DISCLAIMER

DISCLAIMER: The author is not a registered stockbroker nor a registered advisor and does not give investment advice. His comments are an expression of opinion only and should not be construed in any manner whatsoever as recommendations to buy or sell a stock, option, future, bond, commodity, index or any other financial instrument at any time. While he believes his statements to be true, they always depend on the reliability of his own credible sources. The author recommends that you consult with a qualified investment advisor, one licensed by appropriate regulatory agencies in your legal jurisdiction, before making any investment decisions, and that you confirm the facts on your own before making important investment commitments.
Showing posts with label GlaxoSmithKline. Show all posts
Showing posts with label GlaxoSmithKline. Show all posts

Sunday, June 27, 2010

GlaxoSmithKline Settles 200 Birth Defects Cases Linked to Antidepressant

Pharmaceutical giant GlaxoSmithKline has entered into confidential settlements with nearly 200 families who claimed that its antidepressant Paxil caused congenital birth defects.

Most of the claims alleged that babies born to mothers taking Paxil suffered heart defects. Last October, a suit filed on behalf of Lyam Kilker said he was born with three cardiac defects, including a hole between two chambers of his heart that disrupted the aorta.

Kilker’s case is the only one to have gone to trial, and a Philadelphia jury awarded Kilker’s family $2.5 million in compensatory damages. Plaintiffs argued that animal testing revealed potential problems with Paxil, but the company did not follow up with additional tests. A company memo introduced as evidence during the trial also revealed that Glaxo considered covering up any negative test results. “If neg, results can bury,” the 1997 memo said.

In 2005, the Food and Drug Administration warned doctors about a 35,000-person study that found that pregnant women on Paxil were twice as likely to have a child with defects than women taking other antidepressants.

The terms of the settlement will remain confidential. At least 600 Paxil birth defect cases have been filed, and up to 100 cases were settled prior to the settlement announced on Thursday. Paxil generates nearly $3 billion in annual sales, ConsumerAffairs.com reports.

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Tuesday, June 1, 2010

GSK settles more lawsuits over Avandia

Thousands of lawsuits alleging that drug maker GlaxoSmithKline’s diabetes drug Avandia caused heart attacks were settled, the company confirmed today.

The cases were originally scheduled to go to court in Philadelphia this month. GlaxoSmithKline declined to provide details of the settlement.

Why haven't any Wall Street tycoons been sent to the slammer?

More than a year into the gravest financial crisis since the Great Depression, millions of Americans have seen their home values and retirement savings plunge and their jobs evaporate.

What they haven't seen are any Wall Street tycoons forced to swap their multi-million dollar jobs and custom-made suits for dishwashing and prison stripes.

There are plenty of civil and class-action lawsuits from aggrieved investors angered by the losses in their mortgage bonds, hedge funds or pensions. Regulators have stepped up their vigilance after the fact. But to date, no captain of finance tied to the crisis has walked the plank.

There have been some high-profile arrests and federal convictions of financial giants — such as Ponzi scheme king Bernard Madoff and Stanford Financial Group chairman Robert Allen Stanford. They weren't among the causes of the financial meltdown, however, just poster boys for an era of lax enforcement, weak regulation and devout faith in free markets.

"A lot of people who are responsible (for the crisis) seem to have gotten awfully rich in the process," said Barbara Roper, the director of investor protection for the Consumer Federation of America.

The absence of what many would call justice stands out all the more because past financial crises always had their villains. The depression-era had electricity and railroad magnate Samuel Insull, who partly inspired the movie "Citizen Kane." The savings and loan crisis of the 1980's had banker Charles Keating. Energy giant Enron Corp.'s spectacular collapse offered the late CEO Kenneth Lay, a Texas crony of President George W. Bush.

Yet there's no such poster child for the Great Recession, as today's crisis is now called.

