Showing posts with label Pharma/FDA News. Show all posts
Showing posts with label Pharma/FDA News. Show all posts

Wednesday, September 11, 2013

Johnson and Johnson Files A Patent Violation Lawsuit Against Decision Diagnostics For Making Glucose Test Strips That Work With J&J Lifescan Ultra Meters–Stick Wars

J and J wants the strip business and want no competition and Decision Diagnostics countered with J&J advertising that the One Touch systemimage provides more accurate results than other companies.  Genstrip is the name of the testing strips.  The article here suggests that J&J could buy them up and get rid of the competition, and I guess court costs versus loss of business will some influence on what happens here. 

We used to hear about the J&J stent wars and now we are down to stick wars (glucose strips), but there’s a lot of money in those strips.  Before my mother passes away who was a diabetic the mail order pharmacies are all over get those out and even over supplying at times.  BD


With more than 250 units making and marketing therapeutic products worldwide, Johnson & Johnson JNJ +0.79% (JNJ) is one of the most diversified global healthcare companies. And as a leader in pharmaceuticals, medical devices, and consumer personal-care products, the company not surprisingly makes sure it adequately protects its turf.
Of late, its largest division, the medical device and diagnostic operations that generates some 40% of the company’s total sales, has been a focus of some of its attention. In particular, it’s defending its product called Lifescan Ultra, used for glucose monitoring in diabetes patients, which is estimated to be a $10 billion market. Right now, J&J dominates the market for single-use strips necessary for patients to use the Lifescan Ultra diagnostic device to check their glucose levels.

J&J, the largest player in this market, filed in September 2011 a patent infringement suit against a small company called Decision Diagnostics and sought an injunction to stop the company from selling its product named Genstrip, an alternative glucose testing strip designed specifically for use with Lifescan Ultra meters.

http://www.forbes.com/sites/genemarcial/2013/09/11/jj-seeks-court-aid-to-protect-its-glucose-monitoring-test/

Recalls Kicking Back In for Johnson and Johnson–Mold With Injected Drugs

By the time J and J gets done with all their recalls they should have some of the most uncontaminated stuff out there:)  imageThis time the recall involves Risperdal Consta, the liquid, not the pills so the recalls affect more hospitals and doctor’s offices as not one consumers keep at home.

Here’s the beauty of outsourcing here I guess you could say as another drug  company by the name of Alkermes made the drug who also produces a line of their products.  BD 


Johnson & Johnson JNJ +0.79% recalled another product Wednesday, pulling some vials of its antipsychotic treatment Risperdal Consta after discovering mold during routine quality testing.

In recent years, the New Brunswick, N.J.,image health-products maker has issued dozens of recalls for a variety of products, costing it hundreds of millions of dollars sales and prompting close government oversight of some manufacturing plants.

In the latest case, J&J JJSF +1.19% estimates that 5,000 of the 70,000 vials made in a single lot last year remain unused in doctor's offices, community mental health centers and pharmacies and must be withdrawn. Because it is injected, Risperdal Consta is stored and given at the clinics, rather than the patients keeping and taking the drug themselves.

Risperdal Consta is one of J&J's top-selling drugs, with $1.4 billion in sales last year. It is different from Risperdal pills, which patients store and take at their homes.

The Risperdal Consta that was recalled was the 25mg dose and from lot No. 309316. It was made by another company, Alkermes Inc., ALKS -0.09% and shipped from Jan. 14 to May 20, 2013, according to J&J. An Alkermes spokeswoman directed questions to J&J.

http://live.feedjit.com/live/ducknetweb.blogspot.com/0/

FDA Approves Test for Faster Confirmation of Sterilization of Medical Devices From Steris

Why did the company do this, back in 2009 they had issues and this is great to see the company working to solve it and look how many years we have in this research and development, 5.  It takes time and there’s a lot of robotics and algorithms that go into a project like this. 

Hospitals Need To Replace The Steris System Endoscope Sterilizer in 6 Months – FDA Mandate

This process if I am reading correctly speeds up the time a bit to confirm that devices have been sterilized properly and ready for use.  All the bean counters with measuring medical staff productivity will probably be all over this one:)  BD


The FDA recently granted permission for marketing of the Verify Cronos Self Contained Biological Indicator (SCBI), a new test that can help speed the determination of the effectiveness of steam sterilization of reusable medical devices.

According to the test’s manufacturer, Steris Corporation, the Verify Cronos SCBI is the first biological indicator test that gives test results in two hours.

“This is a novel and innovative use of recombinant DNA technology in biological indicator tests,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “By providing faster confirmation of sterilization, this innovation may help health care facilities provide their medical staff with a faster turnaround of their sterilized reusable devices.”

To support its FDA petition, Steris conducted a number of tests to ensure the performance of the Verify Cronos SCBI. This included subjecting more than 300 Verify Cronos SCBIs to a partial sterilization cycle and then comparing results after two hours and at seven days of incubation. The results showed that samples that fluoresced at two hours also exhibited growth at seven days.

http://www.gastroendonews.com/ViewArticle.aspx?d=FDA%2BUpdate%2B%26%2BProduct%2BNews&d_id=183&i=September+2013&i_id=993&a_id=24045

Tuesday, September 10, 2013

Bar Codes for Drugs Is Not Dead, They are Edible Now, The Battle Against Counterfeit Drugs With Tagging the Pills…

If you have followed my blog then you might remember I had quite a few posts on using bar codes to identify recalls on drugs and devices. image I finally put a bunch of it together on one page and it’s here in my archives.  Microsoft recently announced they are out of the bar code business and services will be transitioned to ScanLife.  TruTag is another company who has developed the bar coding even further so we can eat or swallow them with no harm, made out of things that are already found in our bodies or in food products we eat.   

This is pretty good that any pill could be scanned for authenticity.  How many stories have we read about counterfeit drugs..too many.  TruTag is located in Hawaii so developed right in the good old USA too.  The silica micro tag is pretty durable and in addition to drugs there’s an open door for use with other products that get copied as well.  So far from what I read they have a “specific” reader developed for the process on the drugs and it there’s a phone app for scanning too.  I’m sure the FDA if they haven’t already, will be taking a look at this technology as well.  On consumer products though, I still wouldn’t mind a bar code for recalls to be available, can’t hurt.  Sorry compliance folks this product is not for that:)  Someone will try though you can almost bet given a little time here. 

