This will be replaced by the player.

Posts Tagged ‘AIDS’

GILD (VIDEO!), CRWE, XEC, NR, CRS - Market Update From DrStockPick.com!

Sunday, September 25th, 2011

 

drstock-2-3

signup3m

 

 

 

http://pennyomega.com/img/gild.jpg

Since 1987, Gilead Sciences has worked to discover, develop and commercialize medications to advance the care of patients suffering from life-threatening diseases in areas of unmet medical need.

In just over 20 years, Gilead has become a leading biopharmaceutical company with a portfolio of 14 marketed products, a growing pipeline of investigational drugs and approximately 4,200 employees in offices across four continents.

Gilead’s primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular/metabolic and respiratory conditions.

http://pennyomega.com/img/gildsep23.png

Gilead Sciences, Inc. (Nasdaq:GILD) recently announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera®, combining Gilead’s Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) with Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor Edurant® (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in antiretroviral-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL.

The CHMP’s positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union (EU). Gilead expects the European Commission to issue its decision on the marketing authorization for the Eviplera single-tablet regimen later this year.

“There is a need for the simplification of treatment regimens featuring co-formulated, fixed-dose medicines as patients stay on therapy longer,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “We are pleased to move one step closer to making this potentially important new simplified treatment option available to physicians and patients in Europe.”

The regulatory filing for the Eviplera single-tablet regimen is supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) conducted by Tibotec evaluating the safety and efficacy of rilpivirine compared to efavirenz in treatment-naïve HIV-1 infected adults. Both arms of the studies were administered with a background regimen, in which the majority of patients in the rilpivirine arm received Truvada. A bioequivalence study conducted by Gilead demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.

More about GILD at www.gilead.com

****************************************************

crwenew

The main benefits of Internet marketing is that it can allow a business to reach a larger audience than other marketing methods. Websites are accessible to anyone in the world with an Internet connection so long as they are not blocked by network administrators (some countries and workplaces block certain websites). This means that a website devoted to promoting a company or ads placed on popular websites can potentially be seen by millions of customers across the world.

Crown Equity Holdings Inc. (OTC:CRWE), together with its digital network, currently provides electronic media services specializing in online publishing, which brings together targeted audiences and advertisers.

Crown Equity Holdings Inc. offers internet media-driven advertising services, which covers and connects a range of marketing specialties, as well as search engine optimization for clients interested in online media awareness.

CRWE’s digital network is designed, on behalf of its clients, to bring together targeted high-income audiences and advertisers on its financial websites that include, among others, DrStockPick.com, PennyOmega.com, BestOtc.com, CRWEFinance.com, CRWESelect.com, CRWEPicks.com and StockHotTips.com.

Crown Equity Holdings Inc. is pleased to announce that it has entered into a joint venture to deploy VoIP (Voice over Internet Protocol) technology delivering voice, video and data services to residential and commercial customers. The joint venture company is Crown Tele Services Inc. which was a wholly-owned subsidiary of Crown Equity Holdings Inc. Crown Equity Holdings Inc. will own fifty percent (50%) interest in the joint venture.

Commenting on the joint venture, Kenneth Bosket, President of Crown Equity Holdings Inc., said: “We are excited to deliver VoIP communications solutions specifically designed to meet the business and residential market needs in this fast-growing global market.”

For more information, please visit: http://www.crownequityholdings.com

****************************************************

Cimarex Energy Co. (NYSE:XEC) has declared a regular cash dividend on its common stock of 10 cents-per-share. The dividend is payable on December 1, 2011 to stockholders of record on November 15, 2011. Denver-based Cimarex Energy Co. is an independent oil and gas exploration and production company with principal operations in the Mid-Continent, Permian Basin and Gulf Coast areas of the U.S.

Cimarex Energy Co. operates as an independent oil and gas exploration and production company primarily in Texas, Oklahoma, New Mexico, Kansas, and Wyoming.

****************************************************

Newpark Resources, Inc. (NYSE:NR) announced that it will release its third quarter 2011 results on Thursday, October 27, 2011 after the market closes. In conjunction with the release, the Company has scheduled a conference call, which will be broadcast live over the Internet, for Friday, October 28, 2011 at 10:00 a.m. Eastern / 9:00 a.m. Central. Newpark Resources Third Quarter 2011 Earnings Conference Call. Friday, October 28, 2011 at 10:00 a.m. Eastern / 9:00 a.m. Central. Live via phone — By dialing 480-629-9771 and asking for them. Newpark Resources call at least 10 minutes prior to the start time, or Live over the Internet By logging onto the web at the address, http://www.newpark.com.

