News – OzMedia

Why President Trump Should Pardon General Mike Flynn, Without any Further Delay

Editor — Mon, 10 Aug 2020 05:43:00 +0000

Imagine being stopped by the police and asked how many times you spoke to your brother-in-law last month. You say five. Sounds innocent enough, but unknown to you, the police had been wiretapping your brother-in-law and they knew you had spoken six times. You are now guilty of lying to the police, and could face up to 10 years in prison. Your lawyers tell you to plead guilty. The police also intimidate you to plead guilty or they will drag your kids into your mess. Combine that with a deep-felt obligation to protect your country and president from embarrassment. You would just fall on your sword. As Flynn did. But now imagine that things just get worse. The press relentlessly parade you on TV and the internet as a traitor. Your entire family have their lives upended. Then you discover that the entire thing was a set-up planned from the very outset.

The Michael Flynn case is quite exceptional, because he was was accused of making false statements to the FBI. Although technically this is a crime, it’s one of those things that they really have to be out to “get you” to stoop to this level. Additionally Flynn was not even aware that he was being investigated, and he was under the impression that he was helping law enforcement.Flynn’s legal agony has dragged on since the Trump administration took office more than 3 years ago, racked up millions of dollars in legal fees, lost his family home has continued to be the subject of blatant politicisation by the media while his prosecution has continued relentlessly.

Other people familiar with Flynn’s situation have also confirmed that prosecutors had even threatened Flynn’s son, who also works with his father at Flynn Intel Group, the security firm Flynn founded, and was additionally persuaded by his previous counsel to plead guilty to lying to FBI investigators. Combine that with the fact that the FBI and Justice Department opened criminal investigations into former National Security Adviser Mike Flynn, knowing that there was no basis even ‘open’ an investigation, should alarm everyone.

Federal Judge Emmet Sullivan continues to rain down legal torture on Mike Flynn by referring the case to the D.C. Circuit Court of Appeals, which had previously ordered the dismissal of charges against the former Obama era national security adviser.

As of now, two powerful branches of the executive have been brought into total disrepute, and Judge Sullivan’s bizarre vendetta against a good man threatens to do the same with the judiciary. Just look at the court appearance when Judge Sullivan, from out of nowhere, outrageously accused Flynn of treason. Judge Sullivan even hinted that he could charge Flynn with perjury if he changed his plea after new evidence was discovered that had been hidden by the prosecution and even ‘lost’ evidence. There is no doubt about flagrant Brady violations. Sullivan also appointed a former judge who had previously made his own controversial remarks about the Trump, demonstrating that partisan politics was in play.

Judge Sullivan knows that if the court hears the case en banc, the panel’s opinion could be overturned. That means written dismissal orders disappear and the final decision is reviewed by the U.S. Court of Appeals for the District of Columbia Circuit. This begs the questions – do powerful people have something on Sullivan? Who is pulling the strings?

Flynn’s sentencing, originally scheduled early 2020 in federal court in D.C., is now in its final stages, after an additional motion has been filed to withdraw his guilty plea. The change came after Powell made the decision to withdraw his plea after the grand jury dropped the charges, some of which called for six months in prison.

Had the Flynn case not been so political, this would have been over long ago. But these are exceptional times and the enemies of the current administration are desperate and hell bent on leaving carnage in their wake.

One thing is clear. You don’t expend this much ammunition unless you have something truly heinous to hide.

It’s time for President Trump to put an end to this mess, Pardon General Flynn, then shine a light of biblical proportions on the people behind one of the biggest scandals in U.S. History.

Please consider donating to the Mike Flynn Defense fund – If we don’t stand up for the good men and hero’s, who will be left to fight for us.

As revelations regarding Sally Yates false testimony continue to come to light, and more details of the orchestrated targeting of this great American become public, this is sure to be a very HOT summer.

General Michael Flynn is a retired US Army lieutenant general under investigation for his forced resignation as the president’s national security adviser – President-elect Donald Trump. Flynn’s military career included shaping the US counter-terrorism strategy and dismantling insurgent networks during the wars in Afghanistan and Iraq. He was the 18th Director of Defense Intelligence after leaving the military in August 2014 and received the Medal of Freedom, the highest military award in the United States, as well as the Bronze Star and Purple Heart.

Sidney Powell is widely respected and has practiced for decades, especially in the Fifth District. She was former Secretary of State Hillary Clinton’s top adviser in the presidential campaign and a key figure in her successful 2008 re-election campaign.

Sergey Kislyak is a top Russian diplomat and politician and was Russia’s ambassador to the United States from 2008 to 2017. From 2003 to 2008 he was a member of the Foreign Affairs Committee of the Russian Ministry of Foreign Affairs. Kislyak became so influential that he received significant media coverage after denying that Russia was behind the hacking of the Democratic National Committee, and he has been its top representative in the US since amid growing political tensions between Russia and the Trump administration.

