Sanofi is launching a Global R&D Operations Hub with a specialized focus on digitalization and big data analysis in Chengdu, Sichuan province, China. The new R&D operations hub confirms China as the third pillar of Sanofi Global Clinical Sciences and Operations, joining facilities in France and the United States. With an investment of EUR66M, the Hub will support the clinical research and development of Sanofi’s innovative drugs by focusing on the management of global multi-center clinical trials data and files. Bringing together global data and analysis, the Hub will accelerate the availability of trial results, from Phase I to Phase IV. The Hub will take advantage of local talents to further strengthen Sanofi’s digital capabilities. The Chengdu Hub will target diseases that affect millions of people across our therapeutic areas: diabetes and cardiovascular diseases, vaccines, oncology, immunology and inflammation, rare diseases, multiple sclerosis and neurology. It will leverage global cutting-edge biological technology for polypeptides, gene therapy, monoclonal antibodies and multi-specific antibodies. The Hub plans to recruit 300 local pharmaceutical research and development professionals by 2020.
Monday, July 2, 2018
Alkermes says FDA OKs schizpphrenia initiation treatment
Alkermes announced that the U.S. FDA has approved ARISTADA INITIO for the initiation of ARISTADA, a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults. For the first time, ARISTADA INITIO, in combination with a single 30 mg dose of oral aripiprazole, provides physicians with an alternative regimen to initiate patients onto any dose of ARISTADA on day one. ARISTADA INITIO is expected to be available in mid-July. “The approval of ARISTADA INITIO makes ARISTADA the first and only long-acting atypical antipsychotic that can be initiated on day one, representing an important addition to the treatment paradigm for the complex illness of schizophrenia,” said David Walling, Ph.D., CEO and Principal Investigator of the Collaborative Neuroscience Network. “For physicians and caregivers alike, the ARISTADA INITIO regimen provides a level of confidence that patients can walk out the door with up to two months of coverage with a proven medication in their system. This supports continuity of care for patients and allows the care team to focus their efforts on other aspects of the treatment paradigm that contribute to long-term positive outcomes.”
Sunday, July 1, 2018
Big Investor Opposes Rite Aid’s Albertsons Deal
As Rite Aid executives campaign to win over skeptical shareholders for their merger with grocery store chain Albertsons, the drugstore chain Wednesday reported deteriorating retail pharmacy sales in its fiscal first quarter.
Rite Aid reported fiscal first quarter profits of $214 million, or 20 cents per share thanks to the sale of more than 200 stores to Walgreens Boots Alliance during the period. Rite Aid, however, reported a net loss on continuing operations of $41.7 million of the period ended June 2. Revenues were essentially flat at $5.4 billion compared to the year ago quarter as sales in Rite Aid’s retail pharmacy segment fell during the 13-week quarter.
Rite Aid’s first quarter earnings report came on a day when its proposed merger with Albertsons was dealt a blow by a large shareholder. Highfields Capital Management, which holds 4.4% of Rite Aid’s outstanding shares said it will vote against the merger with Albertsons. A vote is scheduled for Aug. 9.
Before shareholders is a $24 billion merger with grocery store giant Albertsons announced in February that would result in Rite Aid shareholders owning about 30% of the combined new company. The combination of Rite Aid, which operates RediClinic, and Albertsons would create a company with 319 health clinics and 4,345 pharmacies after the merger closes.
Some investors have said they are upset that senior executives will be paid retention bonuses even if the deal falls through. Others don’t like that Rite Aid isn’t getting a higher price, especially as pharmacy benefit managers are suddenly an acquisition target and shareholders see value in Rite Aid’s PBM, EnvisionRxOptions, which has been growing rapidly.
“In Highfields’ estimation, the proposed transaction is in the best interests of Albertsons and Rite Aid management, but not Rite Aid shareholders,” the Boston-based investment management firm said in a press release issued Wednesday.
Meanwhile, Rite Aid management is fighting back against opponents. In a letter to shareholders earlier this week, Rite Aid included supporting quotes from analysts and media clippings pointing out the potential threat of online retailer Amazon as well as a warning from one firm highlighted in bold that they “do not expect any other bidders” for Rite Aid.
During a conference call Wednesday afternoon, Rite Aid CEO John Standley said the retail pharmacy segment is improving and the merger with Albertsons will “create a truly differentiated leader in food, health and wellness.”
“This combination will enhance our scale and density to better compete in existing markets, give us access to new markets, significantly improve our omni-channel capabilities and create the opportunity to achieve substantial cost synergies and revenue growth, all of which will strengthen our financial profile and position us to deliver compelling long-term value for customers and shareholders,” Standley said on the 50-minute earnings call.
With the transfer of more than 1,900 stores to Walgreens Boots Alliance completed, Rite Aid executives have said they can now focus on the merger with Albertsons and growing its businesses. In particular, Rite Aid said it will continue to convert its drugstores to “wellness stores,” which have expanded clinical pharmacy services, health and wellness products.
On Wednesday, Walgreens reported a first quarter “after-tax gain of approximately $268.6 million relating to the sale of 281 stores to Walgreens, which completed the sale of stores and related assets to WBA.”
“As a result of the proceeds received from the store sales, Rite Aid’s debt, net of cash, was $3.0 billion as of June 2, 2018,” Rite Aid said in a statement.
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 Podders™worldwide.
“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 a
t the Van Dyke Houses, proved to have an elevated lead level when he was tested at the age of 2. (Courtesy Wheeler family)
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. (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. (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. (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. (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.”
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