Newpark Resources, Inc., together with its subsidiaries, provides fluids management, waste disposal, and well site preparation products and services primarily to the oil and gas exploration and production industry in the United States and internationally.

****************************************************

Carpenter Technology Corporation (NYSE:CRS) announced a major expansion of its Carpenter Powder Products facility in Sweden (CPP AB). Located in Torshälla, CPP AB is a joint venture operation with Sandvik Materials Technology and is one of three powder metal manufacturing sites associated with Carpenter Powder Products (CPP), a subsidiary of Carpenter Technology Corporation. CPP is the leading global producer of gas atomized powder metal products serving a variety of industries and has additional locations in Pennsylvania and Rhode Island.

Carpenter Technology Corporation engages in the manufacturing, fabrication, and distribution of specialty metals. The company Advanced Metals Operations segment offers metal alloys, stainless steels, and titanium in the form of small bars and rods, wire, narrow strip, and powder.

*************************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. DrStockPick.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold DrStockPick.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://drstockpick.com/disclaimer) . Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

drstbc

 
Share/Bookmark
 
 
 

U.S. Food and Drug Administration Approves Gilead Sciences’ Complera™, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults

Wednesday, August 10th, 2011

stwaug10

http://pennyomega.com/img/gild.jpg

– Complera Combines the Most-Prescribed HIV Product in the United States with the Newest Antiretroviral Agent Approved by the FDA –

– Approval Marks Gilead’s Second Successful Collaboration to Develop a Complete Single-Tablet Regimen for HIV/AIDS –

FOSTER CITY, Calif.–(CRWENewswire)– Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Complera™ (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. Complera combines three antiretroviral medications in one daily tablet – Gilead’s Truvada®, which is a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate, and Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor, rilpivirine (marketed as Edurant™ in the United States by Janssen Therapeutics, Division of Janssen Products, LP). Truvada and rilpivirine were approved by the FDA in August 2004 and May 2011, respectively, for use as part of HIV combination therapy.

“In the 30 years since the first AIDS cases were reported, we’ve made incredible strides in the treatment of this disease,” said Tony Mills, MD, Director of Medical Research, Anthony Mills MD, Inc. and a participating investigator in ongoing Complera studies. “The concept of a single-tablet regimen has become a goal in HIV drug development, and the standard of care in medical practice in the United States. However, no one therapy is appropriate for all patients. Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy.”

The approval of Complera is supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) conducted by Tibotec that evaluated the safety and efficacy of rilpivirine compared to efavirenz among treatment-naïve HIV-1 infected adults. Both arms of the study were administered with a background regimen, in which the majority of patients in the rilpivirine arm received Truvada. A bioequivalence study, conducted by Gilead, demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.

“Complera is the second complete single-tablet regimen that Gilead has introduced, and it represents a collaboration between two organizations that share a vision of simplifying HIV therapy for patients,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Tremendous progress has been made in the field of HIV, but we recognize new therapies are still needed, and we continue to work to advance options that address the needs of patients.”

Complera is the second complete antiretroviral treatment regimen for HIV-1 available to treatment-naïve patients in a single once-daily pill. The first, Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), is marketed by Gilead and Bristol-Myers Squibb. Complera does not cure HIV-1 infection or help prevent the transmission of HIV to others. Complera has Boxed Warnings including lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B; see below for additional important safety information. The following points should be considered when initiating therapy with Complera:

* More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy.

* The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz.

* More subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz.

* Complera is not recommended for patients less than 18 years of age.

Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of Complera in July 2009. Under the terms of the agreement, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of Complera in the United States, Canada, Brazil, the European Union, Australia and New Zealand. Tibotec will be responsible for the commercialization of rilpivirine as a stand-alone product and will hold rights to co-detail Complera in these territories. A marketing application for the emtricitabine/rilpivirine/tenofovir disoproxil fumarate single-tablet regimen is currently pending in the European Union.

The companies also have finalized an agreement for the development and commercialization of the single-tablet regimen for the rest of world, including the developing world. Gilead will be responsible for the registration, distribution and commercialization of the single-tablet regimen in certain European countries, Latin America and the Caribbean. Tibotec will be responsible for all countries outside of the Gilead territories, the most significant of which include Asia Pacific, including Japan, the Middle East, Eastern Europe and all of Africa.

