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Pharma news in brief

Our weekly round-up of news affecting the industry

NICE recommends Pegasys for chronic hepatitis B
The National Institute for Health and Clinical Excellence (NICE) has recommended that Roche's Pegasys (peginterferon alfa-2a) should be the first-line treatment for chronic hepatitis B. The Institute said it reviewed a number of comparative clinical trials, which showed that patients with the HBeAg-positive form of the virus are more likely to achieve lasting remission if treated with Pegasys rather than lamivudine and conventional interferon. ìThe NICE approval provides clinicians with important new tools in fighting the growing problem of hepatitis B,î said Professor Graham Foster, a consultant hepatologist at Barts and The London NHS Trust in East London. Pegasys received European approval to treat chronic hepatitis B in February 2005.

MHRA-led review clears Strattera but with new advice
A Europe-wide review led by the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that Eli Lilly's ADHD drug, Strattera should continue to be prescribed, but should include warnings on the risk of fits and abnormal heart rhythm. Prescribers will also be reminded that Strattera treatment should only be initiated by and under the supervision of a specialist. ìWe have written to health professionals to ensure that they are fully aware of the side effects of Strattera to allow them to make informed prescribing decisions,î said Dr June Raine, director of medicines post-licensing at the MHRA.

Dr Reddy's seals Betapharm deal
Dr Reddy's has won the bidding war for German generic firm, Betapharm, beating off competition from rival Indian firm Ranbaxy, with a Ä480m offer. Betapharm is the fourth biggest German generics company with a 3.5 per cent local market share and was owned by British private equity group, 3i. Analysts said the deal would boost Dr Reddy's presence in Europe, which has up till now lagged behind Ranbaxy and another Indian rival, Wockhardt, to invest in Europe. Shares in Dr Reddy's lifted 9 per cent on the news.

Elan and Biogen given Tysabri clinical trial nod
Elan and its US partner Biogen-Idec have been given the go-ahead by the US Food and Drug Administration (FDA) to resume clinical trials of multiple sclerosis drug, Tysabri. The drug was pulled from the market last year after being linked to the deaths of two patients from brain disease. An FDA advisory committee is scheduled to review Tysabri on March 7 to consider its risk-benefit profile. Both Elan and Biogen have said they expect to be allowed to resume marketing Tysabri for MS later this year, although analysts have warned that the FDA panel will include some external experts not involved in the decision to allow clinical trials.

Meanwhile, an article in the British Medical Journal has argued that Tysabri was approved too quickly and probably should not go back on the market without more data. ìThe rate at which Tysabri was first tracked is absolutely unacceptable for a condition like multiple sclerosis, which can last for 30 years,î said the author. Dr Abhijit Chaudhuri, a consultant neurologist for the Essex Centre for Neurological Sciences at Oldchurch Hospital. ìThey did not even look into the side effects and this is unbelievable. It's a major failing.î

30th September 2008


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