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Sunday, July 1, 2018

Adamis Agrees With Sandoz To Commercialize Allergic Reaction Med


Adamis Pharmaceuticals Corp. (ADMP) said that it has entered into an exclusive distribution and commercialization agreement with Sandoz Inc., a division of the Novartis Group, to commercialize Adamis’ Symjepi product for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
Under the terms of the agreement, Sandoz will obtain the United States commercial rights to Symjepi in exchange for an upfront fee and potential performance-based milestones payments. Additionally, Adamis and Sandoz will equally share net profits, as defined in the agreement, generated from sales of Symjepi in the U.S.
As part of the agreement, Sandoz will have commercial rights to the FDA-approved Symjepi (epinephrine) Injection 0.3mg product, as well as the Symjepi (epinephrine) Injection 0.15mg product if approved by the FDA.
Under the agreement, Adamis will retain the right to commercialize both products in territories outside of the U.S., but has granted Sandoz the first right of negotiation for such territories. Adamis may also continue to develop the Symject injection platform for additional product candidates including the previously announced naloxone product candidate being developed to treat opioid overdose.

Insulet Assumes Direct Operation of Insulin Managing Product Line in Europe


Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced as of July 1, it has assumed direct commercial operations in Europe to provide sales, distribution, customer support and product services for its Omnipod System. Insulet has established a dedicated Customer Care team, committed to providing best-in-class support to its large European customer base.
“We are thrilled to directly support the diabetes community across Europe now and into the future,” said Patrick Sullivan, Chairman and Chief Executive Officer. “We have a very accomplished team in place whose sole focus is to deliver an exceptional customer experience and we are deeply committed to bringing customized innovation to the local European markets.”
Since July 2017, when Insulet announced its intention to assume the distribution, sales, marketing, training and support activities for the Omnipod System across Europe, the Company has established a highly-talented European team of over 100 employees with extensive diabetes knowledge and expertise within the European markets. In addition, Insulet now has 24/7 customer care and product support for over 140,000 Poddersworldwide.
“Insulet has always been committed to putting the patient first and direct operations in Europe is a big step forward for all Omnipod users,” said Professor Eric Renard, Professor of Endocrinology, Lapeyronie University Hospital, Montpellier, France. “Insulet is making a significant, long-term commitment to the diabetes community in Europe and I’m excited they plan to bring new innovations to market that best serve the local European customers.”

NYCHA nightmare: > 800 kids tainted by lead, de Blasio administration concedes


In the last several years, the city has been aware of more than 800 children living in public housing who had tested positive for levels of lead poisoning deemed of concern by the federal government, the Daily News has learned.
This stunning number stands in stark contrast to the city’s repeated claims that only 19 children living in NYCHA accommodation have registered elevated blood-lead levels in the last decade.
That’s because the city chooses not to count hundreds of children with elevated lead levels for whom the Centers for Disease Control (CDC) and Prevention recommends public health intervention. Instead it relies on its own far more conservative level to trigger an investigation.
As a result, the city Health Department has been aware of these children for years but did not notify the city Housing Authority and did not inspect their apartments for the presence of lead paint.
Khemel, who lives aKhemel, who lives at the Van Dyke Houses, proved to have an elevated lead level when he was tested at the age of 2.t the Van Dyke Houses, proved to have an elevated lead level when he was tested at the age of 2. (Courtesy Wheeler family)

Mayor de Blasio has stated that “there has not been harm done to any child because of the mistakes that have been made,” and consistently minimized the effect NYCHA’s well-documented failures to perform required lead paint inspections have had on the families who live in the authority’s aging apartments.
The News requested on June 18 that the city release all data on children with elevated blood-lead levels in public housing. On Friday the city Department of Health responded to The News’ request.
For the first time the city acknowledged that from 2012 through 2016, 820 children ages 5 and under living in NYCHA apartments had tested positive for elevated lead levels of 5 to 9 micro-grams per deciliter of blood.
Since 2012 the CDC has recommended public health intervention for any child from infant to 5 years old with blood-lead levels of 5 micro-grams or greater. Elevated blood-lead levels are known to cause developmental delays in small children.
Helen Jackson holds her two-year-old daughter Makayla, who has lead poisoning, inside their apartment at the Linden Houses.
Helen Jackson holds her two-year-old daughter Makayla, who has lead poisoning, inside their apartment at the Linden Houses. (Debbie Egan-Chin/New York Daily News)

