Posts Tagged ‘GlaxoSmithKline’

U.K. Medical Journal Questions Avandia License

Followup on "After Avandia: Does the FDA Have a Drug Problem?"Ilene 

U.K. Medical Journal Questions Avandia License

BY JASON DOUGLAS AND STEN STOVALL, WSJ

LONDON—The British Medical Journal on Monday said GlaxoSmithKline PLC’s diabetes drug Avandia should never have been licensed and should be withdrawn from sale, a claim the company rejected.

An investigation by the journal found the U.K. Commission on Human Medicines in July advised the country’s drugs regulator, the Medicines and Healthcare products Regulatory Agency, or MHRA, to withdraw Avandia from sale because its risks outweigh its benefits.

The probe also found members of a European panel that reviewed the drug prior to its European Union-wide approval in 2000 had concerns about the long-term risks and benefits of Avandia, also known as rosiglitazone. The journal raised concerns about the quality of the data GlaxoSmithKline used to show Avandia didn’t lead to increased heart problems compared with other diabetes drugs.

Avandia was once Glaxo’s second-biggest drug, raking in about $3 billion a year. But its sales have plunged since a U.S. study linked it to heart attacks in 2007, and second-quarter revenue was only £152 million ($235 million) as patients defected to alternatives, such as Takeda Pharmaceutical Co.’s Actos.

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After Avandia: Does the FDA Have a Drug Problem?

This could have been titled, "Does America Have an FDA Problem?"  My yellow highlighting and red comments. – Ilene

After Avandia: Does the FDA Have a Drug Problem?

MIAMI - JULY 14: A bottle of the diabetes drug, Avandia is seen on July 14, 2010 in Miami, Florida. Today, the U.S. Food and Drug Administration panel voted to recommend that GlaxoSmithKline PLC's (GSK) diabetes drug, Avandia, remain on the market despite concerns that the product could raise the risk of heart attacks. (Photo illustration by Joe Raedle/Getty Images)

By Massimo Calabresi with Alice Park, courtesy of TIME 

Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug’s maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company’s $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia. The most recent studies of Avandia, the GSK officials told the FDA, had "yielded information that is inconsistent with an increased risk of myocardial ischemic events," according to sealed court proceedings obtained by TIME.

What GSK didn’t tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK’s Global Safety Board had noted that a new assessment of Avandia studies "strengthens the [cardiac-risk] signal observed in the [previous] analysis." Or that eight days earlier, the company’s head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an "increased risk of ischemic event ranging from 30% to 43%!" Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group.

But the mixed-evidence argument GSK presented to the FDA worked. After months of deliberation, the agency decided to keep the drug on the market — a move worth billions of dollars to GSK but that also may have put millions of patients at risk.

Such examples of the drug industry’s outmaneuvering FDA regulators are disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring. More than 140 million Americans take at least one prescription drug in any given month, and they rely on the FDA to ensure those drugs are safe. That trust, the story of Avandia illustrates, is…
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Something to Love about GSK

Something to Love about GSK

Courtesy of Pharmboy

Visit Pharmboy here for his previous articles on pharm/biotech stocks and chapters in his TA book. 

UK-based GlaxoSmithKline was ranked as the world’s fourth largest player in 2009 (behind US-based Pfizer, France-based Sanofi-Aventis and Switzerland-based Novartis) based on prescription pharma sales. The company was founded in 2000 via the merger of Glaxo Wellcome and SmithKline Beecham and is headquartered in Brentford, London, UK.  I wrote about GSK in my first PSW write-up in 2009.

In terms of its therapeutic focus, GSK owes its market-leading position in the global respiratory market to the Glaxo Laboratories legacy.  Over 30 years ago, Glaxo launched Ventolin for the treatment of asthma and developed and launched Serevent and Flixotide in 1990.  A combination of these two compounds—sold under the brand names Seretide/Advair ($7.8B in 2009).  Similarly, GSK’s origins in the CNS market—currently its third largest therapeutic area of focus—can be traced back to the Wellcome and SmithKline scientists.  Other therapeutic areas of importance include infectious disease and virology (vaccines).


 

The merger of Glaxo Wellcome and SmithKline Beecham created a company with a strong portfolio of blockbuster brands including Seroxat/Paxil (depression),now off patent Seretide/Advair (asthma, COPD) which dominates the respiratory arena, Wellbutrin (depression) now off patent, Augmentin (infections) now off patent, Avandia (diabetes), Imigran/Imitrex (migraine) and Lamictal (epilepsy) now off patent. However, since its creation in 2000, GSK has failed to add to its portfolio with any additional blockbuster drug launches.  Instead, like its rival Pfizer, GSK has been forced to implement cost reductions in the medium term. Sales of Seroxat/Paxil have been eroded by generics (as have Augmentin and Wellbutrin ) in the US market prior to 2011.  In addition, its second largest product Avandia faces declining sales as a result of concerns that have emerged regarding its side-effect profile (e.g., its association with a heightened cardiovascular risk).  Many feel that the company faces pressure from investors to revive its performance. and must turn to M&A activity.  Thusfar, GSK has been reluctant to make such a move. (Gilead for the HIV franchise?) 

