Acadia Resubmits US Application For Expanded Use In Alzheimer's Psychosis

 Acadia Pharmaceuticals Inc 

ACAD +0.15%

 (Get Free Alerts for ACAD) has resubmitted its FDA supplemental marketing application for pimavanserin for hallucinations and delusions associated with Alzheimer's disease psychosis (ADP).

• This resubmission responds to the FDA's Complete Response Letter (CRL) to the supplemental marketing application initially submitted for a proposed indication for pimavanserin for dementia-related psychosis. 
• The resubmission provides additional analyses from two previously conducted clinical studies, HARMONY1 and Study -0192, to support a proposed indication for ADP and is intended to address the issues raised in the FDA's CRL.

https://www.benzinga.com/general/biotech/22/02/25665925/acadia-resubmits-pimavanserin-us-application-for-expanded-use-in-alzheimers-psychosis

Is Masimo 'Crazy Like A Fox' For Spending $1.03 Billion To Buy Sound United?

 Masimo stock crashed Wednesday on a nearly $1.03 billion foray into the consumer electronics world with its acquisition of Sound United.

The deal marries medical technology player Masimo (MASI) and privately held Sound United, a manufacturer of consumer audio devices like earphones and speakers. Masimo argued the $1.025 billion buyout gives it access to an established distribution channel with major retailers and a potential to cross-sell its products.

But investors and analysts weren't impressed.

"So, is this deal crazy? Or crazy like a fox?" Needham analyst Mike Matson asked in a report to clients. "We do not expect a positive reception from investors."

In morning trades on today's stock market, Masimo stock tumbled 26.1% near 169.20.

Masimo Stock: Unusual Buyout

The deal is unusual for a number of reasons, Matson said.

"This is the first time we have seen a medtech company move into non-health consumer products with a large acquisition," he said.

Further, the transaction will be dilutive to revenue growth and margins, but accretive to earnings. The company also doesn't expect any cost synergies, Matson noted.

Finally, there's a huge difference in valuation between the buyer and seller, he said. Masimo's market cap was roughly $12.6 billion early Wednesday. It's spending $1.025 billion to acquire Sound United. In 2021, Masimo generated $1.24 billion in sales. Sound United brought in $900 million.

Matson kept his hold rating on Masimo stock.

Earnings Beat Expectations

BTIG analyst Marie Thibault said investors likely will struggle valuing the new Masimo, which will be a blended medtech and consumer tech company.

"We commend Masimo's willingness to make a major leap to fulfill a multiyear vis

ion and understand the hesitancy to share more details for competitive reasons — but we are left with little concrete to point to over the near-to-mid-term that makes sense of this tie-up," she said in her note to clients.

Thibault maintained her neutral rating on Masimo stock. Masimo said the deal will close midyear.

Promisingly, Masimo reported in-line fourth-quarter sales of $327.6 million, up 11% on a reported basis. Adjusted earnings were $1.21 per share, above Masimo stock analysts' call for $1.10, Needham's Matson said.

Masimo also retained its 2022 revenue guidance for $1.35 billion, implying constant-currency growth of 9.5%. The company also expects to earn $4.34 per share. That was a hair below expectations and implies 8.8% growth, he said.

Still, Masimo stock plummeted to its lowest point in nearly two years after the open.

https://www.investors.com/news/technology/masimo-stock-is-its-sound-united-buyout-crazy/

Polycystic Ovary Syndrome Common in Teen Girls With T2D

 Nearly one in five adolescent girls with type 2 diabetes also had polycystic ovary syndrome (PCOS), researchers reported.

In a systematic review and meta-analysis of six studies, the prevalence of PCOS in a cohort of 470 girls with type 2 diabetes (T2D) was 19.58% (95% CI 12.02-27.14%, I²=74%, P=0.002), according to M. Constantine Samaan, MD, MSc, of McMaster Children's Hospital in Hamilton, Ontario, and colleagues.

