Archive for 2011

18.12.2011 healthcare 1 Comment

5 Reasons JPM Just Went Bullish On The Healthcare Industry

Business Insider by Mamta Babkar

JP Morgan is optimistic on healthcare stocks for the first time since March 2009. In a new report JP Morgan analysts cite five main reasons for the upgrade to ‘overweight’ from ‘neutral’.
Strong fundamentals – Healthcare companies have an 86% ratio of beating estimates, above the 69% average of all sectors. Free cash flow in the sector that reached $121 billion, which allows the company to pursue opportunities that can boost shareholder value. That reflects 11.3% compound annual growth since Q3 2006.
Cash return – In the past year, healthcare companies returned $78 billion to shareholders via dividends and stock buybacks. Dividends are at an all time high though buybacks are lower than then 2008 peak. Significantly a larger percent of companies are increasing their dividend payouts. read more

19.11.2011 FDA Approved No Comments

Tandem Insulin Pump FDA Approved

20111119-213305.jpg by Liz Jones Hollis

The FDA has cleared San Diego-based Tandem Diabetes Care’s t:slim insulin delivery system (pictured). And according to the company, t:slim is the first pump with a color touch screen and will be the smallest such system once it is commercially launched in the first half of 2012.

The t:slim system was designed to ease diabetes management. User-friendly features include an eco-friendly rechargeable battery and USB connectivity to a web-based therapy management software.

“With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy,” said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.’ The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.”

Of the approximate 1.5 million people in the U.S. with Type 1 diabetes, roughly 20% to 30% use an insulin pump, the company says in a statement, citing industry estimates. Tandem thinks the enhanced ease of use and attractive design of its offering will encourage more patients to consider insulin pump therapy.

The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.

04.11.2011 Uncategorized No Comments

New iPhone 4 & 4S Cases.

New iPhone 4 and 4S cases from element case called the Vapor Pro Series have received excellent consumer ratings.  The custom release of the Medicine logo on the suede back is causing great excitement in the healthcare world.  Doctors are saying that it is a great thing to have your life’s work and passion on your iPhone.  Go to www.mojav.com to get more information and purchase instructions.

11.08.2011 news No Comments

Genetically Modified ‘Serial Killer’ T-Cells Obliterate Tumors in Leukemia Patients

20110811-084849.jpgScienceDaily (Aug. 10, 2011) — In a cancer treatment breakthrough 20 years in the making, researchers from the University of Pennsylvania’s Abramson Cancer Center and Perelman School of Medicine have shown sustained remissions of up to a year among a small group of advanced chronic lymphocytic leukemia (CLL) patients treated with genetically engineered versions of their own T cells. The protocol, which involves removing patients’ cells and modifying them in Penn’s vaccine production facility, then infusing the new cells back into the patient’s body following chemotherapy, provides a tumor-attack roadmap for the treatment of other cancers including those of the lung and ovaries and myeloma and melanoma.

The findings, published simultaneously in the New England Journal of Medicine and Science Translational Medicine on August 10, are the first demonstration of the use of gene transfer therapy to create “serial killer” T cells aimed at cancerous tumors.
“Within three weeks, the tumors had been blown away, in a way that was much more violent than we ever expected,” said senior author Carl June, MD, director of Translational Research and a professor of Pathology and Laboratory Medicine in the Abramson Cancer Center, who led the work. “It worked much better than we thought it would.”

The results of the pilot trial of three patients are a stark contrast to existing therapies for CLL. The patients involved in the new study had few other treatment options. The only potential curative therapy would have involved a bone marrow transplant, a procedure which requires a lengthy hospitalization and carries at least a 20 percent mortality risk — and even then offers only about a 50 percent chance of a cure, at best.

“Most of what I do is treat patients with no other options, with a very, very risky therapy with the intent to cure them,” says co-principal investigator David Porter, MD, professor of Medicine and director of Blood and Marrow Transplantation. “This approach has the potential to do the same thing, but in a safer manner.”

