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Saturday, September 29, 2018

Intra Cellular Therapies in New Drug Application for Schizophrenia Med


Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the Company has completed the rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumateperone, a once-daily, oral investigational medicine with a novel mechanism of action for the treatment of schizophrenia. The NDA submission is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received Fast Track designation from the FDA in November 2017 for the treatment of schizophrenia.
Our first NDA submission represents a significant milestone for the Company and the development of lumateperone, which we believe has the potential to be an important advance in the treatment of schizophrenia. We look forward to the prospect of working with the FDA to bring lumateperone to patients living with this debilitating disease as quickly as possible, said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

Takeda, Lundbeck Apply in Japan for Depression Treatment


Takeda Pharmaceutical Company Limited (TSE: 4502)(“Takeda”) and its partner, H. Lundbeck A/S (“Lundbeck”) today announced the submission of a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults. MDD is a complex but common disorder with more than 3.5 million cases in Japan, affecting 3percent of the population[i].
The NDA filing included data from the pivotal phase III randomized, placebo-controlled study (NCT02389816) in MDD. Approximately 490 Japanese adults with recurrent MDD were randomized to receive vortioxetine (10 and 20 mg) or placebo. The primary endpoint was the change from baseline (i.e. the start of double-blind treatment) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score after 8 weeks of treatment. The study demonstrated positive results of vortioxetine as compared to placebo for the treatment of MDD in adults. Full results will be presented at a scientific meeting in the future. The regulatory submission also featured data from three other key studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147).
“MDD is a multifaceted condition that has emotional, physical and cognitive symptoms. As such, it represents a significant medical need.” said Naoyoshi Hirota, head of Takeda Development Center Japan. “We are pleased by today’s regulatory filing as it demonstrates our joint commitment with Lundbeck, and our belief that vortioxetine has the potential to become a new treatment option for patients in Japan suffering from this serious and complex condition.”

Rensselaer Polytechnic, United Health Put Up $1M to Train Health Data Experts


  • Training will take place through the “Rensselaer Health INCITE Pipeline”
  • Funding supports new entry points into health informatics and experiential learning opportunities
Rensselaer Polytechnic Institute and the United Health Foundation are expanding access to health informatics educational opportunities and applied health data science research experiences through the Rensselaer Institute for Data Exploration and Application (IDEA).
The Rensselaer-United Health Foundation partnership aims to address the growing need for a larger workforce of health data analysts and technologists. The three-year, $1.1 million grant from the United Health Foundation will help launch the “Rensselaer Health Informatics Challenges in Technology Education (INCITE) Pipeline” to prepare students for careers in health data science through several interrelated initiatives, including:
  • enhancing curricula to make health informatics more accessible to students from an array of majors such as biology and mathematics;
  • creating a new “synthetic data generator” to expose students to real-world health data challenges and test solutions; and
  • promoting experiential learning through online challenges available to students at Rensselaer and around the world.
“Rensselaer Polytechnic Institute is a leader in bringing together the physical, digital and biological worlds to drive research innovations and distinct educational opportunities,” said Rensselaer President Dr. Shirley Ann Jackson. “Our partnership with the United Health Foundation will enable us to expand opportunities for researchers and students to tackle the tough challenges of our health care system through the integration of human intelligence with machine intelligence.”
The grant specifically supports the work of the Rensselaer Institute for Data Exploration and Application (IDEA), which enables data science research and education across the Rensselaer campus. The partnership will yield a larger pipeline of students pursuing data science careers in health care, and novel teaching methods that improve undergraduate health informatics education at Rensselaer and beyond.
“The United Health Foundation is honored to partner with Rensselaer to help create a 21st century health care workforce ready to meet the health needs of the nation and the world,” said Dr. Paul Bleicher, a Rensselaer alumnus and CEO of OptumLabs, a UnitedHealth Group company. “Investing in tomorrow’s health care data scientists is vital to helping solve some of the health system’s toughest challenges and creating the actionable insights we need for better care quality and health outcomes.”