During the Bloomberg administration and continuing under de Blasio, the city chose to ignore the CDC recommendation and use a higher trigger of 10 micro-grams per deciliter before notifying NYCHA and inspecting apartments.
On Friday a spokeswoman for the mayor, Olivia Lapeyrolerie, said the Health Department “in general” notifies parents that their children have registered levels between 5 and 9 micro-grams but does not do inspections or notify NYCHA.
She called the CDC standard “a recommendation,” adding, “The CDC recommends each city respond to each case, but leaves it up to each jurisdiction to determine that response. DOH was responding to these cases by contacting each family.”
In fact the CDC makes very specific recommendations about how to respond to these findings, stating that public health authorities should complete an “environmental assessment of detailed history to identify potential sources of lead exposure.”
With the 820 children, that did not occur.
Sherron Page, who lives in the NYCHA Red Hook Houses in Brooklyn, discovered that her 4-year-old son, Kyan, tested positive for having a high level of lead in his blood.
Sherron Page, who lives in the NYCHA Red Hook Houses in Brooklyn, discovered that her 4-year-old son, Kyan, tested positive for having a high level of lead in his blood. (Frank Posillico/New York Daily News)

On Friday in response to The News’ questions, the administration revealed the city Health Department quietly began using the CDC’s 5 micro-gram standard for children living in NYCHA in January. The mayor did not explain why they switched, but his press secretary, Eric Phillips, wrote in an email, “As soon as our health experts believed the new protocol could help further fuel the reduction of kids getting sick, the mayor acted.”
But on Saturday Phillips amended that, stating that in fact the city adopted the CDC standard at the beginning of the year after federal housing officials began encouraging that standard.
At the time the city started using the CDC standard, the mayor and NYCHA were negotiating a settlement with federal prosecutors in their investigation of NYCHA’s failures, including its lies about lead paint inspections that never happened.
The mayor told The News that starting this week, the department will now adopt the CDC standard for all non-NYCHA apartments as well. That should be finished by the end of the year.
“Lead poisoning is down almost 90% since 2005, but that’s not good enough,” de Blasio said in a statement. “We’ve already made our testing protocols more strict for kids in public housing and we are now extending that standard to the entire city. It’s our job to always push the envelope when it comes to our kids’ health.”
The number of children living in NYCHA with blood-lead levels of 5-to-9 micrograms has dropped recently, but each year since 2012 hundreds of children have registered these levels of lead in their blood, starting with 229 in 2012, 184 in 2013, 181 in 2014,112 in 2015 and 114 in 2016, the latest year available.
Questions about the scope of lead poisoning of children living in NYCHA apartments have circulated since 2015, when The News first began reporting on this issue. For years the authority management attacked The News’ reporting on lead paint, claiming to tenants, the public and elected officials that they were regularly performing rigorous testing as required by local laws and federal regulations.
These claims have been exposed as lies, first by the city Department of Investigation in November and then on June 11 by an 80-page complaint filed by Manhattan U.S. Attorney Geoffrey Berman’s civil division.
The federal complaint detailed an elaborate and long-running effort by NYCHA managers and staff to cover up squalid conditions in the authority’s 175,000 apartments, including falsely claiming between 2012 and 2016 that they were performing required lead paint inspections.
Dakota Taylor (l.), 12, and her mother, Tiesha Jones, inside their apartment at the Fort Independence Houses in the Bronx in January. Dakota was found to have a lead level of 45 in her blood when she was only 4 years old.
Dakota Taylor (l.), 12, and her mother, Tiesha Jones, inside their apartment at the Fort Independence Houses in the Bronx in January. Dakota was found to have a lead level of 45 in her blood when she was only 4 years old. (Gregg Vigliotti for New York Daily News)

