Fake?

Ukraine will be free!

Just liver cancer

Is simplicity best...

Disruptive innovation

Music of the week...

Patent losses 2015.

1 Lantus

2 Abilify

3 Copaxone

4 Neulasta

5 Tracleer

6 Namenda

7 Avodart/Jalyn

8 Zyvox

9 AndroGel

10 Synagis

 

http://bit.ly/1sOn3Q0

Let's live forever!!

Fake?

21st century...

The fate...

The route. Bulgaria and Russia are friends forever!

Nexavar vs communists...

http://www.biocentury.com/dailynews/company/2014-12-12/bayer-fails-to-block-generic-nexavar-in-india

The Supreme Court of India dismissed an appeal by Bayer AG (Xetra:BAYN) and upheld a compulsory license issued to Natco Pharma Ltd. (BSE:NATCO; NSE:NATCOPHARM) to manufacture and market a generic version of cancer drug Nexavar sorafenib. Bayer had filed a Special Leave Petition seeking to overturn a Mumbai High Court decision that also left the license in place.

The Indian Patent Office granted Natco India's first compulsory license in March 2012 after finding Bayer did not make Nexavar available to the public at a "reasonably affordable price" (see BioCentury Extra, March 12, 2012).

The license allows Natco to sell its drug in India prior to the 2021 expiration of Bayer's local patent. The Indian company is permitted to sell its version at a price not exceeding Rs8,800 ($141.68) for a month's supply of 120 tablets. Bayer markets Nexavar at Rs280,428 ($4,515).

A Bayer spokesperson said the company is "analyzing the order and will determine any future course of action afterwards."

Bayer and the Onyx Pharmaceuticals Inc. subsidiary of Amgen Inc. (NASDAQ:AMGN) have a worldwide co-development agreement for Nexavar outside of Japan, where Bayer owns rights. Nexavar, an inhibitor of

CRAF (RAF1) and multiple receptor tyrosine kinases, is approved in more than 100 countries to treat kidney, liver and thyroid cancers.

The oil

We win - you lose, sign here...

Conspirology... The beginning...

Fake?

The poost-modern zoology.

Why not?

Let's fly!

Fake?

Why not?

The higher failure rate...

While the average time it takes to bring a drug through clinical trials has grown shorter in recent years, the rate of success of those drugs has gone down by almost half, to just 12 percent.

 

Almost all the attention from Tuesday's release by the Tufts Center for the Study of Drug Development focused on the eye-popping $2.6 billion cost it cited as needed to develop a new drug.

But just as important as the cost — which has gone up 145 percent since 2003 — is the failure rate of drugs that make it to human trials. According to economist Joseph DiMasi, the principal investigator for the study, that failure rate has increased significantly.

"The higher failure rate had a substantial impact on R&D costs. Higher out-of-pocket costs of conducting R&D, and proportionally more failures in clinical testing, are what really drove the increase in costs per approved drug," DiMasi said during a presentation Tuesday.

Based on an analysis of 1,442 experimental drugs that were in clinical tests in recent years through the end of 2013, DiMasi said the overall chance that a drug entering clinical development will be approved for marketing is just under 12 percent. That's down from 11 years ago, when the study set a success rate for drugs that enter human trials of 21.5 percent.

"Approximately seven out of eight compounds that enter the clinical testing pipeline will fail in development," he said. "Put another way, you need to put an average of 8.5 compounds in clinical development to get one approval."

DiMasi arrived at that figure using a weighted average, since as of the study, just 7 percent of the 1,442 drugs had actually been approved. Fully 80 percent had been abandoned by the companies developing them, and the other 13 percent were still in active development. DiMasi said it's likely that many of the drugs in later development will eventually earn approval, hence the overall 12 percent rate.

The chances of a drug moving from Phase 2 to Phase 3 testing was found to be 36 percent, while the rate at which a drug that finished Phase 3 tests went on to have an application for approval was 62 percent.

Another fact DiMasi said is increasingly relevant to the startup-heavy Massachusetts biotech scene: Small biotechs tend to push drugs from early into late-stage development more frequently than large companies, only to have them fail in later stages.

"There's reason to believe that small biotech firms will tend to keep their drugs in development longer than larger firms might, because, they are single or two-product firms, and if the product fails, the company goes under," he said.
http://www.bizjournals.com/boston/blog/bioflash/2014/11/tufts-study-it-takes-eight-drugs-in-clinical.html?page=all

To be healthy and wealthy. The numbers.

15 jahren Putin. I win - you lose, sign here...

Global pharma spending 'to soar 30% by 2018' - when health is a critical resource...

