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Novartis Pharma Tekamlo gets FDA approval

Novartis Pharma has received the go ahead for new blood pressure drug

Novartis Pharma has received US Food and Drug Administration (FDA) approval for Tekamlo (aliskiren and amlodipine) tablets combining with direct renin inhibitor, Tekturna (aliskiren) with amlodipine for the treatment of blood pressure.

Novartis Pharma said that the FDA approval was based on the eight-week, randomised, double-blind, placebo-controlled, multi-factorial study which showed that the combination of Tekturna and amlodipine decreases in systolic/diastolic blood pressure at trough of 14-17/9-11 mmHg, compared to 4-9/3-4 mmHg for Tekturna alone, and 9-14/6-8 mmHg for amlodipine alone.

Novartis Pharma division head David Epstein said that they welcome the FDA's decision to approve Tekamlo, as the treatment of high blood pressure remains a challenge for many patients requiring multiple medications to control their condition.

"This approval reinforces the commitment of Novartis to cardiovascular research and to developing effective treatments for patients who have not reached their blood pressure goal," Epstein said.

Temple University School of Medicine professor of medicine at Alan Gradman said that this new single-pill combination demonstrated greater blood pressure reductions than either drug alone in clinical studies and therefore provides a new option to consider when choosing appropriate high blood pressure therapies.

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Is anyone prepared to solve the NHS funding crisis?

As long as the political taboo on raising taxes endures, the service will be in financial peril. 

It has long been clear that the NHS is in financial ill-health. But today's figures, conveniently delayed until after the Conservative conference, are still stunningly bad. The service ran a deficit of £930m between April and June (greater than the £820m recorded for the whole of the 2014/15 financial year) and is on course for a shortfall of at least £2bn this year - its worst position for a generation. 

Though often described as having been shielded from austerity, owing to its ring-fenced budget, the NHS is enduring the toughest spending settlement in its history. Since 1950, health spending has grown at an average annual rate of 4 per cent, but over the last parliament it rose by just 0.5 per cent. An ageing population, rising treatment costs and the social care crisis all mean that the NHS has to run merely to stand still. The Tories have pledged to provide £10bn more for the service but this still leaves £20bn of efficiency savings required. 

Speculation is now turning to whether George Osborne will provide an emergency injection of funds in the Autumn Statement on 25 November. But the long-term question is whether anyone is prepared to offer a sustainable solution to the crisis. Health experts argue that only a rise in general taxation (income tax, VAT, national insurance), patient charges or a hypothecated "health tax" will secure the future of a universal, high-quality service. But the political taboo against increasing taxes on all but the richest means no politician has ventured into this territory. Shadow health secretary Heidi Alexander has today called for the government to "find money urgently to get through the coming winter months". But the bigger question is whether, under Jeremy Corbyn, Labour is prepared to go beyond sticking-plaster solutions. 

George Eaton is political editor of the New Statesman.