Tag Archives: FDA

Are 90% Of FDA Drugs Approved In Last 30 Years No More Effective Than Existing Drugs?

By John LaMattina Let?s start with AIDS, which began spreading in the early 1980s. When first uncovered, there were no treatments for it. But in little more than a decade, AIDS was no longer a death sentence but a controlled disease thanks to the combined efforts of drug companies and the FDA. Perhaps AIDS drugs are the 10% of the new FDA approvals that Light feels are worthwhile. …read more

Source: FULL ARTICLE at Forbes Health

‘Why Are We Not Talking About PrEP?’

By The Huffington Post News Editors

A month ago, I began taking a blue pill each day, called Truvada.

It’s a combination of two of the three antiretroviral medications that form the cocktail used to treat people with HIV. Last year, the FDA approved the prescription of Truvada for the preventing of HIV in people who are uninfected. The term for this is pre-exposure prophylaxis (PrEP).

I’m HIV negative.

Read More…

…read more

Source: FULL ARTICLE at Huffington Post

A Missed Opportunity This Past July 4th

By Spiritof76

Declaration of Independence SC A Missed Opportunity This Past July 4th

July 4 refers to the day the Declaration of Independence from the British monarchical yoke was issued by some 56 noted individuals who risked their lives, fortunes, and their sacred honor for it. Several thousand American colonists fought and perished over a seven year period so that their posterity will live in a free nation governed with the consent of the people to secure their rights as free people.

The first ten amendments to the US Constitution ratified in 1791 contained the Bill of Rights that prohibits transgressions by the federal government into individual life, liberty, and pursuit of happiness.

In 2013, some 237 years later, the people have lost most of what was enshrined in the US Constitution. The federal government, instead of being limited in scope as intended, has become a dictatorial national government. Patrick Henry opposed the adoption of the Constitution as he feared the uncontained growth of the federal government by destroying the sovereignty of the individual states. He was right!

The American people lost their way in the early 1900s and allowed the concept of big government to come to fruition and to destroy the core principle of federalism during the Woodrow Wilson administration with the enactment of direct federal government taxation of Americans and the simultaneous removal of state representation in Congress by instituting the direct popular election of the Senators.

Article 1, Section 1 is in tatters as Congress has illegally delegated its legislative powers to such unelected agencies as the EPA, IRS, FCC, FDA, and the other hundreds of agencies with the full approval of the US Supreme Court. People did not bother to punish those politicians but accepted the despotic bureaucratic rule that we find today.

The First Amendment is just about erased. Political correctness depending upon the whims of the favorite political groups is allowed to override that right of free speech and declare it hate speech. There is no religious freedom today. If you do not practice what the national government dictates appropriate, you and your group will be punished with the help of the myriad of agencies it controls.

How about the freedom of the press? The government spies on the reporters, tries to intimidate their families, and prevents them from reporting anything unfavorable to it. Wilson jailed some of them for being against the American entry into WWI. Lincoln also did so in the Civil War.

The Second Amendment, whose presence in the Bill of Rights is for preserving freedom (not for hunting or sports shooting), is under severe assault. A national government that has gone rogue will disarm the citizens so that they can be turned into subjects.

The Fourth Amendment is extinct. Americans gave that up in the name of security. The US government with the guidance of the Supreme Court has eliminated the right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures without the required warrants based on probable cause. The president maintains a kill list that includes American citizens, deploys armed …read more

Source: FULL ARTICLE at Western Journalism

National gay blood drive aims to lift donation ban.

What do you think about this?

http://www.cnn.com/2013/07/11/health/gay-blood-drive/index.html?hpt=hp_bn13

— Activists are organizing the first national gay blood drive Friday in an effort to combat the Food and Drug Administration’s ban on blood donations from gay and bisexual men.

The FDA bans donations from men who have had sex with other men since 1977, saying there is an increased risk of exposure to and transmission of infectious diseases — including HIV — in male-to-male sexual encounters.

“FDA uses multiple layers of safeguards in its approach to ensuring blood safety,” the government agency’s website says. The FDA screens all potential blood donors based on risk factors and signs of infections.

…read more

Source: Worthy Christian Forums

2 FDA Decisions You Can't Afford to Miss This Week

By Sean Williams, The Motley Fool

Filed under:

Last week we focused on five can’t-miss earnings reports. This week, we’re going to turn the tables back to the Food and Drug Administration and focus on a PDUFA decision and an FDA panel review slated for this week.