One may yet emerge. The FBI has more than 580 large-scale corporate fraud investigations under way. At least 40 of them are scrutinizing players in sub-prime mortgage lending, which was the first domino to fall and triggered a global financial crisis.

"The investigations are very complex; it's not something that's going to turn overnight," said Bill Carter, a spokesman at FBI headquarters. "They are labor intensive. They involve a review of records."

To date, the closest thing to a prosecution of a major actor in the financial meltdown is a civil fraud case that the Securities and Exchange Commission brought on June 4 against Angelo Mozilo, the perma-tanned CEO of mortgage-lending giant Countrywide.

The SEC, in documents filed in a federal courtroom in central California, accuses Mozilo of "deliberately misleading investors" by misrepresenting the risk that Countrywide posed. The SEC also accused him of insider trading because he sold large shares of company stock and options ahead of what he allegedly knew was a coming collapse of mortgage lending.

Unless the Justice Department brings corresponding criminal charges, however, Mozilo could be hit with penalties and a ruined reputation if convicted — but he wouldn't see the inside of a jail cell.

Another big trial is imminent, however. On Oct. 13, a Brooklyn jury will begin hearing the federal prosecution of former Bear Stearns investment fund founder Ralph Cioffi and his fund manager Matthew Tannin.

Two of their hedge funds, offered to mega-wealthy investors and heavily weighted with investments in mortgage bonds backed by sub-prime loans to the weakest borrowers, collapsed in June and August of 2007. Their collapse signaled a gathering storm in mortgage finance that culminated in March 2008 with the government-brokered fire sale of their bank to JP Morgan Chase.

Both men were charged on June 19, 2008, with defrauding investors, passing off as safe the investment in mortgage bonds even though they described the market for sub-prime mortgages as "toast" in their own e-mails. Cioffi also faces charges of insider trading.

Lawyers for both men declined comment to McClatchy, but when their clients were arrested they called the pair scapegoats for the broader financial crisis.

Court documents filed in August show attorneys for the two are trying to suppress evidence that the executives' special trading notebooks have disappeared. The government suspects that Cioffi and Tannin, or someone helping them, made them disappear to cover their tracks.

Cioffi's attorneys also asked in August that the presiding judge quash the use of evidence that points to their clients' lavish lifestyle, including mansions and Ferraris. The documents accused federal prosecutors of "improper appeal to class prejudice." Tannin's attorneys joined the motion on Sept.15.

Class prejudice against bankers is what many Americans feel, evident in the death threats made against some former or current executives at insurer American International Group and other financial firms earlier this year. Wall Street switchboard operators at some institutions no longer provide addresses to phone callers.

Americans are angry because the suffering on Main Street is a spillover from the excessive risk taking and lavish compensation of executives who invested on behalf of the ultra-wealthy. Investors seeking outsized "alpha" returns turned to Wall Street, both seeking to make a short-term killing even if doing so eventually brought the near collapse of the financial system.

President Barack Obama alluded to this on Sept. 14 in a New York speech to commemorate the anniversary of the collapse of investment bank Lehman Brothers, which sent off a global financial panic.

"We will not go back to the days of reckless behavior and unchecked excess at the heart of this crisis, where too many were motivated only by the appetite for quick kills and bloated bonuses," Obama said, promising new rules. "Those on Wall Street cannot resume taking risks without regard for consequences."

There are persistent but unconfirmed reports that the FBI and grand juries are looking at the e-mails of executives of failed institutions such as Bear Stearns, which pioneered the process of pooling sub-prime loans for sale to investors, and Lehman Brothers, which was a leader in these toxic products when it collapsed.

Records from AIG, which the Federal Reserve saved from collapse on Sept. 17, 2008, are also thought to be under review. The FBI reportedly is also looking at rating agencies Fitch, Moody's and Standard & Poor's to determine if they knowingly gave pools of sub-prime mortgages AAA investment-grade ratings, the best possible, despite evidence to the contrary.