The complaint said the city did not adequately investigate the source of lead poisoning for “many hundreds” of children living in NYCHA, but the feds would not disclose the actual number.
Some of these children registered elevated lead levels during Bloomberg’s term, some during de Blasio’s. In many of these cases during both mayors’ tenures, the child’s apartment was never inspected. As The News has revealed over the last two years, NYCHA failed in numerous ways to scope out and alleviate its lead paint problem. Inspections and clean-ups have been haphazard and more often than not performed by untrained workers.
This obfuscation and trickery regarding the authority’s obligation to protect its tenants from harm has real life consequences.
No governmental agency or officials have released the names of any of these children who’ve tested positive for elevated blood-lead levels. But attorney Corey Stern of Levy Kronigsberg has assembled a list of children who’ve registered elevated levels living in NYCHA, and combined with The News’ own list identifies a total of 28.
There’s Makayla Robinson from the Linden Houses in Brooklyn who registered an elevated level of 12 at age 2. There’s Kyan Dickerson of Red Hook Houses who registered a level of 12 at age 4. There’s Leilani McClain of Pomonok Houses in Queens, who registered a level of 24 at age 2. There’s Dakota Jones of the Fort Independence Houses in the Bronx with a level 45 at age 4.
Marisa Vargas with her daughter Leilani McClain, who registered a lead level of 24. They live at the Pomonok Houses in Queens.
Marisa Vargas with her daughter Leilani McClain, who registered a lead level of 24. They live at the Pomonok Houses in Queens. (Howard Simmons/New York Daily News)

“Our mayor has been steadfast in his position that no child was injured on his watch, and he has now been proven to be delusional or a liar,” Stern said. “We now know — and he has known all along — that since 2012 more than 800 NYCHA children were, by definition, lead poisoned in public housing. New York City citizens should demand that he resign, immediately.”
For NYCHA tenant Jonquella Wheeler, 30, these numbers are anything but abstract. Her youngest son Khemel Green tested at a level of 11 during a routine doctor checkup when he was 2 years old in 2012.
Wheeler, who’s lived her entire life and raised two boys in the same fifth floor apartment in the Van Dyke Houses in Brownsville, says shortly after she was told of her son’s test results, the Department of Health inspectors showed up at her apartment and found the presence of lead paint there.
“They made me feel like if I sued them or anything like that they were going to kick me and my two children out. They made it a hush hush thing,” she said. She is one of 20 tenants who have retained Stern’s firm in the class action suit he’s filed in Manhattan Federal Court.
Khemel is now 7 years old and in school, where he’s been found to have learning disabilities that make it difficult for him to read and write.
“He was a normal baby and I see the difference between him and my older son. I see him not being able to grasp on to reading and writing,” she said.
“We’re talking about children. It’s about other families going through the same thing. I don’t want them to feel like they can’t speak out and talk.”

Neurologist still suggests headache diary to determine, avoid migraine triggers


If you’ve ever had a migraine, you know it’s different from a typical tension headache. A migraine is a type of headache that comes with its own set of symptoms like nausea, sensitivity to light, sound or smells, extreme fatigue or dizziness.
According to the Migraine Research Foundation, approximately 12% of people in the U.S. suffer from migraines, with nearly 90% of migraine sufferers having a family history of migraine. They are also more common in women than men.
“A migraine can be debilitating and can impact daily activities, your family and social life,” says neurologist Sait Ashina, MD, a headache specialist in the Comprehensive Headache Center within the Arnold-Warfield Pain Center at BIDMC. “Unfortunately, migraine often goes undiagnosed and undertreated.”
The exact cause or reason for migraines is still unknown, but what physicians can help you pinpoint are different triggers for your migraine.
“Triggers are what can set off the symptoms of a migraine headache, which is different than the mechanisms of the head pain,” Ashina says. “Triggers are usually individualized-;what could bring on a migraine in one person could not be the case in another person.”
In order to determine-;and subsequently avoid-;migraine triggers, Ashina suggests keeping a headache diary. “Your doctor is going to want to know what you did or ate or how you felt right before a migraine attack,” he explains. “By tracking these occurrences and any details you remember ahead of time, your doctor will be able to find patterns that will guide an individualized treatment plan.”
The American Headache Society offers different resources for headache diaries. There are also a variety of mobile apps available. “List out each migraine, when it happened, how long it lasted and what could have triggered it,” Ashina says.

