Archive for August, 2009
Friday, August 28th, 2009
DURHAM, NC – When enrolling patients in a clinical trial, researchers should disclose relevant financial relationships that might affect a patient’s decision about participation, such as owning stock in the company that funds the study, or having a patent on the device being tested.
It’s a process many believe builds trust and fulfills a patient’s right to know about financial conflicts of interest.
“But patients often don’t understand such disclosures and generally don’t use the information when deciding what they are going to do,” says Kevin Weinfurt, Ph.D., a medical psychologist at Duke University Medical Center and the lead author of a paper published in the August 27 issue of the New England Journal of Medicine. “The public is increasingly demanding transparency, but if our disclosure system isn’t accomplishing what we hope it will, then we may need to change it.”
Weinfurt, along with Jeremy Sugarman, M.D., professor of bioethics and medicine at the Berman Institute of Bioethics at Johns Hopkins and the senior author of the paper, drew upon a five-year research project examining disclosure policies and practices (the Conflict of Interest Notification Study, or “COINS”) and developed the following guidelines for institutions attempting to fully comply with the spirit and intent of disclosure:
* Study participants should not be allowed to be the sole arbiters of acceptable risk when evaluating researchers’ financial relationships with organizations that support their work. Institutional Review Boards, conflict of interest oversight committees, and other such authorities should play a much larger role.
* Disclosure statements during the consent process should be brief and simple, and should encourage patients’ questions.
* Study coordinators need to be thoroughly familiar with researcher or institutional conflicts of interest so they can adequately answer patients’ questions. COINS research showed that coordinators are often ill-prepared to do so, or are unaware of any financial conflicts of interest.
* Boards, committees, or entities charged with designing disclosure regulations should be clear about the goals they want to achieve and should be able to determine if their directives help reach those goals.
“Disclosure alone is not enough,” says Sugarman. “It is not the remedy that many seek, although the process may have a positive effect on patients’ satisfaction with and trust in the research process.”
Posted in Biotech, North Carolina, Pharma, Studies, surveys, reports, University Tech | Comments Off
Friday, August 28th, 2009
MIAMI – Hisamitsu Pharmaceutical Co. Inc. and Hisamitsu U.S. Inc. have completed acquisition of Noven Pharmaceuticals Inc.
All remaining outstanding shares of Noven’s common stock, other than those held by stockholders who properly perfect appraisal rights under Delaware law, were converted into the right to receive $16.50 per share in cash.
As a result of the transaction, Noven has become a wholly owned subsidiary of Hisamitsu U.S., Inc. Hisamitsu expects Noven to continue as a stand alone business unit under the Noven name, operating at its current locations in Miami and New York, and with its existing workforce.
Online:www.hisamitus.co.jp; www.noven.com
Posted in Acquisitions, Biotech, Florida, Pharma | Comments Off
Friday, August 28th, 2009
NEW ROCHELLE, NY—Twitter, the increasingly popular social networking tool that was at first merely a convenient way to stay in touch with friends and family, is emerging as a potentially valuable means of real-time, on-the-go communication of healthcare information and medical alerts.
So says a feature article in the Medical Connectivity section of the latest issue of Telemedicine and e-Health.
Physician groups, hospitals, and healthcare organizations are discovering a range of beneficial applications for using Twitter to communicate timely information both within the medical community and to patients and the public.
Short messages, or “tweets,” delivered through Twitter go out from a sender to a group of recipients simultaneously, providing a fast and easy way to reach a lot of people in a short time.
This has obvious advantages for sharing time-critical information such as disaster alerts and drug safety warnings, tracking disease outbreaks, or disseminating healthcare information.
Twitter applications are available to help patients find out about clinical trials, for example, or to link brief news alerts from the Centers for Disease Control and Prevention (CDC) to reliable websites that provide more detailed information.
The use of social media and Internet-based outlets such as Twitter to communicate medical information requires a high degree of caution, however, to preserve confidentiality and patient privacy in the clinical care setting, and to ensure that information sources are accurate, reliable, and current.
“One way to look at Twitter is as a method of mass communication,” says Joseph C. Kvedar, MD, Director of the Center for Connected Health (Partners Healthcare System, Boston, MA), who is quoted in the article.
Twitter is real-time and was designed for mobility, notes Dr. Kvedar. It allows people to “text 30 people or 50 or 100 people, whatever the number is who are following you.”
