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February 10, 2014
08:27 EDTMDCOFDA team leader recommends not approving cangrelor
Thomas A. Marciniak, M.D., a Medical Team Leader for the FDA, stated in briefing documents ahead of the February 12 panel meeting, "I recommend not approving cangrelor at this time for the PCI indication. I recommend not approving cangrelor until another trial succeeds in correcting the flaws that I have documented in this review and in my parallel review on the ethicalness of the cangrelor development program." Cangrelor is developed by The Medicines Co. and is an intravenously administered P2Y12 platelet inhibitor studied in three clinical outcomes trial in patients undergoing percutaneous coronary intervention. Shares of The Medicines Co. are down 12% to $29.99 after the documents were posted on the FDA's website. Reference Link
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April 23, 2014
07:22 EDTMDCOThe Medicines Co. to acquire Tenaxis for $58M
The Medicines Company and Tenaxis Medical announced an agreement for The Medicines Company to acquire Tenaxis. Tenaxis's sole product, which mechanically seals both human tissue and artificial grafts is approved, but not launched in the US -- having received U.S. PMA approval from the FDA in March 2013 as a vascular sealant. The product is also approved with a European CE Mark as a surgical sealant applicable to cardiovascular, general, urological, and thoracic surgery. Under the terms of the agreement, The Medicines Company will pay $58M upfront on closing of the deal. The Medicines Company will also pay milestone payments of up to $112M contingent upon achieving certain commercial and -- in pursuit of even broader indications -- regulatory approval milestones.
07:08 EDTMDCOThe Medicines Co. reports Q1 adjusted EPS 33c, may not compare to consensus (7c)
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April 17, 2014
09:59 EDTMDCOOn The Fly: Analyst Downgrade Summary
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07:17 EDTMDCOThe Medicines Co. downgraded to Market Perform from Outperform at Leerink
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