Veloci-Raptor time?
First up is Raptor Pharmaceuticals with Procysbi (previously known as RP-103), its oral delayed and extended-release medication to treat nephropathic cystinosis. In trials, Procysbi proved to be non-inferior to the only other FDA-approved treatment for nephropathic cystinosis, known as Cystagon from Mylan .

As my Foolish colleague Keith Speights has already pointed out, both Procysbi and Cystagon are two different forms of cysteamine bitartate. However, Cystagon comes with the need to be taken four times daily (meaning sleep schedules can and will get interrupted) and has a slew of other potential side effects. Procysbi, on the other hand, needs only to be taken twice daily and has milder side effects.

From an ease-of-use standpoint, the drug looks like a slam-dunk for an approval, but the FDA will have to be able to determine that the side effects are diminutive compared to the benefits Procysbi can deliver. If Raptor can get Procysbi approved it would give the company its first revenue generating drug, as well as peak sales potential in the U.S. of $60 million according to JMP Securities. This PDUFA decisions has already been pushed back 90 days to review additional data, so this will certainly be a name to watch on Tuesday.

Will AVEO be on target?
The other FDA decision that should have the attention of biotech investors this week is AVEO Pharmaceuticals‘ Tivozanib, which is set to go before the FDA‘s review panel on Thursday.

Tivozanib is an oral, once-daily treatment for metastatic renal cell carcinoma that works by blocking three VEGR-receptors that are critical for blood vessel growth development for solid renal cell tumors, and is being targeted as a first-line treatment. In trials, AVEO and its partner Astellas Pharma went head-to-head against Onyx Pharmaceuticals‘ Nexavar and delivered good, but not groundbreaking, results. In its TIVO-1 study, released last year, Tivozanib met its primary progress-free survival endpoint and delivered a median PFS of 11.9 months compared with the median PFS of just 9.1 months for Nexavar. The difference was even more pronounced in treatment-naive patients where the PFS difference grew to 12.7 months as compared to 9.1 months for Nexavar. However, overall survival rates for AVEO‘s drug actually were slightly lower than Nexavar over the course of the study.  

Regardless of what the FDA panel has to say about Tivozanib, it could be an uphill struggle given that seven drugs are currently approved by the FDA to treat renal cell carcinoma. In addition to the aforementioned Nexavar, Pfizer‘s Sutent is a lead drug in metastatic renal cell carcinoma, delivering $1.24 billion in sales — a 9% year-over-year increase — in 2012.Even if Tivozanib makes it through the gauntlet,

Source: FULL ARTICLE at DailyFinance

How Apple Accidentally Revolutionized Health Care

By Keith Speights, The Motley Fool

2014 Toyota 4Runner reveal at Stagecoach Music Fest

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Apple didn’t necessarily intend to revolutionize health care, but that’s exactly what happened. Health care has changed dramatically since Steve Jobs first stood in front of an audience to introduce first the iPhone then later the iPad. Much of that change can be directly attributed to Apple.

 

Source: 3D4Medical.

Apples and doctors
It used to be said that an apple a day keeps the doctor away. That could still be applicable, but the opposite is true for doctors and Apple. Physicians love their iPhones and iPads.

A study by Manhattan Research in 2011 found that 75% of physicians owned at least one Apple product. Vitera Healthcare‘s 2012 survey of health-care professionals backed up this high number. The company’s study found that 60% of respondents used an iPhone and 45% owned an iPad.

The real revolution, though, has come from how physicians and other health-care professionals are using Apple’s devices. Mobile applications opened the door for clinicians to instantly access a world of medical information at the point of care.

For example, WebMD‘s Medscape application allows physicians to check drug interactions, look up information about procedures, and see medical news updates on the fly. Medscape ranks first among the most frequently downloaded medical apps for iPhones and iPads.

Yale University’s School of Medicine even did away with paper materials for training upcoming physicians. The school provided iPads and wireless keyboards to all of its medical students. Other schools followed suit.

Health eVillages’ experience underscores the transformational impact of Apple’s technology. The not-for-profit organization provides mobile health technology to medical professionals in areas such as Kenya and Haiti. Lives have been saved that otherwise would have been lost, thanks to doctors in remote areas who use an iPad to access needed information.

