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Monday, May 17, 2021

Incyte: Positive Results in Phase 3 Vitiligo Trial

 Primary and key secondary endpoints met in both TRuE-V1 and TRuE-V2 studies

-Data will support planned U.S. and EU regulatory submissions for ruxolitinib cream in vitiligo in the second half of 2021

Incyte (Nasdaq:INCY) today announced positive topline results from its pivotal Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream, an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy, in adolescent and adult patients (age ≥12 years) with vitiligo.

Both the TRuE-V1 and TRuE-V2 studies met the primary endpoint (p<0.0001 for both studies), demonstrating that significantly more patients treated with ruxolitinib cream 1.5% twice daily (BID) achieved a ≥75% improvement from baseline in the facial vitiligo area scoring index (F-VASI75) compared to patients treated with a vehicle control at Week 24.

The studies also met key secondary endpoints including patient reported outcomes. The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data, and no new safety signals were observed. The long-term efficacy and safety portions of both studies will continue as planned. Additionally, data from both studies will be submitted for publication and presentation at an upcoming scientific meeting in the second half of 2021.

https://finance.yahoo.com/news/incyte-announces-positive-results-phase-113000709.html

Adamis resubmits opioid overdose therapy application to FDA

  Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, today announced that the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for ZIMHI™, a naloxone injection product candidate intended for the treatment of opioid overdose.

“Based on FDA feedback received during our Type A meeting in April, we have resubmitted our NDA for ZIMHI, which I am confident fully addresses the issues raised in the November 13, 2020 Complete Response Letter,” said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals. “We are committed to working collaboratively with the agency as it conducts its review of the resubmitted NDA. I continue to believe the availability of additional naloxone products, especially our higher dose intramuscular injection product, which has definite advantages over the two approved intranasal products, could potentially save thousands of lives.”

https://finance.yahoo.com/news/adamis-pharmaceuticals-resubmits-zimhi-drug-113000579.html

AC Immune Expands Phase 1b/2a Alzheimer’s Vaccine Trial

 Previous interim results showing strong safety and potent immunogenicity support trial expansion and advancement of ACI-35.030 into Phase 2b/3

Alternative vaccine candidate also advances to second highest dose group based on encouraging interim results

AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that the Company and its strategic partner Janssen Pharmaceuticals, Inc., have expanded the ongoing Phase 1b/2a clinical trial of the Companies’ first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer’s disease (AD). The trial expansion, which is based on encouraging interim safety, tolerability and immunogenicity results to date, specifically includes vaccination of additional AD patients at the second highest dose to support continued development of ACI-35.030 into Phase 2b/3. In parallel, the trial continues to evaluate patients in the highest dose cohort, for which the first interim results will be available in Q4 2021.

Interim results from the low and second highest dose groups of the Phase 1b/2a trial showed that ACI-35.030 vaccination generated a potent antigen-specific antibody response against pTau in 100% of older patients with early AD with no clinically relevant safety concerns observed to date. These data, as well as additional interim Phase 1b/2a results, will be presented at an upcoming medical congress.

Long-term immunization with vaccines represents a valuable strategy for treatment and potentially prevention of AD and other neurodegenerative diseases. ACI-35.030 is the first AD vaccine candidate designed to generate antibodies that specifically target pathological pTau proteins in the brain. Anti-pTau antibodies generated continually in the body by ACI-35.030 have the potential to reduce and prevent the spread and seeding of Tau pathology, which is a major hallmark of AD.

https://finance.yahoo.com/news/ac-immune-announces-expansion-phase-110000905.html

ACC: Milestone Pharma Has Late-Breaker Presentation on Etripamil Data

 Statistically Significant Improvements in PSVT-Associated Symptoms and Less ER Visits Observed in Patients Treated with Etripamil Compared to Placebo in the NODE-301 Trial -

- Data Presented at the American College of Cardiology's 70th Annual Scientific Session -

Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the presentation of data related to key secondary endpoints from its Phase 3, multicenter, randomized, double-blind, placebo-controlled NODE-301 trial of etripamil nasal spray, the Company's novel investigational, short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT). The oral presentation, titled "Etripamil Nasal Spray Relieves Symptoms And Reduces Emergency Room Interventions In Patients With Paroxysmal Supraventricular Tachycardia (PSVT): Analysis Of Clinical Outcomes In The Node-301 Trial", was featured during a late-breaker session at the American College of Cardiology's 70th Annual Scientific Session (ACC.21) that was held in a virtual format. A copy of the presentation will be available in the Publications section of Milestone's website.