Online: www.liebertpub.com
Posted in Healthcare, Internet/New Media | Comments Off
Friday, August 28th, 2009
CLEMSON – Optimal control of the spread of the seasonal flu and H1N1 is achieved by prioritizing vaccinations for schoolchildren and for adults aged 30 to 39 in the United States.
Those are the findings of a new study by Clemson University mathematician Jan Medlock and colleague Alison Galvani of the Yale University School of Medicine.
The research was funded with a $650,000 grant from the National Science Foundation.
The researchers have developed models that challenge the recommendations of the Centers of Disease Control and its Advisory Committee on Immunization Practices for which segment of the population should be vaccinated against the flu.
In their findings, published Aug. 20 in Science Express http://www.sciencexpress.org, the researchers say the U.S. population can be best protected by stopping the high levels of transmission among schoolchildren and to their parents, despite the fact that other age groups may suffer more severe symptoms if they catch the flu.
“Current flu vaccination recommendations include children under age 5 and for seasonal flu, people over age 50,” said Medlock.
“The vaccines would be better used to prevent transmission within schools and out to parents, who then spread the flu to the rest of the population. The CDC recommendations have been changing the last few years, particularly due to the new H1N1 strain, and have been moving in the right direction.”
The researchers studied mortality data from the United States and survey-based data on infectious contacts from the influenza pandemics of 1918 and 1957, taking into consideration multiple ways to quantify the impact of an influenza outbreak: deaths, infections and other measures that vary with the age of those infected.
Strikingly, they found that all the measures led to the conclusion that schoolchildren and their parents are the best groups to vaccinate when even a modest amount of an effective vaccine is available.
The World Health Organization has announced the possibility of shortfalls in the production of H1N1 vaccines this year due to the slow growth of the swine-origin H1N1 in chicken eggs.
The researchers concluded that when vaccine availability is limited or when vaccine efficacy is low, optimal allocation of vaccines is imperative to minimize the spread of the illness.
Posted in Healthcare, South Carolina, University Tech | Comments Off
Friday, August 28th, 2009
SAN FRANCISCO (AP) – YouTube hopes to convert more amateur videographers into capitalists as it strives to show more advertising on its Web site and reverse years of uninterrupted losses.
The Internet’s top video channel will try to widen participation in a 20-month-old advertising program by actively recruiting the makers of widely watched clips.
The more aggressive approach is a switch from YouTube’s previous practice of waiting for video makers to apply to the ad program.
The strategy hasn’t been profitable for YouTube so far – something that the site’s owner, Internet search leader Google Inc., wants to change.
After buying YouTube for $1.76 billion in late 2006, Mountain View-based Google initially focused on luring more people to the video site.
As the recession squeezed Google, the emphasis this year shifted to making money, prompting YouTube to explore new ways to show ads alongside more of the millions of clips clicked on its site each day.
YouTube won’t allow advertising without the consent of a video maker, largely to avoid legal fights over who has the right to profit from the work.
That policy means YouTube needs to persuade more video makers to allow ads. Toward that end, YouTube will try to quickly identify videos with a big following and then contact the owners of the clips about advertising opportunities.
YouTube expects the solicitations to boost the number of advertising partners from the thousands to the tens of thousands, said Tom Pickett, the video site’s director of online sales and operations.
It probably won’t require much arm twisting, given that the video owners get most of the revenue from the ads accompanying their clips.
Google won’t specify how much it pays each of its ad partners, though it typically ranges anywhere from 70 percent to 90 percent of the revenue.
Posted in Internet/New Media, Women in Tech | Comments Off
Thursday, August 27th, 2009
ATLANTA – Transcend Services (Nasdaq:TRCR), the third largest seller of medical transcription services to the U.S. healthcare marekt, has agreed to buy Maryland-based Medical Dictation Services Inc. for $16.2 million.
The $16.2 million purchase price consists of $10.2 million in cash payable at closing (less any existing indebtedness assumed and plus or minus certain working capital and tax-related adjustments), $2 million in cash payable after receipt of interim financial statements and audited financial statements for the last two fiscal years, a $2 million note payable to the selling shareholder due one year after closing, and $2.0 million of Transcend common stock (119,940 shares).
Posted in Acquisitions, Georgia, Healthcare, Maryland | Comments Off
Thursday, August 27th, 2009
New research from Econsultancy and Clash-Media, the online customer acquisition specialist, shows that 53 percent of marketing budgets for US companies have increased in the past year, in the face of slow economic conditions.
This extra budget is being used to fund high-return Online Lead Generation campaigns, with Email Marketing the top area of spend, with 75 percent of organizations using it.
