Novel Sleep Apnea Device OK'd

 A new device that prevents the tongue from rolling backwards during sleep, a common proximate cause of snoring and obstructive sleep apnea, won authorization Friday from the FDA.

The eXciteOSA product from Signifier Medical Technologies delivers electrical stimulation to four locations on and below the tongue. The manufacturer says the electrical current strengthens the tongue muscle so that it remains in its proper position during sleep.

Perhaps most noteworthy is that the device -- unlike virtually every other product intended to prevent snoring and sleep apnea -- is for use only when the patient is awake.

Specifically, the FDA explained, patients use the mouthpiece (the system also includes a separate handheld controller and a smartphone app) in daily 2o-minute sessions during wakefulness for 6-8 weeks, then once weekly afterward.

Safety and efficacy were tested in 115 patients with snoring, the FDA said. Participants used the device for 6 weeks followed by a 2-week washout period, at which point their snoring was reassessed. "Overall, the percent of time spent snoring at levels louder than 40dB was reduced by more than 20% in 87 out of the 115 patients," according to the FDA.

Additionally, 48 of these patients also had mild sleep apnea. In 41, the mean Apnea-Hypopnea Index (AHI) declined 48% from baseline (10.21 to 5.27).

The treatment was not without side effects, however. Among them: excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw, the FDA said.

Authorization also came with contraindications for the following groups:

• Patients with pacemakers or implanted leads
• Those with metallic implants, appliances, or jewelry in the mouth
• Potentially or definitely pregnant individuals
• Patients with sores in or around the mouth
• Individuals with AHI values of 15 or higher

The FDA recommends that patients undergo a comprehensive dental exam prior to initial use.

Because the agency classified the eXciteOSA device as low to moderate risk, it authorized marketing via the de novo premarket review pathway -- an intermediate process between 510(k) notification and full premarket approval.

https://www.medpagetoday.com/pulmonology/sleepdisorders/91082

White House: working to speed early production of J&J COVID-19 vaccine

 The Biden administration is exploring every option for increasing manufacturing of Johnson & Johnson's COVID-19 vaccine, which is under regulatory review, and said on Friday that currently expected levels of early doses were less than hoped.

The White House has invoked the Defense Production Act to help Pfizer Inc ramp up COVID-19 vaccine production and that "every option" was on the table to produce more Johnson & Johnson vaccine should it be authorized.

It will also use the wartime powers to increase at-home COVID-19 tests, and make more surgical gloves in the United States, officials said at a Friday media briefing.

"As is the case with other vaccines, we have not found that the level of manufacturing allows us to have as much vaccine as we think we need coming out of the gate," said Andy Slavitt, senior adviser to the White House’s COVID-19 response team, referring to the J&J vaccine.

J&J applied on Thursday for U.S. emergency use authorization. It expects to have some vaccine ready for distribution as soon as authorized but has not said how much.

Emergent Biosolutions' Chief Executive Robert Kramer said in an interview on Friday that the company currently is making bulk drug substance for J&J "at large scale." Emergent is only producing bulk vaccine, which is then filled into syringes or vials and packaged for shipment by another contractor.

Kramer said they were on track to make enough product for hundreds of millions of doses a year. It remains unclear what other supply bottlenecks may be. Kramer said his company had already benefited from the Defense Production Act under the Trump Administration, which helped the company get to the point where it's ready to go.

Under the authority of the Defense Production Act, the government will give priority ratings to two components important to Pfizer’s vaccine production - filling pumps and tangential flow filtration units, the officials said.

“We told you that when we heard of a bottleneck on needed equipment, supplies, or technology related to vaccine supply that we would step in and help, and we were doing just that,” said Tim Manning, the supply chain coordinator for the national COVID-19 response.

The government will also invoke its powers under the Defense Production Act to increase at-home COVID-19 tests with six, unnamed manufacturers, aiming to produce 61 million tests by the summer, Manning said.

It will also invoke its powers to increase the nation’s supply of surgical gloves, which are made almost exclusively overseas.

Manning said the government will build factories that make the raw materials for surgical gloves and help build plants in the United States to make the gloves.