"With current standards of care for the acute termination of PSVT restricted to the burdensome and costly acute care setting, this condition represents an area of particularly high unmet need," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Etripamil holds the potential to enable patients to treat their episodes in the at-home setting and ultimately take control of their condition. We remain focused on the execution of our ongoing Phase 3 program and our vision to help patients suffering from episodes of SVT."

https://finance.yahoo.com/news/milestone-pharmaceuticals-announces-breaker-oral-110200451.html

Covid-19 Vaccine Works, Even if Side Effects Differ for All: Doctors

 Infectious-disease specialists are working to reassure people that they are still getting protection from Covid-19 vaccines, even if they don't experience the flulike side effects that hit some people after vaccination.

Fatigue, chills and other symptoms in the days following vaccination are evidence that the vaccine is having the desired effect on the body's immune system, according to public health officials. The U.S. Centers for Disease Control and Prevention and the World Health Organization say on their websites that side effects mean the body is "building protection" against the coronavirus.

That message may lead some people to infer that the absence of side effects indicates that vaccination isn't causing the body to build immunity to the virus. Yet infectious-disease doctors say most people get protection from the vaccines, even if they don't experience side effects.

"I don't think someone should correlate the extent of their reactions to the vaccine with protection from infection," said H. Cody Meissner, chief of the pediatric infectious diseases division at Tufts University School of Medicine in Boston. "We know that people who don't respond to a vaccine in terms of the side effects still are well protected. The vaccines work even if you don't have fatigue and headache and fever and muscle pain and joint pain."

Experts say more research is needed to establish what vaccine-related side effects, or their absence, tell us about the strength of people's immune responses. "There are just so many nuances in terms of how you respond," said Kathryn Edwards, professor of pediatrics and a vaccine researcher at Vanderbilt University School of Medicine in Nashville, Tenn.

Dr. Edwards said there is a biological basis to tell people "it's good to feel bad" because side effects can be a sign of an immune response. But, she added, "I think we should have confirmation there is a relationship." She said she has fielded questions from vaccine recipients who didn't experience side effects and worried that the absence meant they weren't getting protection.

Vaccines against other diseases have been known to cause side effects because the immune response releases inflammatory substances in the body.

A small study conducted recently by scientists at the University of Pennsylvania found that people who had more robust side effects after receiving either of the two leading vaccines in the U.S. -- from Pfizer Inc./ BioNTech SE and Moderna Inc. -- had slightly higher antibody levels than those who had less robust side effects. Yet all people getting the vaccine in the study had good immune responses, said study co-author E. John Wherry, director of the Penn Institute for Immunology.

The Pfizer and Moderna vaccines use RNA-based technology and can cause similar side effects. Ranging from injection-site pain, fatigue, headache, muscle pain, joint pain, in addition to fever and chills, these typically arise within a day of vaccination and resolve within a couple of days. The side effects can often be managed by taking acetaminophen or another pain reliever.

The vaccines were at least 94% effective at protecting against Covid-19 in separate, large clinical trials that started last year.

Injection-site pain or swelling is the most common reaction, occurring in 92% of Moderna vaccine recipients and 84% of those getting the Pfizer shot, the studies found.

A Pfizer spokeswoman said side effects don't indicate the level of immunity conferred by its vaccine. It wouldn't be able to demonstrate such high efficacy, if the only people protected were the ones with symptoms, she said.

Moderna didn't immediately reply to a request for comment.

Johnson & Johnson's one-shot Covid-19 vaccine uses a different technology than the Pfizer and Moderna shots. A large study found that injection-site pain affected about 49% of recipients, while headache, fatigue or muscle ache occurred at lower rates. A small number of J&J vaccine recipients have developed serious blood clots.

Age appears to be a factor in determining who experiences side effects. People over age 65 are less likely than younger people to experience side effects. Older adults tend to have less robust immune responses to vaccines.

Vanderbilt's Dr. Edwards said women appear to be more likely than men to experience the side effects, which may be related to hormonal or weight differences.

