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R&D news in brief

Our weekly round up of R&D news in brief

Novo Nordisk plans phase III for inhaled insulin drug
Novo Nordisk is set to start phase III trials of its inhaled insulin drug, code-named AERx, according to a job advertisement for a clinical trial manager for the project posted on the firm's website.

The Danish firm will officially announce on January 27, when its financial report for 2005 is due, whether it will start the final human tests of AERx.

Inhaled insulin is seen as a potentially lucrative growth driver for the diabetes drug industry because it could significantly reduce the need for insulin injections. Pfizer's inhaled insulin drug, Exubera, is expected to be approved for the US market later this month.

Impotence drugs linked to increased risk of eye damage
Impotence drugs such as Viagra and Cialis may increase the risk of optic nerve damage in men with a history of heart attack or high blood pressure, according to a study in the British Journal of Ophthalmology.

Healthcare professionals prescribing these drugs should warn patients of the potential risk, say the authors of the small study, conducted at the University of Alabama.

The study found that men who had had a heart attack were 10 times more likely to have optic nerve damage, diagnosed as non-arteritic anterior ischaemic optic neuropathy (NAION) if they had taken Viagra or Cialis.

In May, the US Food and Drug Administration (FDA) said it had received more than 40 reports of NAION involving impotence drugs but had not determined whether they were responsible.

Allergy test problems stop Xolair trial
Genentech has halted a clinical trial of Xolair, a drug it hopes can be used to prevent peanut-allergy reactions, due to safety concerns with an allergy test rather than the drug itself.

The US biotech firm said two children in the 150-person trial experienced ìsevere hypersensitivity reactionsî when given a trace amount of peanut protein, an initial step designed to gauge the severity of a patient's allergies. Neither child had received the drug.

Xolair is on the market, approved as a treatment for allergic asthma.

Pennsaid data released
Canadian firm Nuvo Research has released new phase III data for its non-steroidal anti-inflammatory treatment Pennsaid, saying it has achieved all primary efficacy endpoints.

The Ontario-based company said it was working toward submitting an amended new drug application to the US Food and Drug Administration. The study, which included 775 patients in the US and Canada with symptoms of primary osteoarthritis of the knee, was designed to address specific deficiencies identified in the FDA non-approvable letter sent to Nuvo in 2002.

Nuvo said final data from its long-term, open-label safety trial will be available next month (February).

30th September 2008


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