Erbitux failed to meet both its primary endpoint of progression-free survival and secondary endpoint of overall survival in the first-line treatment of advanced non-small cell lung cancer in a Phase III trial. However, given that Erbitux’s efficacy was previously demonstrated in the larger Phase III FLEX trial, these latest results are unlikely to jeopardise a US approval for the same indication.

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With the costs of providing healthcare spiralling, governments and payers across the seven major markets are implementing cost-cutting initiatives in an effort to combat these escalating healthcare costs, which in turn is putting even greater pressure on pharma companies. Recently the National institute of clinical excellence (NICE) in the UK rejected four new kidney cancer therapies on the basis of cost effectiveness. This decision effectively denies patients access to these novel drugs, a decision that has angered healthcare professional and patients alike.

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With the growing cost of developing novel drugs combined with the fact that from year-to-year fewer such drugs are gaining regulatory approval, the use by pharmaceutical companies of lifecycle management (LCM) techniques is playing an ever-more important role in the increasingly cost-conscious pharma industry.

Continue reading “Will the Healthcare Industry Benefit from Switching Patients from Prescription to Over- the-Counter Medicines?” »

Demand for cosmetic surgery products in the US is forecast to increase 8.1 percent per year to $2.5 billion in 2012, based on increases in cosmetic surgery procedures, which are forecast to reach 16 million over the same time period. So why are we buying into this industry?

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The UK’s cost-effectiveness watchdog National Institute of Health and Clinical Excellence (NICE) has delivered another blow to the developers of targeted cancer therapies by recommending against the use of four new kidney cancer drugs in the UK. This recommendation suggests that NICE is likely to look unfavorably on a number of other targeted therapies in development, severely limiting future growth of the targeted cancer therapies market in the UK.

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Eli Lilly has announced that it will hand over a large proportion of its R&D efforts to contract research organization Covance. The deal, which involves Covance acquiring Lilly’s 1,700-acre R&D site at Greenfield, is one of a number of major structural changes engineered by Lilly to improve its fiscal performance in the face of increasing market pressures, particularly the impact of generic drugs.

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As competitive pressure from the post-patent-expiry entry of generics and new brands onto the market mounts, drug product lifecycles are becoming shorter and shorter with lower peak sales – a double edged sword for pharmaceutical companies. In fact, products worth more than $100 billion in sales (1) will be going off-patent and subject to generic incursion between 2008 and 2012. Thus, effective lifecycle management is becoming a must for pharma companies looking to maximize the return on their considerable investment. Continue reading “Is drug lifecycle management the answer to the $100billion question?” »

Pharmaceutical markets in China and India reached $20.5 billion in 2007 and are expected to double over the next five years.

Companies in India and China are placing themselves in a good position to compete worldwide with developers of innovative biological products.

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Pharmaceutical giant Pfizer has announced that it intends to make further changes to its R&D model after splitting its R&D division into small therapy area units. This is a much-needed step for the company, which desperately needs to increase its product pipeline. However, a further overhaul of R&D processes may be necessary as patent expirations and intense generic competition come ever closer.
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Pharma companies have been dragged into the firing line this week. The UK’s Observer quoted Professor Michael Rawlins, the chair of the health watchdog, NICE, as saying the drugs industry is overpricing critical new medicines to improve its profits.

His remarks came in the wake of the current outcry surrounding NICE’s refusal to approve costly new kidney drugs for NHS use. He told The Observer, “We are told we are being mean all the time, but what nobody mentions is why the drugs are so expensive.”

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