutics represent one of the most exciting new developments in the field of oncology and include angiogenesis inhibitors; apoptosis stimulators and; signal transduction inhibitors. Apoptosis stimulators lead by Genta's Genesense are particularly appealing. Canadian researchers are focusing on a stimulator of apoptosis known as pancratistatin. This molecu
Oncology is the third largest pharmaceutical market, behind the cardiovascular and CNS therapy areas, and is currently experiencing strong growth. Worth an estimated $35 billion in 2003, analysts predict that the sector will grow to $60 billion by 2010, yielding a compound annual growth rate of 8%…

Parkinson's disease drug revenues grew an impressive 17% across the seven major markets to reach $1.7 billion in 2003. Despite the commercial success associated with this therapy area, currently available treatments focus on levodopa which replaces the loss of striatal dopamine, the hall mark of Parkinson's disease, rather than targeting disease progression. The efficacy of levodopa eventually declines in most patients and new therapies with disease modifying activity are urgently required. A gr
Parkinson's disease is a chronic and progressive neurological condition that affects approximately 1.5 million people in the US alone. While its cause is unknown, the symptoms of Parkinson's disease are primarily the result of degeneration of dopaminergic neurons, in the substantia nigra, a part of…

Hypertension continues to represent a highly prevalent clinical problem affecting 190 million people in the 7 major pharmaceutical markets. This therapeutic area is also a highly lucrative field for pharmaceutical companies with sales exceeding $30 billion in 2003. Despite the improved efficacy and tolerability of the angiotensin receptor blocker class led by valsartan, physicians remain frustrated by the lack of efficacy of antihypertensive agents and the current trend is towards the use of com
Hypertension is defined as a systolic blood pressure of >139mmHg or a diastolic blood pressure of >89mm. Once these values increase past 160 and 100 respectively patients are classified as having stage 2 disease. Although there is a growing awareness of cardiovascular risk factors and the n…

Earlier in 2005, LeadDiscovery published an in depth report on the development of the novel anti-cancer class, the HDAC inhibitors. As this class advances with therapeutic candidates now entering phase II trials, companies are seeking to optimize therapeutic margins by targeting specific isoforms of histone deacetylase that are involved in tumor progression. In a recent NEJM study Prof. Peter Barnes and colleagues demonstrates that the inhibition of HDAC2 could introduce airway risks, possibly e
Earlier in 2005, LeadDiscovery published an in depth report on the development of the novel anti-cancer class, the HDAC inhibitors (see Histone deacetylase inhibitors-Moving from the bench to a promising companion for classic and targeted cancer therapies). This report, in addition to discussing the…

The overlapping fields of angiogenesis and growth factor biology represent two extensively investigated areas of modern day oncology and the recent success of Avastin, a monoclonal antibody that binds to and neutralizes one such growth factor, VEGF has not only resulted in the introduction of an effective clinical tool for the treatment of cancer but it also helped spark a wave of optimism in the angiogenesis inhibitor arena. As a result companies are evaluating new approaches to target VEGF in
The overlapping fields of angiogenesis and growth factor biology represent two extensively investigated areas of modern day oncology (see Innovative Cancer Therapies: Targeted therapy, a clinical and commercial revolution) and the recent success of Avastin, a monoclonal antibody that binds to and ne…

Rheumatoid arthritis affects an estimated 2.1 million Americans. The initial success of biologics that neutralize TNF alpha mean that these therapeutics dominate the US and European rheumatoid arthritis markets. Although the development of biologics has revolutionized treatment of rheumatoid arthritis therapies remain far from optimal. Since biologics are peptidic in nature they must be administered by injection. Moreover, multiple dosing is required and this can be disruptive to the patient.
Rheumatoid arthritis affects an estimated 2.1 million Americans and is characterized by chronic inflammation of the lining of the joints and the development of the pannus, a structure composed of fibroblast-like synovial cells that erode the joint and surrounding bone.  The initial success of…

It is estimated that there are more than 38 million people in the seven major markets with diabetes and this figure is set to rise to 50 million in 2012. Despite the presence of well established treatments of diabetes significant unmet needs remain driving a large body of research and development activity. The highlighted JCI paper described work by Lilly researchers advancing FGF-21 or its mimics as a novel therapeutic candidates for the treatment of diabetes.
It is estimated that there are more than 38 million people in the seven major markets with diabetes and this figure is set to rise to 50 million in 2012 (for an in depth evaluation of the diabetes market size and value, plus an analysis of emerging therapeutics see our recent feature Non-insulin Antidiabetics - Three New Classes C…

Although cytotoxics agents represent a cornerstone of oncology, toxicity and drug resistance has driven the development of targeted anticancer therapies. The current study highlights a novel antimitotic agent, PTX-2. This molecule, like the Taxol and Taxotere, blocks the cell cycle in late mitosis channelling cells into an apoptotic program. In direct contrast to Taxol and Taxotere, PTX-2 targets cells with p53 mutations; the plant alkaloids on the other hand are relatively insensitive in such c
Cytotoxic agents represent a cornerstone of oncology however many established agents are reaching patent expiry and the last cytotoxic genericization is expected in 2011 (Xeloda). One good example of the effects of genericization is the plant alkaloid Taxol (paclitaxel). Taxol, one of a group of al…

Despite the cardiovascular risks that have recently emerged following prolonged treatment with COX-2 inhibitors, this class of drug continues to receive interest as an approach to chemoprevention. Celebrex, which was approved in 1998 for the treatment of familial adenomatous polyposis (FAP) has been shown to reduce the development of precancerous colorectal polyps by 28%. Data recently highlighted in the FASEB journal suggests that at least part of the efficacy of celebrex may be related to the
Until preventative and diagnostic approaches to cancer are significantly improved patients will continue to present to clinicians with tumors that have progressed to a stage where metastasis will in many cases be inevitable. This is particularly the case for the 160,000 patients seen yearly in the…