And in a sensitivity analysis where the researchers excluded studies that didn't report PCOS diagnostic criteria, the calculated prevalence was 24.04% (95% CI 15.07-33.01%, I²=0%, P=0.92), they stated in JAMA Network Open.

However, the authors stressed that "Heterogeneity [among the studies] was moderate to high..results of this meta-analysis should be considered with caution because studies including the larger numbers of girls did not report the criteria used to diagnose PCOS, which is a challenge during adolescence."

Still, the "prevalence of pediatric T2D is increasing globally, and the majority of these patients are female," they pointed out, adding that the PCOS prevalence in the study was "substantially higher" than the PCOS prevalence in the average female adolescent population, which is estimated at 1.14% to 11.04%.

Ultimately, the relationship between type 2 diabetes and PCOS is "bidirectional" with insulin resistance playing a large role in the pathogenesis, and research "has shown that girls with PCOS have decreased insulin sensitivity and compensatory hyperinsulinemia," Samaan's group noted.

They added that early diagnosis is key for PCOS in order for girls to avoid associated complications, such as hypertension, hyperglycemia, dyslipidemia, cardiovascular complications, and even psychiatric comorbidities like anxiety and depression.

For the systematic review, the authors searched through several databases of cross-sectional, retrospective and prospective cohort studies. Of the 722 screened articles, they settled on five retrospective and one prospective. The mean age at type 2 diabetes diagnosis ranged from 12.9 to 16.1 years.

For a PCOS diagnosis, three studies used diagnostic criteria that included persistent oligomenorrhea and clinical or biochemical hyperandrogenism. The other studies used medical records or general clinical symptoms for a PCOS diagnosis, but didn't specifically define the exact symptoms used. These were the studies excluded from the sensitivity analysis.

In the two studies that reported PCOS prevalence by race -- one done in South India and one that included Aboriginal children in Canada -- prevalence was higher in Indian girls (23.10%) than white girls (17%).

Samaan's group noted that none of the included studies reported obesity so they could not determine if obesity played a role in the relationship between diabetes and PCOS, and that was a study limitation.

"The results of this study reflect the lack of consensus and difficulty in diagnosing PCOS in adolescents," the authors stated. "The European Society of Human Reproduction and Embryology/American Society of Reproductive Medicine (ESHRE/ASRM), the Pediatric Endocrine Society, and the International Consortium of Paediatric Endocrinology guidelines suggest that ultrasonography showing increased ovarian size could be used to aid in diagnosis, but other guidelines are more conservative in using these findings to diagnose PCOS."

The ESHRE/ASRM guidelines "state that biochemical hyperandrogenism needs to be present, and not just clinical signs of hyperandrogenism, whereas other guidelines state that either is sufficient for diagnosing PCOS," they added.

Samaan and colleagues called for a consensus in establishing pediatric criteria for PCOS diagnosis in order to cut down on the rate of misclassification, and to bolster the rate of accurate diagnoses.

Disclosures

Samaan and co-authors disclosed no relationships with industry.

Primary Source

JAMA Network Open

Source Reference: Cioana M, et al "Prevalence of polycystic ovary syndrome in patients with pediatric type 2 diabetes" JAMA Netw Open 2022; DOI: 10.1001/jamanetworkopen.2021.47454.

https://www.medpagetoday.com/endocrinology/diabetes/97195

Russian coach and doctor with doping past in focus over Valieva case

 

• There may be widespread outrage over Kamila Valieva testing constructive for a banned coronary heart drug. 
• Fingers are being pointed at her physician, coach, and different adults within the 15-year-old’s life.
• Valieva’s case has shone a lightweight on the circumstances endured by Russian youngsters who dominate determine skating.

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The turmoil engulfing a 15-year-old Russian determine skater who examined constructive for a banned substance has thrust her eminent coach and a health care provider with previous doping offences into the highlight on the Beijing Video games.

