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Ceravix Receives Commendatory Advice From FDA Advisory Committee

admin — Fri, 11 Sep 2009 01:16:20 +0000

Ceravix Receives Commendatory Advice From FDA Advisory Committee

GlaxoSmithKline recently advised the public that the US FDA’s Vaccines and Related Biological Products Advisory Committee voted that Ceravix, the company’s cervical cancer vaccine, presented data that substantiates the efficacy and safety of the treatment.

With regards to the prevention of cervical pre-cancers and cervical cancer relevant to human papillomavirus (HPV) types 16 and 18, Ceravix proved to be both extremely impactful and satisfactory endured in girls and young women. In addition, the committee conversed on data which presented Ceravix’s efficacy while in contact with other cancer-causing viruses.

GlaxoSmithKline’s Vice President and Director of North American Vaccine Development, Barbara Howe, MD exclaims that their recent favorable FDA recommendations marks and “important step in cancer prevention for the millions of girls and young women at risk for cervical cancer … if approved, Ceravix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in US women each year.”

The FDA will review the committee’s commendatory advice during its concluding evaluation of the Biologics License Application for the candidate vaccine. If accepted, the FDA will finalize prescribing information.

General side effects displayed during clinical trials of the Ceravix vaccine were pain, swelling and redness, fatigue, headache, muscle ache and joint pain, gastrointestinal symptoms and fever. Major side effects were mainly similar between the groups who received Ceravix and the control groups.

March of 2009, marks the date when GSK presented their Phase III pivotal study concluding data, a trial study that was the biggest efficacy trial of a cervical cancer vaccine. The data included information harvested from clinical trials hosted in more than 30 countries which utilized 30,000 Ceravix participants, revealing an ethnically and racially varied female population. The study also covered a rigorous safety assessment applicable to girls and young women between the ages of 10-25.

Research Argues, Over Time, Lead Subjection May Lead To Heart Disease

admin — Wed, 09 Sep 2009 20:41:56 +0000

Recent research argues that long-term subjection to lead may increase the risk of death caused by heart disease.

The Boston veterans’ age study, used 868 participants of mostly Caucasian men, where they inspected lead concentration in their bones and blood.

At the beginning of the study the average age of male participants was 67. These men exhibited lead concentration in both their blood and their bones of the kneecap and shin, which during their nine year analyses 241 participants reportedly died.

Of the participants, the researchers infer that men with an elevated mass of lead in their bones had a six time considerable r chance of dying from cardiovascular disease than those with a lower mass.

In addition, participants with the most elevated lead levels had a 2.5 times higher chance of dying of all causes than the participants with the minimalist levels.

Study author Marc Weisskopf, assistant professor of environmental health and epidemiology at Harvard School of Public Health, states “Cumulative subjection to lead, even in an era when current exposures are low, represents an important predictor of cardiovascular death … the findings with bone lead are dramatic. It is the first time we have had a biomarker of cumulative subjection to lead, and the strong findings suggest that it is a more critical biomarker than blood lead.”

In general, the study participants’ lead blood levels were somewhat higher than the average of similar US men. Although very few of the participants were involved in jobs with lead subjection, jobs such as construction and painting put men at a greater risk.

Present-day sources of lead subjection include chipping, flaking lead in paint, water pipes (found in older homes), food and drinking water, ammunition, toy soldier, fishing weight casting as well as lead can be located in the solder that is used for stained glass and some ceramic glazes.

The World Health Organization Qualifies Ceravix For Prequalification

admin — Tue, 08 Sep 2009 22:21:49 +0000

Ceravix will become the main component in the fight against cervical cancer in developing nations.

The World Health Organization (WHO) has granted Cervarix prequalification (GlaxoSmithKlein’s cervical cancer vaccine). This decision will enable UN agencies and GAVI Alliance to purchase and utilize the vaccine in union with developing countries.

