Pharmaco - Articles

Covering all the major topics surrounding EDC and other e-Clinical technologies, this year’s e-Clinical Trials event will also look carefully at how to integrate a range of systems for a successful e-Clinical programme and bring you up-to-date on current standards and the latest technological options. Delegates will also benefit from a highly detailed interactive workshop on managing e-Clinical Trials in exotic and difficult locations. Furthermore, This year’s e-Clinical Trials conference wil
Join us for the most comprehensive e-Clinical Trials event this year and with over 12 manufacturer case-studies, this is the place to be to learn and share your experiences with leading experts in this field. Just some of the case-studies include: - Astellas will share their experiences of inter…

Infusion-related reactions occur with a wide variety of therapeutic agents used in the treatment of cancer but have become a particular concern of the targeted monoclonal antibody therapies. A post-hoc analysis performed on data from a recent large study suggests a way of minimising risk.
Infusion-related reactions occur with a wide variety of therapeutic agents used in the treatment of cancer but have become a particular concern of the targeted monoclonal antibody therapies. A post-hoc analysis performed on data from a recent large study suggests a way of minimising risk. A simple means to help avoid the complication of infusion-related reactions (IRR) affecting patients receiving monoclonal antibody treatments, has been identified in MABEL, a major European open-label study of metastat…

The Appendage of the letter "i" to a word as an aim to create an icon is silly…
The Appendage of the letter "i" to a word as an aim to create an icon is silly… momentary, short-term fame and glory may be possible, but to create a long lasting, global, iconic mark is very doubtful. What makes an icon is also the exclusive longevity of its unique name, and for that reason, you have examples of Rolex and not iWatch, Panasonic and not iTV Terms like, interactive- portable- device were behind creating the name iPod, and has now become responsible for the race for the letter "i" to be ingrained in just about every product category, from: iCell, iCar, iBank to iBrick and just about every word including iCopy. Feeble minds somehow gravitate towards the copying process and feel secure by joining…

Thrombocytopenia, the bleeding disorder caused by a deficiency of platelets, has no easy-to-administer or satisfactory treatment at present. However, eltrombopag (Promacta) a new oral drug in development by GlaxoSmithKline (GSK) has progressed to phase III
Thrombocytopenia, the bleeding disorder caused by a deficiency of platelets, has no easy-to-administer or satisfactory treatment at present. However, eltrombopag (Promacta) a new oral drug in development by GlaxoSmithKline (GSK) has progressed to phase III following encouraging early results regarding efficacy and tolerability. Latest results of a phase II study were presented at the annual American Society of Hematology (ASH) meeting in Orlando, Florida. Patients with too few circulating platelets (thrombocytes) experience problems wi…

With drug pipelines yielding fewer blockbusters and profits from branded drugs being increasingly eroded by generic incursion, pharmaceutical companies are looking to maximize the return on investment of their drugs that do make it to market. Consequently, reformulation has become a common defense by drug makers to prolong the lifecycle of their top sellers.
Pharma turns to reformulation to maximize ROI Reformulation is a popular method of lifecycle management. In fact, from 2002-2005, 39% of the total product launches from the 50 top manufacturers were reformulations. However, before embarking on a reformulation strategy companies must weigh-up whether it is appropriate to commit the required R&D, sales and marketing resources to the project, as opposed to dedicating them to the deve…

Frost & Sullivan, along with their panel of distinguished industry experts, will take a look at the changing dynamics in today's U.S. pharmaceutical industry. The panel will review traditional adherence programs, examine what is and is not working, and what the next steps are toward addressing the multiple barriers contributing to non-adherence. For additional information, please visit http://ebroadcast.frost.com/loyalty
The approaches that many pharmaceutical companies are using to advance patient loyalty and adherence provide opportunities for optimization. These strategies are typically short-term and fail to appreciate the complex and personal issues surrounding a patient's individual barriers to compliance and persistency. There is a significant growing need for companies to move…

Despite almost 200 million people suffering from high blood pressure in the western world alone, the growth rate of the antihypertensive market is actually slowing, largely as a result of generic incursion. In fact many pharmaceutical companies, including those with strong cardiovascular portfolios, are turning their back on this market in favor of more profitable indications, such as oncology.
The number of sufferers of hypertension is expected to climb to over 210 million by 2015, however pharmaceutical companies with an interest in the cardiovascular face a number of challenges which will impact heavily - most notably brand erosion and healthcare reforms. The slow and declining growth rate does not reflect a stationary market, but the battle between the branded and generic drugs. The g…