The Food and Drug Administration says age, sex and general health likely influence the occurrence and severity of common side effects in the first couple of days after vaccination. Side effects don't correlate with the effectiveness of a vaccine in an individual, an FDA spokeswoman said.

Some doctors say heredity may also play a role. "I am sure that our genes at some level determine differences in these responses," Paul Offit, director of the vaccine education center at Children's Hospital of Philadelphia, said of varying levels of symptoms following vaccination.

For some receiving the RNA vaccines, side effects are more pronounced after the second dose, making it hard for people to work or be active. In contrast, people who were previously infected with the coronavirus have had more pronounced side effects after the first dose, Dr. Edwards said.

Major Hayden, a 38-year-old software developer living near San Antonio, said he began feeling chills, fatigue and fever several hours after getting the second dose of Moderna's vaccine in early May. He took acetaminophen and began to feel better the following day.

"For me it just seemed like the risks from the vaccine were much smaller than the risks of Covid," he said.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Covid-19-Vaccine-Works-Even-if-Side-Effects-Differ-for-All-Doctors-Say-33276309/

Virus testing strategies, opinions vary widely in US schools

 Children are having their noses swabbed or saliva sampled at school to test for the coronavirus in cities such as Baltimore, New York and Chicago. In other parts of the U.S., school districts are reluctant to check even students showing signs of illness for COVID-19.

Education and health officials around the country have taken different approaches to testing students and staff members — and widely varying positions or whether to test them at all as more children give up virtual classrooms for in-person learning. Some states have rejected their share of the billions of dollars the Biden administration made available for conducting virus tests in schools.

Officials in districts that have embraced testing describe it as an important tool for making sure schools reopen safely and infections remain under control. They note that the virus might otherwise elude detection since young people with the virus often are asymptomatic and most teachers have been vaccinated.

But many school administrators and families, weary of pandemic-related disruptions, see little benefit in screening children, who tend not to become as sick from COVID-19 as adults. Meanwhile, each positive test that turns up at a school can trigger quarantine orders that force students back into learning from home.

In Nebraska, Superintendent Bryce Jorgenson said he doubts parents with children in the Southern Valley Public School District would embrace school-based virus tests. His rural, 370-student district eliminated its mandatory mask policy in March.

“I can tell you right now, I would say that not just in our district, but in many districts around, there is not an appetite for that at all,” he said of ongoing screening. “I don’t know as a leader, too, if I want to get into testing kids because we don’t test kids for any other virus, really.”

Elected officials in Iowa and Idaho made their opinions known by turning down millions in federal aid for voluntary COVID-19 testing in schools.

“Here’s your $95 million back,” Iowa Gov. Kim Reynolds, a Republican, declared on Fox News after commenting that in her view, President Joe Biden “thinks that COVID just started.”

In Idaho, the state House of Representatives rejected $40.3 million in offered funding.

“Schools are not medical facilities, and we shouldn’t want to place that responsibility and liability on our schools,” Republican state Rep. Tammy Nichols said in an email. “That is why we have medical facilities and staff who are licensed, certified and insured to handle those things.”

Experts are divided about how worthwhile it is to test for the coronavirus inside schools as more people are vaccinated and confirmed cases decline.

Joshua Salomon, a professor of medicine at Stanford University who supports screening students, said the procedure could help curb outbreaks involving more contagious variants.

“Basically, it gives you an insurance policy against things we may not be able to anticipate,” Salomon said. “The virus has really kind of caught us off guard in a few instances.”

But Dr. Monica Gandhi, a professor of medicine at the University of California, San Francisco, said the nation’s vaccination program makes the tests less useful because immunized individuals are so much less likely to get infected. At the same time, she said, false positives in school settings carry significant consequences when they cause a return to online learning.

Screening tests have played a key role in reopening plans for schools in New York City and liberal-leaning states like California and Massachusetts.

Some districts, like Baltimore City Public Schools, use so-called pooled testing methods that combine multiple samples from students in kindergarten to eighth grade; a positive result leads to everyone in the pool being quarantined. The district is using individual saliva-based PCR tests to screen its high school students..

“By doing this screening testing, you can actually catch the cases early, and that is really effective at preventing transmission,” Cleo Hirsch, who oversees the testing in Baltimore’s public schools, said.