According to WHO more than 80 percent of the 280,000 cervical cancer deaths a year exist in developing, resource-lacking nations. Due to the deficiency of screening resources and the rampancy of HIV/AIDS, poor women of developing nations are increasingly susceptible to cervical cancer.

Ceravix’s journey to headline the WHO’s crusade against cervical cancer in developing nations, began nearly two years ago. GSK submitted Ceravix for WHO prequalification in September 2007, a short week after European Medicines Agency approved the vaccine.

GSK has built an impressive reputation as a result of their dedication to making vaccines available to those in developing nations, which includes 10 WHO prequalification. Jean Stephenne, president of GSK Biologicals echoes the company’s humanitarian sentiments as he states: “Ceravix can save millions of women’s lives throughout the world.” Recently, GSK received another extended WHO prequalification for their vaccine Rotarix, thereby making rotavirus vaccines available to children.

GSK is participating in several interactive demonstration vaccine projects aimed to alleviate the challenges posed by introducing Ceravix to developing nations. Ceravix has donated 100,000 doses of the HPV vaccine in an attempt to create implementation fluidity. Of these projects PATH is leading Uganda and India into what CEO and President Christopher J. Elias believes is a “strengthening of healthcare systems and [a] mobilization of local communities.”

FDA Maintains Insulin Theft Alert

admin — Thu, 03 Sep 2009 18:22:28 +0000

The U.S. FDA warns the public that there is a potential for stolen long-acting insulin Levemir, produced by Novo Nordisk Inc, to still be active on the market.

Based on the FDA’s evidence, their proof suggests that the stolen insulin was improperly stored and handled, leaving the public vulnerable to risk. Many patients have informed the FDA of adverse side effects they experienced after using a vial from the stolen group, their glucose levels were incorrectly managed.

Since the FDA’s original warning of the insulin theft was made in June, only two percent of the 129,00 vials of Levemir has been retrieved.

As the FDA maintains their aggressive investigation and they recommend that all Levemir patients:

Check your current stock of insulin to verify whether you have Levemir insulin from one of the following lots: XZF0036; XZF0037; XZF0038. You can find the lot number on the side of the insulin box as well as on the side of the vial.

If your insulin originates from one of these lots do not use it! Exchange it with a vial of Levemir from another lot. If you must change to another insulin brand, do not do so before contacting your health care practioner, as you may require dosage modifications.

Palio Partners Up With Zemoga

admin — Tue, 01 Sep 2009 16:38:53 +0000

In an attempt to manage the evolution of digital media in the healthcare industry, Palio has joined with Zemoga (a full-service interactive agency). This partnership comes as a result of the changing technological environment as well as a result of the changes in consumer abilities and demands.

Consumers have become increasingly technological savvy and independent. The internet provides them with healthcare information resulting in a boosted demand for worth and relevance. Businesses must then react to these consumer needs and according to Guy Mastrion, Palio’s chief global creative officer “It’s our responsibility to develop and build best-in-class practices to proactively meet our clients’ needs in the digital world, to help fuel future growth for their brands in the new economy.”

DJ Edgerton, Zemoga’s president echoes the sentiment “Together we have created a powerful suit of services that goes beyond what we could achieve separately.” Mastrion continues to contend “the joining of our best practices has created great opportunities for both our firms; the sharing of our collective insight and expertise has already proven invaluable for our clients.”

Following from their partnership, Palio and Zemoga have launched Pixels and Pills ( HYPERLINK “http://www.pixels” www.pixelsandpills.com), a blog that provides information on the coming together of the digital and pharma worlds.

Off-Label Prescription Use Driven By Mistaken FDA Approval?

admin — Tue, 01 Sep 2009 16:36:51 +0000

A recent national survey revealed that a considerable minority of physicians inaccurately

thought that specific off-label uses of prescription medications had been approved by the U.S Food and Drug Administration.

