Search This Blog

Monday, July 8, 2019

LightStrike Robot Destroys Deadly Superbug Candida auris in Study

Candida auris (C.auris) is an emerging, often multi-drug resistant, fungus that causes serious and often deadly infections in healthcare settings. The Centers for Disease Control & Prevention (CDC) recently issued a warning about C.auris, terming it a “serious global health threat.”
Nearly 700 C.auris cases have been reported in the U.S. thus far, but hospitals overseas have been battling the deadly pathogen for quite some time. The Netcare Hospital Group, which operates the largest private hospital network in South Africa, was the first and is the only hospital group in South Africa to utilize Xenex high intensity, broad spectrum mobile disinfection robots that have been proven effective against viruses and bacteria that can threaten patient safety. Dr. Caroline Maslo is Senior Clinical Advisor and Head of Infection Control for Netcare’s Hospital Division, and the lead author of a new peer-reviewed study “The efficacy of pulsed-xenon ultraviolet light technology on Candida auris” that validates the efficacy of LightStrike™ pulsed xenon ultraviolet (UV) disinfection technology in destroying C.auris.
In the BMC Infectious Diseases study, researchers reported a 99.6% reduction in C.auris after a 10-minute treatment with pulsed xenon UV disinfection, stating, “The PX-UV mobile device is easy to use and has significantly shorter cycle times that makes it easier to disinfect all areas outside the room where the patient received care, as recommended by the CDC.”
Dr. Mark Stibich, co-founder and Chief Scientific Officer of Xenex, said, “As an evidence based company, seeing this research documenting the efficacy of pulsed xenon UV disinfection technology against C.auris is very exciting. We began hearing reports of C.auris some time ago and began testing in government laboratories to create protocols for how our technology should be utilized to combat it. This data from Dr. Maslo’s group further validates our best practices. Adding LightStrike robot disinfection to your hospital’s infection prevention bundle can help combat the spread of C.auris in the hospital environment, and our team is prepared to help healthcare facilities integrate the technology into their infection prevention strategy.”
Xenex LightStrike robots quickly destroy bacteria, viruses, mold, fungus and spores on hospital surfaces. The portable disinfection robots are effective against the most common as well as the most dangerous pathogens, including Clostridium difficile (C.diff), norovirus, influenza, Ebola, carbapenem-resistant Enterobacteriaceae (CRE), Vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA). Trained hospital cleaning teams operate the robot, which is brought in after the patient has left the room as part of a hospital’s comprehensive infection prevention strategy. The intense pulsed xenon UV light quickly destroys invisible pathogens lurking on surfaces (bedrails, tray tables, door knobs, wheelchairs, etc.).
More than 400 healthcare facilities worldwide are using LightStrike Germ-Zapping Robots™ daily to disinfect rooms against a full spectrum of agents, including C.auris. Several hospitals in the northeastern U.S. utilized their Xenex robots after treating C.auris patients, and no additional infections were reported. The robots can be used in any department and in any unit within a healthcare facility, including isolation rooms, operating rooms, general patient care rooms, contact precaution areas, emergency rooms, bathrooms and public spaces.
LightStrike robots have been studied extensively in the hospital environment and credited in numerous peer-reviewed, published studies with helping hospitals decrease their C.diff, MRSA and Surgical Site Infection (SSI) rates from 46% – 100%.
Netcare purchased and implemented LightStrike devices in hospitals across South Africa from Kiara Healthcare, Xenex’s authorized reseller in Africa.
Xenex’s patented Full SpectrumTM pulsed xenon UV room disinfection system is used for the advanced disinfection of healthcare facilities. Due to its speed and ease of use, the Xenex system has proven to integrate smoothly into hospital cleaning operations. Xenex’s mission is to save lives and reduce suffering by destroying the deadly microorganisms that cause healthcare associated infections (HAIs). The company is backed by well-known investors that include EW Healthcare Partners, Piper Jaffray Merchant Services, Malin Corporation, Battery Ventures, Tectonic Ventures, Targeted Technology Fund II and RK Ventures. For more information, visit Xenex.com.

Trump Plans ‘Favored Nations Clause’ to Tie Drug Prices to Cost Other Nations Pay

In his latest move to drive down the costs of prescription drugs in the United States, President Donald Trump is planning to issue an executive order that will tie the costs of prescription drugs paid for by the federal government to the lowest price paid in other countries.
On Friday, Trump announced a “favored nations clause” which will instruct government agencies buying prescription drugs to only pay the lowest price paid for by foreign countries. “As you know, for years and years, other nations paid less for drugs than we do, sometimes by 60, 70%,” Trump told reporters on Friday, according to a video posted by CNBC.
Last fall, Trump initially announced a price-negotiation plan for Medicare-supported infused and injected drugs that the administration claimed could save $17 billion over five years. Part of that plan also included a “benchmark” for Medicare costs against the pricing of drugs in 16 other nations as part of an international pricing index. Trump made drug pricing a central point of his 2016 presidential campaign, which included the infamous claim that pharmaceutical companies are “getting away with murder” when it comes to the prices the companies charge for medication.