Officials have said that once J&J's vaccine is authorized, it would mean that millions more doses would be available to states. The vaccine is one-shot, as opposed to Pfizer's and Moderna Inc's two-dose vaccines, and can be stored in a refrigerator.

Officials have hoped that the ease of giving the J&J vaccine will mean that states will be able to more quickly immunize residents.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-White-House-says-it-is-working-to-speed-early-production-of-J-J-COVID-19-vaccine-32370226/

Sinovac Biotech: COVID-19 vaccine effective in preventing hospitalization, death

 China's Sinovac Biotech on Friday said late-stage trial data of its COVID-19 vaccine from Brazil and Turkey showed the inoculation prevented hospitalization and death in COVID-19 patients, but had a much lower efficacy overall.

The 12,396-person trial found the CoronaVac vaccine was 100% effective for hospitalized, severe and fatal cases, 83.7% effective at stopping cases that require medical treatment and 50.65% for all cases, according to a statement. 

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/Sinovac-Biotech-says-COVID-19-vaccine-effective-in-preventing-hospitalization-death-32371342/

CanSino vaccine seeks emergency approval in Mexico

 China's CanSino Biologics Inc is formally seeking emergency use authorization in Mexico for its Covid-19 vaccine, Mexico's foreign minister said on Friday, as the company seeks quick approval prior to wide-scale distribution.

Foreign Minister Marcelo Ebrard wrote on Twitter that the one-dose CanSino vaccine has been successfully tested on more than 14,000 volunteers in Mexico since last October.

https://www.marketscreener.com/quote/stock/CANSINO-BIOLOGICS-INC-59318312/news/CanSino-vaccine-seeks-emergency-approval-in-Mexico-foreign-minister-32371504/

COVID-19 expected to take bite out of Super Bowl bets

 The Super Bowl typically creates a legal gambling frenzy in Nevada but fewer tourists in the Western state due to COVID-19 will likely keep wagers from setting a record despite Sunday's mouthwatering matchup.

Plenty of money is still expected to be wagered in Nevada ahead of the Super Bowl showdown between the defending champion Kansas City Chiefs and host Tampa Bay Buccaneers - but topping the record $158.6 million handle, or total amount of bets, set in 2018 is unlikely.

"In Nevada, (the) Super Bowl handle is driven by visitation dollars, and Las Vegas, along with other areas across the state, are destination markets for customers to come and wager on the game," Mike Lawton, senior research analyst for the Nevada Gaming Control Board said in an email.

Lawton also said that, due to the capacity limits sportsbooks are required to comply with because of the pandemic, "we estimate that betting totals will be softer when compared to amounts recorded over the last few years in spite of a great matchup."

Last year, sports bettors wagered $154.7 million in Nevada on the Super Bowl that pitted the Chiefs against the San Francisco 49ers. That was 6% above the 2019 championship game and 2.5% below the record $158.6 million wagered in the previous year.

The Chiefs, led by dynamic 25-year-old quarterback Patrick Mahomes, are vying to become the National Football League's first repeat champion in 16 years. On the other side, Bucs veteran quarterback Tom Brady, 43, is seeking a record-extending seventh Super Bowl championship.

The impact of COVID-19 on Super Bowl bets this year is expected to be felt across the United States, according to a recent survey by the American Gaming Association (AGA) industry group.

The AGA forecast $4.3 billion will be wagered on the NFL's championship game, down nearly 37% from last year, a drop attributed to pandemic restrictions at retail sportsbook operations and fewer casual bets in office pools or social settings.

But the pandemic has boosted online and phone betting. Among Super Bowl bettors, a record 7.6 million will place wagers on online sportsbooks this year, up 63 percent year-over-year, the AGA said. And phone betting has accounted for 82% of all legal sports betting nationwide during the crisis, according to the group.

Aside from the more traditional bets, gamblers can take a chance on proposition bets, such as the outcome of the coin toss before the game, deciding which team will score first, and what color liquid will be poured on the winning coach.