Use of Apple’s products goes beyond serving as a reference tool, though. An application that allows radiologists to view MRIs as well as CT, PET, and SPECT scans on iPhones and iPads received FDA approval in 2011. More recently, the FDA cleared the way for privately held Welch Allyn to connect its portable ophthalmoscope to an iPhone for doctors to view retinal images using the company’s app.

iPatients
Apple perhaps unwittingly opened new horizons for patients also. By April 2012, the company’s App Store included more than 13,600 health-related applications.

A peek at some of the current top-selling apps shows how much Apple’s technology has empowered patients. One application allows individuals to monitor their sleep cycles. Another provides a detailed guide to help expectant mothers through their pregnancies.

Pharmaceutical companies are getting into the act. For example, Vivus recently introduced an app for iPhones (and Android phones) that complements its weight-loss drug. The app allows patients to record what they eat and track their weight plus receive regular information updates.

Vital Art and Science recently gained FDA approval to sell its myVisionTrack product, which enables people with macular degeneration and other degenerative eye diseases to monitor their

Source: FULL ARTICLE at DailyFinance

The FDA, Surrogate Endpoints, And Blood Pressure Drugs

By Larry Husten, Contributor

In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels– the surrogate endpoint– serious questions emerged about the cardiovascular safety of the drug, eventually leading to its near withdrawal from the market in the US (and full withdrawal in Europe). Questions have also been raised about the long term health effects of drugs targeting a specific endpoint– including cholesterol and other lipids, blood glucose, weight loss, and blood pressure.

From: http://www.forbes.com/sites/larryhusten/2013/04/22/the-fda-surrogate-endpoints-and-blood-pressure-drugs/

Fast Food's Green Trend: Making Big Macs and Lattes More Earth-Friendly

By Bruce Watson

Filed under:

MyNameMattersNot, Flickr.com
When you think of green companies, fast food chains don’t exactly top the list. Fast food, after all, takes ingredients grown in monocultures around the world, transports them in gas-guzzling trucks and ships, then prepares them in air-conditioned kitchens before swaddling them in piles of plastic and paper that will eventually find their way into landfills. Overall, not an Earth-friendly process.

But what if fast food companies could find ways to chip away at those problem areas?

Some, like Chipotle, have started using solar cells and hyper-efficient plumbing to cut down on their carbon footprints. Others have installed recycling bins and segregated trash, to ensure that compostable materials and recyclables get disposed of properly.

But perhaps most impressively, some fast food chains are taking aim at their packaging. To anybody whose memory stretches back to the 1980s, a company like McDonald’s might feel like the least-green business on the planet. After all, it spent decades packing its billions and billions of burgers into petroleum-based Styrofoam containers.

For that matter, fast food coffee can be similarly un-green. Between Styrofoam cups, plastic lids and cardboard sleeves, your basic latte is eight ounces of rainforest-destroying caffeine surrounded by another few ounces of Earth-killing waste products.

But it doesn’t have to be that way. Starbucks and McDonald’s have emerged as leaders in the green fast food movement. For the past few years, the two companies have been working on improving their sourcing, cutting down on their packaging, and lobbying the FDA to increase the amount of recycled fibers that are allowed in fast food packaging.

Recently, Starbucks took the trend a step further with its reuseable cups. Sold for $1 apiece, the cups last for about a month, cut down on the company’s paper waste, and offer customers a low-cost way to improve their own carbon footprints. Not surprisingly, they’re also profitable: By reducing waste, Starbucks trims its trash hauling costs. Beyond that, it also drives sales — customers save 10 percent on their refills if they use the cups, a factor that seems likely to lure them in more often.

Sponsored Linksadsonar_placementId=1505951;adsonar_pid=1990767;adsonar_ps=-1;adsonar_zw=242;adsonar_zh=252;adsonar_jv=’ads.tw.adsonar.com’;

Starbucks isn’t the only chain hopping on the reusable trend. Many companies offer pricey reusable mugs, but a growing number are bringing in inexpensive, semi-disposable, reusable vessels. For example, Just Salad, a New York-based chain, offers reusable salad bowls. When customers bring them back in, they get free toppings on their salads.