Carter, the FBI spokesman, declined comment on ongoing investigations.

The lack of any prosecution to date doesn't mean authorities aren't investigating, added Ian McCaleb, a spokesman for the Department of Justice.

"There are ongoing cases. But from a prosecution standpoint, it takes a significant amount of time to develop these things. Most financial fraud cases are very complex and it could take a while to unravel the specifics of each case," he said. "I would characterize financial fraud as one of our top priorities."

Another possibility is that a new politically appointed Financial Crisis Inquiry Commission could turn up something that leads to prosecution. The 10-member panel, created by Congress this month, began probing the origins of the crisis, has subpoena power and could compel testimony. This could, however, lead to conflicts with ongoing legal investigations.

Another reason that there've been no arrests of the perpetrators of the financial meltdown is that agencies such as the SEC, which regulates trading in stocks and bonds, and the Commodity Futures Trading Commission, which oversees the trading of contracts for future delivery of energy and farm products, lack powers of criminal prosecution.

They can bring civil charges that result in fines or pass information to federal prosecutors or the FBI, which under the Bush administration was reorganized to focus less on white-collar crime and more on national security matters and crimes against children.

Legislation introduced in the House and Senate would make it easier for the CFTC to prosecute, especially allegations of market manipulation. Measures would lower the current high threshold for determining manipulation. In 35 years, the agency has won only a single manipulation case, and it's under appeal. The bills also would give commodities regulators powers to bring criminal cases.

"Folks who do the crime shouldn't just pay a fine, but do the time," said Bart Chilton, a CFTC commissioner who's championed the need for prosecutorial powers.

Because it saves time and money, regulators traditionally have negotiated settlements with bad actors, and fines often amount to a business cost.

That, too, may be changing, however. The SEC on Sept. 14 was hit with a stinging judicial rebuke for its half-hearted efforts to punish Bank of America for alleged disclosure failures in the government-brokered purchase of investment bank Merrill Lynch.

U.S. District Judge Jed Rakoff tossed out a $33 million settlement between the SEC and Bank of America, effectively calling it a fig leaf. The agency, he said, looked as if it was enforcing the law while the bank and its CEO, Kenneth Lewis, got away with a slap on the wrist.

"It is not fair, first and foremost, because it does not comport with the most elementary notions of justice and morality, in that it proposes that the shareholders who were the victims of the bank's alleged misconduct now pay the penalty for that misconduct," Rakoff wrote in a scathing 12-page opinion that ordered the complaint to proceed to trial.

Thursday, May 6, 2010

GlaxoSmithKline receives UK approval for Combodart

GlaxoSmithKline has been granted a licence approval for Combodart, a new treatment for moderate-to-severe benign prostatic hyperplasia (BPH).

The therapy, which is a combination of dutasteride and tamsulosin hydrochloride, has been approved on the basis of results from a four-year clinical study, which showed its efficacy in reducing the risk of urinary retention and BPH-related surgery.

It is the first treatment to be approved in the UK which combines the positive effects of two separate recommended monotherapies.

Dr Jon Rees, a GP from Bristol with a special interest in urology, said the effectiveness of the treatment makes it more likely that patients will stick to medication regimes and avoid disease progression.

He added: "By delivering all the advantages of two treatments in one single capsule, the arrival of Combodart represents a new approach to BPH management in the UK."

Last week, GlaxoSmithKline published its financial report for the first quarter of 2010, reporting a year-on-year turnover increase of 13 per cent.

Saturday, May 1, 2010

For Investors, Diabetes Is a Growth Industry: GlaxoSmithKline

The numbers are sobering. Approximately 24 million Americans today have diabetes, and another 12 million are expected to be diagnosed by 2020, according to the American Diabetes Association. One survey puts the toll of lost productivity and caring for diabetes patients at $218 billion annually in the U.S. alone.Yet for investors, the fast-growing diabetes industry suggests something else: opportunity.

