Infection Rates Drop at Westchester Medical Center When Pulsed Xenon UV Used to Disinfect Rooms; 3rd Xenex Customer Reports HAI Reduction in Peer-Reviewed Literature

A new study published in the American Journal of Infection Control, the official publication of the Association for Professionals in Infection Control and Epidemiology (APIC), reports that the use of pulsed xenon ultraviolet (UV) light technology enabled Westchester Medical Center (Valhalla, NY) to reduce healthcare associated infections (HAIs) by 20 percent. About Acomplia without prescription This is the third hospital to publish a study demonstrating a decrease in patient infections as a result of utilizing Xenex Disinfection Services’ pulsed xenon UV room disinfection technology. Xenex will participate in and demonstrate its germ-zapping robots during APIC’s annual conference in Anaheim, California, June 7-9, 2014.

“We congratulate Dr. Haas and her team for their commitment to patient safety. About Dilantin (Phenytoin) Despite the challenge of double-occupancy rooms, the hospital was able to disinfect a significant percent of their rooms – and saw a significant drop in infections as a result”

According to the AJIC study (Haas JP, Menz J, Dusza S, Montecalvo MA: Implementation and impact of ultraviolet environmental disinfection in an acute care setting. Am J Infect Control 2014, 42:586-590), healthcare-associated vancomycin-resistant enterococcus (VRE), methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile (C.diff), and other multidrug-resistant organisms (MDRO) decreased among patients after adding pulsed xenon UV environmental disinfection to the hospital’s cleaning regimen. The retrospective study discovered that the rate of HAIs caused by MDRO and C.diff was significantly lower during the 22 months of pulsed xenon UV disinfection use compared with the 30-month period before UV disinfection (2.14 cases per 1,000 patient-days vs 2.67 cases, respectively). Buy Luvox (Fluvoxamine) without prescription This dramatic decline in incidence occurred despite missing 24 percent of pulsed xenon UV disinfection opportunities.
According to the authors, “In our study, overall decreases in MDRO plus C.diff infections were led by a decrease in VRE infections, which is our most common hospital-acquired MDRO. Although there were many other simultaneous infection control interventions occurring at our hospital that could have contributed to the reduction in VRE acquisition, the rates experienced during ultraviolet disinfection are the lowest incidence rates of VRE at our institution for the past 10 years and were sustained for 22 months.”
Xenex’s patented pulsed xenon UV disinfection system has been repeatedly proven effective against C.diff and other MDRO. Buy Lozol Sr (Indapamide) with no prescription “We congratulate Dr. Haas and her team for their commitment to patient safety. Despite the challenge of double-occupancy rooms, the hospital was able to disinfect a significant percent of their rooms – and saw a significant drop in infections as a result,” said Dr. Mark Stibich, Xenex co-founder and Chief Scientific Officer. “Eliminating superbugs like MERS, C.diff and MRSA from the environment before they harm patients is what can and should be done – right now. Buy Vitamins online Our customers publishing their infection reduction results in leading peer-reviewed journals like AJIC demonstrates to other hospitals the benefits of Xenex disinfection for patient safety. Reducing the risk of infection through disinfecting the environment is an essential component of infection control."
Multiple peer-reviewed studies have proven that Xenex germ-zapping robots are highly effective and approximately 200 hospitals and Veterans Affairs (VA) facilities in the U.S. are using the Xenex system, which is capable of disinfecting a patient room in just 5 -10 minutes. A study published in AJIC in August 2013 reported that Cooley Dickinson Hospital (an affiliate of Massachusetts General Hospital) experienced a 53 percent decrease in the rate of hospital-acquired C.diff infections after implementing the Xenex system. Pharmaceutical Journal A study published in Journal of Infection Prevention in 2013 reported that Cone Health experienced a 56 percent reduction in its hospital acquired MRSA infection rate after implementing an infection prevention program that included the Xenex room disinfection system.
Xenex’s germ-zapping robots use pulsed xenon ultraviolet light to quickly destroy the viruses, bacteria, mold, fungus and bacterial spores in the patient environment that cause HAIs. Uniquely designed for ease of use and portability, the superbug zapping robot is operated by hospital staff without disrupting hospital operations. With a five minute disinfection cycle, the robot disinfects dozens of rooms per day, including patient rooms, operating rooms (ORs), equipment rooms, emergency rooms, intensive care units (ICUs) and public areas. The Xenex robot contains no mercury and is the only “green” technology used in automated room disinfection.
About Xenex Disinfection Services
Xenex's patented pulsed xenon UV room disinfection system is a pesticidal device used for the advanced cleaning of healthcare facilities. Due to its speed and ease of use, the Xenex system has proven to integrate smoothly into hospital cleaning operations. The Xenex mission is to eliminate harmful bacteria, viruses and spores that can cause hospital acquired infections in the patient environment, and to become the new standard method for disinfection in healthcare facilities worldwide.

