Friday, November 8, 2013

Reuters: Regulatory News: UPDATE 1-FDA staff flag safety fears over Sanofi MS drug Lemtrada

Reuters: Regulatory News
Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com 
UPDATE 1-FDA staff flag safety fears over Sanofi MS drug Lemtrada
Nov 8th 2013, 14:32

Fri Nov 8, 2013 9:32am EST

Nov 8 (Reuters) - U.S. regulatory officials have raised concerns about "multiple serious and potentially fatal safety issues" in patients given Sanofi's new multiple sclerosis drug Lemtrada, fuelling uncertainty about whether it will be approved.

Food and Drug Administration (FDA) staff said in a report prepared ahead of a Nov. 13 advisory panel that the risks might be too great to justify approval, unless the drug showed "substantial clinical benefit".

Shares in Sanofi fell 2 percent after the documents were posted on the FDA's website on Friday.

Lemtrada, also known as alemtuzumab, is given via an intravenous drip for five days and for three days one year later. It is designed to re-programme the immune system.

Sanofi acquired it when it bought U.S. biotech firm Genzyme for $20.1 billion in 2011. Lemtrada's prospects were at centre-stage in that drawn-out takeover battle, leading to an eventual deal that included listed contingent value rights linked to Lemtrada's future success.

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Reuters: Regulatory News: FDA staff raise safety concerns over Sanofi MS drug Lemtrada

Reuters: Regulatory News
Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com 
FDA staff raise safety concerns over Sanofi MS drug Lemtrada
Nov 8th 2013, 14:16

Fri Nov 8, 2013 9:16am EST

Nov 8 (Reuters) - U.S. regulatory officials raised concerns about "multiple serious and potentially fatal safety issues" in patients given Sanofi's new multiple sclerosis drug Lemtrada, raising concerns over its approval.

Shares in Sanofi fell 2 percent after the documents were posted on the FDA's website on Friday.

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Reuters: Regulatory News: FSB to name 29 banks on too-big-to-fail list - Russia

Reuters: Regulatory News
Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com 
FSB to name 29 banks on too-big-to-fail list - Russia
Nov 8th 2013, 13:54

MOSCOW Fri Nov 8, 2013 8:54am EST

MOSCOW Nov 8 (Reuters) - The Financial Stability Board, a global regulatory body, will name 29 banks that are "too big to fail" in a final list due to be published next week, Russia's top international finance official said on Friday.

"Among the 29 banks, there will be Chinese institutions," Deputy Finance Minister Sergei Storchak said, referring to large banks that will have to hold more capital than smaller local rivals from 2016 to guard against financial instability.

Storchak was speaking at a news conference in Moscow during a visit by FSB Secretary General Svein Andresen. The FSB coordinates global financial regulation for the Group of 20 leading economies.

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Reuters: Regulatory News: UPDATE 1-Q3 market slump knocks broker Tullet Prebon's revenue

Reuters: Regulatory News
Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com 
UPDATE 1-Q3 market slump knocks broker Tullet Prebon's revenue
Nov 8th 2013, 14:01

Fri Nov 8, 2013 9:01am EST

* Q3 revenue 252 million pounds vs 276 million a year ago

* Hit by low trading activity as traders wait for Fed

* Shares drop 4 percent

By Clare Hutchison

LONDON, Nov 8 (Reuters) - Interdealer broker Tullett Prebon posted a 9 percent drop in third-quarter revenue on Friday, hit by a slump in business while traders waited to see whether the U.S. central bank would withdraw monetary stimulus measures.

Tullett, which like rival ICAP makes money by matching buyers and sellers of bonds, currencies and swaps, reported revenue for the four months from July to October of 252 million pounds ($404.35 million) compared to 276 million pounds a year earlier.

Revenue was lower across Tullett's three major divisions - foreign exchange, treasuries and interest rate derivatives. Nine-month revenue was 692 million pounds, 5 percent lower than the 731 million pounds earned in the same period in 2012.

Tullett's performance echoes that of a number of investment banks, which saw trading revenues battered in the third quarter, particularly in fixed income and currencies, following the Federal Reserve's surprise decision not to start withdrawing its monetary stimulus.