Each week seems to bring another development. Earlier this month, Swiss pharma giant Roche Holding AG announced its acquisition of a unit working on a new type of insulin patch. That development came on the heels of AstraZeneca's rollout of the new diabetes drug, Onglyza, in India — a country that is projected to have the most diabetes cases globally by the end of 2010, according to the International Diabetes Federation (IDF). In January, Novo-Nordisk got approval for its new once-a-week diabetes drug, Victoza, one of a new generation of similar medications.

Of course, not every new diabetes product is a success. The FDA may be considering halting trials of GlaxoSmithKline’s diabetes treatment Avandia due to possible side effects like increased risk of heart attack. (In a statement, GlaxoSmithKline says it “welcomes additional scientific information that could help guide decisions around clinical trials and ultimately patient safety.”) Inhaled insulin drugs have also been something of a bust, with Eli Lilly, Pfizer and Novo-Nordisk abandoning efforts to develop those products.

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Friday, April 30, 2010

NRG Energy, Inc. to Present First Quarter 2010 Earnings on May 10

NRG Energy, Inc. to present the Company's first quarter 2010 financial results to the financial community in a conference call to be held Monday, May 10, at 9:00am eastern.

Investors, the news media and others may access the live webcast of the conference call and presentation materials by logging on to NRG's website at http://www.nrgenergy.com and clicking on "Investors." The webcast will be archived on the site for those unable to listen in real time.

About NRG

NRG Energy, Inc., a Fortune 500 and S&P 500 Index company, owns and operates one of the country's largest and most diverse power generation portfolios. Headquartered in Princeton, NJ, the Company's power plants provide more than 24,000 megawatts of generation capacity--enough to supply more than 20 million homes. NRG's retail business, Reliant Energy, serves more than 1.6 million residential, business, commercial and industrial customers in Texas. A past recipient of the energy industry's highest honors--Platts Industry Leadership and Energy Company of the Year awards, NRG is a member of the U.S. Climate Action Partnership (USCAP), a group of business and environmental organizations calling for mandatory legislation to reduce greenhouse gas emissions. More information is available at www.nrgenergy.com.

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GlaxoSmithKline launches mini Nicorette lozenges

GlaxoSmithKline said Tuesday it is selling a fast-dissolving lozenge version of its Nicorette anti-smoking lozenges.

The British drugmaker said the new mini lozenge dissolves up to three times faster than similar products. It is designed to help relieve nicotine cravings and withdrawal symptoms, and comes in a small pocket-size vial. The company is launching the lozenges with a campaign that includes a Facebook contest.

GlaxoSmithKline reported about $529 million in nicotine replacement therapy revenue in 2009, including sales of Nicorette gum, Nicoderm CQ patches and Commit lozenges.

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GlaxoSmithKline Q1 results 'strong'

The pharmaceutical company, which rivals AstraZeneca, says it was encouraged by underlying revenue growth which was driven by emerging markets and consumer health growth.

The stock has marginally underperformed the rest of the FTSE 100 on concerns over US Healthcare reform, however rose swiftly by about 1.2 pct on the news.

It remains down since however since then.

The profits at the group beat market expectation at £7.36 bn whilst margins were affected as the Group prepares its business to absorb any future US Healthcare reform.

Overall, profits were £2.23 billion and 30.7p earnings per share - slightly under some expectations of £2.41 billion and 31.3p earnings per share which investment bank Nomura gave.

The earnings however did beat consensus.

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Sunday, April 18, 2010

FDA Chides Glaxo for Cancer-Drug Ad

The Food and Drug Administration on Friday said an advertisement for a GlaxoSmithKline PLC cancer drug and a Web site for a bladder treatment the company co-promotes were "false or misleading."

The agency also took issue with a consumer email from Novartis AG about its pain gel Voltaren.

