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Tuesday, July 2, 2019

Weight loss support helps people with fatty liver disease

People who have fatty liver disease related to being overweight may get the disease under better control when they get lots of support to lose weight, a research review suggests.
Most people have a little bit of fat in their liver, but fatty liver disease can be diagnosed when more than 5% of the liver is made up of fat. If the condition isn’t linked to liver damage from heavy drinking, it’s known as non-alcoholic fatty liver disease (NAFLD) and is most often associated with obesity and certain eating habits.
For the current analysis, researchers examined data on 2,588 patients who were participating in 22 clinical trials of various interventions to help them lose weight. Fifteen studies tested behavioral weight loss programs; six tested medications; one tested weight loss surgery.
The trials also looked at whether those interventions would improve biomarkers for NAFLD that can help predict the likelihood of serious complications.
Compared with little or no weight loss support, the interventions that offered the most support were associated with greater weight loss and bigger reductions in biomarkers for NAFLD like elevated liver enzymes in the blood, elevated blood sugar, and reduced sensitivity to the hormone insulin, or insulin resistance.
“It shows clearly that weight loss improves the health of the liver,” said Dimitrios Koutoukidis, a researcher at the University of Oxford in the U.K. and lead author of the study.
“We found some evidence that weight loss improved NAFLD through improvements in the control of blood glucose levels and reductions in insulin resistance, but we need more research to understand the exact mechanisms,” Koutoukidis said by email.
Different approaches to weight loss didn’t appear to impact whether fibrosis, or scarring, in the liver got better or worse.

Worldwide, about one in four adults have NAFLD, as do at least half of people with obesity, researchers note in JAMA Internal Medicine.
There’s no drug treatment for NAFLD. Doctors typically advise patients to lose weight by cutting calories and getting more exercise, or sometimes by taking weight-loss medications or considering weight-loss surgery. The new findings, according to the researchers, “appear to support the need to change the clinical guidelines and to recommend formal weight loss programs for people with NAFLD.”
One limitation of the analysis is that the smaller studies tested a wide range of weight-loss interventions over varying lengths of time and used different tests to assess patients’ liver disease.
Still, weight loss through a combination of dietary improvements and increased exercise can improve fatty liver, said Dr. Danielle Brandman, director of the Fatty Liver Clinic at the University of California San Francisco and coauthor of an editorial accompanying the study.
Ideally, patients should try to lose 7% of their weight and maintain this weight loss in order to have long-term improvements in NAFLD, Brandman said by email.

“Patients have the potential to improve or cure their disease,” Brandman said.
“However, they should know that this is an ultra-marathon rather than a sprint,” Brandman added. “Weight loss – and the behavior change needed to achieve it – can be really difficult for many patients for a variety of reasons.”
SOURCE: bit.ly/2ZZq9Cs JAMA Internal Medicine, online July 1, 2019.

Vietnam says will have African swine fever vaccine ‘soon’, experts skeptical

Vietnam said on Tuesday it has had initial success in creating a vaccine to fight African swine fever, which has infected farms throughout the Southeast Asian country and prompted the culling of around 10% of its pig herd.
African swine fever – which has spread to Laos and North Korea as well after being detected in China in August 2018 – was first detected in Vietnam in February and has spread to farms in 61 of the country’s 63 provinces.
More than 2.9 million pigs have been culled in Vietnam, Agriculture Minister Nguyen Xuan Cuong said on Tuesday, out of a hog population of about 30 million.
“I think we’re on the right track, and we will soon have a vaccine,” Cuong said, according to the official Vietnam News Agency (VNA).
The vaccine, developed at the Vietnam National University of Agriculture, has been tested in its laboratory and at three farms in northern Vietnam, state broadcaster Vietnam Television (VTV) said in a separate report on Tuesday.
Experts on vaccines and African swine fever, though, were skeptical over the claims of progress and said there needed to be much more research to prove the viability of any vaccine.
“We need different phases of clinical trials, first in an experimental setting with controlled exposure, and then a field trial with natural exposure to the virus, and that cannot be a small trial,” said Dirk Pfeiffer, a professor of veterinary epidemiology at the City University of Hong Kong.