Traumatic Brain Injuries Affect 2.5% of US Kids


The prevalence of traumatic brain injury (TBI) is 2.5 percent among U.S. children, and TBI is associated with several health conditions, according to a study published online Sept. 24 in JAMA Pediatrics.
Juliet Haarbauer-Krupa, Ph.D., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues examined the lifetime prevalence of TBI in a nationally representative sample of U.S. children using data from the 2011 to 2012 National Survey of Children’s Health. For children with and those without TBI, the likelihood of reporting specific health conditions was compared.
The researchers found that among children, the lifetime estimate of parent-reported TBI was 2.5 percent, representing more than 1.8 million children nationally. Compared to those without a TBI history, children with a lifetime history of TBI were more likely to have a variety of health conditions. The most prevalent conditions included learning disorders; attention-deficit/hyperactivity disorder; speech/language problems; developmental delay; bone, joint, or muscle problems; and anxiety problems (21.4, 20.5, 18.6, 15.3, 14.2, and 13.2 percent, respectively). The proportion of children with private health insurance and higher parent report of adequate insurance was more likely to be higher in states with a higher prevalence of childhood TBI.
“For more comprehensive monitoring, health care professionals should be aware of the increased risk of associated health conditions among children with TBI,” the authors write.

Hidden health problems can appear up to two years after elective hip surgeries


Up to two years following elective, arthroscopic hip surgery, a substantial proportion of patients reported troubling new health issues ranging from sleep problems, to arthritis to cardiovascular disease.
While such problems can be transient and diminish as full mobility returns, the findings suggest that patients and doctors should be prepared to manage a variety of complications over time, even as the surgeries themselves are considered a success.
“Our study focused on a younger group — current and former military personnel ages 18-50 — and compared their medical records both before and after surgery,” said Daniel Rhon, D.Sc., an adjunct professor at the Duke Clinical Research Institute and lead author of a study published online Sept. 28 in the British Journal of Sports Medicine.
“Even among this younger group, the number and frequency of these hidden complications that arose after elective hip surgery suggests we should be taking a more wholistic approach, proactively assessing patients for risks other than the standard surgical complications we more commonly look for,” Rhon said.
Rhon and colleague — including senior author Chad Cook, Ph.D., program director of Duke’s Doctor of Physical Therapy Program — conducted the observational study by examining Military Health System records of 1,870 former and current service members undergoing arthroscopic hip surgery between 2004-2013. Patient records were collected for the 12 months prior to and 24 months after surgery.
In their analysis, they identified incidents of mental health disorders, chronic pain, substance abuse issues, cardiovascular ailments, metabolic syndrome, arthritis and sleep problems that were noted in the patients’ medical records both before and after their elective hip surgeries.
Post-surgery incidence of all comorbidities after the procedure rose dramatically: mental health disorder increased 84 percent; chronic pain diagnoses soared 166 percent; substance abuse ticked up 57 percent; cardiovascular disorders rose 71 percent; metabolic syndrome cases rose 86 percent; arthritis spiked 132 percent; and sleep disorders jumped 111 percent.
“Hip arthoscopy is becoming more common even among younger people, and it can be quite successful in resolving chronic, painful conditions,” Cook said. “But it’s important to be prepared for a lengthy recovery. These are surgeries where people are prohibited from fully bearing weight for several weeks, so they can’t exercise, they can’t sleep comfortably, they are in pain.”
Rhon said disruptions in sleep can be particularly problematic. Without proper rest, the sense of pain escalates, leading to a negative spiral of fatigue and pain that then depresses mood, energy levels and general health.
“These issues are compounding on each other,” Rhon said. “Our study serves as an important alert to both doctors and patients. Armed with this knowledge, we can be vigilant in addressing these problems earlier and potentially stopping others from developing.”
In addition to Rhon and Cook, study authors include Tina Greenlee, Bryant Marchant and Charles D. Sissel.
The research received support from the US Defense Health Agency.
Story Source:
Materials provided by Duke University Medical CenterNote: Content may be edited for style and length.