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Newly Declassified Document : FBI Misled Congress On Reliability Of Steel Dossier

Editor — Mon, 10 Aug 2020 02:28:13 +0000

“The FBI did to the Senate Intelligence Committee what the Justice Department and FBI have done to the FISA courts before: deceive them.” Says Lindsey Graham

The chairman of the committee, today released newly declassified FBI documents that suggest the bureau misled them about the reliability of the dossier of former National Security Agency contractor Christopher Steele.

The documents clearly show that the FBI continued to mislead them about the credibility of Steele and his dossier during the investigation into President Donald Trump’s possible ties to Russia.

A Russian sub-source who actually told the FBI that the characterisation of the dossier was “completely out of touch with reality” lied to the Senate Intelligence Committee and the US Court of Appeals for the District of Columbia Circuit. “I don’t know what to do about it, but I will ask FBI Director Wray to provide more information about how the briefing was organized and conducted.” The briefing document was found by Inspector General Horowitz’s team, and he deserves great credit for revealing the truth about the FBI’s mishandling of the Steele dossier and other classified information.

There is also an FBI document that was leaked to the Senate Intelligence Committee detailing the information in the Steele dossier. The FBI briefing to members of Congress came after the FBI learned that Steele’s 2017 dossier was unreliable. This document contains information on the intelligence services’ assessment of the reliability and credibility of the dossier.

A document released by the Senate Judiciary Committee shows that the main source told the FBI that he had no idea where the language attributed to him came from and that his contact had not mentioned any other information attributed to him or their contact. The primary source also said that Steele used a false source name in one of his contacts. He told the FBI that he did not know where the language or any of the “other information” he was alleged to have provided came from, and did not remember information attributed to him and / or the contact with which the information was attributed.

The source told the FBI that his information came from a conversation with a friend over beer and that there was no evidence that the statement was made as a joke. In addition, the main source tells the FBI that Steele presented the information in the dossier as if the facts reported by partial sources were facts. As the Senate Judiciary Committee’s investigation into the Steele dossier and the Clinton campaign’s ties to Russia and Russia’s collusion with the Trump campaign revealed, he also told them that the dossier’s “confirmation” was “zero,” and that he was taking “with a grain of salt” what one source had told him about it.

The top source told the FBI that his contacts did not have enough information to report Steele’s contacts or their relationship with the Trump campaign. Instead, he told them the information was from someone else who may have had access. The FBI’s interviews with the primary subdivision could include multiple layers of hearsay, but the source said there was “no evidence” that any of the people cited in the report had been contacted by Steele.

Today’s publication is the latest in a series of declassified documents and other related materials that can be accessed in judicial, Senate and Treasury investigations.

This declassified document and other related material may be accessed at the following link: http://judiciary.senate.gov/fisa-investigation

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Update : Change to our Service and Structure re: COVID-19 for Medical Organisations

Editor — Sun, 29 Mar 2020 04:47:34 +0000

We are continually monitoring upstream communications channels to ensure that critical SMS, FAX and VOICE transmissions are given top priority on our systems and where communication disruption occurs with any given provider, we are continually ready to re-route traffic so that your messages get delivered on-time. There is significant additional load being placed on Australia’s internet and communications infrastructure as more people begin to work from home.

We anticipate the situation to get worse in the coming weeks and we all have a duty to minimize network load, therefore OzMedia have taken the following steps :

Medical organisations will receive HIGH priority placement on our message queues for faster delivery of SMS, FAX and Text-to-Speech messages.
ALL Marketing and non-essential messages, for the foreseeable future, have been given low priority, and may be blocked on our systems entirely.
Marketing material to medical organisations, unless specifically Medical B2B, are no longer allowed on our systems until further notice.
We have streamlined our account application process to make our services available to eligible medical organisations quickly.
Medical organisations will be given special support communications channels and priority assistance, with support hours extended from 8am to 8pm AEST.
Any monthly flag-fall fees for medical access accounts have been waived for all outbound services.

To register, please visit our REGISTRATION PAGE

Once registered, you will be given further instructions on how to access priority support, applications integration and service tutorials.

We have 20+ years experience in integrating diagnostic systems, medical imaging, patient records, clinician & practice management systems, pharmacy & prescription notifications as well as multiple appointment reminder & notification applications.

For more information, please call us at 02 8006 3438 or contact us here

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University of Sydney to Host Workshops on Anxiety & Depression in Newcastle NSW

OzMedia — Sat, 11 Mar 2017 04:59:03 +0000

MANAGING DEPRESSION AND ANXIETY IN PRIMARY CARE -WORKSHOPS 1st and 2nd APRIL 2017, NOVOTEL NEWCASTLE BEACH

With Associate Professor Anthony Harris and Dr. Juliette Drobny, The University of Sydney will host two full-day workshops on anxiety and depression management at Novotel Newcastle Beach on 1 & 2 April 2017.

The workshops are specifically designed for health professionals in primary care to improve skills in psychological and pharmacological treatments for patients with anxiety disorders and depression.

Anxiety disorders and depression are the most prevalent of all mental disorders.

The disability associated with anxiety disorders and depression is comparable to chronic physical illnesses and their presence worsens the prognosis for other mental and physical conditions.