Important Product Safety Information About Complera, Including Boxed Warnings

BOXED WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of Complera, in combination with other antiretrovirals.

Complera is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Complera have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of Complera. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Complera. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

CONTRAINDICATIONS

Complera should not be co-administered with the following drugs, as significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to Complera or to the class of NNRTIs:

* the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin

* the antimycobacterials rifabutin, rifampin, rifapentine

* proton pump inhibitors, such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole

* the glucocorticoid systemic dexamethasone (more than a single dose)

* St John’s wort (Hypericum perforatum)

WARNINGS AND PRECAUTIONS

* New onset or worsening renal impairment
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir disoproxil fumarate. Assess creatinine clearance (CrCl) before initiating treatment with Complera. Monitor CrCl and serum phosphorus in patients at risk for renal impairment, including patients who have previously experienced renal events while receiving Hepsera® (adefovir dipivoxil). Avoid administering Complera with concurrent or recent use of nephrotoxic drugs. Patients with CrCl below 50 mL per minute should not receive Complera.

* Drug Interactions
Complera should be used with caution when given with drugs that may reduce the exposure of rilpivirine.

Complera should be used with caution when co-administered with a drug with a known risk of Torsade de Pointes.

* Depressive Disorders
The adverse reaction depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) has been reported with rilpivirine. During the Phase 3 trials (N = 1,368), the incidence of depressive disorders (regardless of causality, severity) reported among rilpivirine (N = 686) or efavirenz (N = 682) was 8% and 6%, respectively. Most events were mild or moderate in severity. The incidence of Grade 3 and 4 depressive disorders (regardless of causality) was 1% for both rilpivirine and efavirenz. The incidence of discontinuation due to depressive disorders among rilpivirine or efavirenz was 1% in each arm. Suicide attempt was reported in 2 subjects in the rilpivirine arm while suicide ideation was reported in 1 subject in the rilpivirine arm and in 3 subjects in the efavirenz arm. Patients with severe depressive symptoms should seek immediate medical evaluation to assess the possibility that the symptoms are related to Complera, and if so, to determine whether the risks of continued therapy outweigh the benefits.

* Decreases in bone mineral density
Bone mineral density (BMD) monitoring should be considered for patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Cases of osteomalacia (associated with proximal renal tubulopathy and which may contribute to fractures) have been reported in association with the use of tenofovir disoproxil fumarate.

* Co-administration with other products
Complera should not be administered concurrently with other medicinal products containing any of the same active components, emtricitabine, rilpivirine, or tenofovir disoproxil fumarate (Emtriva, Edurant, Viread, Truvada, Atripla), with medicinal products containing lamivudine (Epivir, Epivir-HBV, Epzicom, Combivir, Trizivir), or with adefovir dipivoxil (Hepsera).

* Fat redistribution
Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.

* Immune reconstitution syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of Complera. Further evaluation and treatment may be necessary.

ADVERSE REACTIONS

The most common adverse drug reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2-4) were insomnia and headache.

The most common adverse drug reactions to emtricitabine and tenofovir disoproxil fumarate (incidence ? 10%) were diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

DRUG INTERACTIONS

* Complera should not be used with drugs where significant decreases in rilpivirine plasma concentrations may occur (See CONTRAINDICATIONS).

* Complera is a complete regimen for the treatment of HIV-1 infection; therefore Complera should not be administered with other antiretroviral medications for the treatment of HIV-1 infection.

* Drugs inducing or inhibiting CYP3A enzymes: Rilpivirine is primarily metabolized by cytochrome P450 (CYP) 3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of rilpivirine. Coadministration of rilpivirine and drugs that induce CYP3A may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs. Coadministration of rilpivirine and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine.

* Drugs increasing gastric PH: Coadministration of rilpivirine with drugs that increase gastric pH may decrease plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs.

* Drugs affecting renal function: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, coadministration of Complera with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine, tenofovir, and/or other renally eliminated drugs. Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir and valganciclovir.

* QT prolonging drugs: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and drugs that prolong the QTc interval of the electrocardiogram. In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the electrocardiogram. Complera should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes.