Journal Reference:
  1. Daniel I Rhon, Tina A Greenlee, Bryant G Marchant, Charles Dennis Sissel, Chad E Cook. Comorbidities in the first 2 years after arthroscopic hip surgery: substantial increases in mental health disorders, chronic pain, substance abuse and cardiometabolic conditionsBritish Journal of Sports Medicine, 2018; bjsports-2018-099294 DOI: 10.1136/bjsports-2018-099294

Healthcare Providers Are Common Source of Data Breaches


More than 176 million confidential health records were breached between 2010 and 2017, including 37.1 million records controlled by healthcare providers, according to a study published online in JAMA this week.
Researchers found that whereas healthcare providers were most likely to experience data breaches, breaches at insurers led to the disclosure of far more records. In addition, the number of breaches of records controlled by providers rose steeply during the study period, but increased more slowly for health plans and declined for business associates.
The 1999 Health Insurance Portability and Accountability Act (HIPAA) and the 2009 Health Information Technology for Economic and Clinical Health Act established privacy rules for healthcare data and mandate reporting of healthcare data breaches.
Although large breaches are widely reported in the media, few data are available regarding smaller breaches or the type of organization affected by breaches.
For the current study, Thomas H. McCoy Jr, MD, and Roy H. Perlis, MD, both of the Psychiatry Center for Quantitative Health at Massachusetts General Hospital in Boston, separated breaches of data confidentiality into three categories on the basis of type of organization handling the records: healthcare providers, health plans, and “business associates.” Business associates include claims processors and others who do not provide or pay for care but have access to HIPPA-protected health records.
Healthcare providers accounted for 70% (1503 incidents) of the incidents. But the number of patient records held by providers made up a smaller percentage of the overall number that were compromised, at a cumulative total of 37.1 million (21%) between 2010 and 2017.
In contrast, health plans suffered a smaller number of breaches (278; 13%), but more records were compromised (110.4 million; 63%).
McCoy, director of research at the center, told Medscape Medical News he started looking at data breaches to assess the risk posed to his patients and clinical trial subjects. He used mandated reports of breaches collected by the Department of Health and Human Services, which are publicly available data.
“Large healthcare data sets present an important means of potentially translational discovery,” he said. “They also come with a risk of large-scale disclosure. That trade-off between risk and benefit…is part and parcel of the practice of medicine.”
He said the database allowed him to understand the parameters and scope of unauthorized disclosure of patient records. However, he said that it is not possible to know how many confidential patient records are produced in a single year, which makes it difficult to gauge what percentage of all records have been compromised. He also noted that each cited disclosure may not represent an individual patient, as some patients may have had multiple records compromised.
However, if one looks at the number of records compromised, 176 million during the study period, in light of a US population of roughly 300,000, “bottom line, it’s a big number,” he said.
The authors analyzed 2149 instances of unauthorized release of patient records. The number of records in each incident ranged from 500 to 78.8 million records. (In 2015, health insurer Anthem reported the breach of 78.8 billion records.)
With the exception of 2015, the number of breach reports increased each year, from 199 in 2010 to 344 in 2017.
The most common source of breached records shifted from laptop and paper or film records in 2010 to network server and email in 2017.
Whereas paper or film records were the most common data breached overall during the study period, accounting for 510 breaches (24%), they accounted for only 2% of all records breached.
In 2015, the cumulative number of records breached via network servers rose from 12.3 million to 123.7 and continued to rise. That figure reached 139.9 million (79%) in 2017, representing the largest share of breached records.
“These shifts were paralleled by increases in hacking or information technology (IT) incidents and unauthorized access, which both surpassed theft by 2016,” the authors write.
David Blumenthal, MD, helped oversee the implementation of electronic medical records as the national coordinator for Health Information Technology from 2009 to 2011. In a 2015 JAMA editorial, he wrote, “The personal health information of patients in the United States is not safe, and it needs to be…. Threats to the safety of healthcare data need much more focused attention than they have received in the past from both public and private stakeholders.”
McCoy said that his research does not speak to particular solutions to the problem.
“It speaks to the aspects of the system that are most often breached,” he said.
He said it is not possible to know whether patient records will become more secure as payers and providers gain more experience in working with electronic health records.
“It’s — try hard, cross your fingers, and wait and see,” McCoy said.
JAMA. 2018;320:1282-1284. Abstract