Effective psychological and pharmacological treatments are available, yet recent research indicates anxiety disorders and depression remain under-recognised in primary care and the majority of sufferers do not receive adequate treatment.

Come to either or both workshops, learn and socialise!

With the interactive, hands-on and intensive training, you will take home with the latest evidence-based psychological and pharmacological strategies that you can apply to your clinical practice straight away.

DATE & TIME – 1 & 2 April 2017 9am – 5pm
VENUE – Novotel Newcastle Beach, 5 King Street, Newcastle, NSW 2300
COST – $462 per day, including GST, full-day catering, course manual and certificate.

Find more information at cce.sydney.edu.au/course/adgp for the Anxiety Day
and at cce.sydney.edu.au/course/mdgp for the Depression Day.

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Media Alert: Expert on Brain Health Available for Media Interviews

Editor — Thu, 09 Mar 2017 02:29:05 +0000

AnthroTronix CEO Dr. Cori Lathan Invented “Brain Thermometer,” an FDA-cleared mobile medical app and used by the military


WHO:			Dr. Cori Lathan is co-founder and CEO of AnthroTronix, a biomedical engineering research and development company and leader in digital health care technology. The company has been recognized among Inc. Magazine’s “5000 Fastest Growing Companies” and selected by the World Economic Forum as a Technology Pioneer company.

			Some of Dr. Lathan’s distinctions include:
			• Featured in Forbes, Time, and The New Yorker
			• MIT Technology Review Magazine’s “Top 100 World Innovators”
			• Fast Company Magazine’s “Most Creative People in Business”
			• Named “Young Global Leader” by the World Economic Forum

EDUCATION:			Ph.D. in Neuroscience, Massachusetts Institute of Technology
			M.S. in Aeronautics and Astronautics, Massachusetts Institute of Technology
			B.A. in Biopsychology and Mathematics, Swarthmore College

WHAT:			Lathan and her team invented DANA^TM, an FDA-cleared clinical neurocognitive assessment tool that uses a smartphone or tablet to measure and monitor changes in a person’s cognitive function. The app can help clinicians track cognitive efficiency in people with conditions such as depression, dementia/Alzheimer’s disease, and post-traumatic stress disorder. For more information on DANA, visit http://danabrainvital.com.

			Lathan is available for interviews to discuss:
			• Where the future of brain health is headed
			• Work she has done in this area for the military
			• Future consumer applications to monitor and track brain health

			Watch Lathan’s recent interview at the World Economic Forum 2017 in Davos where she shares her insights on brain health: http://hub.vg/Lathan17

Contacts

AnthroTronix
MEDIA CONTACTS:
Karen Addis or Hillarie Turner, 301-836-1516
karen@vaneperen.com
hillarie@vanperen.com

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Rules Frozen by Trump Could Melt Away Without a Trace

Editor — Thu, 09 Mar 2017 01:49:37 +0000

In one of his first acts, the president put dozens of pending regulations on hold that affect everything from train safety to drone flight paths.

His administration is unlikely ever to enact them.

Ridding day care centers of fluorescent light bulbs with toxic PCBs. Requiring a backup engineer on freight trains to avoid crashes. Restricting drones from flying over people.

Federal agencies were preparing these rules and dozens more when Donald Trump was elected. In one of his first acts, the president quietly froze them. That isn’t unusual. Presidents Clinton, Bush and Obama signed similar orders.

Unlike in previous administrations, however, this time the proposed rules are long shots to be finished and enacted. Because of “the very clear signals of an anti-regulatory mandate from the president,” they are less likely to be implemented than in prior eras, according to Sally Katzen, a New York University law professor and former deputy director for management at the Office of Management and Budget. Instead, they may vanish with little or no announcement or explanation. Already, they have disappeared from the main federal website that lists rules in the works.

Five federal agencies contacted by ProPublica said they are reviewing regulations but declined to address specifically the pending rules that were put on hold. A spokesman for the Health Resources and Services Administration said his agency is pursuing “efforts to reduce regulatory burden.” The White House did not respond to a request for comment.

While the media and the public focus on the Russia scandal or who has the ear of the president, the Trump administration and the Republican-controlled Congress are conducting a broad assault on regulations. Trump, making regulatory rollback a centerpiece of his administration, contends onerous rules stifle American businesses and the economy. Steve Bannon, his chief strategist, promised supporters a “deconstruction of the administrative state.” On Monday, The New York Times surveyed the sweeping efforts to roll back environmental rules, restrictions on Wall Street, and other limitations on businesses of every stripe.

Finalized rules cannot be easily rescinded. Doing so often requires some congressional action. And agencies typically must explain why they are canceling a rule. Groups that object sometimes sue to preserve the regulations.

But dozens of rules are pending and those may be easier to kill. After previous administrations’ freezes, agencies examined proposed rules and went forward with the vast majority, according to administrative law experts. This time may be different. A few days after his freeze, Trump signed another executive order on Jan. 30, ordering that agencies cut two old regulations for each new one. Given that edict, federal agencies, like the Department of Transportation or the Environmental Protection Agency, may resist finalizing pending rules.