“Your headache diary will be your doctor’s best resource for avoiding any of these triggers,” Ashina says. “By controlling what you can, you may reduce the frequency and severity of your headaches.”

Is waiting almost over with Geron?


Shares of Geron Corp. (NASDAQ:GERN), a clinical-stage oncology company, rose by as much as 14.9% around mid-June.
The spark? The drugmaker’s shares are responding positively to the company’s oral presentation over the weekend at the European Hematology Association meeting in Stockholm, Sweden. Specifically, Dr. David Steensma, from the Dana-Farber Cancer Institute, provided an update on the ongoing Part 1 portion of the combined Phase 2/3 trial known as “IMerge” that’s assessing the first-in-class telomerase inhibitor, imetelstat, in patients with lower risk myelodysplastic syndromes (MDS).

This conference presentation provided investors with a few key insights into imetelstat’s emerging clinical profile. First off, the company reported that a respectable 34% (11 of 32) of patients achieved red blood cell transfusion independence (TI) of greater than two months. That’s noteworthy because IT is the study’s primary endpoint, and over a third of the patients in this trial appear to be benefiting from imetelstat treatment. Normally, that sort of positive response in an experimental cancer trial is enough to warrant a larger, randomized trial.
Dr. Steensma also noted that a small sub-set of patients have now gone without blood transfusions for over a year at this point following imetelstat treatment. Although this initial part of the study lacks a control arm to put this intriguing result into the proper statistical context, this lengthy period of TI is impressive nonetheless, and suggests that this drug might even be a functional cure for a select few patients.

Looking ahead, Geron said it plans on unveiling the data from the expanded portion of the trial focusing on patients naïve to lenalidomide and hypomethylating agents and who lacked a certain mutation known as del(5q) at a future medical conference. While these particular data were arguably the main reason investors were tuning into this EHA presentation, the fact that the company expects to present additional data from this trial later on is a noteworthy development in and of itself.
In short, Geron and its shareholders are currently waiting on the all-important continuation decision by its partner Johnson & Johnson (NYSE:JNJ) regarding imetelstat’s fate. This decision is expected to come by the end of the third-quarter, but the next major hematology conference isn’t until December of this year. That’s not to say investors should read too much into this intriguing timeline, but this stated plan of action certainly implies that the two companies are indeed making plans that extend beyond the third-quarter of this year.

Are the Eyes Windows to Early Dementia?