The complex nature of the virus and gaps in knowledge concerning infection and immunity have so far hindered other global efforts to develop a vaccine against the disease, which is harmless to humans but deadly to pigs.
Researchers elsewhere have abandoned attempts to use a killed virus for a vaccine and teams in the United States, Europe and China have been working on live vaccines instead, which carry higher safety risks.
In Vietnam’s initial trials, 31 out of 33 pigs injected with the test vaccine are still healthy after receiving two shots over a period of months, according to the VTV report.
Other pigs at the farms have died from the virus, the report said, without giving specific figures. No further details were given about the vaccine or the trials.
The agricultural university’s director, Nguyen Thi Lan, said the vaccine still needed further research, and required testing on a larger scale.
Lan declined to comment on the report and referred questions from Reuters to the agricultural ministry, which did not immediately respond to a request for comment.
Pork makes up three-quarters of total meat consumption in Vietnam, a country of 95 million people where most of its farm-raised pigs are consumed domestically.
The country’s pork industry is valued at 94 trillion dong ($4 billion) a year, and accounts for nearly 10% of Vietnam’s agricultural sector.
African swine fever was first detected in Asia last year in China, the world’s largest pork producer. As many as half of China’s breeding pigs have died or been slaughtered because of the disease, twice as many as officially reported.

U.S. drugmakers institute new round of increases

Early July is typically one of the two times each calendar year that U.S. drugmakers hike prices. Yesterday, on cue, many appeared to do just that.
B. Braun raised the price of its Isolyte saline solution by more than 100% to almost $6/package. Saline solutions, used to rehydrate patients and dilute medicines before administration, have been in short supply in the past few years.
GlaxoSmithKline (GSK +0.1%) raised the price of ovarian cancer med Zejula (niraparib), acquired in Tesaro merger, by 5% to $6,913 for a 30-day supply.
Amneal Pharmaceuticals (AMRX -1.3%) hiked the price of thyroid med Unithroid by ~10%.
According to Rx Savings Solutions, 20 companies raised prices on over 40 products by an average of 13.1%, both higher than July of last year when 16 firms boosted prices by an average of 7.8%.
Many pharmaceutical makers have pledged to restrict increases to less than 10% per annum. During Q1, list prices for U.S. branded drugs rose 3.3% versus 6.3% a year ago per SSR Health LLC.
Some observers believe that many companies may raise prices later this year when there is less attention on the issue.
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Selected tickers: Takeda (TAK +0.2%), Bristol-Myers Squibb (BMY +1%), Merck (MRK +0.3%), Pfizer (PFE +0.8%), Johnson & Johnson (JNJ -0.2%), AbbVie (ABBV -0.4%), Eli Lilly (LLY +0.7%), Novartis (NVS +0.1%), Roche (OTCQX:RHHBY +0.1%), Allergan (AGN +0.1%), Amgen (AMGN -0.3%), Biogen (BIIB +0.1%), Gilead Sciences (GILD +1.4%)

NewYork-Presbyterian to grow telehealth services with innovation institute

NewYork-Presbyterian, based in New York City, has launched the new Hauser Institute for Health Innovation with a specific focus on expanding telehealth services including remote patient monitoring and teleparamedics.
The new innovation institute is named in recognition of philanthropists Rita Hauser and Gustave Hauser, who have given more than $50 million to NewYork-Presbyterian in support of the hospital’s comprehensive telehealth services, according to the health system.
Gustave Hauser was the founding chairman and CEO of Warner Cable Communications and later established Hauser Communications. Rita Hauser, president of the Hauser Foundation, is an international lawyer and was a senior partner for more than 20 years at a major New York City law firm.
NewYork-Presbyterian is an 11-hospital system that experiences 2.6 million patient visits annually. The system employs 10,000-plus physicians and is equipped with 4,000-plus certified beds.
“With the Hausers’ extraordinary support, NewYork-Presbyterian is transforming the way health care is delivered, using technology to put patients’ needs first and expand access to our world-class care,” Steven Corwin, M.D., president and CEO of NewYork-Presbyterian, said in a statement.