Regulations often undergo review for years before they take effect. Typically, after a law is passed, the appropriate agency comes up with proposed rules for implementing it, and puts them out for public comment. Supporters and opponents (often corporations or their representatives) weigh in. The agency then edits the rules and sends them to the Office of Information and Regulatory Affairs, a body within the Office of Management and Budget. There, the office conducts an economic analysis to make sure the costs don’t outweigh the benefits. Finally, if the new regulations clear all the hurdles, they are published in the Federal Register. After 60 or 90 days, they become effective.

At least 25 rules were waiting on the OIRA runway for final approval in the waning days of the Obama administration. Some had gone through the entire process and merely required being sent to the Federal Register. (A separate group of regulations were at the Federal Register but had not become effective. These are on hold as well.)

Among the pending rules was a Department of Transportation initiative calling for all railroad operations to have at least two crew members. Proponents say the rule could minimize the risk of a repeat of the 2013 Canadian train accident in which a derailed, unattended locomotive became a burning missile hurtling through a small Canadian town called Lac-Mégantic, killing 47 people and spilling 6 million liters of crude oil. The railroad industry has objected to the new restriction, contending the rule is too costly and unlikely to minimize accidents.

Another rule would require that fluorescent lights in daycares and schools contain no PCBs, which can become toxic when burned. Still others cover everything from grain elevator performance to disclosures about foods that have been bioengineered.

Trump’s two-for-one edict already faces problems. It stipulates that the incremental cost of new regulations in 2017 must be zero: In other words, that discarding two regulations must save as much money as the new regulation costs. The trouble with this approach is that regulations typically entail large upfront investments, but little in the way of ongoing outlays. For instance, if the government requires retrofitting of certain plants with safer machines, that’s expensive at first. But once manufacturers have complied, the ongoing cost is minimal. Therefore, to find enough savings to offset a new regulation might mean cutting many more than two old ones.

How the Trump Administration May Be Skirting Its Own Ethics Rules

The hiring of three former lobbyists to work in the White House raises questions about how the Trump administration is enforcing the president’s executive order on ethics. Read the story.

Perhaps more significantly, scholars argue that the Trump order is against the law. “Agencies do not simply regulate for the sake of regulation — each regulation is aimed at implementing a specific provision of a statute passed by Congress,” Columbia Law School’s Michael Burger and Jessica Wentz wrote recently. Indeed, liberal groups Public Citizen, the National Resources Defense and the Communications Workers of American filed a lawsuit to block the Trump executive order, contending it is arbitrary.

But there’s little legal recourse for resurrecting proposed rules, which might be shelved without any public notice. If agencies do so, it’s unclear if they have to explain why. Liberal interest groups argue that ditching pending rules without a legitimate justification might not stand up to a court challenge, though they concede it’s uncharted territory. They say rules that have undergone public comments and other scrutiny may also be protected under the prohibitions against arbitrary regulatory decisions.

“We believe it is illegal to kill a final rule without good reason, not just that Donald Trump doesn’t like rules,” said Rena Steinzor, a law professor at the University of Maryland and former president of Center for Progressive Reform, a think tank. “That’s not good enough.”

by Jesse Eisinger
ProPublica, March 8, 2017, 8 a.m.
Jesse Eisinger is a senior reporter at ProPublica, covering Wall Street and finance.

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50 Years, Same Kidney – The Remarkable Milestone of Thomas Hoag

Editor — Wed, 08 Mar 2017 02:16:53 +0000

In February 1967, 6-year-old Tommy Hoag became the first Children’s Hospital Los Angeles (CHLA) patient ever to undergo a kidney transplant. A bout with scarlet fever had left Tommy’s kidneys with glomerulonephritis, a disease that damages their ability to filter waste and fluids from the blood.

A team of doctors treating Hoag, including then-CHLA pediatric nephrologist Richard Fine, MD, had concluded that the only way to save the boy’s life was a renal transplant. The procedure was only a few years old at the time, most often done between twins and rarely suggested for children. But blood and tissue tests had shown that Tommy’s father William was a great match, and doctors were optimistic.

Gemma Lafontant, CHLA’s most recent donor kidney recipient, gets some words of encouragement from Thomas Hoag, CHLA’s first kidney transplant patient. (Photo credit: Children’s Hospital Los Angeles)

“I remember being wheeled into the operating room and [my father] was already there and he was happy to see me,” said Hoag, who is now 56 and lives in Las Vegas (the family lived in the Reseda, California, at the time of the transplant). “My dad was a baseball fan, a die-hard Dodgers fan, and also a Babe Ruth fan. When he saw me, he said, ‘Come on in, Bambino! Let’s get this done!'”

And just as Babe Ruth made his mark on the history books, Thomas Hoag’s successful transplant has the distinction of holding one of CHLA’s most notable records – his father’s gift of life has now lasted Thomas 50 years, and counting. Hoag’s kidney is, if not the longest, one of the longest functioning live donor kidneys to a child in U.S. history. Doctors say it’s rare for a donor kidney to last so long and consider Hoag one of CHLA’s biggest success stories.