Retinal neurodegeneration was linked to cognitive decline, adding to a growing literature that suggests retinal structures may be biomarkers for dementia, according to results from two prospective studies.
A thinner retinal nerve fiber layer (RNFL) was tied to worse cognitive function in people without neurodegenerative disease and greater odds of future cognitive decline, reported Paul Foster, PhD, of the University College London, and colleagues, for the U.K. Biobank Eye & Vision Consortium.
And among Rotterdam Study participants in the Netherlands, thinner RNFL was associated with increased risk of dementia, including Alzheimer’s disease, according to M. Kamran Ikram, MD, PhD, of Erasmus MC University Medical Centre.
Both studies, published in JAMA Neurology, used optical coherence tomography (OCT) scanning to assess eyes.
“Our primary motivation was to confirm if the RNFL-cognition association held true in the very early stages of cognitive decline,” Foster told MedPage Today. “Our results suggest it does. This is important because, between 2002 and 2012, 99% of clinical trials into treatments for Alzheimer’s disease failed. A probable reason for the high failure rate is that treatments are being tested on those who already have irreparable damage to the brain.”
The eye is an easily accessible outpouching of the brain and retinal changes can parallel cortical findings, noted Christine Nguyen, PhD, of the University of Melbourne in Australia, who was not involved in either study “These two studies show in large cohorts that the axonal layer of retinal ganglion cells in the eye appears to be a useful early marker of cognitive decline,” she said.
“OCT is increasingly widespread in optometric and ophthalmic clinics. It is relatively inexpensive, takes a few seconds to conduct, and is comfortable for the patient. As such, it has a high potential as a screening tool,” she told MedPage Today.
In the U.K. Biobank study, 32,038 people without a neurodegenerative disease were included at baseline testing; their average age was 56 and 53.6% were women. Those in the thinnest quintile of RNFL were 11% more likely to fail at least on3 cognitive test. When 1,251 people completed follow-up cognitive tests 3 years later, those with an RNFL thickness in the two thinnest quintiles were almost twice as likely to have at least 1 worse test score (quintile 1: OR 1.92; quintile 2: OR 2.08; P<0.001 for both).
“The size of our study gave us unparalleled statistical power, and we believe this now confirms the link between thinner RNFL and very early cognitive weaknesses, and subtle future changes, in the general population,” Foster said.
The Rotterdam Study also revealed eye-related associations in 3,289 people with an average age of 69, of whom 41 (1.2%) already had dementia at baseline. While thinner ganglion cell–inner plexiform layer (GC-IPL) was associated with prevalent dementia (OR per SD decrease in GC-IPL 1.37), RFNL was not.
Over an average follow-up of 4.5 years, 86 people (2.6%) developed dementia, mostly Alzheimer’s disease. Thinner RNFL at baseline was associated with an increased risk of developing dementia (HR per SD decrease in RNFL 1.44; similar for Alzheimer’s disease), but no link was seen between GC-IPL thickness and incident dementia (HR 1.13).
Brain scans and spinal taps show it may be possible to detect Alzheimer’s early, but “given these are costly and painful, doctors are understandably reluctant to use them widely,” Nguyen observed. “What’s needed is an early, easy and cheap method to detect Alzheimer’s disease.”
While OCT may help fill this gap, “the challenge with the technology and the marker to retinal nerve fiber layer thinning is the lack of specificity for Alzheimer’s disease, as other diseases such as glaucoma also exhibit these changes,” she pointed out.
Extrapolating these findings to clinical practice should be approached cautiously, Foster noted. “There may be a role for population-wide screening with either a broad or narrow focus,” he said. And cognitive decline is an emotive subject, he noted. “People who previously thought themselves healthy may feel labeled as ‘early dementia’ or ‘high risk for dementia,’ and this may have significant, adverse psychological impact.”
There’s no systemic disease that doesn’t have an eye sign, he added. “Retinal morphometry, either of vessels or neuroretina, can contribute to risk profiling for stroke, myocardial infarction, hypertension, diabetes, and dementia. These tests currently are limited to the research arena, but are likely to become available to general practitioners within 5 years.”
The UK Biobank analysis was supported by the Eranda Foundation via the International Glaucoma Association.
Foster disclosed no relevant relationships with Allergan, Carl Zeiss, Google/DeepMind, and Santen, as well as support from Alcon and the Richard Desmond Charitable Trust/Fight for Sight. Co-authors disclosed multiple relevant relationships with industry.
The Rotterdam Study was funded by Erasmus Medical Center and Erasmus University, the Netherlands Organization for the Health Research and Development, the Research Institute for Diseases in the Elderly, the Ministry of Education, Culture and Science, the Ministry for Health,Welfare and Sports, the European Commission, and the Municipality of Rotterdam.
Ikram and co-authors disclosed no relevant relationships with industry.
  • Reviewed by F. Perry Wilson, MD, MSCEAssistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Comorbidities Can Help Predict Migraine Progression


