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Corporate-Non Profit Partnership Developing Tuberculosis Vaccine

Posted: October 30th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , | Comments Off on Corporate-Non Profit Partnership Developing Tuberculosis Vaccine

GlaxoSmithKline will work with nonprofit biotech Aeras to test a tuberculosis vaccine in Africa and India, making headway in developing new ways to prevent the disease.

After promising early-stage clinical trials of GSK’s TB vaccine candidate, the partners will conduct a Phase IIb trial in Kenya, Indiaand South Africa next year pending approvals from authorities. Both GSK and Aeras will provide resources to test the vaccine candidate in healthy adults between ages 18 and 50.

“When considering the massive public health impact and costs to society of neglected diseases including tuberculosis, global financing for R&D remains critically low in this area,” Jim Connolly, president and CEO of Aeras, said in a release. “Working in partnership with GSK–sharing resources, capabilities and know-how–affords us the opportunity to conduct this pivotal, multicountry proof-of-concept trial, getting us that much closer to potentially one day having a TB vaccine that could protect adolescents and adults from one of the world’s deadliest infectious diseases.”

The TB vaccine Bacille Calmette-Guerin (BCG) prevents some forms of the disease, but not pulmonary TB–and that’s the one responsible for the majority of infections and deaths. GSK and Aeras plan to use their candidate in conjunction with BCG.


New Attempt to Create Staph Vaccine Begins

Posted: October 25th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , | Comments Off on New Attempt to Create Staph Vaccine Begins

Pfizer, GlaxoSmithKline and NovaDigm Therapeutics are each in search of a vaccine to stop methicillin-resistant Staphylococcus aureus, a staph infection that kills more people in the U.S. than skin cancer, Bloomberg reports.

The drugmakers take up the task after two other companies failed to make an effective vaccine–most recently Merck in 2011.  The staph infection can cost as much as $8 billion a year to treat.

“It’s very clear we need a vaccine, and we need it soon,” Robert Daum, a pediatrics professor at the University of Chicago and principal investigator at the school’s MRSA Research Center, told Bloomberg.  “The challenge is, we don’t really know what makes people immune to staph infections.”

The vaccines from the three companies are in early stages in the pipeline, working through the first of three phases typically required for market approval. Pfizer has two vaccines in early trials, while GSK has completed its first-stage trial of a four-component vaccine. NovaDigm completed two Phase I trials that showed its therapy, NDV-3, is safe in humans.

Generally, benign Staphylococcus aureus bacteria live on people’s skin and in their nasal passageways, Bloomberg reports.  The bacteria can enter the skin through cuts, sores, catheters and breathing tubes, making infection common in hospitals and nursing homes. MRSA kills more than 11,400 Americans a year.

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Cancer Vaccines Advance to Phase IIb

Posted: October 23rd, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , , , | Comments Off on Cancer Vaccines Advance to Phase IIb

CureVac, a biotech company pushing therapeutic cancer vaccinesinto Phase IIb studies, landed a cool $104 million from German multibillionaire Dietmar Hopp’s investment group, Dievini Hopp BioTech Holding.

Image representing CureVac as depicted in Crun...

Image via CrunchBase

Image representing dievini Hopp Biotech Holdin...

Image via CrunchBase

CureVac will use the hefty sum to advance the development of its two lead RNActive cancer vaccines against prostate cancer and non-small cell lung cancer.  The company will also use some of the funds to further develop its prophylactic vaccines and adjuvants for infectious diseases.  The first task will be to run a Phase IIb study on prostate cancer vaccine CV9103, CureVac CEO Ingmar Hoerr told FierceBiotech.

To date, CureVac has raked in about €145 million ($189 million) in equity financing.

“Our technology is based on a major new understanding of the medical potential of mRNA, and our novel mRNA vaccines and RNA-based adjuvants may transform the treatment of many debilitating diseases, including prostate and lung cancer, as well as the prophylaxis of many infectious diseases,” Hoerr said.

Last September, CureVac and Sanofi Pasteur inked a deal to develop and apply the RNActive technology platform to the development of vaccines against several infectious diseases.  In another deal, the two companies–along with France’s In Cell Art–undertook a $33 million DARPA research program to identify and create a universal vaccine technology platform for infectious diseases.

