News Breaks |
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| March 5, 2013 |
| 07:39 EDT |  | HSP | Hospira says FDA completed inspection of Rocky Mount facility on March 1
In a filing, Hospira says that the FDA completed an inspection on March 1 of Hospira's facility located in Rocky Mount, North Carolina, which was conducted by five inspectors over a three week period. The company is making this disclosure because the Rocky Mount facility has been subject to an FDA warning letter since April 2010. At the close of the inspection, the FDA issued a Form 483 with 20 observations, three of which were designated as repeat observations. A number of the observations deal with matters for which remediation was already underway but not yet complete or are matters previously self-identified for remediation by the company that are scheduled to be addressed in the latter part of the Company’s remediation and modernization plans. The company will be seeking input from the FDA regarding the scope and timing of remediation efforts at the facility. Over the last few years, the company has been working with the FDA to balance remediation efforts with the production of market critical drugs and will be dialoguing with the FDA as to whether this balance remains appropriate. The company takes this matter seriously. Any actions by the FDA or the company in response to this inspection could impact the company’s ability to increase supply of products to the market, could impact the company’s costs for remediation activities or have other adverse impacts on the company’s operations. The company will evaluate whether there will be any financial impact from this matter and will include any such impact as part of its previously announced intention to issue 2013 guidance as part of its first quarter 2013 earnings call. |
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News For HSP From The Last 14 Days Check below for free stories on HSP the last two weeks. |
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| May 21, 2013 |
| 09:25 EDT | | HSP | FDA sends warning letter to Hospira over adulterated devices
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| May 20, 2013 |
| 15:56 EDT | | HSP | Cubist move higher attributed to patent construction in suit against Hospira
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| 15:42 EDT |  | HSP | Cubist options active on speculation of a favorable patent ruling
Cubist (CBST) June 55 calls and June 47 puts are active on total call volume of 3K contracts (3K puts). June call option implied volatility is at 37, August is at 40; compared to its 26-week average of 36 according to Track Data. Active option volume suggests traders taking positions for movement on speculation of a favorable patent ruling vs.Hospira (HSP). |
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| 15:28 EDT |  | HSP | Rumor: Cubist up on speculation of a favorable patent ruling vs.Hospira
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| May 14, 2013 |
| 09:10 EDT | | HSP | Hospira reappoints Dr. Sumant Ramachandra to Chief Scientific Officer
Ramachandra has been reappointed to his role as Senior VP and Chief Scientific Officer effective May 17. Ramachandra returns to Hospira after a brief departure earlier this year. |
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| May 12, 2013 |
| 13:29 EDT | | HSP | Apotex recalls Hospira injectable drugs on health risks
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| May 8, 2013 |
| 10:57 EDT | | HSP | ICU Medical jumps after report says company considering sale
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