DOSAGE AND ADMINISTRATION

Adults: The recommended dose of Complera is one tablet taken orally once daily with a meal.

Renal Impairment: Because Complera is a fixed-dose combination, it should not be prescribed for patients requiring dose adjustment such as those with moderate or severe renal impairment (creatinine clearance below 50 mL per minute).

Important Safety Product Information About Truvada, Including Boxed Warnings

Truvada, a combination of Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate [DF]), is indicated in combination with other antiretroviral agents (such as non nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection.

The following points should be considered when initiating therapy with Truvada for the treatment of HIV-1 infection:

It is not recommended that Truvada be used as a component of a triple nucleoside regimen.
Truvada should not be coadministered with Atripla (efavirenz/emtricitabine/tenofovir DF), Emtriva, Viread, or lamivudine-containing products.
In treatment-experienced patients, the use of Truvada should be guided by laboratory testing and treatment history.

WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread, a component of Truvada, in combination with other antiretrovirals.

Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

WARNINGS AND PRECAUTIONS

New Onset or Worsening Renal Impairment

* Emtricitabine and tenofovir are principally eliminated by the kidney. Renal impairment, including acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir DF.

* Assess CrCl before initiating treatment with Truvada. Routinely monitor CrCl and serum phosphorus in patients at risk for renal impairment, including patients who have previously experienced renal events while receiving Hepsera (adefovir dipivoxil).

* Dosing interval adjustment of Truvada and close monitoring of renal function are recommended in all patients with CrCl 30–49 mL/min. No safety or efficacy data are available in patients with renal impairment who received Truvada using these dosing guidelines, so the potential benefit of Truvada therapy should be assessed against the potential risk of renal toxicity. Truvada should not be administered in patients with CrCl <30 mL/min or patients requiring hemodialysis.

* Avoid administering Truvada with concurrent or recent use of nephrotoxic drugs.

Coadministration With Other Products

* Since Truvada contains emtricitabine and tenofovir DF, Truvada should not be coadministered with Atripla, Emtriva or Viread. Due to similarities between emtricitabine and lamivudine, Truvada should not be coadministered with other drugs containing lamivudine, including Combivir (zidovudine/lamivudine) Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine).

* Truvada should not be administered with Hepsera.

Bone Mineral Density

* Decreases in bone mineral density (BMD): BMD monitoring should be considered for HIV-1 infected patients who have a history of pathologic bone fracture or who are at risk for osteopenia. Cases of osteomalacia (associated with proximal renal tubulopathy and which may contribute to fractures) have been reported in association with the use of Viread.

Fat Redistribution

* Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Immune Reconstitution

* Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Truvada, which may necessitate further evaluation and treatment.

Early Virologic Failure

* Triple nucleoside-only regimens: Early virologic failure has been reported in HIV-infected patients on regimens containing only 3 nucleoside reverse transcriptase inhibitors (NRTIs). Monitor carefully and consider treatment modification.

ADVERSE REACTIONS

* The most common (incidence ?10%, any severity) and/or treatment-emergent (Grade 2–4, occurring in ?5% of subjects) adverse reactions occurring in subjects treated with efavirenz, emtricitabine and tenofovir DF in Study 934 through 144 weeks include diarrhea, nausea, fatigue, sinusitis, upper respiratory tract infections, nasopharyngitis, headache, dizziness, depression, insomnia, abnormal dreams and rash.

DRUG INTERACTIONS

* Didanosine (ddI): tenofovir disoproxil fumarate increases ddI concentrations. Use with caution and monitor for evidence of ddI toxicity (eg, pancreatitis, neuropathy) when coadministered. The ddI dose should be reduced to 250 mg for patients weighing >60 kg. Data are not available to recommend a dose adjustment of ddI for patients weighing <60 kg. Coadministration of didanosine buffered tablet formulation with Truvada should be under fasted conditions.

* Atazanavir (ATV): coadministration decreases ATV concentrations and increases tenofovir concentrations. ATV 300 mg should be boosted with ritonavir 100 mg only and taken with food when administered with Truvada. Monitor for evidence of tenofovir-associated adverse reactions and discontinue Truvada if appropriate. ATV without ritonavir should not be coadministered with Truvada.

* Lopinavir/ritonavir (LPV/r): coadministration increases tenofovir concentrations. Patients receiving LPV/r and Truvada should be monitored for tenofovir-associated adverse reactions and discontinue Truvada if appropriate.