People with migraine can be classified into eight clinically meaningful subgroups according to comorbidities, which may offer clues about headache causes and lead to individualized treatment, researchers reported here.
A modeling analysis showed that comorbidity patterns were correlated with a range of headache features. For example, people with respiratory and psychiatric comorbidities were most likely to experience photophobia and phonophobia, while those with cardiovascular comorbidities were least likely to experience nausea in conjunction with their headaches, according to Richard Lipton, MD, of Albert Einstein College of Medicine in New York City, and colleagues.
“We started with a set of questions,” Lipton said during the Harold G. Wolff award lecture at the American Headache Society (AHS) annual meeting. “Why is migraine so common? Why are the clinical features of migraine so variable from person to person? Why do some people respond well to one preventive treatment but not another? Why do we have to work so hard to find the right treatment for our patients? Why can’t we find genes that account for most people with common forms of migraine?”
“The answer to all these questions is that migraine is really more than one thing,” Lipton continued. “It becomes quite important to understand the heterogeneous nature of migraine and to find approaches for identifying natural subgroups of people with migraine — groups that are characterized by common risk factors, common biology, and if we’re lucky common treatment response.”
Lipton’s group used a statistical technique called latent class analysis to identify subgroups of migraine patients with shared features, focusing on comorbidities and concomitant conditions.
The analysis was based on data from CaMEO (Chronic Migraine Epidemiology and Outcomes), a prospective web-based survey that has collected data on symptoms, treatment, and quality of life from thousands of people with migraines in the U.S.
Out of a total population of nearly 13,000 respondents, those with no self-reported comorbidities were excluded, leaving a sample of 11,837 patients. The researchers initially looked at 62 comorbidities, but excluded those that were not useful in discriminating between groups, leaving 22.
After exploring a series of models, they found that a model with eight subgroups best fit the data. The researchers then determined whether various comorbidities, symptoms, and other headache features were more or less common than average in each subgroup.
  • Class 1: high on many comorbidities
  • Class 2: highest on respiratory and psychiatric symptoms
  • Class 3: highest on respiratory and pain symptoms
  • Class 4: highest on respiratory comorbidities
  • Class 5: highest on psychiatric comorbidities
  • Class 6: highest on cardiovascular comorbidities
  • Class 7: highest on joint pain
  • Class 8: low on comorbidities
Each natural subgroup had a distinct profile of demographic characteristics and clinical characteristic varied across classes, Lipton reported. For example, the respiratory/psychiatric group included a higher proportion of women, the cardiovascular group included more men and the psychiatric group was the youngest.
Patients who had many comorbidities were over four times more likely to have chronic migraine compared with people in the low comorbidities group (23.1% vs 4.8%). This group was also most likely to experience aura, allodynia, moderate to severe intensity pain, nausea, and worsening of pain with routine activities.
Those in the respiratory/psychiatric group were most likely to report pounding or throbbing headaches and were most likely to be bothered by light and sound. In contrast, the cardiovascular group was least likely to experience any of these symptoms.
Patients with many comorbidities were most likely to say they had severe migraine-related disability, or MIDAS grade IV (48.1%), followed by the respiratory/psychiatric (31.9%), respiratory/pain (28.6%), and psychiatric (26.1%) subgroups. Again, the cardiovascular group reported the least severe disability (14.1%).
The researchers then asked whether these comorbidity subgroups could be used to identify which patients were at greatest risk for progression from episodic migraine to chronic migraine.
“If you want to understand the mechanism of something, it’s very often useful to understand what it co-localizes with,” AHS scientific program committee chair Peter Goadsby, MD, PhD, told reporters during a media briefing ahead of the meeting.
“Those of you with family members with migraine, if I tell you people with more comorbidities are more likely to progress, maybe you’re not going to be surprised. If you start to understand the mechanisms of that interaction, you start to understand better how people with infrequent migraine develop frequent migraine,” he continued. “If you understand how they get there, you can understand how to lead them back.”
After excluding people who already had chronic migraine at baseline, Lipton’s group looked at an analysis sample of 8,658 patients.
Compared with the low comorbidities subgroup, those in the high comorbidities group were 5.3 times more likely to develop new onset chronic migraine over the course of a year after, adjusting for demographic factors only, Lipton reported. When other migraine features such as symptom severity and medication overuse were added to the model, the effect was attenuated (3.0 times more likely), but comorbidity subgroup still predicted the risk of progression.
“The hope is that as we identify biologically homogeneous groups, we’ll be able to do for a larger fraction of people with migraine what’s been done for familial hemiplegic migraine — that this work can help us predict prognosis and treatment response and ultimately perhaps lead to more powerful clinical trials,” Lipton said.
“At the moment, the drugs we discover are the ones that are effective for large subgroups of migraine,” he added. “If there were a treatment that works for 10% or 15% of migraine, the way we do our trials right now, we’d completely miss those effects.”
These results represent a step toward more individualized treatment for people with migraine.
“We can see how this work can lead us into an era of precision medicine for migraine,” said ASH session moderator Todd Schwedt, MD, of the Mayo Clinic in Phoenix.
The CaMEO study was sponsored by Allergan.
Lipton disclosed support from and relevant relationships with several companies including Allergan, Amgen, Biohaven, Dr. Reddy’s, Eli Lilly, GlaxoSmithKline, Merck, and Teva.