Global spending on medicines is set to soar by as much as 30% from 2013 to 2018, and by the latter year total expenditures will be nearly $1.3 trillion, according to new forecasts.

 

The world pharma market will increase at a compound average growth rate (CAGR) of 4%-7% during 2013-18, rising $305-$335 billion over the period (based on constant exchange rates) compared with $194 billion growth seen in the previous five-year period, 2009-13, when the CAGR was 5.2%, says the research, from the IMS Institute for Healthcare Informatics.

 

This fast growth will be driven primarily by increased specialty drug innovation, greater access to medicines and reduced impact of patent expiries, says the study.  It also forecasts that annual spending growth will spike this year at $70 billion, up from $44 billion in 2013 and $26 billion in 2012 and will moderate in the years to 2018, although remaining at higher levels than those seen during 2009-13.

 

“The higher level of spending growth we’re projecting over the next five years reflects an unusual combination of higher spending on the surge of innovative medicines for patients and lower savings from patent expiries,” says Murray Aitken, IMH Health senior vice president and executive director of the IMS Institute.

 

“This is particularly evident this year and next in developing countries, and especially in the US, which accounts for more than a third of the global market,” he adds.

 

The developed markets – led by the US, the five major European markets (France, Germany, Spain, UK and Italy) and Japan – will be the primary drivers of this increased growth; while they will moderate as cost-containment measures further limit price levels, rising volumes will continue to contribute to overall market growth. Only France and Spain will see a contraction in pharmaceutical spend per capita in 2018, as a result of policies aimed at curbing spending growth.

 

The 21 “pharmerging” markets which currently account for 25% of global medicines expenditures will increase their spending by more than 50% by 2018, with a CAGR of 8%-11% over the forecast period as they continue to broaden access to treatments due to their expanding economies and ongoing government efforts to provide universal health coverage. By 2018, over 80% of growth in the pharmerging markets will be attributed to non-branded medicines, including greater use of biologic drugs.

 

China, which is already the world’s second-largest pharmaceutical market, will reach spending levels of $155-$185 billion in 2018, the report adds.

 

Specialty medicines are expected to contribute 40% of total global spending growth to 2018, with higher expenditures particularly in the developed markets. Much of this growth will be from products which bring patients new treatment options, with particularly notable advances expected in the areas of oncology, autoimmune, respiratory, antiviral and immunosuppressant therapies.

 

The recent surge in cancer drug innovation will continue and contribute to global spending on all oncology drugs, which is set to rise from $65 billion in 2013 to around $100 billion in 2018, while the introduction and uptake of potent new hepatitis C therapies are forecast to producing spending totalling about $100 billion in the five years to 2018, the report forecasts.

 

Moreover, almost 200 new drugs are expected to be launched in the next five years. Over 2,000 products are currently in late-stage development, a quarter of which are oncology drugs. However, the IMS Institute notes that the availability of new medicines to patients worldwide varies significantly by country and disease area  and that, on average, fewer than half the medicines launched during the previous five years are now available across the major developed markets.

 

- The IMS Institute points out that its estimates are measured at ex-manufacturer level and do not factor in a range of rebates, discounts, taxes and other adjustments that affect the net amount received by manufacturers. The impact of these factors is estimated to reduce growth by $60-$80 billion, or around 25% of the increase forecast, over the next five years, it says

They have done it! Biotech's 3 Most Influential CEOs

http://www.fool.com/investing/general/2014/11/20/biotechs-3-most-influential-ceos.aspx

The correct propaganda!

3D printed liver tissue

http://finance.yahoo.com/news/organovo-begins-selling-3d-printed-194446024.html
 

"Let's dance!" as a critical resource!

http://www.youtube.com/watch?v=PIN4zpEtMhU

Sexual health as a critical resource

https://www.yahoo.com/health/its-been-more-than-15-years-since-viagra-first-102898752242.html

No money - no children...

Personally I do not have any comments...

 

Pfizer, the Bill & Melinda Gates Foundation and the Children’s Investment Fund Foundation have teamed up to expand access to the drug giant’s injectable contraceptive Sayana Press (medroxyprogesterone acetate) in 69 of the world’s poorest countries.

 

 

The collaboration will effectively subsidise the sale of Pfizer’s contraceptive, which is already available throughout Africa for around $1.50 a dose, so that qualified purchasers can get it at the cheaper price of $1 per dose, giving the poorest women in these countries access at reduced or no cost.

 

Sayana Press combines a long-acting, reversible, contraceptive with an all-in-one pre-filled, single-use, non-reusable Uniject injection system that eliminates the need to prepare a needle and syringe. This allows the the drug to be administered by health workers to women at home or in other convenient settings. 