The product specifically addresses FDA’s PCID (physical-chemical identifier) guidance for anti-counterfeiting measures.  BD 


The microtags developed by TruTag Technologies are made from silica — an ingredient already found in many foods, including sweeteners — and are independent of packaging and labels and can be integrated directly into a product’s infrastructure. About the size of a dust particle and smaller than the width of a human hair, the silica “TruTags” provide aimage vast library of unique codes, allowing for improved tracking and authentication of electronics, industrial parts and consumer goods. Each tag’s coded, nano-scale pattern can be scanned using the company’s proprietary instruments. These patterns are like ID numbers that can be associated with a variety of information, such as product strength, site of manufacture, expiration date and country of authorized sale.

Putting product intelligence on a pill, instead of the package, could help drug manufactures and product security teams authenticate their product. A few years ago, GSK, one of the top pharmaceutical companies in the world, was found guilty of felony distribution of adulterated drugs and paid a $750 million fine for mixing up an anti-anxiety drug and a diabetes drug in the same GSK packaging. Had the drugs been equipped with TruTag microtags, the inspectors could have determined where each pill was made to help diagnose where the problem was in their global supply chain.

TruTag has been named a 2014 Technology Pioneer by the World Economic Forum, an award given to 36 companies that are designing, developing and deploying innovative technologies that affect business and society.

http://news.discovery.com/tech/gear-and-gadgets/edible-bar-codes-choke-counterfeit-drug-market-130910.htm#mkcpgn=rssnws1

Theranos, Inc. And Walgreens Partner to Offer In Store Lab Tests Requiring a Few Small Drops of Blood, The Cost For Each Test = 50% of What Medicare Charges For Any Test, Insured or Not Insured

This has been quit a story that has been developing for years with the company Walgreens is now going to business with, Theranos.  This also stands to be a bit disruption to how we perform and get lab tests.  LabCorp and Quest I’mimage sure have been watching it closer than anyone else as they are the ones who stand to be impacted by a new process here.   Elizabeth Holmes, the CEO dropped out of Stanford to create her company at 19 and she’s 29 now so we are looking at 10 yeas of development.  She’s an engineer and has the talent.  Prior to starting her company while in high school she started a business to distribute C++ sharp software to Asian universities.   She was spending all her time talking to VCs and was not making the classes so she took the break. 

 

Anyway back on track with the story the company makes inexpensive and efficient lab tests and I looked at the website and read quite a bit of what was on there.  The first location will be a Walgreen store in Palo Alto.  In addition there will be a lab on the east coast in Newark.  The economic development folksimage in Newark said this was the most secretive company they had ever worked with so lips have been sealed and due to the nature of the business I can see why.

With a few ounces of blood, hundreds of diseases can be diagnosed in a very short time.  In 2010 they raised $45 million so there was serious attention here and nice compared to seeing VC money going like that out on games.  Theranos actually selected Walgreens as a partner and with all the stores they have and are buying up, it was the biggest way to get the product out there I would guess.  They just bought yet another chain I posted earlier today.

Walgreens Makes Another Purchase, Buys Regional Pharmacy Chain In North Carolina, Kerr Drug

I read somewhere that Larry Ellison was on the board as well as some pretty other high ranking business executives so she’s connected well.  You can see who’s on the board here.  The Wellness Centers will be inside the Walgreen stores so I am guessing it might resemble something like the retails clinics as far as having an area and maybe smaller in size, and might be right inside the clinics in stores where they have them.  With what they are doing you can obviously see the military connection with a member of the DOD on the board as well. The president and CEO is a computer scientist so again this is a focused technology company and no digital illiterates in the key positions here. 

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The work appears to be done for integration with medical records as well with electronic results available from anywhere with an internet connection.  The site has a place where doctors can sign up and they can send patients to Walgreens where the Theranos wellness centers will be located. 

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This is the kicker and the huge advantage here is the price…50% less than what Medicare pays, so there would be a rush on this I would think as I don’t any insurer or Medicare or Medicaid is going to complain in this area. 

“We’re committed to making lab testing more accessible to everyone. That means pricing our tests at dramatically low rates. We can accept major insurance carriers as well as Medicare and Medicaid. And if you’re uninsured, we offer you the same discounted prices we offer everyone else. Because a test should cost the same, no matter who you are.”

Here’s a couple screenshot samples of what tests will cost:

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Glucose test for example $2.70, anyone can afford that.  The allowable error margins are less than 10%.  This also stands to save Medicare a ton of money if you have not figured that one out yet if the prices are half and stay there. 

I think the company is going to make a big stir and again how it impacts the current giants in the business will be very interesting.  Right now it has to get started and running.  Stay tuned as I’ll update this one as more information becomes available and I’m sure once the Palo Alto store opens up on Monday we will be hearing a lot more.  BD 


Theranos, Inc. and Walgreens (NYSE: WAG) (Nasdaq: WAG) today announced a long-term partnership to bring access to Theranos' new lab testing service through Walgreens pharmacies nationwide. As the service becomes available through Theranos Wellness Centers inside Walgreens stores, consumers will be able to access less invasive and more affordable clinician-directed lab testing, from a blood sample as small as a few drops, or 1/1,000 the size of a typical blood draw. The samples are either taken from a tiny finger stick or a micro-sample taken from traditional methods, eliminating the need for larger needles and numerous vials of blood required for most diagnostic lab testing.

Theranos and Walgreens are taking the first step in making this service available to consumers with the first Theranos Wellness Center location opening this month at Walgreens drugstore at 300 University Ave. in Palo Alto, Calif., in the heart of Silicon Valley. The companies plan to offer the service at Walgreens locations nationwide.