Among some of the more unique proposition bets offered are how many times Brady's supermodel wife Gisele Bundchen will be shown during the broadcast and which coach will lower their protective mask first and expose their nostrils. 

https://www.marketscreener.com/news/latest/NFL-COVID-19-expected-to-take-bite-out-of-Super-Bowl-bets--32371139/

Spark Therapeutics launches gene therapy trial for late-onset Pompe disease

 Pompe disease is a hereditary genetic disorder caused by a deficiency of acid alpha-glucosidase leading to build-up of glycogen in the lyosomes, which then causes cell damage in various tissues, in particular the heart, the muscles, the liver and the nervous system.

In patients living with late-onset Pompe disease the respiratory system and mobility are most frequently the most affected by the disease, often requiring the use of a wheelchair and respiratory assistance, and life expectancy can be reduced.

The company Spark Therapeutics has just announced that a first study participant has been dosed in the USA as part of an international gene therapy clinical trial. The product tested - SPK-3006 - is the result of collaboration with Genethon. It utilizes technologies developed at Genethon, and which, in mouse models, have already helped correct the build-up of glycogen in the muscles and nervous system.

The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). This study is taking place first in centers in the USA, and then should be continuing in Europe.

The study plans to recruit and treat around twenty patients, and is set to end in October 2023.

https://www.news-medical.net/news/20210203/Spark-Therapeutics-launches-gene-therapy-clinical-trial-for-late-onset-Pompe-disease.aspx

Ziopharm's activist drama continues as another board member resigns

 The very public and very bitter fight between Ziopharm Oncology and a minority activist investor continued Friday with the resignation of a board member to whom the latter had objected.

In a letter to shareholders sent Friday morning, Ziopharm announced it had accepted the resignation of Elan Ezickson, following calls to replace him from 3.3% stakeholder WaterMill Asset Management Corp. Ziopharm has not announced a replacement and it remains to be seen if they will, effectively shrinking the board to seven for the time being.

“Over the last several weeks the Board has taken further actions in response to shareholder feedback, including most recently accepting the resignation of Director Elan Ezickson,” Ziopharm said in a statement. “We sincerely thank Mr. Ezickson for his many contributions to the Board and wish him well.”

Ziopharm’s board has seen heavy churn in the last 18 months, appointing 5 new members during that time.

WaterMill launched its activist attack in early November, seeking to oust four of its then-eight board members and replace them with three individuals it had nominated itself — including WaterMill founder Robert Postma. Two of the four, Ezickson and Scott Braunstein, have now been replaced or left entirely, but WaterMill continues to call for Ziopharm chairman Scott Tarriff to step down as well.

The minority shareholder had also raised objections over a former board member at Ziopharm’s annual investor meeting over the summer, and that individual was replaced in September.

For those keeping score at home, WaterMill has essentially pressured out three of Ziopharm’s board members over the last six months. But Ziopharm has not nominated any of the three individuals put forth by WaterMill and continues to object to one specific nominee, Holger Weis.

After the proxy adviser Institutional Shareholder Services recommended last week that Ezickson and Tariff step down in favor of Weis and another WaterMill nominee, Ziopharm claimed Weis proved a key force in driving the biotech DemeRx to bankruptcy in 2018. Ziopharm highlighted several pieces from a publicly available Chapter 11 filing in 2018 detailing what it says shows a history of Weis’ corporate malpractice during his tenure as president, COO and CFO of DemeRx. The company reiterated those concerns in its Friday letter.

WaterMill subsequently accused Ziopharm of engaging in a “desperate, low-road smear campaign” and maintained Weis is a highly qualified nominee. Postma noted two former DemeRx executives vouched for Weis and claimed the filing from which Ziopharm quoted was cherry-picked and “completely unsubstantiated.”

With WaterMill aiming to submit its written consent letters next Friday, this drama may likely soon draw to a close, and Ziopharm acknowledged in its statement it’s “open to reaching a resolution.” But if the last month has given any indication — with the two entities fighting over the Thanksgiving weekend — the final act may not be pretty.

https://endpts.com/ziopharms-activist-drama-continues-as-another-board-member-member-resigns-is-the-end-in-sight/