Specifically, an advertisement that ran in a cancer medical journal involving Glaxo's drug Arzerra omitted "important information about the drug's safety and effectiveness," the FDA said in a letter to the company that was posted on the agency's Web site. Arzerra was approved in October to treat chronic lymphocytic leukemia after other therapies fail.

The agency said the ad, which ran in December, failed to reveal any risks associated with the product, including a serious brain infection, pneumonia, fevers and other blood disorders. The agency said a Web-site address provided in the ad that directed people to all the prescribing information for Arzerra doesn't mitigate the "misleading omission of material information from the ad."

Mary Anne Rhyne, a Glaxo spokeswoman, said the Arzerra ad referenced by the FDA won't be used again.

"We are working to resolve any remaining questions and ensure our materials reflect the direction provided by the FDA," she said.

In another letter released Friday, the FDA said a Web site for the drug Vesicare, which is co-promoted in the U.S. by GlaxoSmithKline, of Brentford, England, and Japan's Astellas Pharma Inc., presented unsubstantiated superiority claims and overstated the effectiveness of the product. Vesicare is approved to treat a condition known as overactive bladder.

The agency said information on the Web site suggested Vesicare was better than another drug, tolterodine, at improving incontinence, by citing a study comparing the products. The FDA said the information used to make a superiority claim involved a secondary study endpoint, rather than a main study goal, and doesn't provide enough evidence to suggest Vesicare is better than the other drug.

Both Astellas and GlaxoSmithKline said the Vesicare Web site has been changed to remove the content the FDA was concerned about.

The FDA said a so-called "adherence email" sent by Novartis involving Voltaren, a gel applied to the knees or hands for osteoarthritis pain, "minimizes risks associated with the use of Voltaren Gel, overstates the efficacy of Voltaren Gel and broadens the indication for Voltaren Gel."

The agency said the email "prominently presents efficacy claims" or effectiveness information "in large bolded font size and in colorful text and graphics surrounded by a significant amount of white space" while the "risk information is relegated to the bottom of the email...in single-spaced paragraph format that makes the information very difficult to read."

In a statement, a Novartis spokeswoman said the Swiss company was reviewing the letter it received from the FDA. "We plan to work with the FDA to address concerns," she said.

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Tuesday, April 13, 2010

Glenmark settles malaria drug patent dispute with GlaxoSmithKline news

Glenmark Generics Inc., USA, the US subsidiary of Glenmark Pharmaceuticals Limited (GPL), today announced that it has settled patent issues with GlaxoSmithKline (GSK) concerning atovaquone and proguanil hydrochloride tablets, the generic version of GSK's Malarone tablets use in the treatment of malaria.

Under the terms of the agreements, which are still subject to review by the US Federal Trade Commission and the Department of Justice, Glenmark will be able to market and distribute its atovaquone / proguanil 250mg and 100mg tablets under a royalty-bearing license from the London-based GSK in the 3rd quarter of calendar year 2011, or earlier under certain circumstances.

Glenmark said in a statement that it believes that it is entitled to 180 days of exclusivity with respect to its atovaquone / proguanil tablets as the first generic to file an Abbreviated New Drug Application (ANDA) for the drug.

ANDA is an application filed for a generic drug approval in the US for an existing licensed approved drug. GSK, the UK's biggest pharmaceutical company, currently markets its product as Malarone in the US, a drug prescribed for the prevention and treatment of malaria.

The IMS Health has reported that the total US sales of Malarone for the 12 month period ending December 2009 were approximately $56 million.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader.

GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the US and the European Union, as well as its oncology FDF products in South America.'

The Company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.

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Thursday, March 25, 2010

GlaxoSmithKline: The Unluckiest Pharma Company in the World

GlaxoSmithKline (GSK), the world’s second-largest drug maker, just can’t seem to catch a break.

It appears the Swiss pharma giant can do nothing right these days. First, there was Advair, the asthma drug that worsened the condition with prolonged use, then there was Avandia, the diabetes drug which has been shown to cause heart attacks. Now, there is GSK’s vaccine for the diarrhea-inducing virus Rotarix. The vaccine was found to contain traces of the supposedly innocuous pig disease called porcine circovirus.