For the first time, Theranos is introducing CLIA-certified laboratory services with the ability to run its tests on micro-samples. Theranos' proprietary laboratory infrastructure minimizes human error through extensive automation to produce high quality results. Test results are available to physicians in a matter of hours, enabling fast diagnoses to help informed treatment choices. Theranos tests are low cost -- always 50 percent of Medicare reimbursement rates or less -- and are reimbursed by major insurance carriers, Medicare, and Medicaid. Developed to be accessible to everyone, Theranos tests cost the same amount for everyone, regardless of insurance plan or whether they are uninsured.

http://online.wsj.com/article/PR-CO-20130909-904497.html

Monday, September 9, 2013

Rite Aid To Place Commissioned Insurance Agents in Stores to Sell Health Insurance in 31 States And in DC Where the Feds Are Running the Exchanges

As we all know open enrollment begins October 1st and in one form or another with contingencies in place to mail applications instead of theimage mass IT project being totally finished to handle all of it.  Now in those states where the Feds are running the show you can expect to see agents at Rite Aid stores.  They will be independent and not associated with the store but when a policy is sold, Rite Aid gets a small cut of the sale. There had to be some incentive for Rite Aid in all of this I suppose.

So when you get your flu shot or prescription there will be yet one person at your disposal in the pharmacy areas.  This will be interesting to see how this goes.  At one point in time it was discussed on the web that Walgreens would sell insurance, and that way long before we got closer to the insurance deadline here.  Rite Aid seems to be coming back from 2009 when they actually had to sell a few of their stores to Walgreens and in 2010 they closed their distribution center in Rome New York.  BD 


HOBOKEN, N.J. (AP) -- One of the nation's largest drugstore chains has signed on to promote the implementation of the federal Affordable Care Act, pledging to have insurance agents on hand at its stores in 31 states and the District of Columbia to help consumers navigate the new system.

U.S. Health and Human Services Secretary Kathleen Sebelius announced the partnership with Rite Aid on Monday, along with company chairman John Standley.

Standley said the agents would be available in 2,000 stores. Rite Aid has about 4,600 locations nationwide. He said they will be independent and not affiliated with insurers who are offering health insurance through newly created exchanges, but they will receive commissions if they sign people up for policies. Rite Aid also will receive a small commission for each policy sold, he said.

The agents will be in stores beginning Oct. 1 when the first open enrollment period for the health exchanges begins. The Congressional Budget Office has estimated that 7 million people currently uninsured will sign up for health insurance during the first six-month period.

http://finance.yahoo.com/news/health-care-initiative-announced-nj-184843710.html

Express Scripts Buys CMS Sanctioned SmartD Medicare Prescription Drug Plan

According to the news business will continue at usual at SmartD and Express grows another 87,000 Medicare clients.  The sanctions from CMS are recent and imagebegan in April of this year.  SmartD cannot market and pick up new customers as the sanction was in place as CMS said they were a danger to Medicare clients due to some of their current operations methodologies.  You can read the CMS letter here. 

Before acquisition, SmartD RX was owned by SmartD insurance and I’m not sure if they are all wrapped in this together, hard to tell.  BD


Pharmacy benefit manager Express Scripts (ESRX: Quote) Monday announced the acquisition of the SmartD Medicare Prescription Drug Plan, or PDP, which will add 87,000 covered Medicare lives. The financial terms of the deal were not disclosed.

"Working together with independent and chain pharmacies, we look forward to serving SmartD members and we are pleased in the continued growth and enhancement of our Medicare PDP offering," said Brit Pim, vice president and general manager, government programs at Express Scripts.

http://www.rttnews.com/2185281/express-scripts-acquires-smartd-medicare-prescription-drug-plan.aspx?type=maa

Monday, September 2, 2013

Treating Prostate Cancer in the Future Could Become A Lot More Affordable And Less Toxic–Allspice in Lab Testing Shown to Substantially Slow Tumor Growth Of Cancer Cells

One thing nice is Allspice is non toxic and if you read the article in full the researchers were kind of astonished themselves to see it work and target the androgen receptor.  The University of Miami hopes not too far down the road to start clinical trials for men being treated for prostate cancer.image  They are not far enough along yet but in one statement in the article is says they are also curious if this could help even “prevent” some cancer development.

This is kind of amazing with the finding as look at the millions and billions spent on developing prostate cancer drugs and this in no way is saying it would be a full on replacement, too early to tell.  I can find some Allspice in kitchen with my other spices.  Again the lack of toxicity here is a real plus for sure.  The clinical trials they hope to begin would be for men who have not reached the point of needing treatment yet, so a safe place to start with just using it as a daily supplement. 

Now for a little more good news, they have also shown that the extract also slows the speed of breast cancer too, a double win for both sexes but researchers are not as far along and there’s a different polyphenol.  BD


“Androgen receptor, or AR for short, is the principal drug target for the treatment of prostate cancer, but there is no drug that completely eliminates AR. This complex compound in allspice seems to do that,” Lokeshwar said. “The most interesting data shows that it actually kills tumor cells which express the very specific prostate cancer marker, the androgen receptor. That is not to say that people should start eating allspice with every meal, but there exists the potential that the slow and steady consumption of this chemo-dietary agent may slow or even prevent prostate cancer.”

Essential to jerk seasoning, allspice is known for flavoring Jamaican and other cuisines around the world with a blend of cinnamon, cloves, nutmeg and pepper but, according to a new study by Miller School researchers, the aromatic spice could be known one day for impeding the growth of, or maybe even preventing, prostate cancer, the No. 2 cancer-killer of men in the U.S.

In the study published online May 8 in the Oxford Journals’ Carcinogenesis and led by Bal L. Lokeshwar, Ph.D., professor of urology and radiation oncology and Co-Director of Research in the Department of Urology, researchers demonstrated that Ericifolin, a complex compound in the allspice berry, significantly slows the growth of prostate cancer tumors by suppressing the androgen receptor (AR). A molecule central to the growth and metastasis of prostate cancer, AR enables prostate cancer cells to survive even after hormone therapy, which along with surgery and radiation is the standard treatment for prostate cancer.

They also hope to begin a clinical trial in the near future with UHealth patients who are under active surveillance for early-stage or slow-growing prostate cancer, which does not yet warrant treatment. Since allspice is not toxic, Lokeshwar reasons those patients would be ideal candidates to take Ericifolin as a daily dietary supplement.