Teen skater Kamila Valieva was cleared on Monday to compete in her remaining occasion. However the drug cost towards her is unresolved and anti-doping authorities in Russia are unlikely to listen to her case till effectively after the Winter Video games finish.

As Valieva prepares to retake the ice on Tuesday, the position of her physician and coach, together with different adults within the prodigy’s sporting profession, has prompted outrage over how a minor might have taken the banned coronary heart drug trimetazidine.

Valieva’s case has shone a lightweight on the circumstances endured by the Russian youngsters who now dominate determine skating.

She informed Russia’s Channel One after coaching: 

These (previous few) days have been very tough for me.

“It is as if I haven’t got any feelings left. I’m pleased however on the identical time I’m emotionally drained.”

The World Anti-Doping Company (WADA) stated it might launch an impartial investigation into the adults surrounding Valieva. WADA stated the Russian Anti-Doping Company was already investigating.

US anti-doping officers stated the Russians who’ve directed Valieva may be prosecuted underneath the American Rodchenkov Act. The brand new legal guidelines empower US prosecutors to hunt fines of as much as $1 million and jail phrases of as much as 10 years, even for non-People, if their actions have affected the outcomes of US athletes.

Valieva’s coach Eteri Tutberidze, who is understood in skating circles for harsh coaching strategies, faces heightened scrutiny on the Beijing Video games. She is essentially the most extremely sought-after determine skating coach in Russia.

Filipp Shvetsky might be seen rink aspect throughout Russian determine skaters’ competitions and practices. The towering, dark-haired doctor works at a conflict veterans’ hospital in Moscow along with treating members of Russia’s determine skating staff.

Shvetsky and several other Russian rowers had been suspended from the game between 2007 and 2010 for anti-doping violations, stated Jim Walden, an lawyer for Grigory Rodchenkov, the previous head of Russia’s anti-doping laboratory who turned whistleblower.

Rowing’s worldwide governing physique stated on the time that the violations had been associated to prohibited intravenous infusions.

After his suspension was lifted, he joined the nationwide determine skating staff. The blame, Shvetsky stated in a 2016 interview, was placed on him within the hope of lowering the athletes’ suspensions.

Walden stated the physician’s prior offences and the accusations made in regards to the punishing surroundings Tutberidze creates for skaters made them prime targets for US investigators.

He stated:

They’ve somebody who has a disciplinary historical past with performance-enhancing medication already, and you’ve got an extremely controversial coach.

“The FBI and Division of Justice, I believe, are going to be wanting very laborious on the physician and the coach to see if they will piece collectively the proof.”

Tutberidze and Shvetsky haven’t been charged with any wrongdoing and Reuters has no proof of their potential position in Valieva’s constructive doping take a look at.

Tutberidze and Shvetsky didn’t reply to requests for remark.

A spokesperson for the US Division of Justice declined to touch upon Reuter’s inquiries about whether or not there was an lively investigation.

Tutberidze is a formidable presence. The willowy 47-year-old in sombre trench coats is a hanging presence rinkside and within the kiss-and-cry space the place determine skaters obtain their scores.

Tutberidze, who informed state tv on Saturday she was sure Valieva was “clear and harmless”, has Russian dad and mom going to nice lengths to have her prepare their kids.

Russian Olympian Yulia Lipnitskaya was 10 years outdated when she and her mom drove the 1 800 km (1 120 miles) between Yekaterinburg and Moscow to see Tutberidze. Lipnitskaya and her mom had agreed that if Tutberidze refused to coach her, she would give up the game, Russia’s Channel One reported.

Reuters was unable to achieve Lipnitskaya or her mom for remark.

Her skaters are among the many solely ones in girls’s competitors who can execute quadruple jumps.

Youthful skaters could have a bonus with the quad as a result of their slender hips and shoulders might assist them to rotate quicker within the air, Ithaca Faculty biomechanics skilled Deborah King stated.