DOSAGE AND ADMINISTRATION

* Recommended dose: one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food in adults and pediatric patients 12 years of age and older with body weight greater than or equal to 35 kg (greater than or equal to 77 lb.).

Renal dosing guidelines
Creatinine clearance (mL/min)a
(>=)50 30-49
<30 (including patients requiring hemodialysis)
Recommended dosing
Every 24 hours Every 48 hours
Truvada should not be administered
aCalculated using ideal (lean) body weight.

* The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment; clinical response to treatment and renal function should be closely monitored in these patients.

Please see full Prescribing Information for Complera and Truvada (including BOXED WARNINGS).

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that physicians may not see advantages of Complera over other therapies and may therefore be reluctant to prescribe the product, and payers may be reluctant to approve or provide reimbursement for the product. In addition, pending marketing applications such as those in the European Union may not be approved or approval may be delayed, and marketing approval, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Complera is available at www.Gilead.com.

U.S. full prescribing information for Truvada is available at www.Truvada.com.

U.S. full prescribing information for Atripla is available at www.Atripla.com.

Complera, Truvada, Viread, Emtriva and Hepsera are trademarks or registered trademarks of Gilead Sciences, Inc. or its related companies.

Edurant is a trademark of Tibotec Pharmaceuticals.

Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact:

Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Erin Rau, 650-522-5635 (Media)

Source: Gilead Sciences, Inc.

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a newswire as well as an IR and PR firm. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
Share/Bookmark
 
 
 

DrStockPick Takes A Look At AutoNation (AN), Automatic Data Processing (ADP), MusclePharm (MSLP) and Autoliv (ALV).

Tuesday, September 28th, 2010

drstock-2-3

signup3m

 

 

 

 

MusclePharm Corporation (OTCBB:MSLP), one of the fastest growing nutritional supplement companies in the United States with a proprietary formulation used in eight performance products, recently reported the appointment of Mariel Selbovitz, MPH, as Director of Global Therapeutics Product Procurement Development.

“We are thrilled to have Ms. Selbovitz join the MusclePharm team as we enter the therapeutic, nutritional supplementation market that is focused on products to meet the nutritional requirements of people living with HIV/AIDS,” stated Cory Gregory, MusclePharm’s President. “MusclePharm is working to greatly expand our sales of therapeutic, nutritional supplementation and provide increased help to people in need across the globe.”

Mr. Gregory continued, “We believe Ms. Selbovitz expertise and experience in the field of HIV will assist us secure distribution of MusclePharm products, such as Recon, to people living with the HIV disease in developing nations thru The Global Fund to Fight AIDS, Tuberculosis and Malaria, and The Presidents Emergency Plan for AIDS Relief (PEPFAR).”

The Global Fund to Fight AIDS, Tuberculosis and Malaria is an international financing institution that invests the world’s money to battle disease. To date, it has committed US$19.3 billion in 144 countries to support large-scale prevention, treatment and care programs against these three diseases.

By securing procurement of the Global Fund and PEPFAR, MusclePharm will be able to distribute Recon and other supplements to millions of people with HIV/AIDS worldwide thru government funds. In July 2010, MusclePharm presented at the 18th International AIDS Conference on the benefits of Recon in people with HIV/AIDS, sponsored by the National Association of People with AIDS (NAPWA) and the AIDS Institute, both leading HIV legislative and advocacy organizations.

 

**************************************************************

Autoliv Inc. (NYSE:ALV) has decided to increase the Company’s quarterly dividend to shareholders by 17% to 35 cents per share from 30 cents per share to be paid in September for the third quarter.

The fourth quarter dividend will be payable on Thursday, December 9, 2010 to Autoliv shareholders of record on the close of business on Thursday, November 4, 2010. The ex-date, when the shares will trade without the right to the dividend, will be Tuesday November 2.

Autoliv Inc., the worldwide leader in automotive safety systems, develops and manufactures automotive safety systems for all major automotive manufacturers in the world. Together with its joint ventures, Autoliv has 80 facilities with approximately 41,000 employees in 29 countries. In addition, the Company has ten technical centers in nine countries around the world, with 21 test tracks, more than any other automotive safety supplier. Sales in the last twelve months amount to $6.5 billion.

**************************************************************

Automatic Data Processing, Inc. (Nasdaq:ADP) is scheduled to release its financial results for the first fiscal quarter ending September 30, 2010 before the opening of the Nasdaq on Wednesday, October 27, 2010.

