Friday, January 21, 2011

In The News: Hepatitis C Jan 21

An update today on the success of growing human liver cells; "Researchers suggest that this liver tissue could be used in place of donor organs during liver transplantation or during the bridge period until a suitable donor is available for patients with acute liver failure.".. Read more..

From India the news of an Ebola-like hemorrhagic fever has killed three people in western India. It was reported that a woman died after an insect-transmitted illness, as did the doctor and nurse who treated her... Read more....

A new record for organ transplants in BC
More living donors, more people signing up. More living donors and an increase in British Columbians signing donor cards have lead to a new record for organ transplants in 2010. Almost 300 procedures were done in the province last year.. Read More..
Andrea Macpherson Jan 21, 2011 10:21:07 AM
Recent highlights from the Ideas blog
By Joshua Rothman
January 23, 2011

Last week, Apple announced that Steve Jobs would be taking a medical leave. Jobs has struggled with his health since 2004, when he had surgery for pancreatic cancer; in 2009, he had a liver transplant. Among technology and business analysts, the talk is, prematurely, all about the fate of a post-Jobs Apple...Read More..

The Good News

Today Vertex's drug Telaprevir Received FDA Priority Review" both in U.S. and Canada. On Jan 6th Mercks Boceprevir received FDA Priority Review and EMA Accelerated Assessment. Telaprevir and boceprevir have been deemed the new generation of drugs both of which appear to be able to improve sustained response while shortening duration of therapy.
The Confusion

The headlines on these two drugs have been misleading and confusing for anyone newly diagnosed. With tag lines reading; "New Hepatitis C Drugs Telaprevir, and Boceprevir can boost cure rates as high as 75 percent with only 24 weeks of treatment". Okay, maybe I embellished a bit, but you get the gist of what I am trying to convey. If I were new to the world of hepatitis C my assumption would be I had a 75 percent chance at a cure. I may even assume treatment duration would be at 24 weeks. However, there are many factors to consider when figuring in these cure rates. Boceprevir and telaprevir will improve the chance for achieving a cure, but a 75 percent cure rate will not be seen in all people treating HCV. The cure rate for these drugs differ and hinge on genotype, treatment naïve patients, relapsers, partial responders, null responders, amount of liver damage/host factors, race and age. The lingo used by physicians or technicians can be difficult to remember; below is a clear definition of these terms. In this blog entry I hope to establish a better understanding in relation to achieving SVR/cure when treating with telaprevir or boceprevir.... Read More....

From Medical News Today

EHSI Forms Joint Venture To Develop Stem-Cell Treatment For Liver Disease
20 January 2011Emerging Healthcare Solutions, Inc. (PinkSheets: EHSI) announced that it has entered into a joint venture agreement with its wholly owned subsidiary, Celulas Genetica, in order to pursue testing of the revolutionary...Read more

Following a successful Phase 1 study for safety, researchers at MassBiologics of the University of Massachusetts Medical School (UMMS) have announced the beginning of a Phase 2 clinical trial testing the ability of a human...Read article

Biosimilars Update

This blog has covered biosimilars a handful of times. For those of you who have missed the updates biosimilars are copycat versions of expensive biotechnology drugs. Although technically these "biosimilars" are not called generics. Quoted from Reuters ;"Because of the complexity of biotech drugs, which are produced through biological processes that generally involve recombinant DNA technologies, they are often called "biosimilars" rather than generic copies. Biotech drugs are usually made from living cell lines controlled by different manufacturers, it is impossible for generic companies to make identical copies as they do with simple chemical-based drugs, which do not require fresh clinical trials. Biosimilars of drugs like Amgen's white blood cell-booster Neupogen are already on the market in Europe."

Today at pharmalot Mr. Ed Silverman reported the latest battle which involves; "a group of generic drugmakers, insurers and pharmacy benefit managers, which are pushing back against a recent effort by brand-name drugmakers to weaken a part of healthcare reform that is supposed to create competition for expensive biologics."

"The provision says generics can enter the market after a brand-name biologic has had exclusivity for 12 years."............ Read More.........
Friday If I Had.......
Once a week the blog will post a video in a series deemed "If I Had."
These videos cover numerous disorders and diseases.
Physicians share what they would do "IF they Had..." the disease in the topic video.
Today the topic is: If I Had leg swelling and pain…
Dr. Lawrence Hofmann, MD.
Chief of Interventional Radiology at Stanford Hospital & Clinics

From The One And Only Motley Fool

Mark your calendars, Fools: May is going to be a solid month for drug approvals.
The multiyear marathon between Schering-Plough and Vertex Pharmaceuticals (Nasdaq: VRTX) to develop the next-generation hepatitis C drug is finally coming to a close. Vertex announced yesterday that the Food and Drug Administration has accepted its New Drug Application to market telaprevir. Not surprisingly, given the unmet need, the agency will give telaprevir a priority review, so Vertex should hear back on or before May 23.
Merck (NYSE: MRK), which took over development of boceprevir when it bought Schering-Plough, announced a few weeks ago that the FDA had accepted its application with a priority review, as well. Since one drug isn't all that material to Merck's business, the company didn't feel compelled to give an exact date of the submission, so we don't know exactly when the FDA will come back with a decision.

If you want to put it on your calendar, you'll need a highlighter to mark off the potential weeks that Merck could hear. If the FDA took the same amount of time to review the applications, and the two companies announced the acceptance the same amount of time after they heard from the agency -- two big ifs -- Merck's PDUFA date is May 9. Perhaps the drugmaker will give investors an exact PDUFA date on its fourth-quarter earnings call.
In the big picture, which company launches first in the U.S. or Europe -- where Merck will go up against Vertex's marketing partner Johnson & Johnson (NYSE: JNJ) -- doesn't really matter. A few weeks or even a difference of a month or two doesn't really matter compared with who has the better drug.

Vertex clearly has the advantage here. While the drugs haven't been compared head to head, telaprevir appears to work better in every patient population tested so far.
While I think telaprevir is a best-in-class drug, I'm hesitant to invest because everyone else seems to think the same thing. The drugmaker has a market cap of more than $8 billion. That's substantially larger than companies like Dendreon (Nasdaq: DNDN) and Onyx Pharmaceuticals (Nasdaq: ONXX), which already have drugs on the market. Sure, the hepatitis C market is largely untapped, but there's a heck of a lot of sales already baked into that $8 billion.

Off The Cuff

It isn't just dog trainers and the occasional finicky spouse who want you to keep your pets off the bed. A new report in the journal Emerging Infectious Diseases found that of the 250 known zoonotic diseases, which are transmitted between humans and animals, more than 100 are derived from domestic pets — yes, even from your precious Sparkles or Daisy....Read more

‘Give Me Your Heart’
Published: January 21, 2011

Excerpt From Book:

I’ve learned that you, the renowned Dr. K——, are one who has generously signed a “living will” donating his organs to those in need. Not for Dr. K—— an old-fashioned, selfish funeral and burial in a cemetery, nor even cremation. Good for you, Dr. K——! But I want only your heart, not your kidneys, liver, or eyes. These I will waive, that others more needy will benefit...
Related:Sunday Book Review: ‘Give Me Your Heart’ by Joyce Carol Oates (January 23, 2011)


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