Puma Biotechnology Announces Positive Outcome of European Opposition Proceedings

Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced that the European Patent Office has upheld the claims in Puma’s licensed European patent (EP 1848414) which were being opposed by Boehringer Ingelheim International GmbH.

“We are very pleased with the outcome of the opposition proceedings and more specifically that the claims related to the T790M mutation have been upheld”

The intellectual property portfolio that was licensed from Pfizer in 2011 when Puma licensed neratinib included issued patents in a number of countries including Europe (EP 1848414) as well as pending patent applications in several countries including the United States relating to methods of treating gefitinib and/or erlotinib resistant cancer. Buy Eriacta (Sildenafil Citrate) pills More specifically, the patent that was issued in Europe in April 2011 included specific claims that included a pharmaceutical composition for use in treating cancer in a subject with a cancer having a mutation in EGFR with a T790M mutation. On November 28, 2011, Boehringer Ingelheim International GmbH filed an opposition to this patent asking for this patent to be revoked.
The Oral Proceedings of the European Patent Office were held in Munich, Germany on February 4, 2014. The decision of the European Patent Office was to uphold the granted claims of the European patent that relate to the T790M mutation without any modification. Estrace (Estradiol) tabs This included specific claims that include 1) claims for the pharmaceutical composition comprising an irreversible EGFR inhibitor for use in treating cancer in a subject having a T790M mutation; and 2) claims for the pharmaceutical composition for use in the treatment of numerous cancers, including lung cancer and non-small cell lung cancer.
“We are very pleased with the outcome of the opposition proceedings and more specifically that the claims related to the T790M mutation have been upheld,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “Although we have no plans to develop neratinib in cancers with a T790M mutation, we recognize the value of this important patent in our overall patent estate and in the T790M landscape and we are committed to strengthening our patent portfolio for the Company. Buy Zithromax (Azithromycin) online We look forward to the continued advancement of this patent portfolio for T790M in other countries and the potential benefit that it may bring to the Company.”
Conference Call and Webcast
The Company will host a conference call to discuss the positive outcome of the European Opposition Proceedings at 2:00 p.m. PST (5:00 p.m. EST) on February 6, 2014.
The conference call may be accessed by dialing 1-877-709-8150 for domestic callers and 1-201-689-8354 for international callers. Please specify to the operator that you would like to join the “Puma Biotechnology Update Call.” The conference call will also be webcast live and accessible through the Investor Relations section of Puma’s website at www.fda-approved-rx.biz and will be archived there for 30 days following the call. Please visit Puma’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Puma Biotechnology
Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. Vitamins online The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The Company is initially focused on the development of PB272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive metastatic breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation.
Further information about Puma Biotechnology can be found at www.drugsrxguide.biz.
Forward-Looking Statements:
This press release contains forward-looking statements, including statements regarding the Company’s development plans. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. Medical News from Gates M.D. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company’s proprietary rights may not adequately protect its intellectual property, intellectual property rights are complicated and continuously evolving, coverage of patents is subject to interpretation by courts and this is not always consistent, defending the patentability of patents and patent applications, and defending against claims that the Company infringes third-party patents, can be expensive and time consuming, and the other risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

EMA Now Accepts SAFE-BioPharma Digital Signatures on eSubmissions

Beginning this month, SAFE-BioPharma digital signatures, widely used throughout the global biopharmaceutical industry, will be accepted by the European Medicines Agency (EMA).

“EMA’s acceptance and use of digital signatures sends an important message to biopharmaceutical companies, many of which have digital signing capability as part of their existing use of SAFE-BioPharma digital identity credentials” Buy Topamax (Topiramate) without prescription

Acceptance of SAFE-BioPharma digital signatures is in line with EMA’s strategy for a “future electronic only workflow” between itself and the pharmaceutical industry by eliminating the need and cost associated with printing, sending, and archiving paper documents. Buy Brethaire (Terbutaline) tabs online without prescription Electronic only workflows involving regulatory submissions will require use of EU-qualified digital signatures such as those based on the SAFE-BioPharma standard.
The agency is starting with digital signature-enabled PDF forms for scientific advice, orphan medicines, and pediatric submissions.
In a related announcement underscoring the agency’s strategy to increase electronic-document-only exchanges with industry, EMA said it “…will start to use digital signatures systematically in outgoing documents that currently require a legally binding signature.” Buy Boniva (Ibandronae Sodium) pills online without prescription
“EMA’s acceptance and use of digital signatures sends an important message to biopharmaceutical companies, many of which have digital signing capability as part of their existing use of SAFE-BioPharma digital identity credentials,” said Mollie Shields Uehling, president and CEO, SAFE-BioPharma Association.
The SAFE-BioPharma standard was established by the pharmaceutical industry with the participation of the EMA and FDA to create and maintain an interoperable digital identity and signature standard that allows secure, trusted exchanges and legally-binding digital signatures. Buy Vitamins online SAFE-BioPharma member companies have conducted several pilots with EMA demonstrating that the SAFE-BioPharma standard meets EU electronic signature requirements and that EMA can recognize and validate SAFE-BioPharma compliant signatures.
The European Union definition of digital signatures is consistent with that of SAFE-BioPharma digital signatures. Specifically, each signature is...