Secret Ingredients:
June thinks there were several “secret ingredients” that made the difference between the lackluster results that have been seen in previous trials with modified T cells and the remarkable responses seen in the current trial. The details of the new cancer immunotherapy are detailed in Science Translational Medicine.
After removing the patients’ cells, the team reprogrammed them to attack tumor cells by genetically modifying them using a lentivirus vector. The vector encodes an antibody-like protein, called a chimeric antigen receptor (CAR), which is expressed on the surface of the T cells and designed to bind to a protein called CD19.
Once the T cells start expressing the CAR, they focus all of their killing activity on cells that express CD19, which includes CLL tumor cells and normal B cells. All of the other cells in the patient that do not express CD19 are ignored by the modified T cells, which limits side effects typically experienced during standard therapies.
The team engineered a signaling molecule into the part of the CAR that resides inside the cell. When it binds to CD19, initiating the cancer-cell death, it also tells the cell to produce cytokines that trigger other T cells to multiply — building a bigger and bigger army until all the target cells in the tumor are destroyed.

Serial Killers:
“We saw at least a 1000-fold increase in the number of modified T cells in each of the patients. Drugs don’t do that,” June says. “In addition to an extensive capacity for self-replication, the infused T cells are serial killers. On average, each infused T cell led to the killing of thousands of tumor cells — and overall, destroyed at least two pounds of tumor in each patient.”
The importance of the T cell self-replication is illustrated in the New England Journal of Medicine paper, which describes the response of one patient, a 64-year old man. Prior to his T cell treatment, his blood and marrow were replete with tumor cells. For the first two weeks after treatment, nothing seemed to change. Then on day 14, the patient began experiencing chills, nausea, and increasing fever, among other symptoms. Tests during that time showed an enormous increase in the number of T cells in his blood that led to a tumor lysis syndrome, which occurs when a large number of cancer cells die all at once.

By day 28, the patient had recovered from the tumor lysis syndrome — and his blood and marrow showed no evidence of leukemia.
“This massive killing of tumor is a direct proof of principle of the concept,” Porter says.
The Penn team pioneered the use of the HIV-derived vector in a clinical trial in 2003 in which they treated HIV patients with an antisense version of the virus. That trial demonstrated the safety of the lentiviral vector used in the present work.
The cell culture methods used in this trial reawaken T cells that have been suppressed by the leukemia and stimulate the generation of so-called “memory” T cells, which the team hopes will provide ongoing protection against recurrence. Although long-term viability of the treatment is unknown, the doctors have found evidence that months after infusion, the new cells had multiplied and were capable of continuing their seek-and-destroy mission against cancerous cells throughout the patients’ bodies.
Moving forward, the team plans to test the same CD19 CAR construct in patients with other types of CD19-positive tumors, including non-Hodgkin’s lymphoma and acute lymphocytic leukemia. They also plan to study the approach in pediatric leukemia patients who have failed standard therapy. Additionally, the team has engineered a CAR vector that binds to mesothelin, a protein expressed on the surface of mesothelioma cancer cells, as well as on ovarian and pancreatic cancer cells.
In addition to June and Porter, co-authors on the NEJM paper include Bruce Levine, Michael Kalos, and Adam Bagg, all from Penn Medicine. Michael Kalos and Bruce Levine are co-first authors on the Science Translational Medicine paper. Other co-authors include June, Porter, Sharyn Katz and Adam Bagg from Penn and Stephan Grupp the Children’s Hospital of Philadelphia.

The work was supported by the Alliance for Cancer Gene Therapy, a foundation started by Penn graduates, Barbara and Edward Netter, to promote gene therapy research to treat cancer, and the Leukemia & Lymphoma Society.

28.07.2011 blog 4 Comments

FDA Approves Hepatitis C drugs.