A few of Tutberidze’s skaters have medalled on the Video games however retired throughout the subsequent Olympic cycle. Alina Zagitova and Evgenia Medvedeva, gold and silver medallists on the 2018 Pyeongchang Video games, have since left the game. Lipnitskaya, a staff gold medallist in Sochi on the age of 15, retired in 2017.

Igor Lyutikov, who coached Valieva as an eight-year-old and briefly labored with Tutberidze, praised the coach in an interview with Reuters in Moscow.

He stated her strict coaching strategies, which stored athletes and training workers on their toes, had revolutionised the game.

Lyutikov identified that athletes might select whether or not to be subjected to her coaching strategies. He recalled that when Tutberidze “got here out every single day as if on cue, no person relaxed.”

“Nobody is forcing you,” he stated. “However if you wish to soar, you have to work, you have to grind away.”

Champion sacrifices

Liptniskaya, who skated to Schindler’s Checklist in a stunning pink coat on the Sochi Olympics, serving to Russia to gold within the staff occasion, introduced her retirement in 2017 on the age of 19, citing an extended battle with anorexia.

Tutberidze stated in a 2014 interview that Lipnitskaya’s weight loss program consisted of powdered vitamins when she wanted to drop some weight.

Tutberidze stated in a uncommon interview with Russia’s Channel One in December that she kicked out Alina Zagitova from her coaching group as a result of “she had begun to get lazy”.

Zagitova, who at 15 grew to become Olympic champion in South Korea, might return on one situation, Tutberidze stated.

“The situation was that her mom wouldn’t dwell in Moscow and virtually not go to till an Olympic medal,” she stated within the interview. Zagitova didn’t reply to a request for remark.

The coach beforehand has admitted her harshness within the pursuit of gold.

She stated within the interview: 

Strictness and harshness are current at coaching classes as a result of generally I am extremely pissed off when an athlete is at coaching however can do significantly better.

“If I did not do this, the athlete would not have the medals and the enjoyment of stepping on the rostrum.”

https://newslogged.com/?p=810749

US 'could spend $22M monthly on testing unvaccinated federal workers'

 A White House official warned that the federal government could end up having to spend up to $22 million a month on testing employees for COVID-19 if the ban on President Biden's vaccine mandate isn't lifted.

Jason Miller, deputy director for the White House Office of Management and Budget, gave the assessment in a declaration cited by the Department of Justice on Monday, Reuters reported.

"While most federal civilian employees are fully vaccinated, hundreds of thousands of them are not vaccinated," Miller said in declaration made late last month. According to Miller, the federal government hires about 20,000 new employees every month and is unable to require them to get vaccinated.

Last month, a federal judge in Texas blocked Biden's vaccine mandate for federal workers, ruling that the mandate exceeded his authority as U.S. president.

Currently, workplace safety protocols requires federal employees to get tested weekly for COVID-19 if they are unvaccinated.

According to Miller, this requirement "could cost taxpayers on the order of $11 million to $22 million each month, or $33 million to $65 million each quarter."

He added that if the block on the vaccine mandate remains in place, "it will imperil the federal government's ability to protect the health and safety of the federal workforce." 

https://thehill.com/homenews/administration/594466-us-government-could-spending-22m-monthly-on-testing-employees-for

3G network shutdown will affect medical devices, phones: FCC

 Older adults and low-income Americans using older medical devices, cell phones and alert and alarm systems will need to replace or upgrade those devices ahead of a shutdown of 3G cellular networks and service, according to the Federal Communications Commission.

Mobile carriers are phasing out their 3G networks, which rely on older technology, to make room for their more advanced 5G network services. As a result, older 3G mobile phones and certain older 4G mobile phones that do not support Voice over LTE will not be able to make or receive calls and texts — including 911 services — or use data services. 