In Chicago, surveillance testing for COVID-19 was part of the district’s reopening agreement with the teachers union. For elementary students who are at least 10, the district tests a percentage at random, focusing on zip codes with the most confirmed COVID-19 cases. The district tests a sampling of high school students citywide. The tests require parental consent.

In Massachusetts, which also relies on pooled testing, the collected data indicates a positivity rate within schools of 2 cases for every 1,000 people, said Russell Johnston, a senior associate commissioner at the state’s Department of Elementary and Secondary Education.

“That just again gives us enormous confidence in the mitigation strategies that we have available in the schools,” he said.

Oregon is beginning to pilot testing of unvaccinated school employees and plans to expand the health surveillance effort to children attending overnight summer camp before deciding how to proceed in the fall. Some school administrators have expressed trepidation about adding surveillance testing, state epidemiologist Dr. Dean Sidelinger said.

“COVID has added 12 new challenges every hour for them on top of everything else they were already burdened with,” Sidelinger said. “So many of them just kind of, I think instinctively, said, ’No, you cannot ask us to do another thing.’”

In Minnesota, the 8,500-student Edina Public Schools has quarantined hundreds of close contacts of students with positive results. The district began a “Test The Nest” surveillance program at its high school and middle schools in mid-March in an attempt to identify individuals without symptoms who are carrying the virus, spokeswoman Mary Woitte said.

But Nicole Schnell, of the group Edina Parents 4 Progress, opposes the expanded testing, saying a single positive case can lead to massive disruptions.

Schnell said her daughters, age 15 and 18, spent two weeks quarantined in the fall and another two weeks in the spring despite testing negative because they were considered close contacts of people who were infected. Her 17-year-old son decided to keep attending classes virtually because he didn’t want to risk a potential exposure that might force him to miss the spring baseball season.

“I have seen firsthand effects of keeping kids out of society,” Schnell said, adding that one of her children was diagnosed with depression after being quarantined. “We are not just talking about out of school. We are talking about out of any sport that they play, out of any activity, out of anything outside, out of seeing their friends, because of a potential positive exposure.”

https://apnews.com/article/coronavirus-pandemic-education-health-082ade974a5c3257b9f7baa35cb9eec2

Airlines May Start Weighing Passengers Amid Obesity Crisis

 The issue of weighing passengers before flights have been a challenging one. It may not be known to travelers but calculating the weight of an aircraft is critical to flight safety that informs pilots of much fuel the aircraft needs, hence why check-in baggage is weighed. But now, "U.S. airlines may need to start weighing passengers to comply with FAA rules," according to travel website View From The Wing.

"For safety reasons, carriers need to calculate an aircraft's weight and balance, and it has to be within allowable limits for the plane. However, the assumptions they've been using for passengers are outdated," said Gary Leff, a world travel expert who penned the piece on View From The Wing. 

Leff said Americans are becoming more obese, and that's become a significant problem for the aviation industry and the federal government who want to find out how much passengers weigh for smaller aircraft. 

He said the FAA realizes passenger weight can fluctuate by route, and airlines want to document this difference for safety reasons and fuel calculation, adding that "standard weights may not be appropriate for smaller planes, with smaller sample size and greater likelihood of variance from average."

An analysis from aviation research firm AirInsight Group LLC. says the pending FAA weight and balance rule "is going to make American air travelers very unhappy. VERY UNHAPPY." 

The group said airlines would update "standard average passenger weights," and these weights increase regularly. Airlines are being told they need to weigh crew, bags, and passengers. 

The language in the FAA document has guidance on examining travelers weight:

"Regardless of the sampling method used, an operator has the option of surveying each passenger and bag aboard the aircraft and should give a passenger the right to decline to participate in any passenger or bag weight survey. If a passenger declines to participate, the operator should select the next passenger based on the operator's random selection method rather than select the next passenger in a line. If a passenger declines to participate, an operator should not attempt to estimate data for inclusion in the survey."

The document continued: 

"An operator that chooses to weigh passengers as part of a survey should take care to protect the privacy of passengers. The scale readout should remain hidden from public view. An operator should ensure that any passenger weight data collected remains confidential."

There was no mention of when the new pending FAA weight and balance rule goes into effect, but it will undoubtedly irritate some travelers who can barely stand wearing a mask. 

https://www.zerohedge.com/medical/airlines-may-start-weighing-passengers-amid-obesity-crisis