P&G tries to break out of consumer product stagnation


Last fall, Procter & Gamble Co. Chief Executive David Taylor, waging the costliest board fight in history, took the stage at the company’s annual shareholder meeting and vowed the maker of Tide and Pampers had made “dramatic changes” and was headed to “new heights.”
But a year after its duel with activist investor Nelson Peltz, the Cincinnati consumer-products giant has stagnated, stymied by competition, rising materials costs and its own bureaucracy, according to executives, analysts and people familiar with the business. Mr. Peltz joined P&G’s board March 1, invited on by P&G after the company won the shareholder vote by only a razor-thin margin.
P&G investors have lost 8.8% over the past year, including dividends, while the S&P 500 has climbed 18.4% and touched new heights. Over the past decade, the S&P has returned 198% including dividends, while P&G has returned 65%.
P&G’s near-loss to Mr. Peltz was a reality check for the company, which had long enjoyed an investor base supportive of company management and willing to ride out tough times. Mr. Peltz’s arrival on the board has lessened some of the immediate pressure on P&G, analysts and investors say, but shareholders’ patience may be limited following a decade of spotty results, CEO turnover and near-constant restructuring.
The company’s morass is further proof there is no quick fix for big consumer brands in mature markets, more of which are struggling to compete and grow amid seismic shifts in retailing, advertising and shopper preferences. From Kraft Heinz Co. and Campbell Soup Co. to P&G rivals Unilever PLC and Kimberly-Clark Corp., the biggest names in consumer products have been forced to rethink and resize their businesses, often under pressure from investors and, in some cases, influential activists like Mr. Peltz.
“I certainly can’t say there is any evidence that things are different at P&G,” said SunTrust analyst Bill Chappell. “It feels like the same P&G: ‘Don’t worry, next year will be better.’ Then disappointing results, then, ‘Don’t worry, next year will be better.’ ”
At P&G, one of Mr. Taylor’s biggest ideas — a plan to acquire Pfizer Inc.’s consumer-health business with brands such as Advil, ChapStick and Robitussin — was sidelined earlier this year by a contingent of directors, including Mr. Peltz, and also skeptics within the company, according to people familiar with the situation.
The board believed the Pfizer unit, with a valuation as high as $10 billion, was too pricey. Instead, P&G struck a smaller deal in April, agreeing to acquire the consumer-health business of Germany’s Merck KGaA for $4.2 billion. That deal will add vitamins and food supplements mostly sold outside the U.S. to the P&G unit that includes Crest toothpaste and Vicks cold medicine.
The changes P&G has undertaken to overhaul how it invents, markets and sells its products have yet to show up in results. P&G’s “organic” sales — a closely watched metric that strips out currency moves, acquisitions and divestitures — rose 1% in the fiscal year ended June 30, below the company’s goal of 2% to 3%. The company is losing share in 24 of its top 50 product categories and geographies, though that number is an improvement from a year ago.
“We’re making progress, but we’re still not where we want or need to be, ” a P&G spokesman said. He said P&G’s results improved as the year wore on and the company is more focused on growing by developing new brands and products than on taking share from rivals.
In the past year, P&G U.S. sales are up 1.2%, in line with overall industry growth, according to Nielsen data provided by Wells Fargo. Performance of the biggest brands have been mixed. For instance, the company’s liquid laundry detergent sales rose 2.3% compared with a year ago, while sales of laundry pods jumped 4.2%. But the Gillette razor business continues to lose ground, despite slashing prices in early 2017.
“I just couldn’t come back to them,” said Randy Merrill, a 70-year-old retired lawyer from Atlanta. He used Gillette razors until a few years ago when he tried Schick razors and found the five-blade cartridge was cheaper and worked better than Gillette’s three-blade offering. “I’m a stockholder and I voted for P&G in [the Peltz] fight. I’m disappointed.”
Mr. Peltz, who declined to comment through a spokeswoman, argued in his campaign last year that the company had settled for “mediocrity” and needed to restructure its operations. The billionaire had previously waged proxy fights and taken board seats at Heinz, industrial conglomerate Ingersoll-Rand PLC and money manager Legg Mason Inc.
In targeting P&G, Mr. Peltz’s Trian Fund Management LP tapped mounting frustrations among shareholders, including P&G’s large investor base of current and former employees. Mr. Peltz argued that P&G suffered under a “suffocating bureaucracy” and a board that failed to hold management accountable. He also said the company was overly reliant on aging, big-name brands and needed to focus on trendy, niche product lines.
