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Pharma news in brief

Our weekly round-up of news affecting the industry

New child medicines guide

A new handbook, BNF for Children (BNFC), that could revolutionise doctors' access to information on medicines for children, has been launched. The guide, the first comprehensive information resource for healthcare professionals on paediatric medicines, covers newborn babies to 18-year olds. It gives a range of guidance from choosing the best available treatment and specific details on doses and formulations - all of which doctors usually have to research from a number of different sources. The guide will provide doctors with the information they need to calculate dosages based on weight and age.

While most drugs for children's everyday illnesses are licensed for paediatric use, drugs for more serious conditions that are developed for use in adults are not tested for use in children, leading to off-label prescribing. The BNFC will play a pivotal role in the UK-led European initiative to develop more medicines for children and increase R&D output in this field. Dr Sheila Shribman has been appointed as the new national director for children to spearhead the government's drive to modernise and reform child healthcare services.

Risk assessment models outdated

Outdated risk management frameworks that have failed to keep pace with dramatic changes to its business and reputation mean that the pharma industry is no longer a defensive investment, according to KPMG. The consultancy firm believes that pharma is struggling to take a comprehensive view of risk, warning that the industry's tendency to work in business silos and a highly regulated environment means companies are unable to keep pace with changes to business models and industry profiles.

The report from KPMG highlights how both positive and negative events have a major impact on shareholder value. Research also revealed that there is no single, uniform approach to risk in the sector, with risk management and assessment varying dramatically from one company to another. ìThis research indicates that companies' approaches to risk management are generally detective in nature, reactive in approach and vary widely,î said Richard Sharman, head of enterprise risk management at KPMG. ìAt a time when boards and management are being encouraged to better understand, anticipate and manage their business risks, many pharma companies urgently need to review and update their approaches,î he added.

US in talks over Tamiflu

The US is in talks to buy record volumes of the antiviral drug, Tamiflu, in an attempt to respond to growing concern about the threat of flu pandemic. The value of the deal could elevate Tamiflu, made by Roche, to blockbuster status; however, producing a sufficient supply to meet the growing demand may cause problems. Head of virology at Roche, David Reddy confirmed that the company was in talks with the US about a significant quantity of Tamiflu doses.

Clinical studies have shown Tamiflu to be effective against all existing flu strains, as a well as the H5N1 strain of bird flu that many scientists fear could result in a human pandemic.

EMEA pulls Hexavac

The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Hexavac on concerns about its long-term protection against hepatitis B. The recommendation for the vaccine, which is used for children against diphtheria, tetanus, whooping cough, hep B and polio, was made after the agency's Committee for Medicinal Products for Human Use (CHMP) identified a decreased effectiveness against hep B.

The concerns raised do not affect the protection against the remaining indications. However, CHMP has asked manufacturer Sanofi Pasteur MSD to create a specific surveillance programme to investigate if children would need to be revaccinated at a later stage.

FDA approves generic HIV drugs

The Food and Drug Administration together with the US Department of Health and Human Services (HHS) has approved the marketing of several generic versions of drugs to treat HIV. As of September 19, 2005 the following products received full marketing authorisation in the US: zidovudine tablets (Ranbaxy); zidovudine tablets and oral solution (Aurobindo Pharmaceuticals); zidovudine tablets (Roxane Laboratories). The drugs are the first generic versions of GlaxoSmithKline's Retrovir to be approved for marketing in the US.

Novartis sticks to its guns

Novartis has said that it stands by its $40-a-share bid for vaccine maker, Chiron. Chairman and chief executive Daniel Vasella said that the company had a `walk away' price and stressed that he is reluctant to be drawn into a competitive auction and raise the offer. Vasella believes that the deal represents a good fit offering a number of growth opportunities. Chiron has turned down Novartis' $4.5bn bid for the 58 per cent of the company it does not already own.

30th September 2008


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