Gilead Sciences, Inc. (Nasdaq:GILD) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The mission of Gilead Sciences is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead Sciences has operations in North America, Europe and Asia Pacific.
Gilead Sciences yesterday announced that it has resolved all outstanding issues raised in a Warning Letter issued by the U.S. Food and Drug Administration (FDA) in September 2010 related to its San Dimas, California manufacturing facility.
The FDA notified Gilead yesterday that Gilead Sciences’ response and the actions that have been adopted and implemented at the San Dimas site have sufficiently addressed the FDA’s observations, which were primarily related to the manufacturing environment for AmBisome® (amphotericin B) liposome for injection, as well as general observations related to systems, procedures and controls focused on ensuring product quality at the San Dimas facility.
Gilead Sciences’ products include Atripla, Truvada, Viread, Emtriva for the treatment of human immunodeficiency virus infection in adults; Hepsera, an oral formulation for the treatment of chronic hepatitis B; AmBisome, a amphotericin B liposome injection to treat invasive fungal infections; Letairis, an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension; Ranexa for the treatment of chronic angina; Vistide, an antiviral medication for the treatment of cytomegalovirus retinitis in patients with AIDS; and Cayston, an inhaled antibiotic used as a treatment to enhance respiratory systems.
Gilead Sciences’ products also comprise Tamiflu, an oral antiviral for the treatment and prevention of influenza A and B; Macugen, an intravitreal injection for the treatment of neovascular age-related macular degeneration; and Lexiscan/Rapiscan, an injection used as a pharmacologic stress agent in radionuclide myocardial perfusion imaging. Gilead Sciences’ products under the Phase III clinical trials consist of Cobicistat, a pharmacoenhancer that is under evaluation as a boosting agent for HIV medicines; Elvitegravir, an oral integrase inhibitor being evaluated as part of combination therapy for HIV; Integrase Single-Tablet, a ‘Quad’ regimen of elvitegravir, cobicistat, tenofovir disoproxil fumarate, and emtricitabine for the treatment of HIV/AIDS in treatment-naive patients; and Aztreonam for inhalation solution for the treatment of cystic fibrosis patients with Pseudomonas aeruginosa.
For more information about Gilead Sciences, please visit: www.gilead.com.
Dover Motorsports Inc. (NYSE:DVD) reported results for the three months ended June 30, 2011. Revenues for the quarter ended June 30, 2011 were $26,381,000 compared with $29,946,000 in the second quarter of 2010. The decrease in revenues was primarily due to the schedule change noted above and from lower admissions and event related revenues at the Company’s NASCAR triple-header in Dover.
Dover Motorsports, Inc., through its subsidiaries, markets and promotes motorsports entertainment in the United States. The company operates motorsports tracks in two states and promotes events under the sanctioning body, the National Association for Stock Car Auto Racing.
Mistras Group, Inc. (NYSE:MG) reported record financial results for the fourth quarter and fiscal year ended May 31, 2011. Revenue for the fourth quarter of fiscal 2011 was $102.1 million, an increase of 28%, over the $79.8 million reported in the fourth quarter of fiscal 2010. Adjusted EBITDA*, a non-GAAP measure detailed later in this release, increased 28% to $17.5 million in the fourth quarter of fiscal 2011 versus $13.7 million in the fourth quarter of fiscal 2010. Net income for the fourth quarter of fiscal 2011 grew by 27% to $6.7 million, or $0.25 per diluted share, versus $5.3 million, or $0.20 per diluted share, in the fourth quarter of fiscal 2010. For the year, net income was $16.4 million, or $0.61 per diluted share, versus $10.4 million, or $0.43 per diluted share, in fiscal 2010. Fiscal 2011 net income includes a fourth quarter pre-tax provision of $0.7 million for slow-moving inventory. Earnings per share would have been $0.26 and $0.63 per diluted share for the 2011 fourth quarter and fiscal year, respectively, without this inventory charge.
Mistras Group, Inc. and its subsidiaries provide proprietary, technology-enabled non-destructive testing (NDT) solutions used to evaluate the structural integrity of critical energy, industrial, and public infrastructure worldwide.
Noah Holdings Limited (NYSE:NOAH) announced its unaudited financial results for the second quarter 2011. Net revenues in the second quarter of 2011 were US$23.3 million, a 199.1% increase from the corresponding period in 2010. Income from operations in the second quarter of 2011 was US$10.6 million, a 346.4% increase from the corresponding period in 2010. Net income attributable to Noah shareholders in the second quarter of 2011 was US$8.9 million, a 367.4% increase from the corresponding period in 2010. Non-GAAP1 net income attributable to Noah shareholders in the second quarter of 2011 was US$9.3 million, a 213.6% increase from the corresponding period in 2010. Net income per basic and diluted ADS in the second quarter of 2011 were both US$0.16. Non-GAAP net income per diluted ADS in the second quarter of 2011 was US$0.16.
Noah Holdings Limited engages in the distribution of wealth management products to the high net worth population in China.
Cleantech Transit Inc (CLNO)
Cleantech Transit Inc. was founded to capitalize on technology advances and manufacturing opportunities in the growing clean energy public transportation sector. Cleantech Transit Inc has expanded its focus to invest directly in specific green projects that could maximize shareholder value. Recognizing the many economic and operational advances of converting wood waste into renewable sources of energy, Cleantech Transit Inc. has selected to invest in Phoenix Energy (www.phoenixenergy.net).
The biomass is used and produced throughout the world. It is the most inexpensive way of producing electricity. So far it looks like an inexhaustible natural resource. Biomass energy as a renewable energy source is capable of replacing fossil fuels. Agriculture biomass energy products add more worth to agricultural activities. The growth of biomass plants and crops produces oxygen and utilize more carbon dioxide present in the air.
Cleantech Transit, Inc. (CLNO) is pleased to announce it has met its funding requirement to secure the Company’s ability to earn in 25% of the 500KW Merced Project.
The Company is in the final stages of closing its initial interest in the Merced Project and is currently working on completing the necessary documentation and expects closing the transaction soon. As previously announced Cleantech has the option to earn up to 40% of the Merced Project and the Company plans to continue to work towards increasing its interest in the Merced Project as they move ahead.
A huge percentage of the world’s fossil fuels come from the world’s most volatile places. By reducing our dependence on oil derivatives, we in turn can reduce our dependence on foreign energy sources. By converting energy from waste Cleantech Transit hopes to help in increasing its country’s energy security.
For more information about CLNO, visit www.cleantechtransitinc.com
PMI Group Inc. (NYSE:PMI) reported a net loss for the second quarter of 2011 of $134.8 million, or $0.83 per basic and diluted share, compared to a loss of $150.6 million, or $1.11 per basic and diluted share, for the same period one year ago. Losses from continuing operations (which excluded a $150.5 million gain on sale in the second quarter) were $285.3 million, or $1.76 per basic and diluted share, for the second quarter of 2011 and $150.6 million, or $1.11 per basic and diluted share, for the second quarter of 2010.
The PMI Group, Inc., through its subsidiary, PMI Mortgage Insurance Co., provides residential mortgage insurance products to mortgage lenders and investors in the United States.
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