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USFDA withdraws approval for Nexium and Valcyte for Ranbaxy; forfeits exclusivity on Valcyte (-ve for short to medium term)

In a negative move for Ranbaxy, USFDA has withdrawn the previously granted tentative approvals for Ranbaxy’s ANDAs for Nexium and Valcyte. USFDA has determined that Ranbaxy’s ANDAs of concern did not have any data integrity issues but its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time of tentative approvals. As a consequence in FDA’s view, Ranbaxy has forfeited its eligibility for 180-day exclusivity for its ANDA for Valcyte. Expected PAT of USD25mn from Valcyte during exclusivity.

In case Ranbaxy also loses its exclusivity on Nexium then it would be a big negative as it was expected to generate PAT of USD105m during exclusivity.

ECB’s Draghi Signals Further Action

European Central Bank President Mario Draghi reiterated that the central bank rate-setting body is unanimous in its commitment to use more tools and stands ready to take additional stimulus measures if needed. Draghi said the central bank will soon start its asset-backed securities purchases, after it began buying covered bonds last month. The bond-buying programme will last at least two years and coupled with the targeted long-term refinancing operations to be held until June 16, they ‘will have a sizeable impact’ on the ECB balance sheet, he added.

U.S. Weekly Jobless Claims Pull Back More Than Expected

After reporting increases in first-time claims for U.S. unemployment benefits in each of the two previous weeks, the initial jobless claims pulled back by more than expected in the week ended November 1st. The report said initial jobless claims fell to 278,000, a decrease of 10,000 from the previous week’s revised level of 288,000. Economists had expected jobless claims to edge down to 285,000 from the 287,000 originally reported for the previous week.

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