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First U.S. Rules for Generic Biotechnology Drugs Set Out in Draft Proposal Bloomberg US regulators proposed guidelines for approving the first lower-cost copies of biologic drugs derived from living cells in a move that will help cut national health spending by an estimated $25 billion over a decade. The Food and Drug Administration ... Biotechnology Drug Copies to Get New FDA RulesThirdAge US Releases Draft Guidelines for Generic Biotechnology DrugsBusinessWeek FDA sets draft rules for biotech drug copiesFox News MarketWatch (press release) -NASDAQ all 245 news articles »

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Proactive Investors USA & Canada

Aradigm to Present at the Biotechnology Industry Organization (BIO) CEO ... MarketWatch (press release) HAYWARD, Calif., Feb 08, 2012 (BUSINESS WIRE) -- Aradigm Corporation /quotes/zigman/401285 ARDM -3.57% (the "Company") today announced that President and Chief Executive Officer, Igor Gonda, Ph.D., will present at the 14th Annual BIO CEO & Investor ... Lexicon Pharmaceuticals to Present at the 14th Annual BIO CEO & Investor ...PR Newswire (press release) all 197 news articles »

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Gene therapy has markedly improved vision in both eyes in three women who were born virtually blind. The patients can now avoid obstacles even in dim light, read large print and recognize people's faces. The operation, researchers predict, should work even better in children and adolescents blinded by the same condition.

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This has been a big week in Alzheimer's news as scientists put together a clearer picture than ever before of how the disease affects the brain. Three recently published studies have detected the disease with new technologies, hinted at its prevalence, and described at last how it makes its lethal progress through the brain.

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Via Scoop.it – inPharmatics

pharmaceuticals Researchers say pharmaceutical and other life sciences companies are ramping up their uses of analytics…
Via smartdatacollective.com

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The invention of an internet set top box has nothing to do with healthcare or  clinical trial at first look. But if HP and other companies are capable of delivering the research, then internet on any display device could change the way clinical trial is practiced at-least beginning with EDC. Yes I agree it is bit far fetched wild thought, but why not. It can also perhaps bring some transformation into patient waiting rooms in hospitals. HP’s invention along with Microsoft Kinect for PC is capable of bringing some big changes to healthcare  practice, mostly notably in TeleHealth.

If nothing else it would atleast bring internet to the masses much faster and cheaper than Android, 3G, and LTE, WiMax all put together, for the simple reason that most of the households that are capable of benefiting from the internet has access to TV as well. atleast in India

Take a look at news coverage “ HP India Research Labs brings Internet TV for the masses with the help of a TV set top box that cost less than $150″ news by Times of India

HP Labs has recently came out with what they call as “Internet TV Set Top Box for the masses” the product is called  Vayu Internet Device or VInD. HP Labs India has created the product which was reviewed by Times of India News paper. The solution enables people to receive internet content on even the most basic TV sets and manage all screen operations using basic TV remotes.

More About HP Labs Vayu Experience Platform

The HP product offers the following solutions,

Task Genie: This is a store of  apps, Yes apple has tons of them , but how many of them are useful , and several of those apps are me too products. Before anyone shouts shoot him let me tell you I have an iPhone4 loaded with 319 apps, I don’t think any one can beat that, and yet I don’t use almost 300 of them at-least once in a month, despite the fact that except one or 2 games most  other are serious apps. Yes I agree among the 300 are several apps which are me too copy cat apps which offers same function, like contact management and duplicate remover, SMS apps, chat solutions. The point is more the apps the better is not true, its the quality that matters that’s were Android fails

Web Tuner: This allows the user to create web categories, such as say News or Tech or Nature, and within each he can have the particular websites he is most interested in

Libraries: allows users to store photos, videos, music and documents in the set-top box’s hard disk. Users can tag and share them with others who have similar set-top boxes.

Contacts and Whiteboard: Users can create and store a contacts list. They can share content or have a video-conference with others who have similar set-top boxes.

Pairing with mobile phone: The set-top box can be paired with mobile phones. So, if it is paired with the user’s phone,he  can send messages to his  TV

Sensor: VInD comes with a built-in Zigbee sensor network. VInD detects the motion and sends an alert to the paired phone.

Keyboard and mouse: Vayu, which uses aLinux  operating system, can also be used as a regular PC, with a keyboard and mouse with a browser and with the TV acting as the monitor. It can be a wired or a wireless keyboard and mouse. This is were I think ViND can bring some advantage in clinical research space, every clinical trial monitoring room has  a TV

Tech Specs#: VInD has 1 GB of built-in RAM, 8GB of flash memory and the ability to add an additional 300 GB hard-disk. It comes with built-in Zigbee sensor network, USB ports, Wi-Fi, ethernet and Bluetooth 2.1 and infrared connectivity. It connects to the TV via HDMI and regular AV channel ports. It also supports GPRS, 3G and HSDPA through the use of a USB modem. It has in-built microphone and speakers and a display

Microsoft has released the Kinect for PC. It was reported that Microsoft is keen to see kinect taking an active part in Healthcare industry. Doctors are using Kinect to help stroke patients regain movement full St0ry Here. Then later there was news that Microsoft and Asus have built a laptop with Kinect motion-sensing technology.