Several governments have advised their doctors to avoid treating patients with the drug until the risk of the unintended ingredients can be determined. Switzerland is the most recent country to issue a cease and desist order. The company spokespeople insist this is only a temporary precaution, and that those who have already been inoculated with the drug have nothing to fear. Stay tuned for further mishaps from GlaxoSmithKline, we predict their heavy-hitter, Tums, will be shown to cause indigestion and heartburn.

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Pfizer and GlaxoSmithKline in deal to supply low-cost vaccines

Pfizer and GlaxoSmithKline will supply hundreds of millions of doses of their pneumonia vaccines to the world's poorest countries at heavily discounted prices under a novel agreement, reports the New York Times.


The deal was announced by the Gavi Alliance, a non-profit organisation, which estimated the program could save a total of 900,000 lives by 2015 and up to seven million lives by 2030.

Pneumococcal disease not only kills small children but also maims, leaving survivors with high rates of mental disability, seizures and deafness, says Sarah Boseley in the Guardian. She continues: "There's no doubt about the good that such a vaccine can do. But there will continue to be questions about the way the deal has been done, not least because it is the first of its kind and sets a pattern for the future".


Pfizer and GlaxoSmithKline will provide up to 300 million doses each of their vaccines over a 10-year period under the new agreement. The price for the first 20% of the supply will be $7 a dose. Then the price will drop to $3.50 a dose for the remainder. The vaccines would be paid for by donations raised by Gavi and by the governments of the countries that ordered the vaccines. In Western markets, the pneumococcal vaccines sell for $54 to $108 a dose.

"For the price of a Starbucks latte, developing countries are going to be able to buy a dose of a life-saving vaccine," said Orin Levine, director of the international vaccine access center at the Johns Hopkins Bloomberg School of Public Health, who has worked with GAVI.

The NYT reports that officials involved in the deal say that it historically took many years for a vaccine developed in the West to trickle down to developing countries. But the new program would make the first vaccines available to Africa this year.

"American kids and African kids will get this new vaccine in the same year," Dr. Levine of Johns Hopkins said. "That's just never happened before."


Sunday, March 14, 2010

GlaxoSmithKline makes vaccine executive changes

British pharmaceutical company GlaxoSmithKline PLC on Friday announced two changes in the executive lineup of its vaccines business.

Jean Stephenne was appointed chairman of GSK Biologicals with immediate effect. He will also continue in his current role as president of GSK Biologicals.

Over the next two years, Glaxo said, operational responsibility will be taken over by Dr. Moncef Slaoui, who will also continue as chairman for research & development.

"Jean has built a world-leading vaccines business and as chairman will continue to be instrumental in driving forward our public health agenda," said Chief Executive Andrew Witty.

"Moncef has more than 17 years experience working in the vaccines area and has played a critical role in developing the strong pipeline we have today. These changes will ensure continued strong focus on delivery and development of this pipeline."

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Saturday, February 13, 2010

GlaxoSmithKline to cut 380 jobs at UK research facility

UK-based pharmaceutical group GlaxoSmithKline is planning to reduce its workforce at the company's R&D facility in Harlow, Essex. According to reports, approximately 380 employees are likely to lose their jobs at the facility.

The company has decided to implement the job reductions following the completion of projects for pain relief, anxiety and depression drugs.

Andrew Witty, CEO of GlaxoSmithKline, was quoted by Canadian Business Online as saying: "Glaxo would discontinue research in some areas including depression and pain, and would focus more on degenerative and inflammatory diseases such as Alzheimer's disease and Parkinson's disease."