Author of the research and Assistant Professor of Medicine at the University of Chicago Medical Center, Caleb Alexander M.D., says “Off-label prescribing is common, but researchers have not always known why. Our research shows that some off-label prescribing might be driven by mistaken beliefs about FDA approval and the level of evidence supporting off-label drug use … the results indicate an urgent need for more effective methods of informing physicians about the level of evidence supporting off-label drug use – especially for common off-label uses that are ineffective or carry unacceptable risks of harm.”

The survey composed of 22 drug-indication pairs – a specific drug prescribed for a specific medical condition – of those, the physicians were able to accurately distinguish the FDA-approval status of roughly half.

The survey was administered during 2007 – 2008 and included 1,199 physicians (of those physicians, 599 were primary care physicians and 600 were psychiatrists), and 22 drug-indication pairs. The indications were diverse in their FDA approval status from on-label use to off-label use substantiated by medical evidence to off-label use considered incapable.

The FDA states that they only regulate prescription drug marketing, not drug prescription. Once the FDA has deems a drug adequate for marketing, an official label is created informing health care practitioners of specific indication, dose, intended population and duration of use. As a result, health care practitioners are not bound to the FDA’s indications on their drug approved list, they may prescribe any approved drug for any indication.

Alexander hopes that their “research will increase awareness of off-label prescribing and highlight the pressing need for more evidence-based use of prescription drugs.” He continues on to admit that “some off-label uses are well supported, many are not.”

Alexander presents the following disadvantages and advantages of off-label drugs:

Disadvantages:

Could minimize public expectation that drugs will be gauged for safety and efficacy before use

Blunts industry motivation to perform studies required for FDA label changes

Off-label drugs may have unrecognized safety and efficacy problems

Encourages the use of drugs in populations, such as children and the elderly, for which they have not been tested

Advantages:

Permits clinical innovation, especially for patients who do not respond to standard treatments

Could be the only available option for unique conditions or for unstudied patient populations

Physicians are able to anticipate growing evidence of efficacy before formal evaluation

Increases pharmaceutical return on investment

Experts Assure That Swine Flu Delays are Under Control

admin — Tue, 01 Sep 2009 16:34:56 +0000

American experts are not convinced that the postponed receipt of the swine flu vaccine will derail the American government’s intention of defending their country against the virus’ recent spread.

Regardless, the government will only receive 45 million doses for October, as opposed to their initial expected amount of 120 million doses, which will, without question, cause stress and concern when it comes to their original vaccination strategy.

Federal health authorities estimate that after mid-October, an increase of 20 million vaccine doses will be made available and shipped each week. Dr. John Treanor, professor or medicine and microbiology and immunology at the University of Rochester Medical Center in New York City says “The vaccine will undoubtedly be useful … it may not be as useful than if it were ready in September, but I think it will still be useful.”

The vaccine production demands are not only complex but are also vulnerable. Treanor goes on to attribute the vaccine postponements as a result of the fragile requirements “…making a flu vaccine is a committed process. There are many steps … and all it takes is for something to be a little bit off … and you are going to see delays or shortages.”

A key issues is the manufacturers’ inability to produce the amounts of dosages originally hoped for. Treaner clarifies that the vaccine substrate growth is “slower and wimpier,” and “the amount vaccine manufacturers are getting out of millions of eggs is less than expected, and it’s taking longer to make.”

According to the Associated Press, although the government has sent new “seed strains” of the H1N1 virus in an attempt to speed up production, there still remains the an issue of packaging. The AP, further states that there are not enough manufacturers to package the vaccine. Fortunately, the government is currently mobilizing additional companies for packaging.

Federal officials have soothed the public’s minds by assuring that there is enough vaccine supply to immunize priority groups. These groups total roughly 160 million people and include such groups as pregnant women, public health workers and small children.

New Anti-T-Cell Globulin Treatment May Minimize Graft-Versus-Host Disease

admin — Wed, 19 Aug 2009 18:47:08 +0000

A recent study proclaims that patients who require a blood stem-cell transplant may be able to lessen the risk of graft-versus-host disease (GVHD – transplanted materials attack the body), thanks to ant-T-cell globulin treatment.

