FDA issues response letter on Astra's diabetes drug
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The US Food and Drug Administration has issued a complete response letter regarding AstraZeneca’s new drug application for the investigational fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adult patients with type 2 diabetes. Astra said the letter states that more clinical data are required to support the application, including data from ongoing or completed studies. In addition, the FDA may require information from new studies. The pharmaceuticals giant said it will work closely with the FDA to determine the appropriate next steps for the NDA and remains committed to the development of the saxagliptin/ dapagliflozin fixed-dose combination.
British American Tobacco has purchased the final necessary number of shares in listed Brazilian subsidiary Souza Cruz to enable it to take the company private in coming months. An auction launched by wholly owned subsidiary British American Tobacco Prestação de Serviços has snapped up BRL 9.33bn (£1.58bn), or 22.4% of Souza Cruz, to take London-based BAT's total ownership to 97.7% of Brazil's largest cigarette maker.
In the press
Bankers declared themselves victorious in a key battle with the authorities over new regulations intended to make them accountable for mistakes after the Treasury abandoned its controversial “guilty until proven innocent” rule. The stipulation was to be the financial regulators’ most powerful tool in putting senior bankers on the hook for severe wrongdoing and was a response to public fury that almost no individuals were seriously punished for the banking crisis. - The Times
The City on Thursday won the second clear signal in 24 hours of a political shift in its favour when financial regulators granted a key concession on the ringfencing rule for the UK’s largest banks. In rules set out by the Bank of England, “ringfenced” banks will be allowed to transfer capital from their retail arms to other parts of their businesses in the form of dividends. - Financial Times
China’s military establishment has reacted angrily to a planned US naval mission to skirt artificial islands Beijing has constructed in the South China Sea, as the US gears up to challenge Chinese claims in the area. - Financial Times
US close
Wall Street ended the day sharply higher as investors digested a raft of mixed data, possibly reinforcing the case for the Federal Reserve to stand pat on rates for longer, along with key earnings reports.
The Dow Jones Industrial Average was up 1.28%, the S&P 500 advanced 1.49% and the Nasdaq by another 1.82%.
The number of first time unemployment benefits claimants in the US unexpectedly fell last week to match the lowest level in 42 years.
According to the Department of Labor, new claims declined by 7,000 in the week ended 10 October 255,000, compared with analysts' expectations for a modest increase to 270,000.