Analysts said it was hard to see good news in the short term.

"A significant recovery is not likely to materially manifest itself until there is the prospect of an increase in U.S. interest rates," said Numis analyst James Hamilton.

"We believe the Banks will continue to reduce trading activities and restrict the growth of their balance sheets."

Tullett's shares, down 4.4 percent to 303 pence, were among the biggest fallers on the FTSE 250 index at 1318 GMT.

The tough trading environment is another burden for banks who are also having to comply with new rules on capital requirement, which for many means scaling back their trading operations in turn hurting brokers who rely on bank traders for large portions of their revenue.

Tullett said uncertainty over the impact of new regulations relating to over-the-counter markets had also contributed to reduced trading.

Global regulators decided after the financial crisis that derivatives like interest rate swaps and credit default swaps, previously bought and sold through dealers, should be traded on electronic platforms, centrally cleared and recorded, in the interest of improved clarity and lower risk.

Tullett launched a swap execution facility (SEF) last month to comply with new U.S. rules on swaps trading. It is yet to publish trading volumes for its SEF.

British competitor ICAP, the world's largest interdealer broker, will report its first half results on Nov. 13.

Analysts expect ICAP's revenue for the six months to the end of September to fall to 742.49 million pounds from 746 million pounds in 2012, according to Thomson Reuters data.

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Reuters: Regulatory News: UPDATE 1-ECB set to clash with Germany over fund for banks clean-up

Reuters: Regulatory News
Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com 
UPDATE 1-ECB set to clash with Germany over fund for banks clean-up
Nov 8th 2013, 14:05

Fri Nov 8, 2013 9:05am EST

* Central bank warns that common fund needed in banking union

* ECB backs early rules to imposes losses on bank creditors

* Germany's Schaeuble, ECB's Draghi meet at ministers' meeting

By Eva Taylor and Sakari Suoninen

FRANKFURT, Nov 8 (Reuters) - Leaving countries to cope with their problem banks alone would defeat the point of banking union, the ECB said on Friday, putting it on a collision course with Germany before crucial negotiations next week.

The remarks, issued in a legal opinion, represent a fresh attempt to win over Germany's reluctant finance minister Wolfgang Schaeuble to a central tenet of banking union - the creation of a single fund to cover the cost of bank failures rather than leaving countries to foot the bill alone.

Germany could yet soften its stance but only on condition that 'bail-in' rules to impose losses on the bondholders and big depositors of failing banks are introduced three years earlier than planned - in January 2015.

In the legal opinion, the European Central Bank sided with this German demand, saying an early introduction would offer clarity to investors.

"The ECB supports implementing the bail-in tool earlier than 2018. Bail-in is considered to already be priced in to a large extent, so the impact on funding is expected to be marginal," it said.

But the ECB also said the euro zone needed a single fund to break the debilitating link between countries and their troubled banks, contradicting the German emphasis on national obligations.

"Coordination between national resolution systems has not proved sufficient," the ECB said.

"By pooling resources, the (fund) will be able to protect taxpayers more effectively than under national arrangements, and thus break the adverse nexus between banks and their respective sovereigns."

The debate will come to a head when Schaeuble meets ECB President Mario Draghi at a gathering of European ministers next week to negotiate building the second pillar of the banking union - an agency and fund to close troubled lenders.

Having tasked the ECB to police euro zone banks from late 2014, ministers are under pressure to agree this joint scheme for closing or salvaging troubled banks by a self-imposed deadline of the end of the year.

Resolving these differences of opinion is critical to banking union, the most ambitious European project since the start of the single currency, aiming for closer integration to draw a line under the financial crisis.

Germany, Europe's biggest economy, has been putting the brakes on discussions, fearing that such a scheme would leave it to foot the bill for bailing out troubled lenders in other euro zone countries. It also does not want to be told by Brussels to close a German lender.

STILL IN TROUBLE

Between 2008 and 2011, the European Union spent the equivalent of a third of its economic output on saving its banks, but relied on taxpayers' cash. In the case of Ireland, reckless bank lending almost bankrupted the country.

Yet five years after the financial crisis erupted, many European banks remain in trouble, holding back the euro zone economy as it gradually recovers from recession.