What GSK has done instead is sought to in-license product rights in order to boost the sales potential of its portfolio.  Of the eight products launched by GSK since 2000, four have been in-licensed (Lexiva from Vertex, Levitra from Bayer, Boniva from Roche and Vesicare from Astellas). However,


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Study Suggests HPV Vaccine Is Safe, but Doctors Wary

Study Suggests HPV Vaccine Is Safe, but Doctors Wary

A nurse administers a shot of Gardasil — a vaccine for HPV, or human papillomavirus — to a 14-year-old patientBy Alice Park, courtesy of TIME

Generally the fact that a vaccine appears to be as safe as the manufacturer had promised shouldn’t be news. It should be a given. But when it comes to the controversial vaccine against human papillomavirus (HPV), even the most straightforward data come with an asterisk.

The vaccine, called Gardasil and manufactured by Merck, is one of the first immunizations to protect against a cancer — in this case, cervical cancer, which is most commonly caused by infection with HPV. Because the virus is sexually transmitted, the Centers for Disease Control and Prevention (CDC) recommended in 2006 that girls get the vaccine at ages 11 and 12, before they become sexually active, so they have the best chance of avoiding the cancer and genital warts caused by HPV. States joined in, attempting to mandate HPV vaccination for school entry, but parents balked, in part because of concerns about encouraging promiscuity. It didn’t help that girls were prone to fainting after getting the shot or that more than two dozen girls died shortly after getting immunized.

Cryo-electron micrograph of human papilloma virus - TIMETo address those concerns, researchers at the CDC and the FDA, which keep track of adverse events related to vaccines once they are approved, now report in the Journal of the American Medical Association (JAMA) that the rate of adverse events associated with the 23 million doses of Gardasil administered since 2006 is similar to the prelicensing rate among the 21,000 girls and young women who tested it in clinical trials and to that of other vaccines.

That should be reassuring. But the study did find that users of Gardasil faint and develop blood clots more often than those receiving other shots. The clots are extremely rare, though. In about 90% of these cases, the girls may have been more vulnerable to developing clots because they smoked or were overweight or on birth control pills. "Was it that this age group also tends to have these risk factors or did the vaccine have some sort of role?" asks the CDC’s Dr. Barbara Slade, lead author of the paper. "We really don’t know."

It’s that uncertainty that is beginning to bother many physicians about the HPV vaccine. According to Dr. Charlotte Haug, editor in chief of the Journal of the Norwegian Medical Association and author of an editorial that JAMA
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Phil's Favorites

The British election explained in five key phrases

 

The British election explained in five key phrases

Courtesy of Veronika Koller, Lancaster University

The UK government’s decision to hold its third general election since 2015 is a baffling one to many – including the weary voters who have to take part.

Tensions have been high as the country attempts to resolve the identity crisis first sparked by the Brexit vote in 2016. It’s a complicated moment for the nation and, at times like these, it can help to observe the big issues through the lens of language. The slogans and terms that get thrown around again and again during a campaign can often tell us a lot about the bigger picture. Here are five such slogans that can help explain what’s happening in the UK right now.

‘Get Br...

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Zero Hedge

Why "This Sucker Is Going Down"

Courtesy of ZeroHedge View original post here.

Authored by Charles Hugh Smith via OfTwoMinds blog,

Once the contagion starts spreading, loose money won't put the fires out.

As the nation's political and economic leaders struggled to contain the 2008 financial meltdown, President George W. Bush famously summed the situation up: "If money doesn't loosen up, this sucker will go down."

Eleven years into the loose money recovery, this sucker is finally going down for reasons tha...



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Digital Currencies

Three Men Arrested In NJ For Running Alleged $722 Million Crypto Ponzi Scheme

Courtesy of ZeroHedge View original post here.

Authored by Kollen Post via CoinTelegraph.com,

United States authorities in New Jersey have announced the arrest of three men who are accused of defrauding investors of over $722 million as part of alleged crypto ponzie scheme BitClub Network, per a Dec. 10 announcement from the Dep...



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Kimble Charting Solutions

Is Freeport McMoRan (FCX) Making A Run For the "Gold"?

Courtesy of Chris Kimble

Mining company Freeport McMoRan NYSE: FCX is enjoying the tailwind from a strong year for gold and silver prices. And although Copper prices are down, Copper has been turning up lately.