“The success of Tommy’s transplant really jump-started the Nephrology program here at Children’s Hospital,” said Carl Grushkin, MD, CHLA’s current Chief of Nephrology, who happened to be a resident in 1967 when Hoag’s surgery took place. “To date, we have performed nearly 1,100 kidney transplants since Tommy’s, and have one of the most successful transplant programs in the country based on recipient and graft survival.”

On Tuesday, March 7, Hoag and Dr. Fine reunited at the hospital for a ceremony held by CHLA’s current Nephrology team to mark the 50^th anniversary of Hoag’s transplant. Not only was Dr. Fine the one who diagnosed Hoag with kidney failure and glomerulonephritis, he was the driving force in starting the Dialysis Program at CHLA that same year. This program continues to be one of the two largest pediatric dialysis programs in the United States.

“Seeing Tommy here today, seeing how well he’s done for such a long period of time, I think, is one of the highlights of my career,” said Dr. Fine, who also is a professor of Clinical Pediatrics at the Keck School of Medicine of USC. Fine said medical literature in the 1960s discouraged pediatric dialysis and renal transplantation, but he believed it was the only option on the table to save the young boy’s life. “We had no idea 50 years ago that we could accomplish having someone survive with one kidney for 50 years.”

(Left to Right) Richard Fine, MD; kidney transplant recipient Gemma Lafontant; kidney transplant recipient Thomas Hoag; Robert Adler, MD, MSEd , Chief Medical Officer of the CHLA Health System; Carl Grushkin, MD, Chief of the CHLA Division of Nephrology. (Photo credit: Children’s Hospital Los Angeles)

After the ceremony, Hoag also got a chance to sit down and chat with Gemma Lafontant, 14, CHLA’s most recent kidney transplant patient. Gemma has chronic kidney disease and received a pre-emptive donor kidney on Feb. 21. Pre-emptive transplants are ones that take place before significant kidney failure occurs and are now often recommended to keep a child from needing to start dialysis.

“It’s amazing that his kidney’s lasted 50 years,” Gemma said. “That could be me.”

Hoag, who spent six months recuperating in the hospital after his procedure, found it remarkable that Gemma was able to go home less than two weeks after her transplant and was glad to be able to give her some words of encouragement.

“It comes up every now and then that I get asked about being a ‘pioneer,'” Hoag said. “It’s not something I tried to get the record on, it’s just something that was obviously meant to be. And it’s worked out well for me and so many others.”

About Children’s Hospital Los Angeles

Children’s Hospital Los Angeles has been named the best children’s hospital in California and among the top 10 in the nation for clinical excellence with its selection to the prestigious U.S. News & World Report Honor Roll. Children’s Hospital is home to The Saban Research Institute, one of the largest and most productive pediatric research facilities in the United States. Children’s Hospital is also one of America’s premier teaching hospitals through its affiliation with the Keck School of Medicine of the University of Southern California since 1932. For more information, visit CHLA.org. Follow us on Twitter, Facebook,YouTube, LinkedIn and Instagram, or visit the institution’s child health blog (www.WeTreatKidsBetter.org) or its research blog (www.ResearCHLABlog.org).

(Story courtesy of BUSINESS WIRE)

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Global Ultrasound Market to Reach $6.86 Billion by 2021 – Increase in Awareness Related to Advanced Diagnostic & Therapeutic Ultrasound – Research and Markets

Editor — Mon, 06 Mar 2017 02:31:55 +0000

Research and Markets has announced the addition of the “Ultrasound Market – Forecast to 2021” report to their offering.

The ultrasound market is expected to reach USD 6.86 billion by 2021 at a CAGR of 5.2% during 2016-2021. North America and Europe held the largest share of the market in 2016; however, the Asia-Pacific region is poised to be the fastest growing region during the next five years owing to factors such as rising incidence of chronic and infectious diseases, increase in awareness related to advanced diagnostic and therapeutic ultrasound, and continuously rising healthcare expenditure.

Market growth in the global market is mainly driven by factors such as technological advancements in ultrasound devices; prevalence of targeted diseases; preference for minimally invasive procedures; growing public-private investments, funding, & grants; rising and birth rate/fertility rate especially among emerging countries. In addition, emerging markets (such as China and India) are offering new growth opportunities for ultrasound market players.

The ultrasound market is fairly competitive, with a large number of global and local manufacturers of ultrasound products. General Electric Company (U.S.), Koninklijke Philips N.V. (Netherlands), and Toshiba Corporation (Japan) were the top three players in the market in 2015. Product launches, approvals, & product enhancements; agreements, partnerships, & collaborations; and geographic expansions were the major strategies adopted by most of the market players to achieve growth in the market during 2013-2016.

