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Biopharmaceutical firm Alimera Sciences (ALIM) is considerably lower Monday (more than 16% at the time of writing) thanks to news that regulators have declined to approve it treatment for retinal swelling. The FDA sent Alimera a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Alimera's investigational drug ILUVIEN saying that it can not approve the drug in its current form. While the CRL didn't request new studies, it asked for analyses of the safety and efficacy data through month 36 of the FAME Study - which includes exploratory analyses and those previously submitted to the FDA. These analyses will be done to further assess the benefits and risks of ILUVIEN. The original New Drug Application (NDA) only included data through 24 months.regulatory posts
FeedAlimera Sciences Plummets on FDA Decision
Biopharmaceutical firm Alimera Sciences (ALIM) is considerably lower Monday (more than 16% at the time of writing) thanks to news that regulators have declined to approve it treatment for retinal swelling. The FDA sent Alimera a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Alimera's investigational drug ILUVIEN saying that it can not approve the drug in its current form. While the CRL didn't request new studies, it asked for analyses of the safety and efficacy data through month 36 of the FAME Study - which includes exploratory analyses and those previously submitted to the FDA. These analyses will be done to further assess the benefits and risks of ILUVIEN. The original New Drug Application (NDA) only included data through 24 months.Bermuda Readies Itself for New Insurance Regulation in Europe
Bermuda is angling to pick up props from European regulators. There's plenty at stake – namely, the huge insurance and reinsurance presence on the island. If the Bermuda Monetary Authority can demonstrate its oversight chops, the industry won't need to seek greener pastures when Solvency II, a new insurance regulatory measure, takes effect. Changes to capital and supervision rules in Europe, particularly with Solvency II in the works, could affect companies like Axis (AXS), Catlin (CLNGF), Flagstone Re (FSR), RenaissanRe (RNR) and XL Insurance (XL). So, what's on the table? Well, gross written premium hit $104 billion in Bermuda last year. If you use Lloyd's of London as a reference point, Bermuda is four times larger. Though the U.S. leads in throwing business to insurers in Bermuda, Europe isn't far behind in second. This is why Bermuda is thinking about Solvency II. Even though the directive only applies directly to European carriers, secondary effects will be evident around the world.
Continue reading Bermuda Readies Itself for New Insurance Regulation in Europe
EU investigating Oracle's bid to buy Sun
On Thursday morning, European Union regulators announced the launch of an antitrust probe into U.S. software maker Oracle's (NASDAQ: ORCL) takeover of Sun Microsystems. The regulatory group believes that the deal could lead to higher prices and limited choice for database software. Approval from this group is considered the main stumbling block for the deal, which has cleared the Department of Justice in the United States.
The final decision has a deadline of 90 days, or January 19, 2009. By this date, the European Commission can decide to clear or to block the deal. More often than not, the Commission will force companies to make changes that would eliminate any concerns over antitrust regulations.
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