They are not sure yet which one but, in Lokeshwar’s mind, that discovery raises the possibility that allspice may have many anticancer properties worth exploring.

http://med.miami.edu/news/miller-school-researchers-discover-prostate-cancer-fighting-compound-in-all/

Thursday, August 29, 2013

Pharma and Health Insurance Companies Pairing Up, Humana’s Analytics Subsidiary and Lilly To Figure Out How to Save (Make) Money and Provide Better Patient Care–Selling Research Data That Competes With FDA Sentinel Initiative

I guess one could make a lot of comments about this but as I have stated if you think insurance is just about claims and policies anymore, you better take a second look, and here’s one good example with truckloads of subsidiaries that all put money to the corporate bottom line and with an army of subsidiary companies they can stay under the radar easier as nobody pays much attention what kind of organizations are getting their hard earned dollars.  On the other hand, perhaps this affiliation may find more potential patients for the drugs that Lilly makes (grin).  I laugh at my satire but we really don’t know.  Medical device companies have been partnering up with insurance companies too.  They all want to go where timagehe money’s at.  Here’s a fairly recent post on how the device folks are flocking to the trade associations and lobbyists of health insurers. 

Medical Device Companies Joining America’s Health Insurance Plans Trade Association (Lobbyists), Affiliations Allow for More Data Selling Between Both Entities–The Epidemic Continues to Grow

Ok so we talking about selling data again it appears and here’s a screenshot right from the Comprehensive Health Page…Data Sales…well and at least they are up front about selling our data to a degree.  So is Lilly a big data customer?  Just a good question one might ask..

Well the subsidiary comes full equipped to run out those surveys we all hate and present outcomes.  Sounds familiar as United got a deal going like this too with selling data to pharma and device companies. 

United Healthcare Buys Humedica and Gets More Data to Analyze and Sell To Medical Device and Drug Companies–More Big Profits From Health Data

Bottom line here is the entire economy is being afflicted by the data selling epidemic and when is enough enough?  We need to license and excise tax these folks as when you see the likes of Walgreens taking in about a billion a year just selling data it does put dollar amount on the huge pot of gold companies and banks are making with “flipping algorithms” for profit by selling data.

Of course what we all worry about is data being used out of context against us and we have history on this with tons of news stories on denied claims and the reasons used, and that goes back years and years, but today it’s the wild west out there to query data bases and use some non linear methodologies and gee, next week you see some new analytics services available for purchase as well. 

Big Data/Analytics If Used Out of Context and Without True Values Stand To Be A Huge Discriminatory Practice Against Consumers–More Honest Data Scientists Needed to Formulate Accuracy/Value To Keep Algo Duping For Profit Out of the Game

They already purchase MasterCard and Visa records so will they combine their research with this and claim they have some brand new predictive software available?

nsurance Companies Are Buying Up Consumer Spending Data-Time is Here to License and Tax the Data Sellers-As Insurers Sell Tons of Data, Gets Flawed Data When Data Buyers Uses Out of Context Too

The FDA with their Sentinel Program is doing all this and I guess now they have competition with insurers who found out they can create an analytics subsidiary and make money at it instead of being “for” consumers as the FDA project is targeted…from a prior post…BD

This sounds like it’s direct competition for the FDA Sentinel program too as remember back a few years ago when insurers were going to donate claim information to add to the device and drug files that were being gathered to evaluate for safety along with medical records added?  Dr. Hamburg has talked about the program quite favorably as it is helping with safety devices and drugs, but did the insurance companies decide not to send claim information to the FDA and decide to make a buck instead selling data?   About the FDA Sentinel below:

“Monitoring the safety of its regulated products is a major part of FDA’s mission to protect public health. But, currently, the Agency’s efforts are limited to its largely passive safety monitoring systems, which depend on healthcare professionals, patients, consumers and pharmaceutical companies to report any adverse effects of FDA-regulated products. The Sentinel System would enable FDA to actively query diverse automated healthcare data holders—like electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely.


Louisville-based health benefits and wellness provider Humana Inc. (NYSE: HUM) plans to collaborate on research with Indianapolis-based Eli Lilly & Co. (NYSE: LLY).

Through a partnership, the companies will analyze data and information withimage a focus on improving health care quality and outcomes, according to a news release. The partnership aims to address the challenges of improving quality of care and reducing treatment costs.

Comprehensive Health Insights, a subsidiary of Humana, will serve as the research engine in the collaboration, according to the release.

http://www.bizjournals.com/louisville/blog/health-care/2013/08/humana-lilly-sign-multi-year-research.html

Wednesday, August 28, 2013

FDA Approves A New Drug to Fight HIV From Glaxo

This is not a new approval that has additional claims to do what other drugs can’t do, just one more drug.  It is a once a day pill.  BD


The Food and Drug Administration recently added Tivicay, also known as dolutegravir, to the arsenal of pharmaceuticals availableimage to fight HIV-1 infections.

The drug is a daily pill meant to be taken along with other standard antiretroviral drugs. According to the FDA, Tivicay hinders HIV multiplication inside the body by obstructing one of the key enzymes essential to the process.

“This provides a new option for patients who have HIV,” said FDA spokeswoman Stephanie Yao. “HIV patients are normally treated with a cocktail of three drugs and these drugs are personalized to each patient as they are needed.

Four trial studies for the drug involved more than 2,500 participants. Side effects include insomnia and headaches. The drug has been approved for patients 12 and older that weigh at least 88 pounds, and is manufactured by GlaxoSmithKline, in Research Triangle Park, N.C.

http://forwardtimesonline.com/2013/index.php/lifestyle/health-beauty/item/417-fda-approves-new-drug-to-combat-hiv-infection

Monday, August 26, 2013

Amgen Buys Onyx for $10.4 Billion–Biotech Cancer Drugs

Last week there was additional information released referencing some of the  data on the drugs in production at Onyx and this must have done the trick for Amgen to give the go ahead to buy.  Last year Onyx made the news with their approval of a new skin cancer drug.  The drug comes under the category of one of the life extending drugs on the market. 

Carfilzomib From Onyx Gets FDA Approval for Treating Multiple Myeloma For Patients Who Have Had Prior Treatments

In addition, they are also co-marketing a drug with Bayer for a colon cancer drug and will receive a 20% royalty on global net sales of the product, and the drug is being tested for use with breast cancer.  Amgen is the largest biotech company around. 