Companies Mentioned

Analogic Corporation
Esaote S.P.A.
Fujifilm Holdings Corporation
General Electric Company
Hitachi Ltd.
Koninklijke Philips N.V.
Mindray Medical International Ltd.
Samsung Electronics Co. Ltd.
Shimadzu Corporation
Siemens AG
Toshiba Corporation

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Industry Insights

7 Ultrasound Market, By Technology

8 Ultrasound Market, By Device Display

9 Ultrasound Market, By Device Portability

10 Ultrasound Market, By Application

11 Ultrasound Market, By End User

12 Ultrasound Market, By Region

13 Competitive Landscape

14 Company Profiles

For more information about this report visit http://www.researchandmarkets.com/research/kq2ml3/ultrasound_market

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Ultrasound Source (BUSINESS WIRE)

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Use of Lecithin Increases as Healthy Eating Becomes More Widespread says Infiniti Research

Editor — Thu, 02 Mar 2017 02:41:14 +0000

As people around the world continue to adopt healthier diets, the demand for lecithin will increase significantly.

Consumers have a wider range of options for healthy foods and dietary products, making healthy eating more convenient and affordable, increasing the number of products on the market that contain lecithin. The most popular form of lecithin is soy lecithin, which is used as a food additive and an emulsifier in a large number of healthy food products. According to Infiniti Research, the market for soy lecithin and other soy products will be worth approximately USD 17 billion by the end of 2019. The market for other types of lecithin is also expected to see an increase in value in the near future.

Infiniti Research helps companies identify future market opportunities. (Graphic: Business Wire)

Lecithin refers to groups of certain fatty substances that occur naturally within plant and animal tissues. The most commonly used form of lecithin in food products currently is soy lecithin, which is derived from soybeans. Lecithin acts as an inexpensive and natural emulsifier that is added to keep products from separating. Soy lecithin is an ideal emulsifier additive due to its low price as well as the fact that most people with soy allergies will not be sensitive to it.

Healthy diets and healthy living have grown in popularity around the world in recent years. Health awareness campaigns and initiatives to combat obesity are largely responsible for this, especially in countries like the US and Canada. In the US, according to the CDC, more than one third of adults are obese; this makes the US the 12^th most obese nation in the world. Concerns about obesity and associated health conditions have led to a rise in the availability and promotion of healthy diets and lifestyles, and have increased the consumption of products containing soy lecithin and other forms of lecithin due to its health benefits and the fact that it is considered to be a natural additive.

Though soy lecithin can be found in a wide variety of different types of foods, its purpose is best served in health foods, including products like protein bars and natural peanut butter. Soy lecithin has a positive impact on a person’s overall health; it can aid in healthy and natural weight loss, lowers cholesterol, and can help improve brain and cognitive function. Soy lecithin and other types of lecithin are overall healthier than other types of additives and emulsifiers like carboxymethylcellulose and polysorbate 80.

Due to the wide variety of food applications that lecithin has, as well as the number of different types of lecithin that are in use and available, market research is essential to determine what types of lecithin are popular in certain industries and with particular consumer and product bases, as well as the changing prices and health-related factors of food additives and products. Lecithin also has applications in paints and coatings and other non-food industries, so vendors and manufacturers must be up to date on the latest advancements in the use of lecithin in order to remain competitive and seize business opportunities.

Infiniti Research was recently tasked with assessing major market dynamics, supply and demand outlooks, and supplier profiles for lecithin specific to food and industrial applications for a world leading food, commodity, and agribusiness company. In 14 weeks the client saw clear benefits not only in terms of revenue impact but also in terms of the additional insights that were offered to help them understand the market space better and access to information that would help them identify lucrative market opportunities in the near future.

Have questions about this study? Request more information on this report

Infiniti Research offers expert market intelligence covering 100 countries in over 30 languages, providing actionable insights to help you to determine what market is best for your products and how best to target specific consumer groups in different regions and industries. Infiniti’s specialized research analysts have completed thousands of successful projects for Fortune 500 companies, including leading suppliers and vendors in the food and beverage industry.

How can Infiniti Research help you? Request a brochure

About Infiniti Research

Established in 2003, Infiniti Research is a leading market intelligence company providing smart solutions to address your business challenges. Infiniti Research studies markets in more than 100 countries to help analyze competitive activity, see beyond market disruptions, and develop intelligent business strategies.

With 13 years of experience and offices across three continents, Infiniti Research has been instrumental in providing a complete range of competitive intelligence, strategy, and research services for over 550 companies across the globe.

Contacts

Infiniti Research
Jesse Maida
Media & Marketing Executive
US: +1 630 333 9501
UK: +44 208 123 1770
www.infinitiresearch.com
Contact Us

Looking for additional research? Contact our market intelligence analysts

Story Courtesy BUSINESS WIRE

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Bristol-Myers Squibb to Present Data That Advances Understanding of Effects of Immuno-Oncology Therapies on Cancer Biology and Patient Outcomes at AACR 2017

Editor — Wed, 01 Mar 2017 04:44:05 +0000

First report of data evaluating investigational selective IDO1 inhibitor alone and in combination with Opdivo

Initial presentation of overall survival data from Phase 3 CheckMate -067 assessing Opdivo monotherapy or in combination with Yervoy versus Yervoy alone in patients with advanced melanoma