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Thursday, February 11, 2010

GlaxoSmithKline Creates New Unit for Rare Diseases R&D

GlaxoSmithKline (GSK) launched a stand-alone unit that will specialize in the research and development (R&D) and commercialization of medicines for rare diseases. The operation, which will be led by Marc Dunoyer, president of GSK's Asia Pacific operations and chairman of its Japan group, will seek to "leverage existing capabilities and partnerships, and further establish in-licensing opportunities," according to a company press release.

"In addition to our existing discovery effort, alternative opportunities need to be explored to make treatments available for rare diseases," Dunoyer said in the press release. "This complementary approach will combine our existing global expertise with specialist partners. Over time, this new unit has the potential to deliver multiple therapies responding to high medical needs of underserved populations of patients."

In 2009, GSK entered into collaborations with Prosensa (Leiden, The Netherlands) and JCR Pharmaceuticals (Hyogo, Japan), that focus on therapeutics that could be used to treat orphan diseases.

"The entry into this new therapeutic area forms part of our strategy to deliver more products of value and improve returns in R&D through a focus on areas with a higher probability of success," Patrick Vallance, GSK's senior vice-president of drug discovery, said in the press release. "The risk associated with product discovery and development in rare diseases is generally lower than other disease areas, as disease definitions are very clear and clinical trials tend to be small with robust endpoints. In most cases, the molecular target is known, making it easier for specialized physicians to diagnose patients.”

According to GSK, more than 5500 rare diseases have been identified, but less than 10% are being treated.

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Wednesday, February 3, 2010

GlaxoSmithKline to Cut Upwards of 4,000 Jobs

GlaxoSmithKline PLC, a worldwide pharmaceutical company with about 99,000 employees, is expected to announce between 3,000 and 4,000 job cuts this week.

The company, which declined to comment on the published reports, is slated to announce its fourth quarter results Thursday. The job-cut news comes a week after competitor AstraZeneca said it planned to eliminate 8,000 jobs, or 12 percent of its workforce, by 2012.

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Sunday, January 31, 2010

Regain Your Lost Sexual Power with levitra manufactured by GlaxoSmithKline

Recent medical research found that Levitra plays a very significant role in curing your lost sexual urges. It is very effective and one dose is enough for a day. Though side effects are very mild and reversible but consulting a doctor shall benefit you the most. But one should strictly keep this in mind that Levitra helps only to regain your lost sexual power and is not meant for any sexually transmitted diseases.

Levitra, Levitra Online Information, Erectile dysfunction, Online Levitra Prescriptions, Online Levitra

Just imagine you are running from pillar to post inorder to save your married life. Why? Because you have lost you sexual power and is unable to satisfy your partner. It’s really a serious problem that can bring a complete halt to your normal and happy life. Now if you think there is still power inside you but is becoming incapable of utilizing it, then it is the high time that you seek for some remedies as soon as possible.

Now don’t take your sexual dysfunction as a disease rater you should know that there is some metabolic disorder inside you for which you are loosing your sexual power. So it is better to rectify the disorder as soon as possible or else it would be too late. Every problem does have a solution and Levitra can be your option to choose. It is an oral therapy treatment to boost up your sexual power. Each tablet is either of 10mg or 20 mg strength. However two lower doses (2.5 and 5.0) are also available usually for the first time users.

Generally Levitra is taken with or without food just one hour before going to bed with your partner. Some sexual stimulation is needed for a sexual urge to occur with Levitra. A chemical named Verdenafil HCL in Levitra stimulates your nerves in your penis and increase the amount of blood flow to erect your sleeping penis. However erection decreases after the act. It is so effective that 90% of men reported to have improved erections and a dose is enough to work for 24 hours.

Levitra got its approval from FDA on 19th august 2003 and the sole manufacturers of this drug are Bayer and GlaxoSmithKline. Due to its increasingly productive results it has captured the market within a very short span of time.

However no major side affects are reported till date, expect a bit of headache, constipation and dizziness. These are normal affects only for the first timers and tend to fade away as the body gets used to it. But it is always a cleaver idea to consult a sexologist before getting used to it especially for people with heart troubles.