That dovetails with what Ryan Allis, CEO of Research Triangle Park-based iContact told TechJournal South in an interview. “Email is still the professional choice for business communication,” he said. Allis is one of more than 75 top Internet gurus who will participate in TechJournal South’s Internet Summit Nov. 4-5 at the Raleigh Convention Center (see: www.InternetSummit.com for more information).
According to the Clash-Media research, Paid Search has become less popular within online marketing, with 12 percent fewer companies using it compared to last year – largely because ROI is harder to achieve and quantify.
The US leads the way in innovation: 49 percent of companies use social media marketing, compared to 32 percent in the UK and 29 percent in Europe.
Online: www.clash-media.com; http://econsultancy.com
Posted in Events, Internet/New Media, Studies, surveys, reports | Comments Off
Thursday, August 27th, 2009
DELRAY BEACH, FL – VeriChip Corp. (NASDAQ:CHIP), a provider of radio frequency identification (RFID) systems for healthcare and patient-related needs, says that Scott R. Silverman, its current executive chairman, has resumed the role of CEO of the Company.
Earlier this week, the Company announced the re-launch of its Health Link electronic personal health record.
Silverman, who beneficially owns approximately 6.8 million shares of the Company, purchased the majority ownership position in November 2008. He will maintain his role as executive chairman of the Company’s board of directors.
The company developed the VeriMed Health Link System for rapidly and accurately identifying people who arrive in an emergency room and are unable to communicate. This system uses the first human-implantable passive RFID microchip, cleared for medical use in October 2004 by the United States Food and Drug Administration.
Online: www.verichipcorp.com
Posted in Biotech, Florida, Hardware, Healthcare, IT, People | Comments Off
Thursday, August 27th, 2009
ATLANTA – Alimera Sciences Inc. has closed a $5 million extension of its Series C financing which was originally completed in March 2008. The company expects top line data from a Phase III trial of its Iluvien treatment for diabetic macular edema by December this year.
The company has raised a total of at least $88.5 million since it’s inception in 2004.
The company’s initial Series C round secured $30 million.
It closed a $31.8 million B round in 2005 from investors including BA Venture Partners, Domain Associates, Intersouth Partners, Polaris Venture Partners and Venrock Associates, as well as several individual investors.
It raised a $26.75 million A round in 2004.
In connection with this financing, the purchasers of the $5 million in Series C preferred stock received warrants for an additional $10 million in Series C preferred stock.
The warrant holders will have up to 30 days from the delivery of Phase III top-line data for Iluvien to elect to exercise the warrants. If the majority of the holders of warrants make such election, then all warrant holders will be required to exercise their warrants in full.
Currently, nearly 24 million people, or 8 percent of the population, in the U.S. have diabetes. Over time, all diabetics are at risk of developing DME.
Based on published data, Alimera estimates that there are as many as 300,000 new cases of DME each year and 1,000,000 people have DME. There are no ophthalmic drug therapies currently approved by the U.S. Food and Drug Administration for the treatment of this disease.
Each Iluvien insert is designed to provide a sustained therapeutic effect of up to 36 months, for the low dose of Iluvien, and up to 24 months, for the high dose of Iluvien.
Iluvien is inserted into the patient’s eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.
The company also sells the over-the-counter product “Soothe” eyedrops.
Alimera also has entered into an exclusive worldwide agreement with Emory University to explore oxidative stress management – specifically the reduction of reactive oxygen species – as a treatment strategy for ophthalmic diseases.
Under this agreement, Alimera has acquired options to exclusive, worldwide licenses for two classes of nicotinamide adenine dinucleotide phosphate reduced form oxidase inhibitors, which Alimera is studying as potential treatments for conditions such as the dry form of age-related macular degeneration, particularly the late stage of this condition known as geographic atrophy.
Alimera has exercised its option to acquire a license with respect to one of these classes of NADPH oxidase inhibitors.
Online: www.alimerasciences.com
Posted in Biotech, Georgia, Money, Pharma | Comments Off
Thursday, August 27th, 2009
NORCROSS, GA – Ashworth College, an institution selling distance education degree programs, has secured a round of financing from Sterling Partners in an undisclosed amount.
Funds are slated to help Ashworth expand its programs and upgrade its technology infrastructure.
It offers secondary and post-secondary degree programs.
Online: www.ashworthcollege.edu
Posted in Georgia, Internet/New Media, Money | Comments Off
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