AstraZeneca's third biggest-selling drug, Toprol XL, has come up against generic competition sooner than anticipated after losing its protection against copycat launches. AstraZeneca has responded by reaching an agreement with US generic firm Par Pharmaceutical to distribute and supply a 25mg generic version of Toprol XL, a strategy that could be used with its other drugs facing patent expiry.
Toprol XL was originally launched by AstraZeneca in 2001 for the once-daily treatment of hypertension, with the patent protecting the drug expected to expire in September 2007. However, in January 2006, a US district court ruled the patents covering Toprol XL extended-release tablets to be invalid and unenforceable. Following the verdict, Novartis-owned Eon Labs launched a 25mg generic version of the…

Inhalabe insulin treatments promised to revolutionize the treatment of insulin-dependent diabetes by removing the 'injection barrier' from treatment regimes. However, while inhalable insulins will see a reasonable level of uptake, they aren't the sure fire blockbuster they were hyped to be.
The diabetes pandemic (driven primarily by type 2 diabetes) has unfolded in conjunction with the ageing global population and rapid cultural changes such as increasing urbanization, dietary changes and decreased physical activity. However, despite the advent of aggressive health awareness campaigns that draw attention to the health problems associated with the key risk factor of type 2 diabetes - obesity - the prevalence of type 2 diabetes is expected to reach the 40 million mark by 2012.   Commerci…

The treatment of asthma and COPD has dramatically improved following the increased use of fixed dose inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination therapies. Although Advair dominates the total asthma/COPD market, Symbicort's recent US approval and Chiesi's recent European approval of an ICS/LABA combination drug, signal a major change in the market dynamics.
  Sufferers of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) are breathing easier due to being increasingly treated with fixed dose inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination therapies. The appeal of these combinations is three-fold: improved patient compliance, simplified disease management and the certainty of bronchodilator and ster…

Analysis of the GenericsWeb Pipeline Patent Intelligence for Wyeth’s top selling veterinary anthelmintic ProHeart® (Moxidectin) shows that generic manufacturers should be wary of relying upon the US FDA Green Book for their critical patent expiry information.
Analysis of the GenericsWeb Pipeline Patent Intelligence for Wyeth’s top selling veterinary anthelmintic ProHeart® (Moxidectin) shows that generic manufacturers should be wary of relying upon the US FDA Green Book for their critical patent expiry information. The US FDA Green Book lists five critical US patents, of which three relate to formulations, one to a combination of actives, and, most significantly, only one to protection of the Moxidectin molecule.  However, the Pipeline Developer report for Moxidectin compiled by Generi…

The success of neuropathic pain drug Neurontin earned Pfizer its reputation as the "neuropathic pain company" and the US pharmaceutical giant faced very little competition in a relatively untapped market for ten years. Neuropathic pain is now one of the most attractive indications in the pharmaceutical industry but Pfizer still dominates the market.
With just five approved drugs on the market and millions of patients worldwide, neuropathic pain is one of the most attractive indications in the pharmaceutical industry. Estimated to be worth over $1.68 billion in 2005, the neuropathic pain market is forecast to grow to $5.5 billion by 2015, driven in the US by strong uptake of Pfizer's Lyrica (pregabalin), Eli Lilly's Cymbalta (duloxetine), and Endo's Lidoderm (lidocaine 5% patch). Indeed, the…

Recognizing excellence in the application of an e-business approach in pharma and biotech HR in Europe.
PharmiWeb Solutions is pleased to announce that is now accepting entries for its inaugural PharmiWeb.com e:HR award. This will be an annual award, to be  given in recognition of the best e-business initiative relating to human resources in the pharmaceutical and biotech sector.  This could include innovative use of web-based  recruitment and selection, intranet-based solutions for training and development, or some other novel e-business application in the Human Resources environment. The winning entry will embody technology leadership, and return on investment, and will demonstrate how effective e-business deployment can help bring about positive organisational change. The…