FDA Approves Bayer Colon Cancer Drug Stivarga to be Co-Marketed by Onyx Pharmaceuticals

Earlier this year May was also a very busy month for acquisitions in the biotech business with several others that occurred. 


Amgen buying cancer drug maker Onyx for $10.4B
Amgen agrees to buy cancer drug maker Onyx for $10.4B, or $125 per share
NEW YORK (AP) — Biotech drugmaker Amgen will buy cancer drug maker Onyx Pharmaceuticals for about $10.4 billion in cash in a deal that will add several cancer drugs to Amgen's stable and boost its pipeline of new drugs.
Amgen Inc. said Sunday that it will acquire Onyx for $125 per share, and it expects to complete the deal at the beginning of the fourth quarter. The companies value the deal at $9.7 billion excluding Onyx's cash, and Amgen said it will use $8.1 billion in committed bank loans to finance the deal.
Onyx rejected an offer from Amgen worth $120 per share in June.

http://world.einnews.com/article/164897672/aMT6yYsB--RSACVF

Sunday, August 25, 2013

FDA Approves Mass Spectrometer System, VITEK MS That Can Identify 192 Different Tests at Once

This is pretty cool with the VITEK MS device, to have the ability imageto do a large number of tests at one time and there’s the remote connectivity so all don’t have to physically be in one place.  The videos below explain a bit more on how the system works and I would venture to say that the product stands to save some man hours with getting large numbers of results done at once.  4 target slides can be loaded at once with multi stations for collaboration for 4 technologists to work at the same time.  There’s middle ware software that does the connecting.

You can watch in the video that all samples are bar coded for accuracy and matching.    Below is a short description of all the working parts that go into using the testing system from the website.  BD

From the website:

VITEK® MS
An automated mass spectrometry and software system designed for rapid microbial identification, using innovative matrix-assisted laser desorption ionization-time of flight technology (MALDI-TOF). This technology tests up to 192 isolates per run, delivers results in minutes, and requires no pretreatment of samples for even faster turnaround time. VITEK MS is easy-to-use, integrates seamlessly into your lab’s workflow, and enables more confident patient-care decisions with:

Etest®
A predefined, stable gradient of 15 antibiotic concentrations on a plastic strip. Using innovative dry chemistry technology, Etest determines the onscale Minimum Inhibitory Concentration (MIC) of antibiotics, antifungal agents and anti-mycobacterial agents. More than 100 antimicrobials are available in the product range for testing of aerobic bacteria and fastidious organisms.

VITEK® 2
Best-In-Class Technology Makes It More Than a Workhorse - With an expanded identification database and the most automated platform available, VITEK® 2 is your lab’s powerhouse for rapid, complete, and accurate ID/AST:

  • results in 4-8 hours enable targeted therapy sooner
  • broadest range of GN AST cards includes the industry’s only FDA-approved three-drug yeast susceptibility card
  • ergonomically sound automation that enhances workflow and minimizes waste
  • immediate capability to integrate with your lab’s LIS and improve connectivity.

Myla™
An innovative software solution that simplifies lab operations by improving connectivity, workflow and information management.  The system offers an actionable picture of a lab’s workflow that rapidly impacts patient management with an intuitive dashboard and virtual workstations that enable lab personnel to recapture their time. Flexible, scalable, and versatile, Myla is designed to establish synergy with a facility’s existing Lab Information System (LIS) to improve broader access to patient data.

VILINK™
An on-line, highly secure connectivity environment that optimizes instrument ‘up time’ to improve laboratory productivity. It provides immediate access to the latest instrument application/analysis enhancements to further improve testing accuracy, and rapidly resolves platform issues to minimize the need for labor-intensive, off-line back-up testing procedures.


HealthDay News -- The FDA has approved a novel mass spectrometer system designed to identify 193 yeast and bacteria that are capable of causing pneumonia, meningitis and skin and bloodstream infections.

The automated system, VITEK MS (bioMerieux Inc.), can perform as many as 192 different tests in a single automated series, with each test taking about one minute, the agency said in a press release.

“The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health. “Rapid identification of harmful microorganisms can improve the care of critically ill patients.

The FDA approved VITEK MS using its de novo classifcation process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

http://www.clinicaladvisor.com/fda-approves-novel-mass-spectrometer/article/308552/#

Wednesday, August 21, 2013

CVS Comes Up With More Legal Mumbo Jumbo Relative to Privacy And HIPAA To Allow More Access to Data For Sale, Offering a Mere Pittance of $50 Purchasing Credits To Dupe Consumers

Here we go again with the data selling epidemic, and when you think about it, what generates all of this today, money.  In this case it’s more data for imagesale and the ability to query additional data bases.  I have said many times that Walgreens makes about a billion a year on selling data only and of course one would guess that CVS is right up there with them.  They all do it.  I said a while back that we needed to take HIPAA out of the HHS silo and republish the provisions in other areas to easy access for consumers is there.  We have a lot of new entities now that fall under the provisions of HIPAA, so this makes perfect sense.

Time to Take HIPAA Out of the Healthcare Silo–Needs to Be Integrated In Overall Privacy Laws Healthcare Information Is All Over The Place And Privacy Efforts Will Fail Without Real Algorithmic Levels of Regulation

Again I tell folks if you don’t understand the privacy statements, then don’t go there if you don’t have too.  I realize there are incentives and sometimes it’s difficult when the dollar amounts are substantial.  We just had one grocery chain in California, Albertsons, get rid of the their cards for collecting data.  Now don’t think they are totally good guys here with dropping this entirely, it’s probably just that they found a cheaper way to get data and analyze it.  Cerberus Capital Management just bought the grocery/drug chain not too long ago and I might guess it could be cheaper to buy Visa and MasterCard records from the banks and run queries, like the insurers do.  We have no real regulation here so we end up with “laws with no balls”…you can read below where I wrote about this blinding lack of a path to regulate and thus now we have CVS looking at the legal wording here trying to get around HIPAA in a “legal verbiage” way to selling more data. 