The key to these sorts of initiatives is that they don’t just benefit the environment: They also benefit the companies that employ them. After all, while Just Salad’s bowls ensure that less plastic makes its way into landfills, they also give customers an added incentive to walk back through its doors at lunchtime. As an increasing number of restaurants discover the profit potential in going green, it will only become easier for consumers to cut

From: http://www.dailyfinance.com/2013/04/22/fast-foods-green-trend-environmentalism/

2 Things Regeneron Investors Need to Watch

By Max Macaluso, Ph.D. and David Williamson, The Motley Fool

Filed under:

From the impact of Obamacare to cutting edge research, biotech buyouts to FDA decisions, The Motley Fool’s health-care team sits down each week to discuss the most fascinating developments in health-care, and their implications for long-term investors. In this week’s edition, the team talks about the coming trend of penalizing unhealthy employees, the importance of drug branding, the avian flu outbreak, one stock investors need to watch, and more.

In the segment below, health care analyst Max Macaluso discusses two important things he’s watching at biotech company Regeneron .

The best investing approach is to choose great companies and stick with them for the long term. The Motley Fool’s free report “3 Stocks That Will Help You Retire Rich” names stocks that could help you build long-term wealth and retire well, along with some winning wealth-building strategies that every investor should be aware of. Click here now to keep reading.

The relevant video segment can be found between 7:54 and 9:22.

The article 2 Things Regeneron Investors Need to Watch originally appeared on Fool.com.


David Williamson and Max Macaluso, Ph.D. have no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

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From: http://www.dailyfinance.com/2013/04/18/2-things-regeneron-investors-need-to-watch/

Vivus And Its Diet Pill Get A Needed Break, But Will This Make A Difference?

By Ed Silverman, Contributor

After considerable anticipation, the FDA has finally eased restrictions on how the Vivus diet pill can be made accessible. By amending a Risk Evaluation & Mitigation Strategy, or REMS, Qsymia can now be sold through a network of certified retail pharmacies. The drugmaker plans to active this network in about three months.

From: http://www.forbes.com/sites/edsilverman/2013/04/17/vivus-and-its-diet-pill-get-a-needed-break-but-will-this-make-a-difference/

Meningitis Outbreak: FDA Chief Grilled At Congressional Hearing As New Documents Emerge

By The Huffington Post News Editors

By Toni Clarke
WASHINGTON, April 16 (Reuters) – The head of the U.S. Food and Drug Administration conceded on Tuesday that the agency could have been more aggressive in its oversight of the compounding pharmacy at the center of a deadly meningitis outbreak.
Testifying at a contentious congressional hearing, FDA Commissioner Margaret Hamburg said a confusing legal landscape, combined with resistance from compounding pharmacies, had hampered her agency’s ability to act on a myriad of complaints against the New England Compounding Center and its sister company, Ameridose LLC.
“I wish we had acted earlier,” Hamburg told a House Energy and Commerce subcommittee looking into the outbreak, which has killed 53 people and sickened more than 700.
The hearing was the second held by the committee to determine whether the FDA could have prevented the outbreak and whether it needs greater powers to regulate pharmacies that compound drugs tailored for specific patients. In the past decade, some have come to operate more like traditional pharmaceutical manufacturers, but without the same oversight.
Hamburg said the current legal framework “does not provide FDA with the tools needed to identify and adequately regulate these pharmacies to prevent product contamination.” She asked Congress to allow the FDA to require compounding pharmacies to register with the agency “so we know who they are and what they do.”
Hamburg also would like to ensure a consistent set of safety regulations that would require compounding pharmacies to report any problems associated with their drugs.
“We are hopeful that the Senate will come out with a legislative proposal soon,” said Steven Immergut, an FDA spokesman.
Drawing on roughly 30,000 pages of documents turned over by the FDA, committee members honed in on the agency’s decision, in 2011, to stop initiating inspections of compounding pharmacies until it had finalized new guidance designed to clarify how it would regulate the industry in the face of a complex set of legal decisions dating back years.
The FDA has not made the documents public, saying they are

From: http://www.huffingtonpost.com/2013/04/17/meningitis-outbreak-fda-chief-documents-congressional-hearing_n_3096257.html

Santarus and Pharming Announce Submission of RUCONEST Biologics License Application to FDA

By Business Wirevia The Motley Fool

Filed under:

Santarus and Pharming Announce Submission of RUCONEST Biologics License Application to FDA

SAN DIEGO & LEIDEN, Netherlands–(BUSINESS WIRE)– Santarus, Inc. (NAS: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RUCONEST® (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).

