No More Needles? Oral Flu Vaccine Tablet Shows Promise in Phase 2 Trial

Flu Vaccine Oral Tablet
Participants were successfully challenged intranasally with homologous A strain influenza virus 90-120 days after vaccination to see if they had developed any immunity,

An investigational H1 influenza oral tablet vaccine was found to provide similar protection against influenza as an injectable quadrivalent influenza vaccine (QIV) in a Phase 2 clinical trial. 

The trial participants were randomized to receive either a single dose of Vaxart oral tablet vaccine and a placebo intramuscular injection, a QIV injection plus a placebo tablet, or a double placebo. They were challenged intranasally with homologous A strain influenza virus 90–120 days after vaccination. Laboratory-confirmed homologous influenza A infections were compared among the groups.

Results showed that the tablet vaccine provided a 39% reduction in clinical disease relative to placebo, compared to a 27% reduction with injectable QIV. The tablet also demonstrated a safety profile similar to placebo.

“These results provide clinical proof-of-concept for Vaxart’s groundbreaking oral tablet vaccine technology,” said Wouter Latour, MD, MBA, CEO of Vaxart, in a press release. “A convenient and effective tablet vaccine could significantly increase current vaccination rates and generate important public health benefits for at-risk groups and the population as a whole.”

For more information visit Vaxart.com.

 

Click here to read the original article.

 

###

 

 

 

Members of Congress Put Costly Drugs in Their Crosshairs

  • by Shannon Firth

WASHINGTON — Prescription drug prices are getting more attention on Capitol Hill, with two senators from opposite sides of the aisle announcing plans to investigate while House Democrats declared they were forming a task force on the issue as well.

Sen. Claire McCaskill (D-Mo.) and Sen. Susan Collins (R-Maine) this week announced a bipartisan probe into drug costs, according to a press release from McCaskill’s office. The senators are requesting drug pricing information from four companies whose products’ prices have recently spiked: Valeant Pharmaceuticals, Turing Pharmaceuticals, Retrophin, and Rodelis Therapeutics.

“We need to get to the bottom of why we’re seeing huge spikes in drug prices that seemingly have no relationship to research and development costs,” McCaskill said, in the statement.

According to the release, the investigation will look into:

  • “Substantial price increases on recently acquired off-patent drugs”
  • “Mergers and acquisitions within the pharmaceutical industry that have led to dramatic increases in off-patent drug prices”
  • “The FDA’s role in the drug approval process for generic drugs, the agency’s distribution protocols, and, if necessary, its off-label regulatory regime”

The Senate Special Committee on Aging has scheduled an initial hearing on this issue for Dec. 9.

At a press briefing on Wednesday, Rep. Lloyd Doggett (D-Texas) announced the formation of the “Affordable Drug Pricing Task Force.”

House representatives said they hope to advance legislation that would enable Health and Human Services Secretary Sylvia Burwell to negotiate Medicare prices and to force drug companies to be transparent about the cost of making their products.

Doggett cited the now infamous example of Turing Pharmaceutical’s Daraprim (pyrimethamine), a drug for treating infections common in patients with cancer and AIDS. After the company acquired the drug 3 months ago, the price went from $13.50 to $750 per tablet. On Tuesday, the company said it would lower the price by the end of the year, but did not say by how much.

“But exorbitant drug prices are not about one wrongdoing, or one drug, or one class of drugs; they are a systemic problem that involve a wide range of manufacturers,” said Doggett while standing at a podium flanked by posters of Turing’s CEO Martin Shkrelivilified by the media for his tone-deaf comment that his actions would benefit society — and Michael Pearson, CEO of Valeant Pharmaceuticals.

Click here to read the rest of this article

###

Fixing Healthcare Can Be As Close As Your Neighborhood Pharmacy

by John Nosta

The clinical emergency is medicine itself

Demand for primary care services is projected to increase through 2020, due to the increasing aging and population as well as the expanded insurance coverage implemented under the Affordable Care Act (ACA). In other words, the demand for primary care physicians will grow more rapidly than the supply, resulting in a projected shortage of over 20,00 full-time physicians.

The value of your neighborhood pharmacy

Nearly 70% of Americans are on at least one prescription drug and over 50% of Americans are on at least two prescription drugs. Given the shaky assumption that these folks are actually taking their medicines, it’s fair to say that beyond the physician, the pharmacist plays a key role in the health dynamic. Currently pharmacists can provide many services to their patients–from information to specific medicines.  In fact, the pharmacy is often a first source of medical information for many.  Pharmacy services have evolved from strictly dispensing medications to offering services such as medication therapy management, medication education, improving medication adherence, administering immunizations, and health/wellness. In addition, pharmacists can now be found in specialty areas such as oncology, organ transplant and even psychiatry. RxWiki–an on-line patient information service–now extends the pharmacy experience into the digital landscape, offering patients on demand access to medication information, pharmacy transactions, and medication adherence. RxNetwork is another emerging company with a unique methodology to link the pharmacy and patient–providing real-time support from compliance to education.  RxNetwork’s patient relationship management solution bridges the pharmacy-patient communication gap and provides an efficient, non-disruptive solution for the pharmacies with a convenient, rewarding, motivating solution to their connected patients.

Click here to read the rest of this article by John Nosta in Forbes Magazine

University of Texas Medical Branch at Galveston scientists successfully grow human lungs in lab in 3 days

by 

Growing organs may seem like science fiction, but it’s the goal of medical researchers because so many people need organ transplants and many die waiting for one.

“The most exciting part is to shorten the time people have to wait for an organ transplant,” said UTMB Dr. Joaquin Cortiella.

How did they do it? They started with a damaged lung.

“We removed all the cells all the material in it, and just left the skeleton of the lung, or the scaffold, behind — the pieces of the lungs that are no cells. That’s why it’s so white and pretty and there’s no blood in it, it’s very pretty looking. And then we added back cells from another lung that couldn’t be used for transplant but still had some viable cells in it,” said Dr. Joan Nichols, who leads the UTMB team.

But it took months until a UTMB medical student named Dr. Michael Riddle built a piece of equipment that sped up the process.

“He’s the one who went home and actually built using — I’m not kidding — a fish tank that he went and bought from a pet store, is what he built the first piece of equipment,” Dr. Nichols said.

“Took us about four months to take the cells from the lung to where all you have is a bio-scaffold, and we took that process down to about three days,” Dr. Riddle said.

UTMB scientists grew their first human lungs in the lab last year. Eyewitness News is the first to report it.

“It’s taken us a year to prove to ourselves that we actually did a good job with it. You don’t run out immediately and tell the world you have something wonderful until you’ve proved it to ourselves that we really did something amazing,” Dr. Nichols said.

Dr. Nichols says they hope to transplant the first set of lab-grown lungs in animals this year or next.

How soon could their lab-grown lungs be ready to save human lives? They aren’t sure, but estimate between 5 and 10 years, maybe longer.

Click here for a link to the original articlle and a news video

.

Find Christi on Facebook at ABC13-Christi Myers or on Twitter at@ChristiMyers13

(Copyright ©2014 KTRK-TV/DT. All Rights Reserved.)