20110728-083150.jpg

Much Better Hepatitis C Cure Rate When Incivek Added to Standard Combination Therapy
By Daniel J. DeNoon
WebMD Health News Reviewed by Laura J. Martin, MD

May 23, 2011 — The FDA has approved Vertex’s Incivek as an add-on to current interferon/ribavirin therapy for hepatitis C infection.
Like Victrelis, also approved this month, Incivek greatly boosts the chances that hepatitis C treatment will result in a cure — that is, a “sustained viral response” or SVR. Although hepatitis C virus (HCV) may not be totally eliminated, an SVR essentially means a person will never have to worry about developing complications of hepatitis C disease.
Standard treatment with interferon and ribavirin lasts 48 weeks, yet results in an SVR for fewer than half of patients. In clinical trials, adding Incivek to this regimen boosted SVR rates 20% to 45%.
Moreover, most patients taking Incivek will have to tolerate the side effects of the triple combination therapy for only 24 weeks.
Earlier this month, an FDA advisory panel enthusiastically recommended approval of Incivek and Victrelis.
Incivek and Victrelis both target the HCV protease enzyme, making it nearly impossible for the virus to replicate. Although the virus quickly becomes resistant to either drug used alone, combination therapy with interferon and ribavirin keeps HCV in check.
“With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” Edward Cox, MD, MPH, director of the FDA’s office of antimicrobial products, says in a news release.
Incivek and Victrelis increase the already difficult side effects of standard therapy — particularly anemia — but they do not have to be taken for the full 48 weeks of standard therapy. And there’s evidence that patients who have a strong early response to the drugs may be able to shorten the grueling course of treatment.
Incivek is given for the first 12 weeks of combination treatment. Interferon/ribavirin treatment lasts a total of 48 weeks, although early responders may be able to stop at 24 weeks.
Incivek has two major side effects: It increases the anemia seen with interferon/ribavirin, and it causes an itchy rash in more than half of patients. Other side effects include nausea, fatigue, headache, diarrhea, and anal or rectal irritation and pain.
The clinical trials that led to the Incivek reported somewhat higher cure rates than the trials that led to Victrelis’ approval. But the two drugs have never been tested head to head, so it’s impossible to say for sure whether one works better than the other.
A major marketing battle is expected between Merck and Vertex. Although each of the drugs is a major advance over current hepatitis C therapy, even better treatments are in the pipeline.
New polymerase inhibitors promise to make combination treatment even more effective — and may even allow some patients to avoid the interferon/ribavirin combination. But such drugs are at least three years away from the marketplace.

22.06.2011 FDA Approved No Comments

Pain Relief for Anal Fissures

FDA Approves New Drug for Chronic Anal Fissure Pain
Mark Crane
Authors and Disclosures
June 22, 2011 — The US Food and Drug Administration (FDA) has approved nitroglycerin ointment 0.4% (Rectiv, ProStrakan Group) for the treatment of moderate to severe pain associated with chronic anal fissures, the company announced today.

The ointment will be the only FDA-approved prescription product for patients with this condition, according to the company. Marketed under the name Rectogesic, the ointment is already approved in the European Union and has been outlicensed outside Europe by ProStrakan to commercial partners in 34 countries worldwide.

“The pain associated with anal fissures can be unrelenting and debilitating. Prompt initiation of treatment by primary care practitioners, gynecologists, gastroenterologists and surgeons alike is critical to a patient’s wellbeing,” Scott Berry, MD, colorectal surgeon and the principal investigator on one of Rectiv’s clinical trials, said in a news release. “Now we have an effective and easy-to-use topical ointment which allows grateful patients to resume their daily lives.”

Approximately 700,000 people in the United States receive a diagnosis of or treatment for an episode of anal fissures each year. An anal fissure is a small tear in the skin that lines the anus, and it can occur in many ways, such as passing large or hard stools, straining during a bowel movement, or following an episode of diarrhea. When an anal fissure occurs, it typically causes severe pain and bleeding with bowel movements. Chronic anal fissure has been shown to significantly affect patients’ quality of life, the company said. An episode can take 6 to 8 weeks to heal, and if healing does not occur surgery may be required.

ProStrakan expects Rectiv to be available in the United States in the first quarter of 2012.

ProStrakan, based in Galashiels, Scotland, and Bedminster, New Jersey, is a subsidiary of Kyowa Hakko Kirin Co. Ltd., a Japan-based global specialty pharmaceutical company.

Medscape Medical News © 2011 WebMD, LLC
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