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West Nile Virus on the Rise

Posted: October 18th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on West Nile Virus on the Rise

West Nile virusis on the rise in the U.S.  The Centers for Disease Control and Prevention is reporting the most cases since the virus was first detected in the country in 1999.

West Nile Virus Cases in the United States

West Nile Virus Cases in the United States (Photo credit: Wikipedia)

A total of 1,118 cases and 41 deaths were reported to the CDC as of the third week in August. And 75% of the cases come from 5 states: Texas, Mississippi, Louisiana, Oklahoma and South Dakota.  The numbers are trending upward.

Experts say they don’t know why the outbreak is worse this year than in years past, but hot weather does seem to promote the outbreak.

“Hot weather, we know, from experiments done in the laboratory, can increase the transmissibility of the virus through mosquitoes and that could be one contributing factor,” Lyle Petersen, director of the division of vector-borne infectious diseases at the CDC, said in a news briefing.

Texas has seen nearly half the cases of West Nile, a statistic that prompted the CDC to provide more than $2.5 million to support increased surveillance control including spraying. Two CDC teams went to the state to support local healthcare officials, too.

There’s no vaccine for the West Nile virus, but companies are working toward solutions.


Flu Vaccine is Safe for Pregnant Women

Posted: October 16th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on Flu Vaccine is Safe for Pregnant Women

A new study concludes that the flu vaccine is safe for pregnant women, even in the first trimester. The study consisted of nearly 9,000 pregnant women who received the vaccine. And the rate of birth defects was the same from women who got vaccinated and those who did not, Reutersreports.

A pregnant woman

A pregnant woman (Photo credit: Wikipedia)

Though doctors recommend that pregnant women receive a flu shot, because they are more likely than other women their age to get a severe case of the flu or have complications, most in the United Statesdo not, according to Reuters. A mere 10% to 25% of women got vaccinated each flu season over the past couple decades, said Jeanne Sheffield, a professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center in Dallas. This means there’s a market out there that flu vaccine makers are missing.

“The flu is a problem in pregnancy,”Sheffieldsaid. “But we have a vaccine to prevent it. And it’s considered safe and effective in any trimester.”

Earlier this month, the FDA approved 6 flu vaccines from companies licensed to distribute the products in the United States.


Vaccines Get Stronger

Posted: October 11th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements, Uncategorized | Tags: , , , , | Comments Off on Vaccines Get Stronger

Researchers at Oxford University discovered a compound that gives vaccines a little extra might in the fight against viruses such as the flu, HIV and herpesin mice.

None - This image is in the public domain and ...

(Photo credit: Wikipedia)

Mice given a dose of the flu shot that included the polymer, polyethyleneimine (PEI), were protected fully against a lethal dose of the flu.  Formulas without the adjuvant or with different adjuvants didn’t show nearly as positive results.  The Oxford scientists, working with U.S. and Swedish researchers, will soon test the PEI adjuvant on ferrets.

“Gaining complete protection against flu from just one immunization is pretty unheard of, even in a study in mice,” said professor Quentin Sattentau of the Dunn School of Pathology at Oxford University, who led the work.  “This gives us confidence that PEI has the potential to be a potent adjuvant for vaccines against viruses like flu or HIV, though there are many steps ahead if it is ever to be used in humans.”

The most popular adjuvant is alum, an aluminum-based compound. But it’s not the most potent.  However, mice showed a powerful immune response when PEI was included in a vaccine with a protein from HIV, flu or herpes virus.  PEI works well as an adjuvant for mucosal vaccines, those absorbed through the nose or mouth.  This is good news for those who dread needles.

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Vaccine Manufacturer Receives Clean Bill of Health from FDA

Posted: October 9th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on Vaccine Manufacturer Receives Clean Bill of Health from FDA

After more than two years of manufacturing problems, CSL Biotherapies cleaned up its act, snagging a closeout letter from the FDA.

Fda

FDA (Photo credit: Wikipedia)

The FDA slapped the company with a warning letter in June 2011, questioning CSL’s manufacturing quality.  Its processes may have contributed to issues with a flu vaccine and led to the hospitalization of several children in 2010.  Australian regulators put a halt to licensing Fluvax for children under age 5 at the time.

CSL’s missteps included failing to adequately investigate dark particles found in some vials and completing only a limited analysis of the manufacturing process to determine why the adverse events shot up in 2010 compared with previous seasons.  “There was no analysis of all critical parameters and critical processing steps to determine differences in the 2010 lots associated with adverse events reports compared to lots from previous seasons,” the warning letter says.