GVHD effects roughly 60 percent of those who have underwent blood stem cell transplants from the bone marrow or peripheral blood of unrelated donors (commonly referred to as hematopoietic cell transplantation). GVHD is a situation where the immune cells / T-cells from the donor recognizes the recipient’s tissues as unfamiliar and attack. Studies have propose antibodies that remove T-cells could avert the attack.

The recent study comprised of 201 adults who had blood cancer and had planned for a unrelated donor’s transplant. One group was treated to fend off GVHD prophylaxis, whereas the others were treated with standard therapy and anti-T-cell globulin.

After 100 days, roughly 34 percent of the people undergoing the standard treatment succumbed to GVHD or died, contrasted with 21 percent of the patients in the ATG-F group.

The phase 3 trial states that the general occurrence of acute GVHD was minimized in the ATG-F group (12 percent) than those who received the standard therapy (24 percent). The study also discovered that the two-year collective occurrence of chronic GVHD and extensive chronic GVHD in the ATG-F group was roughly 31 percent and 12 percent, contrasted with 59 and 43 percent for the standard therapy group.

The study also found that the ATG-F group did not have increased rates for relapse, deaths not related to relapse or deaths from infection, then the standard treatment.

Dr. Finke of Universitatsklinkum Feiburg in Germany stated in a news release that their study is the first “randomized clinical trial to show that ATG-F can reduce severe acute and clinically relevant chronic GVHD without compromising disease-free survival or overall survival … the use of ATG-F is safe for patients who are going to receive transplantation from matched unrelated donors.”

Decade Long Government Led Effort Results in Reduced Heart Attacks

admin — Wed, 19 Aug 2009 18:45:31 +0000

The August 19 issue of the Journal of the American Medical Association details a decade-long government led effort to minimize the death rate of hospitalized heart attack patients as well as upgrade the hospital’s execution of these daily emergencies.

The report states that between the years of 1995 and 2006, the death rate for in-hospital medicare heart attack patients dropped from 14.6 percent to 10.1 percent, and the 30-day death rate in said conditions decreased from 18.9 percent to 16.1 percent.

The decade underwent major drug and technological progress used in the treatment of heart attacks. In the opinion of study author Dr. Krumholz, professor of medicine at Yale University School of Medicine, the most significant factor in the general enhancement was the undertaking of what was then the Health Care Finance Administration and is now referred to as the Center for Medicare and Medicaid Services. In addition, the standard heart attack hospital stay lowered by roughly 16 percent.

Krumholz believes that “What CMS did was critical … [it would not have] happened without a shift by Medicare in saying ‘We have to look at the entire group of hospitals’ … the whole idea of quality improvement was to find the bad apples … the pivotal point was Medicare saying ‘We’re not going to focus only on the outliers.’”

Study Explores New Colon Cancer Treatment Option

admin — Wed, 19 Aug 2009 18:43:52 +0000

A new study believes that drugs that are intended to treat cell surface molecule ERBB3, can provide a more potent way of treating colon cancer.

ERBB3 is closely associated to epidermal growth factor receptor (EGFR), drugs used to treat EFGR have proven effective at tackling various cancers, but not colon cancer. Drugs used to treat ERBB3 have proven, however, to be more successful than EGFR inhibitors at targeting colon cancer.

Study researchers genetically blocked ERBB3 in lab mice with colon cancer as well as in human colon cancer cells. Lead author David Threadgill, genetics professor at the University of North Carolina stated “If you genetically remove ERBB3, as you would pharmacologically targeting it, then the mice rarely develop colon cancer.”

As a result of the study’s rise in cell termination when ERBB3 was genetically withdrawn from human colon cancer lines, Threadgill explains “If we use an inhibitor to block ERBB3, then it should be a very potent anti-cancer therapy.”