Privacy Relative to Tracking Apps and Data Mining Legislation Will Fail If There is No Regulation Path Created–License and Excise Tax Data Miners & Sellers Otherwise It’s “Laws With No Balls”

Christopher Steiner says it pretty well in this video about “algorithms taking over the world” and the verbiage here with CVS is to allow more algorithms to operate “legally” but still screw you as a consumer.  Again when you see that Walgreens is up around a billion a year for “easy money” from algorithms that mine, query and sell, you can pretty well figure out why the manufacturing tangible business in the US suffers with everyone flipping algos for profit.  If you want more on how some of this works, visit the Algo Duping page for more on models and studies that are tweaked and created for profit only with no concern of how the end consumer is affected. 

Here’s how insurers like Blue Cross and United use the data they purchase and I might add too that United cuts a few fat hogs with selling data and they have been doing it longer than most.  Why keep an entire group of data scientists on board when you can buy the data and not worry about collecting it yourself and of course this means more money for the banks. 

Insurance Companies Are Buying Up Consumer Spending Data-Time is Here to License and Tax the Data Sellers-As Insurers Sell Tons of Data, Gets Flawed Data When Data Buyers Uses Out of Context Too

See how your purchases other than prescriptions can be queried with other purchases you make in the store and one could look at a person being a diabetic and buying a candy bar for a simple example, however that candy bar might not be for you but when they query data, they assume it is for your consumption and this is the danger here with data telling stories that might not be realistic and true. 

Health Insurers and Others Trying to Track Junk Food Consumers Purchase–Attack of the Killer Algorithms for Corporate Profits

Time for a path to regulate data sellers as this game will go on and on with the data scientists that can figure out how to have an algorithm function without violating any English or other language as it is written, it’s all in the interpretation which is pretty scummy anymore as there can be many interpretations just as there can be many models, and thus so we need digitally centric laws and need to starting licensing (and taxing ones who profit) with selling data.  This is the biggest crock of garbage out there and they call this “law”?  Better start looking at the models as that’s what CVS is crafting here and see how much new data they can suck in for sale. 

Time Has Come to License and Tax the Data Sellers of the Web, Companies, Banks, Social Networks..Any One Making a Profit-Latest Microsoft/Google Privacy War Helping the Cause –Consumers Deserve to Know What Is Being Sold and To Who in a Searchable Format

Next time HIPAA laws are reviewed and rewritten, better get some technologists and quants on board to find the loopholes up front before the lawyers figure out how to create additional privacy statements that continue to dupe.  The current FTC deal about collecting data is totally useless as well.  Government should hire some quants that can tell them how this works soon!  It’s a technology farce that hurts all of us.  BD

FTC “Reclaim Your Name Campaign” Not Good Enough–No Path for Regulation Identified–All Data Sellers Including Banks, Insurers, Etc. Should Be Required to Buy a License


Since February, CVS Caremark has been pushing its pharmacists to enroll customers in a prescription-drug rewards program.

The benefit to customers is the opportunity to earn up to $50 a year in store credits that can be used to buy shampoo, toothpaste or other products.

The benefit to CVS is persuading pharmacy customers, through questionable means, to give up federal privacy safeguards for their medical information and permitting the company to share people's drug purchases with others.

"It's very troubling," said Paul Stephens, director of policy and advocacy for the Privacy Rights Clearinghouse in San Diego.

Walgreens and Rite-Aid have their own rewards programs for prescription drugs. But officials at each company said they don't require customers to relinquish federal privacy protections.

Among the site's frequently asked questions for the program is, "Why do I need to sign a HIPAA Authorization?"

The answer: "The HIPAA Authorization allows CVS/pharmacy to record the prescription earnings of each person who joins the ExtraCare Pharmacy & Health Rewards program."

That last step is where you encounter a screen saying you acknowledge that "my health information may potentially be re-disclosed and thus is no longer protected by the federal Privacy Rule."

CVS takes the liberty of assuming you know that HIPAA and the "federal Privacy Rule" are one and the same, although it has nowhere made the connection clear.

What is it about CVS' program that necessitates customers abandoning their federal privacy rights? CVS isn't saying.

But $50 worth of store credits is hardly fair compensation for such a marketing prize.

http://www.latimes.com/business/la-fi-lazarus-20130816,0,6519110,full.column

Saturday, August 3, 2013

Wireless Home Monitoring System Gets FDA Approval With Information Available to Third Parties

Here's yet one more device company that is offering a simplified monitoring system and below is a couple paragraphs from the website so again this looks like we have “data for sale’ here once again.image  It is using a web portal and requires a USB connection to your computer.  Controlling diabetes and hypertension are the main chronic conditions targeted with the system and the targeted sales for the service/devices are insurance companies and home healthcare agencies. 

The company also plans to move into the “live sensor” area next as well and currently will send you text messages and reminders.  Again the privacy policy opens up the information for aggregated information profiles and there’s the usual mumbo jumbo about how they use it, etc. 

“Permission is required before AH discloses Personal Information to a third party.  No permission is necessary for Aggregate Information, since Aggregate Information does not identify a specific individual.

a. For disclosure of Medical Information, Informed Consent is required before AH discloses Medical Information to a third party.  Informed Consent occurs when an individual has sufficient facts about the disclosure, comprehends those facts, and voluntarily consents to the disclosure.  Where a third party such as the employer or healthcare provider of an individual requires the individual to participate in an AH program which collects Medical Information, AH will require the employer or healthcare provider to procure Informed Consent before AH will  release Medical Information to that employer or healthcare provider.”

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There are a few devices out there that do not sell your data and the Tri-Coder is one under development.  Again I wonder how many of these mobile device companies and apps can stay in business without selling data at times.  In the article it also states such information could be available to employers and most folks I have been talking with of late are telling me they prefer to stay outside the radar and have tried some of the wellness programs but some have become way too intrusive with time and reporting so it will be interesting as consumers become more aware of the data selling epidemic as to how many folks actually will use the various technologies.  BD

Data Floating Around the Web and You Don’t Know How It Got There? Time to License and Excise Tax Data Sellers–Identify “Flawed Data” Epidemic At The Root of the Problem


Aging in place and disease management technology developer Ambio Health has gained FDA 510(k) regulatory clearance for its flagship Ambio Remote Health Monitoring System. The system, first introduced at the Consumer Electronics Show in January, essentially adds wireless capability to standard home health monitors and automates data collection.