 

“Pfizer saw an opportunity to address the needs of women living in hard-to-reach areas, and specifically enhanced the product’s technology with public health in mind,” said John Young, president of Pfizer's global established pharma business.

 

More than 200 million women in developing countries want to delay pregnancy or prevent undesired pregnancy but are not using any method of contraception. “Far too many women die or are harmed because of unwanted pregnancies,” said Michael Anderson, chief executive at the Children’s Investment Fund Foundation, noting that the Pfizer deal will help expand the choice of affordable contraceptives

Read more at: http://www.pharmatimes.com/Article/14-11-13/Pfizer_Gates_Foundation_to_expand_birth_control_access.aspx#ixzz3JIwfqmLy

It should be luck!

We win, you lose - sign here!

Sanctions. Sad but true!

Russian Ruble. The falling.

Too simple to be true!

Dendreon - THE disaster!

http://finance.yahoo.com/news/biotech-dendreon-files-bankruptcy-protection-130212961.html
Shares fall as much as 74.5 pct!
What's wrong with vaccine???
 

Russians - let's start the music!

Propaganda

https://www.youtube.com/watch?v=N81Cd-pUrY0#t=33

The expert...

Radio activated nano-particle targeted drug... WTF?

http://www.pharmabiz.com/NewsDetails.aspx?aid=84858&sid=1

The biomedical revolution has begun!

Is it serious?:

 

These developments were being led by personalised medicine and pan-omics (genomics, epigenomics, metabolomics, proteomics and exposomics), which would radically change the way we understand diseases, he said. “We will unpick the omics and patients will be put into a variety of categories based on whether the drug will work and its toxicity.”

http://www.pharmatimes.com/Article/14-10-29/The_biomedical_revolution_has_begun.aspx#ixzz3HhWKx4Lf

Nanomadness?

So this nanoparticle platform we’re talking about essentially does the following: You take a capsule chock full of the nanoparticles, and they absorb into your body and into your bloodstream. These nanoparticles are two thousand times smaller than a single red blood cell. They’re tiny. They’re so little that they can pass through parts of your body, they go through the blood, they go through your lymph system, they just walk around. They’re essentially very benign particles—-there’s already lots of FDA approved nanoparticles for imaging and stuff like that, because they’re simply made out of an iron oxide core, like you take in a One-A-Day Plus Iron pill. And they’re decorated with proteins and amino acids and DNA to make them bind to certain things.

Full story: https://medium.com/backchannel/were-hoping-to-build-the-tricorder-12e1822e5e6a

 

“We are aggressively looking at all alternatives.” No balls - no babies!

The U.S. attempt to block companies from leaving the country for tax reasons wouldn’t stop Pfizer Inc. (PFE) from moving America’s biggest drugmaker overseas if it finds an attractive deal, Chief Executive Officer Ian Read said.

 

“If we believe the value is still there and we believe, under our interpretation of these rules, there is still value, I see no reason why we wouldn’t be able to do an inversion,” Read said yesterday in a telephone interview.

 

Pfizer has been on the hunt for a multibillion-dollar deal that would add to the New York-based drugmaker’s pipeline, cut costs, and help it escape the U.S.’s 35 percent corporate tax rate. Under the strategy called inversion, U.S. companies use mergers to shift their legal address to a lower-tax country without moving their operations.

 

The ideal transaction has all three components, Read said, though U.S. Treasury Department rules announced last month could lower the value Pfizer assigns to the tax advantages. A tax inversion isn’t required for a deal, Read has said.

 

“Certainly I feel a sense of urgency on utilizing our balance sheet and our capital to do deals that are incremental, add incremental value and certainly add revenue growth in the innovative space,” Read said on a conference call with analysts today. “We are aggressively looking at all alternatives.”

 

http://www.bloomberg.com/news/2014-10-28/pfizer-lowers-full-year-sales-guidance-on-competition.html

3D printing of a pill...

http://www.medicalnewstoday.com/articles/284381.php

The top 10 most expensive drugs of 2013. Future goes orphan!

Among the 20 most expensive drugs, only hep C fighter Sovaldi, Roche's breast cancer drug Kadcyla and Bristol-Myers Squibb's ($BMY) colon cancer drug Erbitux are not orphans, drugs approved under a special program to motivate companies to develop treatments for conditions that usually have patient populations of fewer than 200,000.
http://www.fiercepharma.com/special-reports/top-10-most-expensive-drugs-2013

Side effects? Who cares?

■Cometriq, a $10,000-a-month drug for metastatic thyroid cancer that has no proven survival benefit and was linked to four deaths during testing. It received a black box warning for causing holes and bleeding in the gastrointestinal system.