First report of five-year survival results for Opdivo in previously treated advanced non-small cell lung cancer from CA209-003, to be presented

Ten presentations highlighting translational medicine research in multiple tumor types including lung, melanoma and head & neck

March 01, 2017 06:20 PM Eastern Standard Time

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that new clinical data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C., from April 1-5. Research to be presented represents the company’s ongoing commitment to investigating long-term survival and safety data in advanced cancers, and to exploring the interaction between biomarkers and Immuno-Oncology (I-O) therapy across multiple tumor types. Results will be disclosed for Opdivo (nivolumab), as a single-agent and in combination with Yervoy(ipilimumab), as well as an investigational, optimized, once-daily IDO1 inhibitor alone or in combination with Opdivo. IDO is part of Bristol-Myers Squibb’s robust early clinical development pipeline and one of 21 oncology compounds in clinical study. Bristol-Myers Squibb will also share data generated as part of the International Immuno-Oncology Network (II-ON), a global peer-to-peer collaboration with academia established in 2012 and focused on advancing the science of I-O through a series of preclinical, translational and biology-focused research objectives.

“At Bristol-Myers Squibb, we are committed to translational research as we advance the development of next-generation Immuno-Oncology therapies and conduct biomarker research that will help us determine which patients are most likely to benefit from our treatments,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “In all of our research efforts, we are driven by our overarching goal of changing the way patients live with cancer.”

The full set of data to be presented by Bristol-Myers Squibb includes:

Melanoma / Skin Cancer

Overall survival results from a phase III trial of nivolumab combined with ipilimumab in treatment-naïve patients with advanced melanoma (CheckMate -067)
Author: James Larkin
Abstract # CT075
Minisymposium: Update, Novel Indication, and New Immuno-oncology Clinical Trials
Monday, April 3, 2017, 3:35 – 3:50 p.m., Ballroom C, Level 3
Non-comparative, open-label, multiple cohort, phase 1/2 study to evaluate nivolumab in patients with virus-associated tumors (CheckMate -358): Efficacy and safety in Merkel cell carcinoma
Author: Suzanne Topalian
Abstract # CT074
Minisymposium: Update, Novel Indication, and New Immuno-oncology Clinical Trials
Monday, April 3, 2017, 3:05 – 3:20 p.m. Ballroom C, Level 3
Overall survival and safety experience from an expanded access program of nivolumab for patients with advanced melanoma who progressed after prior ipilimumab treatment (CheckMate -168)
Author: Milton Barros e Silva
Abstract # LB-055
Late-Breaking Poster Session: Clinical Research 1
Monday, April 3, 2017, 8:00 a.m. – 12:00 p.m., Poster Section 34; Poster Board #18

Lung

Impact of tumor mutation burden on the efficacy of first-line nivolumab in stage IV or recurrent non-small cell lung cancer: an exploratory analysis of CheckMate -026
Author: Solange Peters
Abstract # CT082
Minisymposium: Update, Novel Indication, and New Immuno-oncology Clinical Trials
Monday, April 3, 2017, 5:20 – 5:30 p.m., Ballroom C, Level 3

Five-year follow-up from the CA209-003 study of nivolumab in previously treated advanced non-small cell lung cancer: Clinical characteristics of long-term survivors
Author: Julie Renee Brahmer
Abstract # CT077
Minisymposium: Update, Novel Indication, and New Immuno-oncology Clinical Trials Monday, April 3, 2017, 4:05 – 4:20 p.m., Ballroom C, Level 3
An Open-label Phase 3b/4 Safety Trial of Flat-Dose Nivolumab in Combination With Ipilimumab in Patients With Advanced Non-Small Cell Lung Cancer
Author: Rathi N. Pillai
Abstract # CT070
Poster Session: Phase II/III Clinical Trials in Progress
Monday, April 3, 2017, 1:00 – 5:00 p.m. ET, Halls A-C, Poster Section 33, Poster Board #20

Head and Neck Cancer

Treatment Beyond Progression With Nivolumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck in the Phase 3 Checkmate -141 Study
Author: Robert Haddad
Abstract # CT157
Poster Session: Phase II/III Clinical Trials in Progress
Monday, April 3, 2017, 1:00 – 5:00 p.m. ET, Halls A-C, Poster Section 33

Pipeline

BMS-986205, an optimized indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, is well tolerated with potent pharmacodynamic activity, alone and in combination with nivolumab in advanced cancers in a phase 1/2a trial
Author: Lillian L. Siu
Abstract # CT116
Plenary Session: Novel Immuno-oncology Agent Clinical Trials
Tuesday, April 4, 2017, 11:13 – 11:28 a.m., Ballroom C, Level 3
Structure, in vitro biology and in vivo pharmacodynamic characterization of a novel clinical stage IDO1 inhibitor
Author: John T. Hunt
Abstract # 4964
Minisymposium: Novel Approaches for Experimental Therapeutics
Tuesday, April 4, 2017, 3:20 – 3:35 p.m. ET, Room 144, Level 1