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GlaxoSmithKline fined $5.8 million for deceptive marketing in Ky.

Franklin Circuit Judge Roger Crittenden has awarded Kentucky more than $5.8 million in civil penalties in its case against GlaxoSmithKline for deceptive or false marketing of drugs including the anti-nausea drugs Kytril and Zofran.

The award was announced by state Attorney General Jack Conway and was the second in two days against a major pharmaceutical company. On Wednesday, Conway announced that Crittenden had awarded $5.3 million in civil penalties against AstraZeneca for violating Kentucky's Consumer Protection Act.

On Nov. 13, a Franklin Circuit Court jury handed down a $661,860 verdict against Glaxo.

Mary Ann Rhyne, a spokeswoman for Glaxo, said the company "is disappointed because we believe the result is disproportionate to what the jury found, and we're considering our options including an appeal."

The state attorney general's office has filed suit against 47 pharmaceutical companies alleging violations of Kentucky's Medicaid Fraud and Consumer Protection statutes, and false and deceptive advertising.

Glaxo, Novartis and AstraZeneca were sued by Alabama based on claims that their actions resulted in the state paying too much for drugs. Judgments against the companies were overturned by the Alabama Supreme Court in 2009 when the court ruled the companies did not defraud the state in pricing Medicaid prescription drugs.

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GlaxoSmithKline's LamictalXR Gets FDA Approval For Tonic-Clonic Seizures - Update

Drug maker GlaxoSmithKline said it has received an approval for LamictalXR from the U.S. Food and Drug Administration for the treatment of tonic-clonic seizures as an once-a-day, add-on therapy for epilepsy in patients aged 13 years and older. The drug is already approved for partial onset seizures for patients in this age group.

The addition of LamictalXR to therapy for patients 13 years of age and older, reduced seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures in the study.

Victor Biton, director of the Arkansas Epilepsy Program and Clinical Trials, Inc., in Little Rock, Arkansas said, "We were encouraged that the study showed such a significant reduction in the number of primary generalized tonic-clonic seizures in patients who received Lamictal XR in addition to their current regimen. Over the 19 week treatment period, the median percent reduction in weekly seizure frequency was 75 percent in patients treated with Lamictal XR compared to 32 percent for those taking placebo."

Also known as "grand mal" seizures, primary generalized tonic-clonic seizures, are most common form of seizure occurring in approximately 20% of patients with epilepsy. Usually, patients experiencing a generalized tonic-clonic seizure lose consciousness and, collapse following which they experience muscle stiffening (the tonic phase) and then jerking involving both sides of the body (the clonic phase).

Lamictal XR may cause a serious skin rash that may cause the patient to be hospitalized or to stop the drug, though it may rarely cause death. Lamictal XR can also cause other types of allergic reactions or serious problems which may affect organs and other parts of the body like the liver or blood cells.

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Friday, January 22, 2010

GlaxoSmithKline, Genmab Get European Approval For Arzerra

The European Medicines Agency Thursday approved a new leukemia medicine from GlaxoSmithKline PLC (GSK.LN) and Denmark's Genmab A/S (GEN.KO), although it still wants further data about the drug's long-term effects.

The EMEA said it granted conditional marketing authorization for Arzerra as a treatment for patients with chronic lymphocytic leukemia who don't respond to fludarabine or Campath, a drug sold by Genzyme Corp. (GENZ).

However, the agency added it wants to see further clinical data about long-term use of Arzerra and data on a specific group of patients who don't respond to fludarabine but can't be given Campath.

An agency spokeswoman said conditional marketing authorization is granted when there's a real need for medicines in serious illnesses.

"We need additional data but nevertheless the benefit is considered quite high," said the spokeswoman.

Also Friday, the EMEA said it approved Arepanrix, a second swine flu vaccine from GlaxoSmithKline.

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