Of-course HP is not the first to come out with this kind of  technology,

 most of the existing expensive solutions are not  comprehensive and too focused on living room with limited or no net browsing capability.

iChip Technolgies has announced their solution called @Box which claimed to bring internet to any display device including even the office projector. @Box is smaller than palm and would be sold in standard package with a key board, track ball, power adaptor and a cable to connect to the TV and would cost less than $100

iChip Technologies which was based in India was later acquired by Techfarm Ventures US-based incubator and early stage investor in technology companies. Gordon Campbell, Chief Executive Officer of Techfarm, is also the CEO and Co-founder of Personal Web (PW) Systems, a company incorporated in the US.

Techfarm Ventures had earlier invested in PortalPlayer, which went in for an IPO in 2004, and subsequently got bought out by nVIDIA in January 2007. Techfarm has earlier incubated more than a dozen companies such as the first Ethernet chip and graphics controller

Neuros Technology produces a similar product that works on Ubuntu platform called Neuros LINK, which seems to be more closer to the HP solution

Logitech and Google has released Revue a solution based on Android

Apple is talking about Apple TV for sometime

UK based Telecom operator Vodafone has launched Webbox a product that seems to draw power from Vodafones EDGE/GSM/3G network using Opera Mini Browser

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Alan Trounson, president of the $3 billion California stem cell agency, says he is "optimistic" that some stem cell treatments developed in California will prove successful in humans in the next five years.

Trounson was quoted in The Sacramento Bee today in an opinion piece written by David Lesher, government affairs director of the Public Policy Institute of California. Lesher provided something of an overview of the agency, including pluses and minuses. He wrote,

"Those who speculate say that the most advanced stem cell treatments are still probably a decade away from becoming available to patients. And the cost to get them there will far exceed California's $3 billion investment."

But Lesher, a former political writer for the Los Angeles Times, also wrote,

"...(T)he president of the state's stem cell agency said he is 'optimistic' that at least a few California treatments will prove successful in humans in the next five years."

Lesher said,

"That may mean a genetically modified stem cell treatment to cure AIDS, (Trounson) said; it may mean a treatment that eliminates the need for some diabetics to monitor or inject insulin; there might be a treatment to restore eyesight to those suffering from a major cause of blindness.

"'These are the kind of things we need to get through,' he said. 'I hope that we have a number of them showing proof by 2015 or 2016. I'm optimistic. The caveat is that nothing is guaranteed.'"

The stem cell agency will run out of cash for new grants in 2017 and will go out of business shortly thereafter unless voters approve another multibillion dollar bond measure or it manages to secure private financing.

Lesher discussed the difficult financial environment for private financing of stem cell therapies and how it has changed since the the stem cell agency was created by voters seven years ago.

"The hope was that California's bond (financing for CIRM) would jump-start a biotech industry by building the laboratories and seeding early research to a point where private support would take over.

"But that point of commercial viability is a moving target as private investors have grown more risk averse and the regulatory path for such radical new therapies is unpredictable. So the biggest question today in the stem cell field is not whether the science will work someday. The big questions are how will we pay for it, how will regulators know when it's ready and when will it happen?"

Lesher said,

"The problem is that even the most advanced experiments in (CIRM's) translational portfolio are still a couple of years away from the same point in the regulatory pipeline where high cost and uncertainty forced Geron out of the field. And there is still no clear answer about how to resolve those same challenges, although the cost-benefit calculation will be different for other treatments."

Lesher concluded,

"Unlike high-speed rail, which continues to have strong support from the governor, the stakes surrounding California's stem cell investment have been largely invisible. That's too bad, because stem cell science is a much smaller investment for taxpayers with a greater possible return."

Our comment? In what CIRM Chairman Jonathan Thomas has declared as a "war" for public support, today's piece in The Bee was a bit of a victory. Although the article did mention difficult issues, it was generally upbeat about CIRM. The piece focused on the wonders of the science and bypassed many of the negatives about CIRM, including its built-in conflicts of interests and its reluctance to correct long-identified problems. Also absent was a discussion of how CIRM signed a $25 million loan agreement with Geron only three months before the company abandoned its clinical trial. That omission could be considered a PR plus for the agency. Overall, however, the folks at CIRM should be pleased by the article.

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The California stem cell agency has decided to put more manpower behind its push to drive therapies into the clinic.

The agency this week posted an opening for a senior development officer, who would be paid up to $226,108 annually.