“We understand completely that [consumer products] is one of the more difficult categories to complete in,” said Jim Russell, a portfolio manager at Bahl & Gaynor Investment Counsel in Cincinnati, which advises hundreds of P&G executives, rank-and-file workers and retirees. “We’re hopeful that Procter is up to the task.”
Mr. Taylor, while generally unflappable, showed frustration amid the fight with Mr. Peltz, sometimes in the form of direct barbs aimed at Mr. Peltz and other times in the way he’d bounce restlessly while addressing investors’ criticisms.
Mr. Peltz, who dropped out of college in the 1960s and got his start loading peaches and strawberries onto trucks for his family’s food-distribution company, takes issue with being called an “activist” investor, instead preferring to be seen as an ally to struggling companies and their shareholders. But he hasn’t shied away from challenging the strategies of iconic companies, including PepsiCo Inc. and General Electric Co., sometimes through sharply worded white papers.
The men, who met and spoke over the phone in what proved to be an unsuccessful effort to avoid the proxy fight, shook hands at the closing of P&G’s shareholder meeting last year. There, Mr. Taylor declared victory over Mr. Peltz, but Trian believed the vote was too close to call. Mr. Peltz congratulated the CEO.
“We’ll talk,” Mr. Taylor said.
“We’ll talk but we don’t listen,” Mr. Peltz replied.
Mr. Taylor responded, “No, no, no, that’s not true.”
P&G executives say there are signs of change, and the company is winning over more millennial shoppers with its big-name brands and stronger online sales. It has streamlined the organization and is more closely aligning pay with company performance. Shortly after Mr. Peltz came on the scene, P&G began touting a new approach to bringing “irresistibly superior” products to market, in which new offerings must meet more-rigorous standards on everything from packaging to efficacy.
The pay changes are the most visible sign thus far of the impact of Mr. Peltz, who criticized P&G’s compensation metrics last year. Mr. Taylor, CEO since November 2015, took a 4% pay cut in the latest fiscal year, earning $17.4 million including his annual salary, bonus and stock awards. P&G’s board made additional changes to the company’s bonus program in June, which will be in effect this fiscal year, according to a regulatory filing.
After long eschewing acquisitions of outside brands, P&G in the past year acquired a trio of startups — Native natural deodorant and two skin-care companies, Snowberry and FAB — with plans to expand direct-to-consumer offerings and smaller brands. With Native, which offers $12 deodorant in scents such as pumpkin spice latte and lemon zest and pomegranate, P&G employed a tactic to which it once fell victim. P&G used its retail clout to get Native on shelves in Target Corp.’s 1,800 stores. Two years earlier, online razor startup Harry’s moved into Target and won share from P&G’s Gillette brand.
P&G, one of the world’s biggest advertisers, has gone on a crusade to clean up the online ad market and force major technology platforms to provide more information about the effectiveness of digital ads. P&G said big players including Alphabet Inc.’s YouTube and Facebook Inc. have made significant changes since the company last year slashed digital ad spending by more than $200 million and issued an ultimatum for tech companies to become more transparent.
The company has also made progress in streamlining its bureacracy, which P&G executives called “the thicket” for its difficult-to-navigate structure.
The company also cut 3,000 jobs globally in the recently ended fiscal year. P&G has reduced its workforce by 25% in the past five years, leaving 92,000 employees world-wide. The company shrunk significantly in 2016 when Mr. Taylor completed the sale of Clairol, CoverGirl and most of its beauty brands to Coty Inc. for $12 billion.
And in a move that will be most acutely felt by American shoppers, P&G recently said it would raise prices on some of its biggest brands, including Pampers diapers, Bounty paper towels, Charmin toilet paper and Puffs tissues. P&G, as the industry’s biggest player, tends to drive industry pricing moves and several rivals, including Kleenex maker Kimberly-Clark, have followed suit.
Many analysts say the 181-year-old company — given industry challenges and the fact that Mr. Peltz has been on the board only seven months — should be allowed more time to show progress.
“There are a lot of investments being made to make the culture more agile, but is that going to translate to improved sales growth?” asked Edward Jones analyst Brittany Weissman. Adding Mr. Peltz to the board, “is going to give them some flexibility to execute on their plan. If that doesn’t work, you are going to see him become more aggressive.”