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April 1, 2014
05:38 EDTMDCO, HSPThe Medicines Co. provides update on Angiomax patent litigation
On March 31, Judge Andrews in the U.S. District Court of Delaware issued his Trial Opinion in The Medicines Company v. Hospira, Inc. The case involves Hospira's (HSP) Abbreviated New Drug Applications, or ANDAs, seeking approval to commercially manufacture, use or sell a generic version of The Medicines Company's (MDCO) Angiomax bivalirudin drug product before the expiration of the patents covering this product. The Delaware Decision follows a September 23-25, 2013 bench trial. With respect to patent validity, the Court held that the two patents in the case, U.S. Patent Nos. 7,582,727 and 7,598,343 were valid on all grounds. Specifically, the Court found that Hospira had failed to prove that the patents were either anticipated and/or obvious. The Court further held that the patents satisfied the written description requirement, were enabled and were not indefinite. With respect to infringement, based on its July 2013 Markman Decision, the Court found that Hospira's ANDAs did not meet the "efficient mixing" claim limitation and thus did not infringe the asserted claims of the '727 and '343 patents. The Court found that the other claim limitations in dispute were present in Hospira's ANDA products. The Court has not yet entered a final judgment. Any appeal to the Court of Appeals for the Federal Circuit would need to be filed within 30 days of such entry. The '727 and '343 patents expire in 2028.
News For MDCO;HSP From The Last 14 Days
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April 15, 2015
17:49 EDTMDCOThe Medicines Co. up 7% after FDA panel backs approval of cangrelor
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17:18 EDTMDCOThe Medicines Co. confirms FDA Advisory Committee backs approval of cangrelor
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15:37 EDTMDCOFDA panel votes in favor of approval for cangrelor
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07:57 EDTMDCOThe FDA Cardiovascular & Renal Drugs Advisory Committee to hold a meeting
The Committee discusses The Medicines Company's New Drug Application (NDA) 204958 Cangrelor injection for proposed indication of reduction of thrombotic cardiovascular events at a meeting being held at FDA Silver Spring, Maryland offices on April 15 at 8 am. Webcast Link
07:41 EDTHSPEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
07:01 EDTMDCOThe Medicines Co. stock trading halted today
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April 13, 2015
11:13 EDTMDCOFDA panel briefing docs look positive for Medicines Co., says Leerink
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10:15 EDTMDCOHigh option volume stocks
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April 10, 2015
07:09 EDTMDCOThe Medicines Co. outlook still upbeat after preannouncement, says RBC Capital
After The Medicines Co preannounced lower than expected Q1 revenue, RBC Capital remains upbeat on the company's outlook, citing what it sees as the success of the company's gram negative franchise, its progress on earlier stage, cardiovascular candidates, and approval of and revenue support from up to four products in the near-term. The firm says the shares are "fundamentally inexpensive," while the company has a number of upcoming catalysts. It trimmed its price target on the shares to $37 from $38 but keeps an Outperform rating on the stock.
06:46 EDTMDCOThe Medicines Co. selloff a buying opportunity, says Leerink
Leerink views the selloff in shares of The Medicines Co. after the company preannounced weaker than expected Q1 revenue as a buying opportunity. The firm expects upcoming pipeline catalysts to create value in 2015. It thinks more visibility into four new products with significant revenue potential will move the stock higher. Leerink believes the preannouncement, driven by hospital customers buying fewer products due to the potential for a generic Angiomax to become available, should not come as a surprise. It keeps an Outperform rating on The Medicines Co.
April 9, 2015
16:32 EDTMDCOThe Medicines Co. down 15% after weaker than expected Q1 guidance
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16:16 EDTMDCOThe Medicines Co. to resume trading at 4:30 pm ET
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16:03 EDTMDCOThe Medicines Co. reports preliminary Q1 revenue $125M-$130M, consensus $184.17M
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16:01 EDTMDCOThe Medicines Co. trading halted, pending news
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April 7, 2015
11:02 EDTHSPHospira responds to FDA warning letter
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09:30 EDTHSPHospira sent FDA warning letter following site inspection
The FDA sent a warning letter to Hospira, dated March 31, following a May 5-9 and 12-13, 2014 inspection of the company's pharmaceutical manufacturing facility. "We have conducted a detailed review of your firmís response dated June 4, 2014 and note that it lacks sufficient corrective actions. We acknowledge receipt of your firmís correspondence dated August 4, 2014, October 2, 2014, December 4, 2014, and February 9, 2015," the FDA states in its letter. Reference Link

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