■Iclusig, a $9,200-a-month leukemia drug that also has not been shown to lengthen lives. The FDA required a black box warning because clots formed in at least 27% of patients leading to possible heart attacks and strokes, potentially fatal heart failure and potentially fatal liver failure.

■Ixempra, a $7,600-a-month drug that improved the scans of advanced breast cancer patients for about a month and a half, but carried a warning for severe liver toxicity and a type of potentially fatal infection.

Critics say using surrogate measures to determine if a drug should be approved can backfire. Surrogates can mask complications that work against survival or quality of life, said Richard Deyo, a professor of evidence-based medicine at Oregon Health and Science University.

"Maybe you live a month longer with a new drug but you are having horrible symptoms or horrible quality of life in the meantime," said Deyo, author of "Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises."

"Patients would want to know that."

And much more...

http://www.jsonline.com/watchdog/watchdogreports/some-drugs-approved-despite-minimal-benefits-severe-side-effects-b99359283z1-280438692.html

Quote of the day

Personalized cancer vaccines? WTF?

Cancer vaccine developers have seen their fair share of disappointments, and failures have spurred some companies to test their treatments in smaller patient subpopulations. Now, researchers at the University of Connecticut are narrowing their focus even further as they gear up to trial personalized cancer vaccines.

Using genome sequencing to identify the differences between protein sequences--called epitopes--in healthy versus cancerous tissue, they'll start up an initial clinical study for ovarian cancer patients once they nab FDA approval. The team will sequence DNA from the tumors of 15 to 20 women with ovarian cancer, using that information to make a personalized vaccine for each woman.

 

http://www.fiercevaccines.com/story/are-personalized-approaches-solution-troubled-cancer-vaccine-field/2014-10-23?utm_medium=rss&utm_source=rss&utm_campaign=rss

Basically it means that cancer vaccines do not work... Surprised? I am not...

Because they are worth it!

http://www.fiercebiotech.com/story/roche-blueprints-18b-rd-complex-pred/2014-10-22?utm_medium=rss&utm_source=rss&utm_campaign=rssThey're building a new home for John Reed and Roche's ($RHHBY) pRED research group in Basel--and the pharma giant is thinking big. Roche said today that it is committing $1.8 billion to build a new research center in Switzerland that will encompass four new office and lab buildings to house 1,900 R&D staffers.

The first step of the process will involve construction of an in vivo center for animal research, slated for completion in 2018. And Roche--the top R&D spender in the world with a 2013 budget of $10.3 billion--plans to clear away older buildings to make way for a new office tower as part of a wider building plan that will cost a total of $3.2 billion.

Quote of the day

Fake?

We want a war...

http://www.youtube.com/watch?v=rAP1caLoHSs

Size does matters!

That's it!

2014's most successful biotech IPOs

http://www.fiercebiotech.com/special-reports/2014s-most-successful-biotech-ipos
2014's most successful biotech IPOs

The top 10 most expensive drugs of 2013

The top 10 most expensive drugs of 2013 http://www.fiercepharma.com/special-reports/top-10-most-expensive-drugs-2013

The fantasy: 'spray-on-skin' for leg ulcers... WTF?

A novel spray-on skin treatment consisting of living cells made by Smith & Nephew, which is designed to work with the body’s own cells to help heal leg ulcers, has failed in a late-stage clinical trial.
The product, known as HP802-247, was viewed by some analysts as a key pipeline asset in the company's advanced wound management division and the Phase III failure is a setback for the healthcare group, which is a regular subject of takeover talk.
The unsuccessful North American trial, announced on Monday, is also something of a surprise, given the promise of earlier studies.
http://in.reuters.com/article/2014/10/13/us-smith-nephew-skin-idINKCN0I20EN20141013?feedType=RSS&feedName=health&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%253A+reuters%252FINhealth+%2528News+%252F+IN+%252F+Health%2529

And he was right...

So what?

Iressa. Game over. Targeted failure of AstraZeneca

MADRID, Sept 28 (Reuters) - Continuing to give AstraZeneca's drug Iressa plus chemotherapy to lung cancer patents whose disease has worsened after previously taking the medicine on its own does not provide any benefit.

Some doctors had hoped that extending the use of Iressa in combination with chemotherapy would help to keep cancers at bay, even when tumour cells had started to develop resistance to the drug.

But a clinical study presented at the European Society for Medical Oncology annual congress on Sunday found no statistically significant improvement in the length of time patients lived without their disease getting worse.

The Phase III study, involving 265 patients, tested Iressa plus chemotherapy to chemotherapy alone. It was sponsored by AstraZeneca.

http://news.yahoo.com/no-benefit-continued-astrazenecas-iressa-065959911.html