Stamford, Connecticut-based Ambio is now free to sell the system in the US, and it will do so at a price point significantly lower than competitors, according to CEO Kevin Jones. The wireless gateway, which plugs into a standard home-based Ethernet router, costs $19.99 by itself or $44.97 bundled with an AgaMatrix Presto blood-glucose monitor and proprietary Ambio wireless connector. A package with a Homedics BPA-060 blood-pressure monitor is priced at $89.97.

An Ambio Health-branded digital weight scale, sold for $84.98 with a wireless gateway or $64.99 without, has the transmitter built in. Monitoring service costs $4.99 a month per device, based on an annual subscription.

http://mobihealthnews.com/24345/fda-clears-ambio-health-wireless-health-monitoring-system/

Tuesday, July 16, 2013

FDA Approves Brainwave Test to Help Diagnose Attention Deficit Hyperactivity Disorder Using EEG Waves, Math and Statistics

ADHD is difficult to diagnose and this is another tool available.  The test is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA).  It is meant to be used in conjunction with a clinical assessment and is not a stand alone to replace that.  Quantitative electroencephalography (qEEG) is the patented technology theimage company acquired for analyzing mood disorders and depression and I am guessing this applies here as the company is also working on mood and depression measurement systems whereby the patent is specific. 

What I find also interesting is this study from a while back at PLOS One…the fear of math creates physical pain in humans too, so we have come full circle if you will and this could be mood altering too:)

“Algo Duping” – PLOS One Journal Publication Explains Why The Fear of Math Plays a Big Role As One Underlying Reason We All Get Duped And Those Who Don’t Fear Math Take All the Money, Gradually, Using “Mathematical Formulas & Algorithms”

There were four large clinical trials to validate the test and the results were better with using the test versus a clinical assessment alone.  It works on a tablet PC and is portable.  BD


US regulators on Monday approved the first brain wave test for attention deficit hyperactivity disorder, saying it may improve the accuracy of diagnoses by medical experts.

Cases of ADHD are on the rise in the United States, as are the number of prescriptions for stimulants doled out to young people who appear to have difficulty concentrating or controlling impulses.

The new test, known as the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, measures electrical impulses given off by neurons in the brain.

The FDA approved the device after a reviewing it as a new and "low- to moderate-risk medical device."

http://medicalxpress.com/news/2013-07-fda-brain-adhd.html

Friday, July 12, 2013

FDA Approves CardioSleeve–A Digital Wireless Makeover for Stethoscopes

Don’t throw away that stethoscope yet..this is a device that attaches and works with mobile devices to attain a lot more information.

From the website:

“CardioSleeve cloud computing entrusts remote servicesimage with a user's interface to record heart sounds and 3 Lead ECG signals for analysis in real time. The cloud maintains an extensive library of cardiac murmurs (including congenital heart disease) and heart sounds database. The sounds have been recorded from real patients at the four main auscultation locations (aortic, pulmonary, tricuspid and mitral) with the diagnosis confirmed by means of echocardiography. The computer logarithms with a 90% or more accuracy assist in the diagnoses of pathological and physiological heart murmurs even at heart rates of up to 180 bpm!”

The results are sent to a cloud server for interpretation and returned to the device.  You can select where the stethoscope will be placed.  The readings are also stored in the cloud EMR where they can be reviewed at any time.  The software also can find the existence of a heart murmur.  It connects to a Smartphone, tablet, laptop and PC with wireless connect ability, so no cords and can use Bluetooth as well.  It comes with a rechargeable battery and should be available later this year, for clinicians only.  BD

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Pennsylvania startup Rijuven Corp. announced Wednesday that the FDA has cleared a first-of-its-kind stethoscope accessory device that allows clinicians to get 3-Lead ECG and Digital Auscultation. The device can also connect wirelessly to mobile devices.image

The ability to listen to the heart using the traditional stethoscope and make a correct diagnosis depends largely on the expertise and training of the physician. In many cases, physicians may order additional tests like an ECG to get a clearer picture of the condition of the heart.

By comparison, the CardioSleeve aims to achieve a similar result by attaching on to the stethoscope and displaying the results on mobile devices like a smartphone, laptop, PC or a tablet

http://www.mddionline.com/article/fda-clears-novel-device-gives-digital-makeover-stethoscope

mHealth Why Battle Over Where the Responsibility Lies, Make the ONC A Division of the FDA, Better Collaboration and Software Engineering Exposure Both Ways Around

Why not?  You get the best of both worlds here with the ONC continuing with their area of business and the ability to work with the FDA a bit closer when it comes to “engineered software” products.  As the industryimage changes, so does how regulation takes place.  Again, if the ONC had specific questions or needed certain tests the FDA resources would be there.  Also if the FDA would have the expertise of consulting the ONC as well.  The ONC could be it’s own division and I think the collaboration between the FDA and ONC would probably be very good.

Let’s face it the lines are grayer than they used to be as technology moves forward and collaboration is the name of the game today.  There are some very intelligent sophisticated engineers at the FDA as well and they are already well versed in complex devices so it’s not like this would be brand new entirely but rather a little different focus.  We do have devices now reporting data to medical record systems and those of course still need certification and the meaningful use criteria to meet and what is one of the devices is one under current review at the FDA, would this not make sense?  The records and devices are collaborating with data and are integrated so why not the regulation portions.  I think this would also satisfy and “duplication of efforts” questions out there as well. 

In addition with some devices needing clinical trials, the ONC could certainly have some substantial input here as relates to work flow too.  This is maybe not a perfect answer but I think it would answer a lot of questions and allow the ONC to keep operating with what they are doing and have greater access to those at the FDA when the gray areas or collaboration efforts are needed.  In addition the patient safety would be addressed from 2 different points of view too and that can’t hurt a bit. BD


While the mHealth Regulatory Coalition and several mHealth advocates have asked the FDA to release its long-delayed guidance – which has been in the works since the agency issued preliminary guidelines in late 2011 – a coalition of roughly 120 health IT stakeholders has asked the government to put the brakes on the FDA until a much more wide-ranging study of HIT regulations is finished.