As for the dark particles, the FDA investigation focused on multidose vials only.  Analysis of the particles showed that they were “discolored influenza virus with the possible presence of mercury compounds,” according to the warning letter.  The company refuted this, saying the dark particles were not foreign to the product.  The FDA disagreed.

The closeout letter comes a few weeks after CSL announced that the company’s CEO, Brian McNamee, will step down next July.  He’ll be replaced by the current president of CSL Behring, Paul Perreault.


Varicella Vaccine Slashes Cases of Chickenpox

Posted: October 4th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , | Comments Off on Varicella Vaccine Slashes Cases of Chickenpox

Chickenpox cases in the United Statessank almost 80% between 2000 and 2010 in 31 states, with the help of Merck’s ($MRK) varicella vaccine. The CDC published the findings Aug. 17 in the organization’s Morbidity and Mortality Weekly Report. The findings show a two-dose round of the vaccine–recommended for children in 2006–caused cases of chickenpox to decline 70% over the course of four years.

Merck has the chickenpox vaccine market cornered in theU.S.There are two chickenpox vaccines licensed in the nation, according to the Centers for Disease Control and Prevention, both made by Merck: Varivax and ProQuad. ProQuad is a combination measles, mumps, rubella and varicella vaccine that the company plans to roll out in theU.S.in October. Varivax, however, is already on the market. In 2011, total sales for the vaccine hit $902 million, according to data from EvaluatePharma. For ProQuad, worldwide sales were at $70 million last year.

CDC figures show the biggest drop in chickenpox cases occurred in children ages 5 to 9. The varicella vaccine made it into the rotation of childhood shots in 1996 and a second dose was recommended in 2006. That second dose helped cut chickenpox incidence 72% from 2006 to 2010.

Chickenpox, an uncomfortable and sometimes serious disease, causes a blister-like rash, itching, tiredness and fever. Before a vaccine entered the picture, about 4 million people in the U.S.came down with the disease each year.

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We Have the Meningitis Vaccine

Posted: October 4th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements, Travel Health Alerts | Tags: , , , , | Comments Off on We Have the Meningitis Vaccine

An outbreak of Meningitis, a disease that causes inflammation of the meninges, the membranes around the spinal cord and brain, has spread to five states with four dead as of Wednesday October 3, 2012.

The disease has affected patients in Tennessee, Virginia, Maryland, North Carolina and Florida, according to the CDC.  Four people have died as a result of the disease; two in Tennessee and one each in Virginia and Maryland.

Meningitis is a vaccine-preventable disease and Passport Health of Sarasota-Bradenton has the meningococcal vaccine.  We urge residents of the Sarasota-Bradenton area to take proactive action to defend their health!  Why would you wait until you had contracted the disease when it is preventable in the first place?

Call to schedule an appointment (941) 362-0304 or come in to one of our offices.

  • Sarasota Office: 2195 Ringling Blvd, Sarasota, FL 34237
  • Bradenton Office: 4800 26th St West, Bradenton FL 34207

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Painless Flu Vaccines

Posted: October 2nd, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , | Comments Off on Painless Flu Vaccines

Five years ago this summer, AstraZeneca decided to pony up to purchase Maryland-based MedImmune for a cool $15.6 billion, a deal that left many wondering whether the bills matched the product.  Now, incoming CEO Pascal Soriot has his work cut out for him.

Come October, the French-native will jump over from Roche , where he served as chief operating officer since 2010. He’s inheriting a vaccines and biotech drugs division with 2,600 Maryland employees and 4,000 globally, The Washington Post reports.  The company will also shutter two California offices, leading to a loss of 200 jobs and a shift of 100 more to other sites.

MedImmune has had its ups and downs, with the vaccines business supplying some upbeat results; in 2009, the company was the first to market a swine flu vaccine.  And this year MedImmune rolled out the first intranasal flu vaccine that contains four strains of the disease.

English: Millington, Tenn. (Oct. 28, 2005) &nd...

(Photo credit: Wikipedia)

Fluenz nasal spray became the vaccine of choice in the U.K. for children ages 2 to 17 in a contract expected to exceed £100 million ($156.7 million).  The company’s FluMist brought in $161 million of AZ’s $33.6 billion in revenue in 2011.