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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As if the country’s astonishing wildlife, palm-fringed golden beaches, ancient temples and its tantalising cuisine would not be reason enough to rank India amongst the world’s top holiday destinations, the country’s expanding medical industry sees the South Asian country grow even more popular among holiday makers.

According to a recent report, India’s medical tourism market has the greatest potential in the world, enjoying a considerable superiority over other popular medical holiday destinations, such as Singapore and Thailand.

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The Food and Drug Administration (FDA) is to investigate a possible association between anti-TNF therapies and childhood cancer. Tumour Necrosis Factor (TNF) blockers have become the latest drug class to undergo a detailed FDA safety review, with the potential link between these agents and cancer, particularly in children and young adults, to be assessed. Although the review could increase prescribing caution of anti-TNF therapies for children in some physicians, ultimately it will not affect the use or sales of these agents in the near-term.

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The FDA is close to adding a black box warning to epilepsy drugs after a safety review showed that they increase patients’ risk of suicidal thoughts and behavior. Rather than impacting sales of such drugs for the treatment of epilepsy, the warning will represent a greater threat to sales of these drugs for indications where alternative drug classes are available.

The FDA has analyzed data from 199 placebo-controlled trials of 11 epilepsy drugs involving a total of 43,892 patients. The results of the analysis showed that 0.43% of patients taking the drugs committed suicide, or thought about doing so, compared with 0.24% of patients taking a placebo. Continue reading “FDA Close to Adding a Black Box Warning to Epilepsy Drugs” »

The ageing population and growing risk factors have made a significant impact on driving up the number of registered heart failure cases. Existing pharmacological strategies are improving the survival rates of acute and early-stage heart failure patients, ironically providing a growing body of patients with progression of the disease to heart failure.

Continue reading “Will Technological Improvements Eliminate Reliance on Heart Transplantation?” »

A new report shows that Introgen Therapeutics has submitted marketing authorisation applications for Advexin p53 therapy on both sides of the Atlantic. However, Introgen may struggle to convince the regulatory authorities that the gene therapy drug will offer an improvement in the treatment of head and neck cancer.

Continue reading “Gene Therapy Drug Advexin to Face Regulatory Hurdles and Increasing Scepticism” »