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Pharma news in brief

Our weekly round-up of news affecting the industry

GSK adds ADHD safety warning
GlaxoSmithKline has added new safety warnings to the label of its attention deficit hyperactivity disorder drug, Dexedrine, following a request from the US Food and Drug Administration (FDA). The wording on the Dexedrine label warns that sudden death has been reported in children taking the drugs who have cardiac abnormalities or other serious heart problems. Doctors are advised to check for family history of heart problems or perform a physical examination for signs of them. Similar information was added to the labels for other drugs in the class, including Concerta (Johnson & Johnson) and Adderall (Shire).

Australian government to subsidise Herceptin
Rocheís breast cancer drug, Herceptin, is to be listed on the Australian Pharmaceutical Benefits Scheme (PBS) from October 1, saving up to 2,000 sufferers a year from having to shell out the full A$50,000 (£20,100) cost of treatment. Health minister, Tony Abbott, said the high cost of Herceptin provided evidence of why the Australian government was reviewing the PBS to arrest the increase in its cost to public finance. ìThis is a good example of the fact that we are prepared to list very expensive drugs if we believe they are genuinely cost effective and it shows how important it is to be constantly vigilant to try to get the best possible value from the existing range of drugs,î he commented.

Yasmin claims 'exaggerated'
Schering Health Care has been asked to issue a corrective statement after the Medicines and Healthcare products Regulatory Agency (MHRA) said a promotional mailer for contraceptive, Yasmin, had exaggerated claims regarding tolerability and continuation. The advert claimed that ësignificantly more women stay with Yasmin than with other combined oral contraceptives (COCs)í and ëYasminís tolerability profile may help minimise discontinuationí. The MHRA said the claims were not representative of the overall evidence on tolerability and continuation between Yasmin and other COCs. In its corrective statement, Schering admitted the promotional claim had ìexaggerated the properties of the product and gave the misleading impression that women who took Yasmin were more likely to continue using it longer than women taking other COCsî. The advert, which was sent out as a mailer to healthcare professionals in November last year, has been withdrawn.

Arxxant gets FDA approvable letter
The US Food and Drug Administration (FDA) has issued an "approvable" letter to Eli Lilly for its experimental treatment for moderate-to-severe nonproliferative diabetic retinopathy, Arxxant. The agency has requested additional data supporting the clinical evidence already submitted by Lilly. Lilly said it intends to meet with the FDA to discuss the possibility of it accepting data from an ongoing study or whether a new trial must be conducted. ìAdditional studies seem likely, despite the unmet medical need, debilitating nature of the disease, and lack of any approved drugs to treat the underlying condition,î Leerink Swann & Co. analyst, Susanna Matter, told Bloomberg.

30th September 2008


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