The safety and efficacy of RUCONEST for the treatment of HAE attacks were evaluated in a clinical program that included a Phase III randomized placebo-controlled study conducted under a Special Protocol Assessment agreement with the FDA. The pivotal Phase III clinical study showed statistically significant and clinically relevant improvement in the primary endpoint of time to beginning of relief of symptoms for RUCONEST compared with placebo. The RUCONEST clinical program also included two additional randomized placebo-controlled studies and four open label treatment studies. In total, the BLA dossier includes ten clinical studies covering 940 administrations in 236 subjects.

Santarus licensed certain exclusive rights from Pharming to commercialize RUCONEST in North America for the treatment of acute attacks of HAE as well as other potential future indications. Under the terms of the license agreement, a $5 million milestone is payable to Pharming upon FDA acceptance for review of the BLA for RUCONEST.

About RUCONEST and Hereditary Angioedema

RUCONEST (INN conestat alfa) is a recombinant version of the human protein C1 esterase inhibitor, and is produced with Pharming’s proprietary transgenic technology. RUCONEST is approved in Europe for the treatment of acute angioedema attacks in patients with HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 esterase inhibitor, resulting in unpredictable and debilitating episodes of intense swelling. The swelling may occur in one or more anatomical areas, including the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals. RUCONEST is an investigational drug in the U.S. and has been granted orphan drug designation by the FDA both for the treatment of acute attacks of HAE and for prophylactic

From: http://www.dailyfinance.com/2013/04/17/santarus-and-pharming-announce-submission-of-rucon/

Health Care's Biggest Movers and Shakers

By David Williamson and Max Macaluso, Ph.D., The Motley Fool

Filed under:

From the impact of Obamacare to cutting-edge research, biotech buyouts to FDA decisions, the Motley Fool‘s health-care team sits down each week to discuss the most fascinating developments in health care and their implications for long-term investors. In this week’s edition, the team talks about the coming trend of penalizing unhealthy employees, the importance of drug branding, the avian flu outbreak, one stock investors need to watch, and more.

In the following segment, health-care analyst David Williamson discusses the week’s biggest movers and shakers, including a trio of stocks receiving the FDA‘s new “breakthrough” designation. Watch and find out what it means for investors.

What macro trend was Warren Buffett referring to when he said “this is the tapeworm that’s eating at American competitiveness”? Find out in our free report: “What’s Really Eating at America’s Competitiveness.” You’ll also discover an idea to profit as companies work to eradicate this efficiency-sucking tapeworm. Just click here for free, immediate access.

The article Health Care’s Biggest Movers and Shakers originally appeared on Fool.com.


Max Macaluso, Ph.D., has no position in any stocks mentioned.
David Williamson owns shares of Pfizer. Follow David on Twitter: @MotleyDavid.

The Motley Fool recommends Vertex Pharmaceuticals. Try any of our Foolish newsletter services free for 30 days. We Fools don’t all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

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From: http://www.dailyfinance.com/2013/04/14/healthcares-biggest-movers-and-shakers/

The Flu: Peril, Profit, and Prevention

By David Williamson and Max Macaluso, Ph.D., The Motley Fool

Filed under:

From the impact of Obamacare to cutting-edge research, biotech buyouts to FDA decisions, The Motley Fool’s health-care team sits down each week to discuss the most fascinating developments in health-care and their implications for long-term investors. In this week’s edition, the team talks about the coming trend of penalizing unhealthy employees, the importance of drug branding, the avian flu outbreak, one stock investors need to watch, and more.

In the following segment, health-care analyst David Williamson gives an update on the avian flu outbreak in China, how a flu drug helped propel Roche‘s strong first quarter, and a new vaccine that should be ready for the next flu season. Watch and learn more about the perils, profits, and prevention of the flu.

What macro trend was Warren Buffett referring to when he said “this is the tapeworm that’s eating at American competitiveness”? Find out in our free report: “What’s Really Eating at America’s Competitiveness.” You’ll also discover an idea to profit as companies work to eradicate this efficiency-sucking tapeworm. Just click here for free, immediate access.

The article The Flu: Peril, Profit, and Prevention originally appeared on Fool.com.


David Williamson has no position in any stocks mentioned. 
Follow David on Twitter: @MotleyDavid. Max Macaluso, Ph.D., and The Motley Fool also have no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools don’t all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

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From: http://www.dailyfinance.com/2013/04/14/the-flu-peril-profit-and-prevention/

3 Can't-Miss FDA Actions This Week

By Sean Williams, The Motley Fool

Filed under:

Earnings season is getting ready to rev into high gear, but earnings are unlikely to be the talk of the sector in the days to come, with three big Food and Drug Administration actions expected in the coming week.