While there have been no new treatments approved for systemic lupus erythematosus (SLE) in almost 40 years, there are some promising treatments currently in the development pipeline. Unfortunately, the ambiguity surrounding the requirements of clinical trials is preventing these drugs from being approved. However, faced with few alternatives, that hasn't prevented physicians using them off-label.
Imagine your body's immune system turning against you and actually attacking your bodies own healthy cells. Far from being restricted to the realm of science fiction, this is the incurable reality for sufferers of SLE and other autoimmune diseases. Unpredictable flares and remission SLE is a chronic, usually life-long, and potentially fatal autoimmune disease characterized by unpredictable flar…

It’s another Monday practice meeting, the usual drug representative has been roped in to provide lunch and is cooling her heels waiting for the team to finish morning surgery. The usual non-descript pile of sandwiches from the local bakery is stacked on the table and the registrar who has finished early has already picked the best sandwiches...
The registrar has struck up a good conversation with her and she thinks that she is onto a winner with this bright eyed and enthusiastic young doctor (little does she know that he is looking for material for the next Vocational Training Scheme session to pick over and analyse to look at the techniques used by drug reps to sell drugs). Time is ticking by and the partner from the other site who often runs half an hour late has not made it – the reps 30…

Despite being the most common cause of death from gynecological tumors, ovarian cancer does not attract the same level of R&D interest as more prevalent tumor types. While surgery still plays a central role in the treatment of ovarian cancer, platinum-based therapy, in particular, carboplatin in combination with paclitaxel, remains the mainstay of cytotoxic treatment for ovarian cancer.
Nearly 60,000 cases of ovarian cancer are being diagnosed in the seven major markets each year, and although five-year survival rates have been trending upwards, prognosis deteriorates as the disease progresses until by stage IV, the five year survival rate is below 20%. Surgery remains important As in other tumor types, surgery remains central to the management of ovarian cancer, even in more advanced st…

Noxafil is a new fungicide developed by Schering-Plough. Already marketed in Europe, it has now received US approval on the basis of clinical trials showing its superiority over fluconazole in preventing invasive fungal infections in immuno-compromised patients. Revenues derived from this new drug will help bolster Schering-Plough's Infectious Diseases division.
The FDA has approved Schering-Plough's Noxafil (posaconazole) Oral Suspension, its new fungicidal drug. The treatment is initially indicated for the prevention of invasive fungal infections (IFIs) caused by Aspergillus (a mould) and Candida (a yeast) species in immunocompromised patients. While healthy individuals are unlikely to develop systemic infections caused by these common fungi, patients whose immune systems have been wea…

Researchers in Auckland have decoded the structure of a molecule that may provide clues for a new type of diabetes drug.
Researchers in Auckland have decoded the structure of a molecule that may provide clues for a new type of diabetes drug. Through a combination of biology and chemistry, researchers at the Maurice Wilkins Centre for Molecular Biodiscovery have mapped the atomic structure of myo-inositol oxygenase (MIOX), a key enzyme involved in the body’s metabolism of sugars. Details of the structure, outlined in the prestigious US journal Proceedings of the National Academy of Sciences, may allow researchers at the Wilkins Centre to create a new class of drug for the treatment of diabetes. Diabetes affects about 200 million people worldwide, and is estimated to kill four million people…

From October 1st 2006 the Employment Equality (Age) Regulations 2006 - is coming in to force, making it illegal in the UK to recruit or select candidates based on their age and to discriminate based on age whilst in employment rather than based on skills and competencies. This will apply to discrimination againt young and old, and it WILL dramatically affect recruitment and employment in the UK.
Here is a quick round up of the main points from the Regulations  According to the Employers Forum on Age: "More generally, employers must audit carefully their recruitment advertising and procedures. For example, minimum requirements for experience or qualifications are likely to constitute indirect discrimination against younger persons - employers in most cases should therefore avoid langu…

In 2005, 44% of 'mid pharma' revenues were derived from products that have been discovered outside of the in-house development pipelines. In fact, even in the absence of any further external sourcing between now and 2010, the dependence on revenues of products that came from external pipelines will continue to increase, coming to stand at 49% by 2010.
Datamonitor defines 'mid pharma' as those companies within the PharmaVitae company universe with less than $10 billion in ethical revenues in 2005, excluding Japanese and biotechnology companies. Within this group, the players can be broken down into further sub-groups: the 'big six,' those focused on the central nervous system (CNS) market, those focused on the cardiovascular (CV) market, and domestic players.  The 'big six' - Boehrin…