The issue of how to pay for bank clean-ups is pressing as the ECB will run a series of tests next year for banks to come clean with any hidden losses before the central bank takes them under its watch.

The exercise is expected to reveal capital holes of billions of euros and the ECB wants to know how such shortfalls will be dealt with before it embarks on its new mission in order to avoid later rattling financial markets.

"Once the single supervisory mechanism is operational and supervision is elevated to the European level, the same needs to happen for resolution," it said, referring to the scope of a new agency to close banks and fund to pay for the fall-out.

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Reuters: Regulatory News: U.S. safety regulators open probe of VW SUVs for lighting issue

Reuters: Regulatory News
Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com 
U.S. safety regulators open probe of VW SUVs for lighting issue
Nov 8th 2013, 12:40

DETROIT Fri Nov 8, 2013 7:40am EST

DETROIT Nov 8 (Reuters) - U.S. safety regulators have opened an investigation into an estimated 61,000 Volkswagen Tiguan sport utility vehicles in the United States after receiving complaints about the loss of exterior lighting.

The National Highway Traffic Safety Administration said it opened the preliminary evaluation into the compact SUVs from model years 2009 through 2011 after receiving 26 complaints from consumers about partial or complete loss of exterior lights, including headlights, brake lights and turn signal lights, due to a heat-damaged electrical fuse.

"The reports suggest the problem worsens over time with additional exterior lighting malfunctioning as the problem progresses," according to the NHTSA document. "Most of the complaints report finding an overheated and melted fuse in the under-hood fuse box. The overheated 30-amp fuse protects, among other things, several exterior lighting circuits."

There were no accidents or injuries related to the issue listed in the NHTSA document posted online. A Volkswagen AG spokeswoman said the German automaker is cooperating with the agency's investigation.

A preliminary evaluation is the first step in a process that can lead to a recall should regulators determine that a manufacturer needs to address a safety issue.

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Reuters: Regulatory News: Ukraine acts to prepare anti-corruption agreement, says EBRD

Reuters: Regulatory News
Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com 
Ukraine acts to prepare anti-corruption agreement, says EBRD
Nov 8th 2013, 10:51

KIEV Fri Nov 8, 2013 5:51am EST

KIEV Nov 8 (Reuters) - Ukraine has renewed a push for agreement with the European Bank for Reconstruction and Development to fight corruption after President Viktor Yanukovich's commitment to improving the business climate was criticised, a bank official said on Friday.

The ex-Soviet republic, which hopes to sign agreements on association and free trade with the European Union at the end of the month, backed away this week from inking the Anti-Corruption Initiative with the EBRD aimed at ending corruption and extortionate business practices which deter investment.

The delay led to dismay among members of the foreign investment community who heard Yanukovich tell a regional economic forum on Wednesday his government intended to deliver a "powerful and systematic attack on corruption in the country".

But an EBRD official said on Friday the bank had now learned that an order had been issued to all government ministries to agree quickly a text of a memorandum of understanding that could be signed with the international lender by Nov. 20.

"We understood that they (the government) will intensify efforts to agree the initiative. Events have marshalled thoughts on this. We would welcome this renewed focus," the EBRD source said. There was no immediate comment from the government.

The international lender invests about $1 billion a year in Ukraine and the EBRD says the delay in signing the initiative - officially because of "technical reasons" - is costing the country hundreds of million of euros in lost EBRD investment.

Commentators say this is not money that Ukraine can afford to pass up lightly, as it faces threats of retaliatory trade action from its biggest partner Russia which has been angered at Kiev's course towards a new trading relationship with the EU.

A text of the draft memorandum of understanding, seen by Reuters, envisages an independent body being set up to examine complaints from companies working in Ukraine about the way they are treated by tax and customs officials and the courts.

Businesses, ranging from the large to the very small often face extortionate demands for hefty bribes and the threat of corporate raiding.

As Ukraine moves towards signing the landmark agreements with the EU on Nov. 28, the EBRD is pushing it to take more robust action to improve the work climate for investors and businesses.

"If the investment climate is right then we have a potential strong pipeline for investment in the country," the EBRD said.

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