ADP also will be hosting a conference call at 8:30 a.m. EDT on October 27, 2010 to discuss the results for the year. Gary C. Butler, president & chief executive officer, Christopher R. Reidy, chief financial officer, and Elena S. Charles, vice president of investor relations, will be participating on the call.

Automatic Data Processing, Inc., with nearly $9 billion in revenues and about 550,000 clients, is one of the world’s largest providers of business outsourcing solutions. Leveraging over 60 years of experience, ADP offers a wide range of HR, payroll, tax and benefits administration solutions from a single source.

**************************************************************

AutoNation, Inc. (NYSE: AN), America’s largest automotive retailer, reports that its retail new vehicle unit sales in August 2010, as reported to the applicable automotive manufacturers, totaled 18,669, a decrease of 17% as compared to August 2009, which benefited from the highly successful Cash for Clunkers program. Retail new vehicle unit sales in August 2010 for AutoNation’s operating segments were as follows:

* 5,451 for Domestic, down 10% versus August 2009 (excluding our estimated impact of Cash for Clunkers, the increase was 39%),

* 9,976 for Import, down 25% versus August 2009 (excluding our estimated impact of Cash for Clunkers, the increase was 15%), and

* 3,242 for Premium Luxury, flat versus August 2009 (excluding our estimated impact of Cash for Clunkers, the increase was 6%).

On a sequential basis, AutoNation’s August 2010 average daily new unit sales increased to 644 per day versus 597 in July 2010.

 

**************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

 

drstbc

 

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. DrStockPick.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold DrStockPick.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://drstockpick.com/disclaimer) .Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings, Inc. (CRWE.OB) is a newswire as well as an IR and PR firm. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period. Crown Equity Holdings Inc. (CRWE.OB) has received twenty five thousand dollars in cash and seventy five thousand free trading shares from a third party (Bishop Equity Partners) for (30) days of advertising for Muscle Pharm Corp. (MSLP.OB).

 
Share/Bookmark
 
 
 

DrStockPick Presents The Latest News From XWES, CBIS and WPNV.

Friday, September 10th, 2010

drstock-2-3

signup3m

 

 

**************************************************************

 

 

Cannabis Science, Inc. (OTCBB:CBIS), a pioneering U.S. biotech company developing pharmaceutical cannabis products, is pleased with its progress with RockBrook Inc. as its first commercialization license for the Cannabis Science Brand of Pharmaceutical Products for the State of Colorado. The licensing agreement grants RockBrook the full latitude and rights to manufacture, develop, produce, distribute, and sell products developed from, or based on Cannabis Science formulations, and delivery systems for the Cannabis Science Brand of Pharmaceutical Products and Cannabis Science Ailment Formulations within the State of Colorado.

On August 30, 2010, FOX affiliate KTXL (”FOX40″) aired one of the first paid U.S. television ads for a Cannabis Dispensary called CannaCare on its FOX40 Live morning news program. The 30-second ad focused on cannabis relief (treatment) for various medical ailments using true-life patient testimonials. Similarly, Cannabis Science is acquiring public testimonials using data acquired from RockBrook patients who use Cannabis Science Brands to evaluate our medical marijuana products prior to FDA clinical trials.

“It is a matter of record within the medical community that medical marijuana can have positive results in helping relieve nausea and vomiting among cancer patients receiving chemotherapy and increasing appetites among AIDS patients,” Mike Armstrong, acting general manager of KTXL in Sacramento, said in a statement e-mailed to FOX40.com, alluding that the ad is no different from that of any medicine advertised by pharmaceutical companies on local television channels and cable networks for decades.

 

WINDPOWER INNOVATIONS, INC. (PINK SHEETS:WPNV), recently reported talks with Energy Plus, an Alternative Energy Company, regarding distribution of its Permanent Magnet Generator and Grid-Tie Technology throughout Mexico and Central America.

Energy Plus distributes alternative energy solutions throughout Mexico and Latin America, and the invitation to expand its palette of offerings, helping to address the requirements of its long standing relationships, represents a strategic marketing opportunity for WindPower Innovations and Energy Plus.