In fact, some are wondering if the FDA is the right agency to oversee mHealth regulation.

Haley pointed out that both the FDA and ONC are "jockeying for jurisdiction" of the mHealth landscape. The FDA recently issued a warning to medical device makers, healthcare providers and other parties about the dangers of cyber attacks on devices – a move that Haley said caught the industry by surprise. More recently, the ONC launched its own Health IT Patient Safety Action & Surveillance Plan, which left some wondering if the two agencies were competing against each other.

http://www.govhealthit.com/news/who-should-regulate-mhealth

Wednesday, July 10, 2013

Myriad Files Suit Against 2 Genetic Companies For Breast Cancer Test Patent Violations

Myriad is filing suit to stop the companies from manufacturing the test, stating they violate other patents that were not covered in the court decision.  Three other companies that receive royalties also joined in the lawsuit. 

Now we are down to a patent battle, which one was it?  Both companies have had an over whelming response as the tests of course are less expensive than the $4000.00 one offered by Myriad.  Myriad has over 500 patents so go figure.  BD 


The court’s decision invalidated patents the company had on two genes that, when mutated, meant a woman had a very high chance of getting breast or ovarian cancer.

Within hours of the decision, various companies and academic laboratories announced they would offer tests of those two genes, breaking the hold that Myriad held for nearly two decades. Many of the new tests were less expensive than the roughly $4,000 that Myriad charged for a full analysis of the two genes, BRCA1 and BRCA2.

But Myriad this week sued two of those competitors — Ambry Genetics and Gene by Gene — saying their tests infringed some of the more than 500 other patent claims that were not invalidated by the Supreme Court, for instance, on synthetic DNA used as probes and on methods of testing.

Ambry, which is based in Southern California, said it would vigorously defend itself. “We have had an overwhelming response from our clients seeking an alternative laboratory to perform BRCA testing, and Ambry is fully committed to support our clients and patients moving forward,” Charles Dunlop, the chief executive of the company, said in a statement.

Gene by Gene, which is based in Houston, could not immediately be reached for comment. Its test costs only about $1,000.

http://www.nytimes.com/2013/07/11/business/2-competitors-sued-by-genetics-company-for-patent-infringement.html?partner=socialflow&smid=tw-nytimesbusiness&_r=0

Saturday, July 6, 2013

Fundraising For Science, Decreasing Federal Funds Sending Researchers to Crowd Fund for Monetary Resources

This is really a big job to get the public interested in funding science projects as indicated by a couple interviewed in this article.  Probably much of the reasoning here is due to understanding what the project may be, while some are easier to understand, others can be a bit more complex in nature.  Below is a screenshot of a few of the projects that are launched or are in the money raising scheme of the process from Microryza.  We are starting to see more fundraising in almost every area of business, except banks, thank goodness as we need their money going the opposite direction to fund projects like this.

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I have my small informal campaign going on here too at the Quack to license and excise tax the data sellers making billions selling data and that is an epidemic and is like the wild, wild west.  It s tough one for most to comprehend as I am talking about taxing an intangible but it’s not bad as it would start a process of moving some money back to the 99% side, which is of course where most researcher are. 

One More Good Reason to Tax the Data Sellers– Create Additional Funding for the NIH and FDA From Sources That Otherwise Are Too Greedy to Share & Contribute

And here’s another look at the idea…

Start Licensing and Taxing the Data Sellers of the Internet Making Billions of Profit Dollars Mining “Free Taxpayer Data”–Attack of the Killer Algorithms Chapter 17 - “Occupy Algorithms”– Help Stop Inequality in the US

In the meantime due to the sequester and other budget cuts scientists are now putting their requests out to the public to help fund their research.  Again, you see crowd funding everywhere.  I have it on this blog although I have not really pushed it a lot but if you do give it any thought, it would be so well appreciated.  BD 


Developing a new drug, exploring space or mapping the human brain can cost millions of dollars.

But in recent years, there's been a decrease in federal funding for these kinds of projects and more scientists competing for what money there is.

That's made it tough for researchers like USC's Daryl Davies.He's studying a drug that could help alcoholics kick their addiction. Testing it safely on humans will cost $1 million to $2 million over the next few years.image

One benefit of the more traditional system of seeking money from the government is that the government has panels of experts who review proposals for potential problems, he said.  He's worried researchers who get funds straight from the public won't get the benefit of this kind of oversight. But anything that helps fund important discoveries should be encouraged.

http://www.scpr.org/news/2013/07/05/38037/fund-my-science-years-of-decrease-in-federal-funds/

Friday, June 28, 2013

FDA Approves 1st Non Hormone Drug for Hot Flashes–Low Dose Paroxetine Used for Depression

The FDA panel voted against the drug and it is unusual for the FDA to approve a drug that does not get panel approval.  Was it due to the fact that there imagewas no non hormonal drug out there for hot flashes?  It supposedly met the goals in clinical trials but those who voted against it said it was only minimally effective.  Does it do better than natural black cohosh is the question that comes to mind.  So I guess if one is on Paxil that has the same active ingredient, you could be getting a double bang for the buck?  We do know that hormones work but they also have their inherent cancer dangers as well.  If you want to learn more about hot flashes scroll down and check out “Hot Flash Havoc” and you will learn a lot.  It costs a few dollars to view but worth it.  I did an interview with the producer a couple years ago. BD


The first nonhormonal drug to treat hot flashes won approval from the Food and Drug Administration on Friday, offering a new alternative to menopausal women.

The move was surprising because an advisory committee to the F.D.A. voted 10 to 4 in March against approval.

The treatment, which will be called Brisdelle, was developed by Noven Pharmaceuticals and consists of a low dose of paroxetine, which is used at higher doses in the antidepressant Paxil.

While the F.D.A. does not have to follow the recommendations of its advisory panels, it is highly unusual for it to approve a drug that receives a strong negative vote. Committee members who voted against it said while there was a need for a nonhormonal therapy, Noven’s candidate was only minimally effective.

The agency did not explain why it went against the panel’s recommendation, saying only that it viewed Brisdelle as a useful treatment that had met its goals in clinical trials.

http://www.nytimes.com/2013/06/29/business/fda-approves-a-drug-for-hot-flashes.html