• uniquely linked to the signatory;
• capable of identifying the signatory;
• created using data that the signatory can use under his/her sole control with a high level of confidence; and WebMD Review
• linked to the signed document in such a way that subsequent change in the document is detectable.

EMA requires that digital signatures on submissions be issued from Certification Authorities (CAs) under the authority of the national agencies on the EU trusted list. TranSped, a SAFE-BioPharma Certification Authority (CA) provider, is included in the EU’s list of trusted CAs, and both TranSped and SAFE-BioPharma CAs are listed under the Romanian Ministry of IT&C list.

New AB SCIEX Software Accelerates Drug Screening Across Broad Range of Compounds for Clinical Research Laboratories

AB SCIEX, a global leader in analytical technologies, today announced the availability of MPX™ TF 1.0 Software to accelerate drug screening with accurate mass-based technology for laboratories performing clinical research. The new software is designed to deliver faster turnaround times, increased sample throughput and lower costs compared to single-stream, mass spectrometry (MS) methods. Buy Priligy (Dapoxetine) without prescription This new software will be showcased to researchers at the American Association for Clinical Chemistry (AACC) conference in Houston, Texas this week.

“We are helping clinical research labs reshape how they conduct drug screening to accurately identify not only known but also unknown compounds.”

With the new MPX TF Software, researchers are now able to increase throughput by as much as twofold. Buy Vepesid (Etoposide) tabs online without prescription This is made possible by enabling the use of two parallel liquid chromatography streams. The ability to stagger chromatographic runs while collecting sample data allows the use of instrument "dead time" to increase the number of samples run in a given time period. This means identifying more compounds in a shorter period of time.
By combining the increased throughput of the MPX software with the capability of the AB SCIEX TripleTOF^® 4600 accurate mass system to produce reliable data for a large number of compounds, researchers will be able to do more in less time compared to single-stream MS methods while significantly reducing rates of false positives and false negatives, thanks to LC separation of potential interferences and the enhanced specificity of high-resolution accurate mass technology.
Among the researchers who are using accurate mass technology today is Dr. Kara Lynch, PhD. from the University of California, San Francisco (UCSF). Buy Vermox (Mebendazole) pills online without prescription She uses a TripleTOF platform to identify unknown compounds, complementing the targeted analysis she does with triple quadrupole instrumentation.
“As the list of drugs and their metabolites are always changing, the value of high resolution, accurate mass technology is identifying unknowns with high specificity,” said Dr. Lynch at UCSF. “Accurate mass-based analysis with a TripleTOF system helps identify compounds that could be missed in a targeted approach if a certain drug is not in the original method. New Therapy for the Management of HIV-associated Enteropathy from Entera Health Furthermore, with this technology, you are able to re-interrogate the data at a later date to answer new questions, without needing to re-run the samples.”
AB SCIEX is committed to providing the tools to enable the adoption of accurate mass technology in clinical research laboratories. Buy Vitamins online By applying MS/MS on an accurate mass system, clinical researchers can take advantage of the enhanced specificity of compound-specific MS/MS fragmentation. FDA Approved Rx : Online Pharmacy This enables more confident compound identification, including ID of unknown compounds, such as new ‘designer’ drugs.
“AB SCIEX continues to drive innovation in clinical research to address existing issues, such as slow turnaround times and false positives or negatives, which hinder these labs from increasing productivity and improving data quality,” said Rainer Blair, President of AB SCIEX. All Best Rx : Buy drugs online “We are helping clinical research labs reshape how they conduct drug screening to accurately identify not only known but also unknown compounds.”

About AB SCIEX
AB SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to push the limits in their field and address the complex analytical challenges they face. Drugs Rx Guide : Buy drugs online The company’s global leadership and world-class service and support in the mass spectrometry industry have made it a trusted partner to thousands of the scientists and lab analysts worldwide who are focused on basic research, drug discovery and development, food and environmental testing, forensics and clinical research. With 30 years of proven innovation, AB SCIEX excels by listening to and understanding the ever-evolving needs of its customers to develop reliable, sensitive and intuitive solutions that continue to redefine what is achievable in routine and complex analysis.
© 2013. AB SCIEX. Unless otherwise noted in our product literature, AB SCIEX Products Are For Research Use Only. Not for use in Diagnostics Procedures. The trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective owners. AB SCIEX^TM is being used under license.