“Many potential markets for wind energy are un-tapped because the technology most widely available requires constant wind speeds at only one to two optimum peaks (+/-5%),” says Ian Griffiths, Chief Technical Officer of WindPower Innovations. “Since it’s a smart technology that can sense variable load demands and adjust power output accordingly, our Permanent Magnet and custom Grid-Tie solutions are ideal for regions that have inconsistent wind supply or power grid challenges, meeting the varying power needs from country to country, small villages, extreme climates and/or areas with developing infrastructure. Constant power can be generated consistently over a very wide band of operation (from 20% TO 125% of rated power).”

WindPower Innovations, Inc., is a wind power infrastructure and smart grid solutions company that are continually working on new innovations for wind turbines, wind energy generation and transmission, in addition to the comprehensive maintenance, repair and re-manufacture of existing equipment.

 

xwes_logo

World Energy Solutions, Inc. (NASDAQ:XWES) has won a major, multi-year contract with the General Services Administration (GSA). The contract provides supply-side energy procurement and management services to the GSA’s Energy Division for its extensive network of federal government agencies. Beginning October 1, 2010 and running through September 30, 2015 — with an option for an additional five-year renewal — the new contract is one of the most important in World Energy’s history.

Over 30 federal agencies, including the Bureau of Prisons, Environmental Protection Agency, Federal Aviation Administration, Internal Revenue Service, National Park Service, Social Security Administration and Veterans Administration, depend on GSA’s Energy Division to help them purchase energy commodities, execute energy strategy, and make sense of the continually changing energy landscape. This makes GSA, which manages more than 11 percent of the Federal government’s total procurement dollars, one of the largest energy buyers in the U.S. The new contract provides GSA a highly-skilled and accountable partner with whom it can address its short, medium and long-term energy challenges anywhere in the country, encompassing services from energy procurement and efficiency to demand response and renewable energy.

“Over the last decade, the GSA has demonstrated tremendous leadership in energy management, embracing state-of-the-art technologies and best practices to bring new efficiencies, greener energy portfolios, and significant cost reductions to a wider and wider sphere of government energy buyers,” said Richard Domaleski, CEO of World Energy. “We view GSA’s long-term contract as tremendous affirmation of our award-winning work together and as our new mandate to help the Energy Division deliver another decade of ’state of the practice’ solutions to its constituents.”

 

 

 

**************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

 

drstbc

 

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. DrStockPick.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold DrStockPick.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://drstockpick.com/disclaimer) .Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings, Inc. (CRWE.OB) is a newswire as well as an IR and PR firm. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period. Crown Equity Holdings Inc. (CRWE.OB) has received five thousand dollars from a third party (VNC Associates LLC) for one (1) day of advertising for CANNABIS SCIENCE INC (OTC BB: CBIS.OB)

 
Share/Bookmark
 
 
 

DrStockPick Updates On NuEarth Corporation (NUEC) and Cannibis Science Inc. (CBIS)

Wednesday, September 8th, 2010

drstock-2-3

signup3m

 

 

**************************************************************

 

NuEarth Corporation (Pink Sheets:NUEC.pk), a manufacturer and marketer of “Clean & Green” products and technology, reports that the company’s Laboratory and Research Division “TerraSolv SA” has renegotiated and finalized its Joint Venture Agreement with Laboratorio Internazionale Agricoltura, S/p/A (”LIA”) of Italy.

The Finalizing of the Joint Venture Continuation Agreement brings 2 new laboratory projects to TerraSolv. These projects are valued currently valued at more than $1.5 Million over the three-month work schedule starting in October 2010. However, each contact has provisions that could triple the final contact value to more than $6 Million USD over their 12 month life cycle. “We’ve seen incredible value from the lab, which has paid for itself several times over in its first year of operations. It represents a new, higher standard for doing business in IT throughout the environmental and agricultural industries. We’re taking more risk out of the system, putting more structure into it, suffering less downtime and delivering higher-quality services,” said Levi Modelevi - CEO of NuEarth Corporation the parent of TerraSolv SA. The TerraSolv SA Laboratory has generated more than $32 Million over its 3 year existence – Mostly due to the Joint Venture with Laboratorio Internazionale Agricoltura, S/p/A.

The joint venture will continue to utilize the TerraSolv SA state-of-the-art development and testing lab currently being relocated to the United States of America. This data center, which collects data from clients around the world to run projects ranging from usability, capacity, spread and weather modeling and performance testing. The heart of the laboratory is a 225-gigabyte database of environmental and agricultural project records running on six HP servers and two Novell servers storing the data and running the software being tested.