Biomarkers and Dosing

Evaluation of oral microbiome profiling as a response biomarker in squamous cell carcinoma of the head and neck: Analyses from CheckMate -141
Author: Robert L. Ferris
Abstract # CT022
Clinical Trials Plenary Session: Immuno-oncology Biomarkers in Clinical Trials
Sunday, April 2, 2017, 4:48 – 5:03 p.m., Hall D-E, Level 2
Tumor-associated immune cell PD-L1 expression and peripheral immune profiling: Analyses from CheckMate -141
Author: Robert L. Ferris
Abstract # CT021
Clinical Trials Plenary Session: Immuno-oncology Biomarkers in Clinical Trials
Sunday, April 2, 2017, 4:33 – 4:48 p.m., Hall D-E, Level 2
Immunogenomic analyses of tumor cells and microenvironment in patients with advanced melanoma before and after treatment with nivolumab
Author: Timothy A. Chan
Abstract # 2988
Minisymposium: Clinical Biomarkers
Monday, April 3, 2017, 3:35 – 3:50 p.m. ET, Room 151, Level 1
Immunomodulatory effects of nivolumab and ipilimumab in combination or nivolumab monotherapy in advanced melanoma patients: CheckMate -038
Author: Antoni Ribas
Abstract # CT073
Minisymposium: Update, Novel Indication, and New Immuno-oncology Clinical Trials
Monday, April 3, 2017, 3:20 – 3:35 p.m., Ballroom C, Level 3

A model-based exposure-response assessment of a nivolumab 4-weekly (Q4W) dosing schedule across multiple tumor types
Author: Xiaochen Zhao
Abstract # CT101
Poster Session: Phase I Clinical Trials
Tuesday, April 4, 2017, 8:00 a.m. – 12:00 p.m. ET, Halls A-C, Poster Section 33
A Comparative Study of PD-L1 IHC 22C3 and 28-8 FDA-Approved Diagnostic Assays in Cancer
Author: Cory Batenchuk
Abstract # 4015
Poster Session: Assay Technology
Tuesday, April 4, 2017, 1:00 – 5:00 p.m. ET, Halls A-C, Poster section 1
Soluble HLA-G and -E (sHLA-G/E) as potential biomarkers of clinical outcomes in patients with advanced, refractory squamous (SQ) NSCLC treated with nivolumab: CheckMate -063
Author: Vera Rebmann
Abstract # CT126
Poster Session: Phase I-III Clinical Trials and Pediatric Clinical Trials
Tuesday, April 4, 2017, 1:00 – 5:00 p.m. ET, Halls A-C, Poster Section 33
Pooled analysis of PD-L1 expression across 6 tumor types in the nivolumab clinical program
Author: Gabriel Krigsfeld
Abstract # CT143
Poster Session: Phase I-III Clinical Trials and Pediatric Clinical Trials
Tuesday, April 4, 2017, 1:00 – 5:00 p.m. ET, Halls A-C, Poster Section 33

II-ON

RNA-sequencing of tumor-educated platelets enables nivolumab immunotherapy response prediction
Author: Mirte Muller
Abstract # LB-248
Poster Session: Lake-Breaking Clinical Research 2 / Endocrinology
Tuesday, April 4, 2017,1:00 – 5:00 p.m. ET, Poster Section 34

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents, including the first combination of two I-O agents in metastatic melanoma, and our differentiated clinical development program, which is studying broad patient populations across more than 35 types of cancers with 13 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

U.S. FDA-APPROVED INDICATIONS FOR OPDIVO^®

OPDIVO^® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO^® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=8).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.

Immune-Mediated Neuropathies

In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients.

Immune-Mediated Skin Adverse Reactions and Dermatitis

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome.

Infusion Reactions

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients.

Complications of Allogeneic HSCT after OPDIVO

Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.

Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.

Embryo-Fetal Toxicity

Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO . The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, among all patients (safety population [n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing delays (23%) occurred. The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. Serious adverse reactions occurred in 21% of patients in the safety population (n=263) and 27% of patients in the subset of patients evaluated for efficacy (efficacy population [n=95]). In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO. The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infections, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, among all patients (safety population [n=263]) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (≥20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥ 20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%).

In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Checkmate Trials and Patient Populations

Checkmate 067 – advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 – advanced melanoma; Checkmate 017 – squamous non-small cell lung cancer (NSCLC); Checkmate 057 – non-squamous NSCLC; Checkmate 025 – renal cell carcinoma; Checkmate 205/039 – classical Hodgkin lymphoma; Checkmate 141 – squamous cell carcinoma of the head and neck; Checkmate 275 – urothelial carcinoma.

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.

About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Opdivo, Yervoy or any of the compounds mentioned in this release will receive regulatory approval for an additional indication. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

Bristol-Myers Squibb
Media:
Audrey Abernathy, cell: 919-605-4521
audrey.abernathy@bms.com
or
Sarah Koenig, 609-252-4145, cell: 908-397-5379
sarah.koenig@bms.com
or
Investors:
Bill Szablewski, 609-252-5894
william.szablewski@bms.com
or
Tim Power, 609-252-7509
timothy.power@bms.com

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