This has helped Freeport’s stock price recover in 2019 and has FCX testing a key breakout level.

Below is a “weekly” chart of Freeport McMoRan (FCX). The shaded channel outlined by each (1) highlights the longer-term downtrend that FCX has been stuck in.

But this could change on a dime, especially if FCX can breakout above (2). This area represents its re...



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Insider Scoop

Economic Data Scheduled For Wednesday

Courtesy of Benzinga

  • The MBA's index of mortgage application activity for the latest week is schedule for release at 7:00 a.m. ET.
  • The Consumer Price Index for November will be released at 8:30 a.m. ET.
  • The Census Bureau quarterly services survey report for the third quarter is schedule for release at 10:00 a.m. ET.
  • The Atlanta Fed's Business Inflation Expectations survey report for December will be released at 10:00 a.m. ET.
  • The Energy Information Administration’s weekly report on petroleum inventories in the U.S. is schedule for release at 10:30 a.m. ET.
  • The Federal Open Market Committee will announce its policy decision at 2:00 p.m. ET.
  • The U.S. Treasury budget report for November will be released at 2:00 p.m. ET.
  • ...


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Lee's Free Thinking

Chart Shows the Fed Ramping Up Not QE - Funding Almost All Treasury Issuance

 

Chart Shows the Fed Ramping Up Not QE – Funding Almost All Treasury Issuance

Courtesy of Lee Adler, Wall Street Examiner 

The Fed is ramping up “Not QE” .

The Fed bought $2.2 billion in notes today in its POMO, “not QE,” operations. Actually $2.15 billion because they sold back a whole $50 million. Must have been a little glitch in the force.

This brings the Fed’s total outright purchases of Treasuries to $170 billion since it started Not QE, on September 17.

It also did $107 billion in gross new repo loans to Primary Dealers to buy Tre...



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Chart School

Silver stock taking the sector higher

Courtesy of Read the Ticker

As the US economy begins to show late cycle characteristics like: GDP slowing, higher inflation, higher wage costs, CEO confidence slump. 

Previous Post: Gold Stocks Review

The big players in the market are looking for the next swing off good value lows. This means more money is finding it way into the gold and silver sector, and it is said gold and silver stocks actually lead the metal prices.

The cycle below shows prices are ready to move in the months ahead (older chart re posted).


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Members' Corner

Sacha Baron Cohen Uses ADL Speech to Tear Apart Mark Zuckerberg and Facebook

 

Sacha Baron Cohen Uses ADL Speech to Tear Apart Mark Zuckerberg and Facebook

By Matt Wilstein

Excerpt:

Sacha Baron Cohen accepted the International Leadership Award at the Anti-Defamation League’s Never is Now summit on anti-Semitism and hate Thursday. And the comedian and actor used his keynote speech to single out the one Jewish-American who he believes is doing the most to facilitate “hate and violence” in America: Facebook founder and CEO Mark Zuckerberg.

He began with a joke at the Trump administration’s expense. “Thank you, ADL, for this recognition and your work in fighting racism, hate and bigotry,” Baron Cohen said, according to his prepared...



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The Technical Traders

VIX Warns Of Imminent Market Correction

Courtesy of Technical Traders

The VIX is warning that a market peak may be setting up in the global markets and that investors should be cautious of the extremely low price in the VIX. These extremely low prices in the VIX are typically followed by some type of increased volatility in the markets.

The US Federal Reserve continues to push an easy money policy and has recently begun acquiring more dept allowing a deeper move towards a Quantitative Easing stance. This move, along with investor confidence in the US markets, has prompted early warning signs that the market has reached near extreme levels/peaks. 

Vix Value Drops Before Monthly Expiration

When the VIX falls to levels below 12~13, this typically v...



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Biotech

Why telling people with diabetes to use Walmart insulin can be dangerous advice

Reminder: We are available to chat with Members, comments are found below each post.

 

Why telling people with diabetes to use Walmart insulin can be dangerous advice

A vial of insulin. Prices for the drug, crucial for those with diabetes, have soared in recent years. Oleksandr Nagaiets/Shutterstock.com

Courtesy of Jeffrey Bennett, Vanderbilt University

About 7.4 million people ...



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Mapping The Market

How IPOs Are Priced

Via Jean Luc 

Funny but probably true:

...

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Promotions

Free eBook - "My Top Strategies for 2017"

 

 

Here's a free ebook for you to check out! 

Phil has a chapter in a newly-released eBook that we think you’ll enjoy.

In My Top Strategies for 2017, Phil's chapter is Secret Santa’s Inflation Hedges for 2017.

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About Phil:

Philip R. Davis is a founder Phil's Stock World, a stock and options trading site that teaches the art of options trading to newcomers and devises advanced strategies for expert traders...

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