No headaches for Allergan shareholders
Up first is the PDUFA decision on Allergan‘s inhaled migraine medication Levadex on Monday. MAP Pharmaceuticals received a complete response letter for Levadex in March 2012 because of manufacturing deficiencies and its delivery device. Levadex wasn’t denied, though, based on safety or efficacy. This was a clean cue to investors that Levadex’s approval seemed like a sure thing barring it worked hand-in-hand with the FDA to meet its demands. With Allergan taking that cue as a reason to buy MAP earlier this year for $958 million, Monday represents decision day as to whether the company has made adequate fixes to its delivery device and manufacturing process to satisfy the FDA.

Levadex’s approval or rejection could also mean a good or bad day for Nektar Therapeutics , which looks to gain from royalty rights based on its contributions to Levadex’s development. While impossible to predict, I’m going to go out on a limb and project an approval for Allergan.

A revolutionary COPD treatment?
On Wednesday, chronic obstructive pulmonary disease, or COPD, treatment collaborators GlaxoSmithKline and Theravance are set to go before the FDA‘s panel with their combo Breo Ellipta. This revolutionary drug combines Theravance’s long-acting beta-2 agonists with Glaxo’s long-acting muscarinic antagonists into a dry powder inhaler to provide long-term COPD relief.

Studies of Breo Ellipta didn’t show statistically significant effects at all doses examined (clinical trials are a bit of trial and error on dosing), but they all showed a measurable improvement in lung function, although not all increases were dubbed significant. In addition, the adverse event profile of Breo Ellipta was similar to the current standard of treatment.  

As for Wednesday, I believe the patient pool should be enough to satisfy the FDA panel, but I’m concerned that it may focus on some of its non-statistically significant trials as a sticking point. Overall, I’m leaning toward a positive review from the FDA‘s panel, but we’ll find out more on Wednesday.

Is this the End-o for Aveed?
Finally, on Thursday we have an FDA panel meeting for Endo Health Solutions‘ Aveed, with is an extended-release male hypogonadism treatment.

The drug itself was acquired when Endo purchased Indevus Pharmaceuticals in early 2009 and is on its second go-around after receiving a complete response letter in its first attempt to gain approval. That CRL spelled out the FDA‘s concerns regarding very rare, but serious, adverse side effects, which included post-injection anaphylaxis and pulmonary oil microembolism. The FDA also noted that Endo’s risk evaluation and mitigation strategy was insufficient. 

It’s been more than three years since that initial CRL, so this should definitely be an interesting FDA panel meeting to say the

From: http://www.dailyfinance.com/2013/04/14/3-cant-miss-fda-actions-this-week/

Hard Times at Eli Lilly

By David Williamson, The Motley Fool

Filed under:

Eli Lilly  recently announced layoffs of roughly one-third of its U.S. workforce. In this video, David Williamson explains why this was both necessary and smart. Several of its key drugs will lose patent protection in the next two years, which represents a third of its revenue and Eli Lilly had to do something to compensate. Most likely, Lilly will expand its workforce once several of its new drugs receives FDA approval. In fact, diabetes drugs are looking like an Eli Lilly forte, with six different drugs in various clinical trials.

So if you have faith in Eli Lilly‘s product pipeline, don’t get rattled by the recent layoffs. Better times are ahead, so let its 3.5% dividend help tide you over.

Is Eli Lilly a buy or sell?
With two of its top three drugs poised to lose patent protection this year, is Eli Lilly a dividend stock headed nowhere fast? In a new premium report, The Motley Fool’s senior pharmaceuticals analyst breaks down all of Lilly’s moving parts, including an in-depth analysis of the company’s must-know opportunities and reasons to buy and sell today. To find out more click here to claim your copy today.

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From: http://www.dailyfinance.com/2013/04/12/hard-times-at-eli-lilly/

FDA Schedules Another 2 Day Avandia Advisory Panel

By Larry Husten, Contributor

Spyker Victor Muller

Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to  “discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.”

From: http://www.forbes.com/sites/larryhusten/2013/04/12/fda-schedules-another-2-day-avandia-advisory-panel/