KYTHERA Biopharmaceuticals Added to Russell 3000, 2000, Global and Microcap Indexes

KYTHERA Biopharmaceuticals Inc. today announced that the company has been added to each of the broad-market Russell 3000® Index, the Russell 2000® Index, the Russell Microcap® Index and the Russell Global® Index as part of Russell's quarterly IPO additions effective as of the close of trading on December 21, 2012.

“We're extremely pleased to be included in these widely known Russell indexes”

"We're extremely pleased to be included in these widely known Russell indexes,” said Keith Leonard, KYTHERA’s President and CEO. Buy Furacin (Nitrofurazone) pills online without prescription “We are committed to building long-term value for our stockholders and we value the significance and increased visibility within the investment community that can result from inclusion in these indexes.”
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. An industry-leading $3.9 trillion in institutional assets currently are benchmarked to them.
The annual reconstitution of Russell’s U.S. indexes captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization. Membership in the Russell 3000 Index, which remains in place for one year, means automatic inclusion in either the large-cap Russell 1000® Index or small-cap Russell 2000 Index, as well as the appropriate growth and value style indexes. Russell determines membership for its equity indexes primarily by objective, market-capitalization rankings and style attributes. The Russell 3000 Index also serves as the U.S. component of the Russell Global® Index.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. KYTHERA’s product candidate, ATX-101, is a potential first-in-class, injectable treatment currently in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable “double chin.” KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding KYTHERA, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including the increased visibility within the investment community that can result from inclusion in the indexes. Such forward-looking statements involve substantial risks and uncertainties that may differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks included under the heading “Risks Related to Our Common Stock” included in the Risk Factor sections of KYTHERA’s reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. KYTHERA undertakes no obligation to update or revise any forward-looking statements.

A Focus on Specialty Pharmacy at Las Vegas Pharmaceutical Conference

Specialty pharmacy takes center stage when leading experts in the pharmaceutical and biotech manufacturers' industries gather in Las Vegas, September 19-21 to discuss the current changes and trends developing in our healthcare system that directly influence the specialty arena. Specialty pharmacy, which develops and markets high-priced medications and treatments used to manage diseases, is gaining more attention as providers and insurers look to streamline delivery and reimbursement policies around these prescribed therapies. Buy Actos (Pioglitazone Hydrochloride) pills online without prescription

“Management of New Drugs on the Medical Benefit”

“The specialty drug trend and healthcare reform are pushing the industry to evolve,” said Kevin Cast, Vice President of Strategy and Contracting for United BioSource Corporation. “Now more than ever manufacturers need a fresh approach to commercialization, access, adherence, reimbursement and safety.”
This newly expanded focus-area at the September Managed Markets Summit will feature more than a dozen distinguished faculty members from major corporations discussing the challenges and trends of selling specialty products in an evolving healthcare marketplace.
Summit presenters include:

• Kirby Eng, RPh, Director, Medical Benefit Drug Management, CVS Caremark Corporation
  "Managing the Oncolytic Space"

• Christine Strahl, Pharm.D., MBA, BCPS, Specialty Pharmacy Program Manager, HealthPartners, Inc.
  "Management of New Drugs on the Medical Benefit"
• Mark Montgomery, Chief Executive Officer & President, Axium Healthcare Pharmacy, Inc.
  "Biotech and Specialty Pharmacy Contracting"

• Julie Thomas, Director, Pharma/Biotech Sales, Exactus Pharmacy Solutions (WellCare)
  "Competing With Products Across Medical and Pharmacy Benefits: What You Should Know"

Additional conference topics include:

• The shifting paradigms in specialty drug management
• How new technologies may affect payers and specialty pharmacy providers
• Payer strategies for managing specialty medications
• What healthcare reform means in today’s specialty environment

The Pinsonault Managed Markets Summit takes place at The Cosmopolitan of Las Vegas, September 19-21, 2012. The cost is $2,595 per person with discounts available to groups of five or more.
About Pinsonault
Pinsonault, a division of Decision Resources Group, is dedicated to and focused on delivering high quality, Managed Markets specific, business and training solutions within the pharmaceutical and biotech industries. The organization strives to create customer specific solutions that provide valuable strategic insight and results oriented tactical tools enabling clients to identify and capitalize on Managed Markets business opportunities.
About Decision Resources Group
Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions.