Articles

The recent announcement by the FDA's associate director for science and medicine that sales of GlaxoSmithKline's asthma drug Serevent should be restricted, or halted, led to an estimated 3.8% fall in the company's share price. However, Datamonitor's Laura Harris comments that, with Seretide accounting for the majority of GSK's asthma sales, the panic may be premature.
During a senate hearing, convened following the withdrawal of Merck & Co.'s COX-2 Vioxx (rofecoxib) in September, the FDA's David Graham commented that the safety profile of five other currently marketed drugs should be closely examined. Pfizer's COX-2 Bextra (valdecoxib), similar to Vioxx, was mentioned, as were Astra-Zeneca's cholesterol-lowering statin Crestor (rosuvastatin calcium), Roche's acne treatment Accutane (iso…

The premier annual global forum for top-level Pharma IT executives, examining innovative IT systems and applications to support and accelerate R&D. This exciting programme is the result of research with well over 100 industry professionals and the InfoTechPharma® scientific advisory board. The programme contains only original content tackling key subjects that are currently impacting R&D in pharma and biotech. The format of this years conference will provide an environment that will facilitate i
The premier annual global forum for top-level Pharma IT executives, examining innovative IT systems and applications to support and accelerate R&D. This exciting programme is the result of research with well over 100 industry professionals and the InfoTechPharma® scientific advisory board. The p…

PharmaSolutions Expo is a unique event gathering the drug discovery, drug development and informatics communities under one roof. Meet face-to-face with solution providers and make comparisons of new technologies. This exhibition will showcase the latest tools and solutions for R&D scientists and Pharma IT professionals. Free exhibition features include: dedicated poster areas and “meet the author” poster sessions, free seminars, lunchtime roundtable discussion groups, biotech start-up presentat
PharmaSolutions Expo is a unique event gathering the drug discovery, drug development and informatics communities under one roof. Meet face-to-face with solution providers and make comparisons of new technologies. This exhibition will showcase the latest tools and solutions for R&D scientists an…

Distinct, original scientific and business content focusing on R&D productivity presented by an international line-up of industry experts. Drug Discovery Technology® Europe is known for its high standard of speakers and coherent case studies, which guarantee that delegates grasp an understanding of the pressing issues that affect their industry. This year, for the first time, the conference will be co-located with two other events, InfoTechPharma® 2005 and PharmaSolutions Expo.
  Distinct, original scientific and business content focusing on R&D productivity presented by an international line-up of industry experts. Drug Discovery Technology® Europe is known for its high standard of speakers and coherent case studies, which guarantee that delegates grasp an understanding of th…

At a recent hearing into the Vioxx affair, the FDA's Dr David Graham named five drugs that he considers too dangerous to be on the market. However, in his testimony, Dr Graham also cited Sanofi-Aventis' Arava as a drug he has recommended be withdrawn. Unlike the other five drugs, Arava has largely escaped the media spotlight, but there may yet be some tough questions asked about its safety.
Arava (leflunomide) is marketed by Aventis, part of Sanofi-Aventis, and recorded sales of $288 million in 2003. It is an oral disease modifying treatment for rheumatoid arthritis (RA), and may be next in the firing line for increased regulatory scrutiny, in the wake of the withdrawal of Vioxx (rofecoxib). Dr Graham, the Associate Director for Science and Medicine in the FDA's Office of Drug Safety, cite…

Given the contribution of drugs to advances in healthcare it often comes as a surprise to those in the pharmaceutical sector that the industry’s public image is so poor.
A poor image Given the contribution of drugs to advances in healthcare it often comes as a surprise to those in the pharmaceutical sector that the industry’s public image is so poor. There is a growing demand for advanced healthcare and without the development of new and effective medicines further progress will not be made. The pharmaceutical industry is the major source of new drugs and its commercial focus has driven innovation. Unfortunately, because companies generate profit and as healthcare is an emotive subject the industry’s activities are often portrayed by the media in a negative light. The media and public ofte…

Unique intelligence from eyeforpharma: 'Barriers, best practices and measuring ROI for patient compliance programmes'
Get your hands on this unique intelligence from eyeforpharma: This report will : Deliver first-hand insight into the present and future concerns for implementing successful patient compliance programs Identify the most pressing issues facing patient compliance teams across the industry Recommend potential solutions to overcome adherence barriers and to maximize compliance program ROI http://www.eyeforpharma.com/pceuro05/report/4 For more information contact Izzy Wakeling on iwakeling@eyeforpharma.com or +44(0) 20 73 75 8522

Study data presented at a major recent conference has demonstrated that Wyeth's novel antibacterial tigecycline acts against drug-resistant pathogens in some serious bacterial infections, including MRSA. While Wyeth will have to work hard to establish tigecycline in this competitive area, its encouraging tolerability profile could give it a useful advantage over existing treatments.
pharmaceuticals company Wyeth presented a range of clinical data at the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in October, including Phase III data from a clinical trial in patients with complicated intra-abdominal infections and from another in complicated skin and soft tissue infections (cSSI). The first trial, which compared tigecycline to Merck & Co's carbapenem Pr…

The recent calamity surrounding Vioxx is one example of what can go awry in the pharmaceutical industry. US drug company Merck (NUSE: MRK) was forced to withdraw this painkiller after in-house studies showed that patients could be at greater risk of suffering heart attacks.
The pharmaceutical industry has over the decades developed an almost unending crop of drugs that has helped to contain disease and improve global health. However, every now and again things can go wrong, and when it does, some investors obviously run for cover. The recent calamity surrounding Vioxx is one example of what can go awry in the pharmaceutical industry. US drug company Merck (NUSE: MRK) was forced to withdraw this painkiller after in-house studies showed that patients could be at greater risk of suffering hear…

Influenza is a global disease which imposes a huge medical and economic burden inevery country of the world. The UK is no exception with one caveat - the virus is probably monitored and tracked more in the UK than any other country around the globe. Over the years, GPs have played a leading role in estimating the quantitative impact of influenza. This started with the pioneering work of William Pickles in the Wensleydale villages and continued with Edgar Hope-Simpson in Cirencester.
Influenza is a global disease which imposes a huge medical and economic burden inevery country of the world. The UK is no exception with one caveat - the virus is probably monitored and tracked more in the UK than any other country around the globe. Over the years, GPs have played a leading role in estimating th…

School can be a difficult place at the best of times, however for the 20 million plus children in the seven major pharmaceutical markets that suffer from attention deficit and hyperactivity disorder (ADHD), it can be especially troubling. This exacerbated by the fact that many patients aren't receiving the best available treatment, according to new research from Datamonitor.
The report suggests that many patients ADHD patients are adversely affected because physicians are sticking with older immediate release, short duration drugs rather than a number of newer long-acting therapies that are on the market. Hugely undiagnosed Datamonitor estimates that 23 million children and adolescents across the seven major pharmaceutical markets suffer from ADHD, a physician perceived prevalence rate o…

As pharmaceutical companies attempt to increase productivity and remain financially viable, the prospect of a merger or acquisition is always on the horizon.
As pharmaceutical companies attempt to increase productivity and remain financially viable, the prospect of a merger or acquisition is always on the horizon. In particular, the problem for the major pharmaceutical companies is that investors have become accustomed to double-digit growth performance and thus there is pressure to develop an ever-greater number of new products with high sales potential. However, the rising costs and risks of drug development combined with the lengthy drug development timescales and increasing competition have made it difficult for companies to keep pace with such expectations. The pharmaceutical industr…

Over the past 30 years, numerous clinical trials evaluating a variety of different classes of drugs have conclusively shown the benefit of blood pressure reduction in reducing the risk of strokes and cardiovascular mortality. Moreover, such trials have clearly demonstrated that blood pressure is unlikely to be controlled with a single drug and often two or more therapies are required to achieve blood pressure targets.
Over the past 30 years, numerous clinical trials evaluating a variety of different classes of drugs have conclusively shown the benefit of blood pressure reduction in reducing the risk of strokes and cardiovascular mortality. Moreover, such trials have clearly demonstrated that blood pressure is unlikely to be controlled with a single drug and often two or more therapies are…