NuEarth is a company dedicated to bringing to market “Clean Solutions to Complex Problems” by offering a wide range of biodegradable, environmentally friendly products and technologies that will substitute for many of the hazardous chemicals commonly used all over the world.

 

 

Cannabis Science, Inc. (OTCBB:CBIS), a pioneering U.S. biotech company developing pharmaceutical cannabis products, has issued a statement regarding a Canadian study on marijuana and intractable post-traumatic or post-surgery neuropathic pain that did not respond to conventional treatment. In this multi-billion dollar market, this is very encouraging news for Cannabis Science shareholders as even small doses of cannabis provided relief from chronic, neuropathic pain, which may be caused by physical injuries or by anti-viral drugs used to treat HIV/AIDS. Neuropathic pain is also common in cancer patients as a direct result of the cancer, or as a side effect of chemotherapy, radiation or surgery.

Cannabis Science President and CEO Dr. Robert Melamede, PhD., commented, “Obviously, this study gives further support to our plans to work within the multi-billion dollar market of chronic neuropathic pain. As Dr. Ware said at the beginning of the CMAJ article, cannabis sativa has been used to treat pain since the third millennium BC, so it is all the more outrageous that it has taken so long for such a study to be done, and it could only be used by patients who did not respond to anything else. Why do they have to suffer so much to prove what almost all medical marijuana users already know?”

McGill’s study is the first double-blind, placebo-controlled trial conducted with outpatients who were allowed to smoke marijuana in their own homes. Participants were divided into four groups and randomly assigned marijuana containing four levels of tetrahydrocannabinol (THC), the active ingredient: at 9.4 per cent, 6.0 per cent, 2.5 per cent, and zero THC. The study was led by anesthesiologist Mark Ware, director of clinical research at Montreal’s Alan Edwards Pain Management Unit at the McGill University Health Centre. It was published in the Canadian Medical Association Journal.

Cannabis Science, Inc. is at the forefront of medical marijuana research and development. The Company works with world authorities on phytocannabinoid science targeting critical illnesses, and adheres to scientific methodologies to develop, produce, and commercialize phytocannabinoid-based pharmaceutical products. Cannabis Science, Inc. is dedicated to the creation of cannabis-based medicines, both with and without psychoactive properties, to treat disease and the symptoms of disease, as well as for general health maintenance.

 

 

 

**************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

 

drstbc

To Unsubscribe: unsubscribe@drstockpick.com

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. DrStockPick.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold DrStockPick.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://drstockpick.com/disclaimer) .Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings, Inc. (CRWE.OB) is a newswire as well as an IR and PR firm. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

Crown Equity Holdings Inc. (CRWE.OB) has received Five thousand dollars from a third party (Paaga Media) for one (1) day of advertising for NuEarth Corp. (NUEC.PK)

Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period. Crown Equity Holdings Inc. (CRWE.OB) has received five thousand dollars from a third party (VNC Associates LLC) for one (1) day of advertising for CANNABIS SCIENCE INC (OTC BB: CBIS.OB)

 
Share/Bookmark
 
 
 
  • Site Translator:
Exclusive Videos










Hot stocks to watch!

Direxion Shs Etf Tr - TZA

eBay Inc - EBAY

Isilon Systems Inc - ISLN

Seagate Technology Plc - STX

QUALLCOMM Inc - QCOM

Yahoo Inc - YHOO

Popular Inc - BPOP

Research In Motion Ltd - RIMM

Pfizer Inc - PFE

Cleantech Transit, Inc. - CLNO.OB

Direxion Shs Etf Tr - FAZ

Gilead Sciences Inc - GILD

Mylan Laboratories Inc - MYL

Motorola Inc - MOT

iShares Down Jones U.S. Real Estate Index - IYR

Apple Inc - AAPL

Crown Equity Holdings Inc. - CRWE.OB

Las Vegas Sands Corp - LVS

Altera Corp - ALTR

MGM Mirage Inc - MGM

Microsoft Corporation - MSFT

Regions Financial Corp - RF

 
 
Live With Dr.StockPick
Coming Soon
 
 
DrStockPick.com Newsletter
hot penny stocks, stock picks

 

Follow Dr Stock Pick at
PennyOmega.com Vision

Every success must begin with a vision. If you can see it, you can achieve it.