In his latest comments concerning pricing, Trump queried why other nations should pay less than the United States, a criticism long aimed at the pricing of prescription drugs. The U.S. is the top market for drugmakers, in part due to the lack of pricing controls. The U.S. pays more per capita for prescription drugs than any other country in the world. Trump said the new pricing policy will be dictated through an executive order. In his remarks though, he did not specify when that order would be issued, only said that his administration was currently working on it. From the president’s remarks, it is unclear what the total breadth of the executive order would be when it comes to pricing. The Wall Street Journal speculated that the executive order would only cover some drugs, possibly the more expensive ones that treat rare diseases.
The latest action for pricing is only part of a series of programs implemented by the White House aimed at lowering drug costs. Other policies put in place include the requirement that prescription drugs advertised on television must include the list price, which is the price negotiated between manufacturers and pharmacy benefits managers. The list price is typically not the price paid by consumers at their retail pharmacy. The inclusion of list prices on television advertisements is part of the White House’s blueprint for lowering healthcare costs, called American Patients First. The White House plan includes four primary strategies to bring down costs — boosting competition, enhancing negotiation, creating incentives for lower list prices and bringing down out-of-pocket costs. Requiring the inclusion of the list price is seen by the White House as a means of making drug prices more transparent and as a way of giving patients some leverage with their prescribers over medication they may require.
Last month, Trump issued an executive order that requires insurers, doctors, hospitals and others in the healthcare industry to provide information about the negotiated and often discounted cost of care. At the time the order was signed, the administration said the goal of the executive order is to arm patients with pricing data so they will have the necessary information to provide them with greater control over health care costs.

ChromaDex Shares Nicotinamide Riboside Study Results

ChromaDex Corp CDXC 0.57% announced the results of its latest clinical study were published in the journal Scientific Reports. The study further validates the safety and efficacy of ChromaDex’s proprietary form of NR, Niagen.
Niagen is the patented and only known FDA safety-notified form of a naturally occurring vitamin B3 known as nicotinamide riboside. ChromaDex says its Niagen is the only commercially available nicotinamide riboside which has twice been reviewed under FDA’s new dietary ingredient notification program.
“The results of this large human trial directly support the efficacy and safety of our NAD-boosting consumer product Tru Niagen,” said ChromaDex CEO Rob Fried in a statement. “The study also provides key data points for regulatory submissions as we continue our global expansion.”

PolarityTE started at Buy by Wainwright

Target $8

Ligand out-licenses Captisol to SQ Innovation

Ligand Pharmaceuticals (LGND -0.5%) has licensed exclusive global rights to its Captisol technology to SQ Innovation AG for use in a high-concentration formulation of diuretic furosemide for the treatment of edema in heart failure patients.
SQ is developing a novel drug-device combo for the subcutaneous delivery of diuretics that are currently administered intravenously.
Under the terms of the deal, LGND will receive milestones, royalties and revenue from Captisol sales.
Captisol is a chemically modified cyclodextrin (sugar molecule) that optimizes the solubility and stability of drugs.

Y-mAbs to start naxitamab application in November for neuroblastoma

Y-mAbs Therapeutics (YMAB -3.3%announces that it expects to commence its rolling BLA submission in November for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma.
It plans to file the Clinical/Safety and non-Clinical sections first, followed by the CRC section in early 2020.
As far as efficacy is concerned, the FDA indicated that available data from the first group of 24 patients from Study 12-230 will be sufficient to support the application. In this cohort, the overall response rate was 73%, including a 55% complete response rate. Complete data from all 37 participants will be available soon.
Naxitamab is a humanized monoclonal antibody called 3F8 that targets a cancer cell surface protein called GD2.

Biotechs and biopharmas under pressure ahead of Trump order on drug prices

Biopharma and biotech players are mostly in the red (again) ahead of an expected executive order from President Trump aimed at corralling U.S. drug prices. Specifically, the order will contain a “favored nation” clause that will be the basis for Medicare reimbursement, i.e., the reimbursement rates will match those in the country paying the lowest prices instead of an index of drug prices from around the world.
Pushback from manufacturers should be substantial. The fireworks will, no doubt, be good theatre.
ETFs: BIBGRXTHWBMEBISIXJARKGCHNAIDNAXLVXBIPJP
Selected tickers: Amgen (AMGN -2.5%), Biogen (BIIB -2.1%), Gilead Sciences (GILD -2.5%), Vertex Pharmaceuticals (VRTX -1.7%), Merck (MRK-2.2%), Eli Lilly (LLY -1.4%), Bristol-Myers Squibb (BMY -1.1%), Pfizer (PFE-1.7%), Novartis (NVS +0.3%), Roche (OTCQX:RHHBY -0.7%), AbbVie (ABBV -2.5%), Bausch Health Companies (BHC -2%), Teva Pharmaceutical Industries (TEVA -2.3%), AstraZeneca (AZN -0.5%), GlaxoSmithKline (GSK-0.5%), Johnson & Johnson (JNJ +0.1%), Takeda (TAK -0.6%), Allergan (AGN -1.3%)