Altana has announced the delay of its US application for Daxas until late 2005 due to clinical trial enrolment taking longer than originally anticipated. The news will be of further concern to the company's investors, coming on the back of the recent announcement that another of its respiratory drugs, Alvesco, failed to win full FDA approval.
Daxas is Altana's selective phosphodiesterase-4 (PDE-IV) inhibitor that is being investigated as a treatment for asthma and chronic obstructive pulmonary disease (COPD) in partnership with Pfizer the and . Altana confirmed earlier this year that a US 12-month long-term efficacy study in COPD was still in the recruiting phase, which is likely to be the 1,100-patient OPUS study that will determine the effect of Daxas (roflumilast) in the treatment of…

Prostate cancer is the most common male malignancy in Western countries. Surgery and radiological procedures for localized prostate cancer offer the possibility for curative treatment. Prostate cancer also represents one of the most lucrative oncology indications for the pharmaceutical industry because drug-based treatment is often very effective at delaying disease progression, even in advanced disease, which encourages high-volume and long-term usage. The use of hormonal manipulation for advan
Prostate cancer is the most common male malignancy in Western countries. Surgery and radiological procedures for localized prostate cancer offer the possibility for curative treatment. Prostate cancer also represents one of the most lucrative oncology indications for the pharmaceutical industry beca…

The pharmaceutical and biotech industries are important contributors to the economies of European countries and are also major employers. If companies in these sectors are to continue to base themselves in Europe they must be seen as positive forces in the field of technology and healthcare rather than a negative drain on a country's finances.
A healthy environment for R&D is essential for the pharmaceutical and biotech industries to successfully bring new products to market. In recent years, the general R&D environment in Europe has become less attractive to companies than that in the US and a number of companies have preferentially shifted investment across the Atlantic (1). The European pharmaceutical industry's own figures demonstrate how dramatic this shift has been. In 1990,…

Hepatocellular carcinoma is the fifth commonest cancer worldwide with about one million new cases diagnosed annually. It is estimated that the incidence of hepatocellular carcinoma in the seven major pharma markets will continue to rise over the next decade. There is no gold standard therapy - the market is characterized by high levels of unmet need, large patient potential and high commercial potential. To mark the publication of its new feature "Hepatocellular Carcinoma" LeadDiscovery's analys
Hepatocellular carcinoma is the fifth commonest cancer worldwide with about one million new cases diagnosed annually. It is estimated that the incidence of hepatocellular carcinoma in the seven major pharma markets will continue to rise over the next decade. There is no gold standard therapy - the m…

Learn about new methods and innovative tools to help you with your translational research.
As you know, translational research is a crucial bridge between pre-clinical and clinical trials for CNS diseases.  Its value is determined by how well it can map a drug’s physiological effects and predict the likelihood that it will be successful in clinical trials.  Consequently, the better and more precise the translational research, the more money will be saved during drug development and the quicker a drug can successfully reach market.             Since translational research is bi-directional in nature, working from the laboratory to the clinic, and from the clinic back to the laboratory, it is inherently collaborative.  To h…

Limitations in the ability to optimize dose modification within the clinical trial setting represents a serious bottleneck in the drug development process. This barrier increases development time, causes the unnecessary early termination of valuable candidates and adds up to $300 million/drug in costs. Petra Biotek are set to knock down these barriers through their computer-based Cycle Dose Modification system. The positive impact that this technology is expected to have on the clinical developm
  [] :  Limitations in the ability to optimize dose modification within the clinical trial setting represents a serious bottleneck in the drug development process. This barrier increases development time, causes the unnecessary early termination of valuable candidates and adds up to $30…

Treatment with combined estrogen/progestin doubles the risk of VTE in post-menopausal women and for obese women the risk is even higher, a recent study showed. However millions of women no longer taking HRT remain at risk of osteoporosis, which presents a huge market opportunity for non-hormonal classes in treating and preventing osteoporosis.
The final data on the incidence of venous thromboembolism (VTE) in the Womens Health Initiative Estrogen Plus Progestin clinical trial was published this month in the Journal of the American Medical Association. The aim of the trial, part of a 15 year program to investigate morbidity and mortality in women that started in 1991, was to determine whether hormone replacement therapy with combined estrogen and progestin may offer some cardioprotection t…