The new hire would have a strong background in industry and an advanced degree. The job posting calls for a minimum of 10 years experience and expertise in "in developing, designing and assessing preclinical and early clinical safety and efficacy, within regulatory framework."

The position reports directly to Ellen Feigal, CIRM's VP for research and development. The job description says the person would "directly interact with investigators on CIRM’s clinically applicable research programs to help provide product development guidance from preclinical, manufacturing, and first in human to early phase clinical regulatory perspectives."

The $3 billion agency, which has yet to produce the cures promised to voters in 2004, is re-examining its strategies, particularly with an eye to backing a product that would actually be used on patients.

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California's $25 million venture into the financing of what once was the first hESC clinical trial in the nation serves as a "cautionary tale" for states that use taxpayer dollars to boost technology, according to a New York public policy expert.

The comments by James W. Fossett, who directs the Rockefeller Institute of Government health, Medicaid studies and bioethics research programs, come midway through an Institute of Medicine examination of the performance of the $3 billion California stem cell agency. Its directors are also currently involved in a revision of of the agency's strategic plan.

Writing on the Rockefeller Institute's web site, Fossett analyzed the fallout from Geron's decision last fall to abandon its clinical trial after it determined the effort was too costly. Just three months earlier, the California stem cell agency had signed a $25 million loan agreement with Geron.

Fossett said,

"For the many states using taxpayer dollars to stimulate jobs in a wide range of technologies, this is a cautionary tale."

He wrote,

"(Geron's) decision has attracted widespread opprobrium from bloggers, stem cell advocacy groups, bioethicists and more than a few newspaper columnists — one blogger called it the 'stem cell misstep of the year.'

"This disapproval has also spilled over onto the California Institute for Regenerative Medicine (CIRM) — the state agency that operates the $3 billion California stem cell research program."

He continued,

"CIRM is coming under considerable political pressure to produce viable therapies to justify the large amount of money it’s been spending, and some have interpreted its hasty involvement with Geron as motivated by the desire to have something concrete to brag about."

Fossett said, however,

"There may be less here, however, than all the rhetoric would suggest. While Geron’s trial had acquired a lot of symbolic baggage because of its status as a 'first,' the decision to pull the plug only reflects one decision by one company about one therapy. The company was looking at having to spend a lot more money over a long period to get the therapy through the clinical trials process for what would likely be a small return.

"The political difficulties that Geron’s withdrawal have caused CIRM, however, have lessons for states proposing to spend significant amounts on biotechnology and other research in hopes of stimulating economic growth. Spending money on research intended to develop new therapies is highly risky. The science is difficult, expensive and evolves at a rapid pace that is difficult to integrate with earlier understandings. There are considerable cultural, political and financial obstacles to getting new products out of the lab and into the clinic."

Fossett suggested several approaches that might ease some of the risks. He cited the 2010 CIRM external review report that recommended adjusting priorities. Fossett said,

"States might experiment with providing more support to biotech companies and entrepreneurs with successful track records and less to basic research, which could increase the odds of short-term success."

At last month's CIRM board meeting, directors engaged in what CIRM is inclined to call a robust discussion of priorities for basic research vs. more focused funding for driving therapies into the clinic.

Fossett cited another external review recommendation that CIRM seek out research with a "high probability of clinical success that could 'come from either inside or outside CIRM-funded research, perhaps out of industry and even from outside of California.'" 

Fossett additionally mentioned the use of venture capital techniques that would give states "a chance to participate in the (financial) benefits of successful therapies."

Nonetheless, he wrote,

"Most products and most companies will likely continue to fail."

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The blue-ribbon Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency will hold its final public hearing within the state on April 10 at UC Irvine.

No details have yet have been posted online about the matters to be discussed or the witnesses to be heard. So far, the panel has not heard publicly from a single independent witness. The panel's final report and recommendations are scheduled to be released this fall, following its only remaining public meeting, scheduled for Washington, D.C.

The IOM has also posted a list of documents provided to the panel during a closed session last month in South San Francisco, its only public hearing in California so far. Virtually all of documents came from the CIRM itself, which is paying the IOM $700,000 for the study.

One exception was the 2009 report by California's good government agency, the Little Hoover Commission.

In its report, the commission concluded,

"CIRM’s governance structure is not adequate to protect taxpayers’ interests or serve its own ambitious goals."

The commission recommended a number of changes to strengthen CIRM's governance structure, improve accountability and reduce conflicts of interest. They included restructuring and reducing the size of the 29-member board and eliminating the controversial dual executive arrangement at CIRM.

CIRM strongly resisted nearly all of the recommendations, some of which would have required legislative or voter approval. As of last week, the IOM panel had not contacted the Little Hoover Commission for testimony.

(Click on the "closed session summary" at this location to find the information about the documents that were provided.)