The 3G network shutdown will affect medical devices, alert systems, mobile phones, tablet computers, smart watches, vehicle SOS services, home security systems and other connected products using 3G network services. The AARP cites an estimate that as many as 10 million people will need new phones.

Plans and timing to phase out 3G services vary by company. AT&T announced it would finish shutting down its 3G network by Feb. 22, whereas Verizon‘s 3G network shutdown will take place by Dec. 31. T-Mobile announced it will shut down Sprint’s 3G CDMA network by March 31, Sprint’s 4G LTE network will shut down by June 30 and T-Mobile’s 3G UMTS network will be gone by July 1. No shutdown date has been announced for T-Mobile’s 2G network.

Many budget carriers — Cricket, Boost, Straight Talk and Lifeline mobile service providers — use the three major carrier networks and also will be affected. Some carrier websites provide lists of devices that will no longer be supported after 3G networks shut down, and discounts or free upgrades may be available.

The FCC offers programs to help eligible consumers with the cost of phone or internet services:

• FCC’s Lifeline program provides a discount on phone service for qualifying low-income consumers.

• FCC’s Emergency Broadband Benefit Program provides a temporary discount of up to $50 per month toward broadband service for eligible households during the COVID-19 pandemic.

The 2021 Link-Age Technology Survey found that smartphone ownership (83%) is up from 2019 (74%), and 58% of older adults own tablet computers.

https://www.mcknightsseniorliving.com/home/news/3g-network-shutdown-will-affect-medical-devices-phones-fcc/

CDC expected to update mask guidance as early as next week

 The Centers for Disease Control and Prevention is expected to loosen its indoor masking guidelines to states soon, according to several people familiar with the matter. The agency’s update could come as early as next week.

Dr. Rochelle Walensky, the director of the CDC, is expected to discuss masking guidance Wednesday at a White House Covid-19 Response Team briefing.

Nothing has been finalized yet, but the CDC is considering a new benchmark for whether masks are needed, basing it on the level of severe disease and hospitalizations in a given community, two people familiar with the situation said.

The White House has been eager for the CDC to provide an update on its indoor mask recommendation, although it wants the agency to get it right and it doesn’t want to appear as though it is putting political pressure on the agency, said the two people familiar with the plans, who weren’t authorized to speak publicly.

The White House declined to comment on the issue, and the CDC didn’t immediately respond to a request for comment. 

In recent weeks, new cases of the omicron variant of the coronavirus have been dropping in every state except Maine. Hospitalizations are declining nationwide, as well, according to an NBC News tally. 

New York and a number of other states led by Democratic governors — among the last to keep mask rules in place — have dropped their mask mandates for private businesses over the last few weeks as the omicron-fueled surge has abated. California is ending indoor mask requirements for vaccinated people beginning Wednesday. In addition, several large companies, including Tyson Foods, are moving to ease mask rules for vaccinated employees.

Dr. Anthony Fauci, the White House’s chief medical adviser, said Tuesday on MSNBC that the CDC will continue to modify recommendations as the trajectory of cases goes downward.

States’ making changes to their mask rules is “entirely understandable,” Fauci said. “At the local level, there is a strong feeling of need to get back to normality.”

Senior administration officials have asked Walensky to provide an update on masks before President Joe Biden’s State of the Union address on March 1, one of the people said. 

The agency currently recommends universal indoor masking in areas with substantial or high transmission, which is determined by the number of cases per 100,000 and the test positivity rate. The vast majority of counties in the U.S. fall under those criteria, according to CDC data. 

Walensky has previously said mask policies should be made at the local level, based on factors such as vaccination rates and hospitalization. Most public health experts agree that universal masking, along with vaccinations, is the most effective way to reduce Covid infections. Still, some states and local communities are shifting their strategies as more vaccines and treatments have become available and as the country has begun moving toward a “new normal.”

https://www.nbcnews.com/health/health-news/cdc-masks-cdc-expected-update-mask-guidance-early-week-rcna16331