“NewYork-Presbyterian is using advanced technologies to fundamentally change the way that health care is provided, making it more convenient and accessible to all,” Rita Hauser said in a statement.
NewYork-Presbyterian has been scaling up telehealth services and seen success with leveraging virtual care tools. The health system’s Express Care telehealth program has helped to cut nonurgent emergency department wait times by nearly two hours, according to The Wall Street Journal. That program enables ER patients with minor injuries to see a doctor via video conferencing.
The health system also launched NYP OnDemand in July 2016 as a comprehensive suite of digital health services. The expansion of telehealth services was also the result of the philanthropic partnership with the Hausers. In collaboration with Weill Cornell Medicine and Columbia University Irving Medical Center, NYP OnDemand has grown to include more than 46 programs, and patients have received healthcare services during more than 230,000 visits.
NYP OnDemand services enable patients to connect with healthcare providers via the hospital’s website and mobile apps as well as self-service kiosks at some Walgreens and Duane Reade stores. The services include digital urgent care, where patients can access emergency medicine physicians through a live video chat; peer-to-peer consults between physicians; and digital second opinion, which enables patients to contact specialists via a portal with no need for in-person appointments.
The Hausers’ financial support also helped NewYork-Presbyterian to expand its fleet of mobile stroke treatment units with advanced telemedicine technology to allow neurologists from NewYork-Presbyterian’s hospital locations to be consulted remotely, according to the health system.

The Hauser Institute for Health Innovation will support innovation and research to benefit patients and bring thought leaders together to advance knowledge in the digital health field, according to NewYork-Presbyterian. A key focus will be expanding telemedicine services deeper into the communities NewYork-Presbyterian serves to provide high-quality, convenient and affordable care with an emphasis on preventive health and wellness, according to the health system.
The new innovation institute will support NYP OnDemand, remote patient monitoring, which can help reduce patients’ length of hospital stays and preventable rehospitalizations, and teleparamedics for high-risk patients who leave the hospital. This service enables emergency management services teams who visit patients in their homes to connect to specialists and coordinate the patient/physician interaction in real time during the home visit.
The new institute will also support the clinical operations center, a remote monitoring system and command center that connects clinical care programs throughout the healthcare system. At this center, registered nurses can track physiologic data of patients in the emergency department in real time, as well as monitor the temperature of refrigerators that store medicine, the health system said.

Galapagos gains on Gilead rheumatoid arthritis plan

Gilead Sciences Inc. GILD, +1.08% announced Monday afternoon that it plans to ask the Food and Drug Administration to approve an arthritis drug this year. Gilead, in partnership with Galapagos NV GLPG, +3.53% has been testing a drug known as filgotinib for rheumatoid arthritis, and the latest study results excited investors in March. In a news release Monday, Gilead said that it met with the FDA to discuss those test results recently. “As a result of this discussion, a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019,” the release said.

Varian to acquire certain cancer-related assets from Boston Scientific for $90M

Aimed at increasing its footprint in cancer, Varian (NYSE:VAR) has agreed to acquire certain interventional oncology lines from Boston Scientific for $90M.
The portfolio of drug-loadable microsphere (Oncozene/Embozene Tandem) and bland embolic bead products (Embozene) are used to treat arteriovenous malformations and hypervascular tumors.
The products generated $21.2M in revenue in 2018.
Varian says the transaction will be immaterial to fiscal 2019 results and guidance but will be accretive to EPS in 2020.

Iovance up 4% premarket on bullish registration path for LN-145

Iovance Biotherapeutics (NASDAQ:IOVA) perks up 4% premarket on light volume in reaction to positive developments on the regulatory pathway for Fast Track- and Breakthrough Therapy-tagged LN-145.
Based on FDA feedback from its End of Phase 2 meeting with the agency, the company says its ongoing Phase 2 innovaTIL-04 study in cervical cancer may be sufficient to support a U.S. marketing application based on a clearer definition of the patient population, specifically, patients who have progressed following first-line systemic treatment for recurrent/metastatic cervical cancer. This population comprises almost all of the advanced patients enrolled in the trial to date.
LN-145 is a tumor-infiltrating lymphocyte therapy derived from the patient’s own immune cells (T lymphocytes). The cells are isolated from the patient’s tumor, expanded in the laboratory, then infused back into the patient where they recognize and kill cancer cells. Patients also receive pre-conditioning therapy to reduce the immune suppressive environment of the cancer and up to six doses of interleukin 2 (IL-2) after LN-145 infusion to support the growth and activation of the TIL therapy.
The company expects to file its BLA in H2 2020.