The IOM also has posted a list of topics discussed by its panel in closed session last month. They included a follow-up on bias and conflicts of interest, committee composition, discussion of the previous day's hearing and discussion of data needs.

The April meeting is being held at the Beckman Center at UC Irvine, which has received $77 million from CIRM. The agency's board of directors includes two top academicians from UC Irvine: Oswald Steward, who serves on the board as a patient advocate and is director of the Reeve-Irvine Research Center for Spinal Cord Injury, and Susan Bryant, associate executive vice chancellor for research at Irvine and who serves on the CIRM board as in her capacity as an executive officer from a UC campus with a medical school.

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Via Scoop.it – inPharmatics

In other words, computing in the banking industry is perfected, so why can’t healthcare get its act together? (Irrespective of the sea change of difference between simple financial data and incredibly complex medical data.) …
Via hcrenewal.blogspot.com

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Via Scoop.it – inPharmatics

Do you want your boss to realize the full potential of social media? Yesterday on Pixels & Pills we talked about John Mack’s observation that very few senior executives attend digital pharma conferences.
Via http://www.pixelsandpills.com

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(HealthDay News) -- While smoking has long been linked to cancer, its frequent companion, drinking, may be as well, a new study suggests.

Three new studies presented at a medical meeting this week find a link between heavy boozing and a rise in risk for the number one cancer killer.

On the other hand, studies also suggest that heavier people are less likely to develop lung cancer than smaller folk, and black tea might help ward of the disease, as well.

The findings were to be presented at the annual meeting of the American College of Chest Physicians, Oct. 22-26, in Honolulu.

More Americans die from lung cancer than any other form, according to the U.S. Centers for Disease Control and Prevention (CDC). In 2007, the most recent year for which statistics are available, more than 203,000 people in the United States were diagnosed with lung cancer, and nearly 159,000 died. Read more...

Immunice for Immune Support

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11-01-2012 23:04 If you would like more information please call us Toll Free at 877-578-7908. Or visit our website at http://www.usastemcells.com Or click here to have a Free Phone Constultation with Dr. Matthew Burks usastemcells.com Real patient testimonials for USA Stem Cells. Adult stem cell therapy for COPD, Emphysema, and Pulmonary fibrosis.

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09-02-2012 23:17 Stem Cell Therapy latest news - Jan 2012, MS options Contact Kevin for help to raise funds for treatment part 3 of 4

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09-02-2012 22:12 Stem Cell Therapy latest news - Jan 2012, MS options Contact Kevin for help to raise funds for treatment part 1 of 4

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09-02-2012 23:02 Stem Cell Therapy latest news - Jan 2012, MS options Contact Kevin for help to raise funds for treatment part 2 of 4

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30-01-2012 06:10 Professor Michael Schneider of Imperial College tells Alan Keys about how stem cell research is leading to treatments for heart disease. Michael describes how the availability of stem cells allows his team to determine the molecules involved in heart cell death and also how to protect those cells from death during a heart attack. Michael foresees a near future where stem cells are combined with other therapies to both repair hearts and enable hearts to self-repair. Alan Keys had his own heart repaired during an operation some years ago and currently chairs a British Heart Foundation patients committee. The British Heart Foundation part-fund the work of Michael's team at Imperial College. This interview was edited down from the original 35 minutes conversation. Read the transcript here: bit.ly Read more about Michael here: bit.ly and here: bit.ly

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12-01-2012 17:50 Dr. H. Joachim Deeg, MD and Dr. Bart Scott, MD, of Fred Hutchinson Cancer Research Center, discuss bone marrow and stem cell transplantation for MDS, MPD and aplastic anemia. This talk is from "Current Management of Myelodysplastic Syndromes, Myeloproliferative Disorders, Aplastic Anemia, and Paroxysmal Nocturnal Hemoglobinuria," a conference for patients and their families that took place on June 19, 2010

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01-02-2012 13:37 Meet founders of Cord Blood Registry, Tom and Wendy. Hear why they started CBR -- a family business dedicated to helping people live healthier lives through cord blood stem cell medicine. Today, CBR has grown, but the attention to healthy families is the same. For more than 15 years, Cord Blood Registry has led the umbilical cord banking industry in technical innovations and provided families with peace of mind and hope. CBR's experience and dedication to quality has enabled CBR to help more clients use their cord blood stem cells in treatments than any other family bank. Our research and development efforts are focused on helping leading clinical researchers advance stem cell regenerative medicine that may help families in the future. Ultimate use of cord blood stem cells will be determined by the treating physician who will consider if they are applicable for the condition and should come from the patient or a suitable donor (like an HLA matched sibling). There is no guarantee that treatments being studied in the laboratory or in clinical trials will be available in the future. CBR is the preferred choice of OB/Gyns. © 2011 Cord Blood Registry. All rights reserved. Privacy Policy.

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