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News Breaks
March 18, 2013
09:19 EDTABTFDA panel says approval 'not appropriate' for Abbott's MitraClip
The FDA posted online a summary for the March 20 meeting regarding Abbott's Vascular MitraClip Clip Delivery System, a first-of-a-kind transcatheter mitral valve repair system. An FDA panel concluded that premarket approval "is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered." The FDA said the trial data submitted, while "interesting and important," lack "valid scientific evidence of safety and effectiveness for the MitraClip CDS for the proposed Indication for use in an inoperable MR population." The agency panel went on, "Because there are limited options for high risk inoperable and high risk mitral valve patients, the FDA has recently worked with the sponsor in a highly interactive manner to develop a new U.S. randomized controlled trial for this patient population called the COAPT Trial. In addition, the sponsor has also recently developed a European randomized trial for this patient population." Reference Link
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February 27, 2015
12:35 EDTABTMylan completes acquisition of assets from Abbott
Mylan N.V. and Mylan (MYL) announced the successful completion of the acquisition of Abbott Laboratories' (ABT) non-U.S. developed markets specialty and branded generics business. Under the previously announced terms of the transaction agreement, Abbott received 110M shares of Mylan N.V., resulting in former Mylan shareholders now owning approximately 78% of Mylan N.V. and Abbott now owning approximately 22% of Mylan N.V. Mylan Inc. and Abbott's non-U.S. developed markets specialty and branded generics business have been reorganized under Mylan N.V., a new public company organized in the Netherlands. Mylan N.V. will be led by the former Mylan Inc. executive team. The company will trade on Nasdaq under the ticker symbol MYL.
February 20, 2015
07:08 EDTABTAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.

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