In Japan, vending machines help ease access to COVID-19 tests

 In Japan, convenience is king and getting tested for COVID-19 can be highly inconvenient. Part of solution, as it is for a range of daily necessities in Tokyo, has become the humble vending machine.

Eager to conserve manpower and hospital resources, the government conducts just 40,000 polymerase chain reaction (PCR) tests a day, a quarter of its capacity, restricting them to people who are quite symptomatic or have had a high chance of being infected.

That’s led to the public to rely heavily on private clinics or buying PCR tests by other means.

Vending machines selling test kits offer consumers the option of avoiding crowded clinics or having to wait for an appointment, said Hideki Takemura, director of the Laketown Takenoko Ear Nose and Throat Clinic which has set up seven machines in the greater Tokyo area.

“Japan was conducting a ridiculously low number of PCR tests and as a result more and more people couldn’t tell whether they had a cold or the coronavirus,” Takemura told Reuters. “Without PCR tests, no diagnosis is possible and I really felt we had to do more so that people could be diagnosed early and isolate early.”

Takemura said there was a huge response from the public when the machines were first deployed and some needed to be emptied of money twice a day.

Demand has since ebbed somewhat as a third wave of cases subsided amid a state of emergency. New cases in Tokyo have averaged around 250 over the past seven days compared with several days of more than 2,000 in early January.

Each vending machine holds about 60 testing kits which sell for 4,500 yen ($40). Customers then mail off a saliva sample for processing.

“As a medical worker, I’d be very happy if the number of tests decrease along with cases,” Takemura said.

Japan has about 4.1 million vending machines in operation, the most in the world per capita, according to a trade group.

In addition to vending machines, PCR tests have become increasingly available to the public via sales at drugstores or over the internet.

https://www.reuters.com/article/us-health-coronavirus-japan-vending-mach/in-japan-vending-machines-help-ease-access-to-covid-19-tests-idUSKBN2B00WO

Genentech Withdraws US Indication For Tecentriq In Metastatic Bladder Cancer

Genentech, a member of the Roche Group (RHHBY), said Monday that it will voluntarily withdraw the U.S. indication for Tecentriq or atezolizumab in prior-platinum treated metastatic urothelial carcinoma or mUC, bladder cancer.

The company said it has taken the decision as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals.

"While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients," said Levi Garraway, chief medical officer and head of Global Product Development.

The company noted that it will work with the U.S. Food and Drug Administration over the coming weeks to complete the withdrawal process. But, the decision will not affect other approved indications for Tecentriq. 

https://www.nasdaq.com/articles/genentech-withdraws-us-indication-for-tecentriq-in-prior-platinum-treated-metastatic

CytoDyn to Release CD12 Trial Detailed Results via Form 8-K Monday, March 8

 CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it will release the CD12 clinical trial data via a Form 8-K after the investment community webcast on Monday, March 8, 2021. The Company’s recently completed CD12 Phase 3 trial evaluated leronlimab for the treatment of patients with severe-to-critical COVID-19.

A summary of the key findings from this CD12 Phase 3 trial with leronlimab as a treatment for severe-to-critically ill COVID-19 patients is as follows:

	1.	Survival benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab versus placebo for invasive mechanical ventilated critically ill patients.
	2.	Shortened time to recovery: The average length of hospital stay was lower in leronlimab group compared to placebo/SoC group in the critically ill population with a statistically significant p-value of 0.0050 using the Rank-ANCOVA model.
	3.	Discharge alive: In addition, the patients who received leronlimab in this group demonstrated an improved probability of "discharged alive" at Day 28 (28% versus 11%), a 166% better rate than in the placebo group.
As a consequence of an imbalance among enrolled patients over 65 years of age and under 65, an “age adjustment” analysis was performed, which resulted in the following primary endpoint analysis:
	4.	Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.
	5.	Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant SoC for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.
	6.	Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65. https://finance.yahoo.com/news/cytodyn-release-cd12-trial-detailed-111000908.html

Cigna (NYSE:CI) Releases FY 2021 Earnings Guidance

 Cigna (NYSE:CI) issued an update on its FY 2021 Pre-Market earnings guidance on Monday morning. The company provided earnings per share (EPS) guidance of 20.00 for the period, compared to the Thomson Reuters consensus estimate of $20.29. The company issued revenue guidance of $165 billion, compared to the consensus revenue estimate of $165.72 billion.

https://www.marketbeat.com/instant-alerts/nyse-ci-earnings-guidance-2021-03/

Passage Bio (PASG) Granted FDA Fast Track for 3 Gene Therapy Candidates

 Passage Bio, Inc. (Nasdaq: PASG) announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s three lead investigational gene therapies: PBGM01 for the treatment of GM1 gangliosidosis (GM1), PBFT02 for frontotemporal dementia with granulin mutations (FTD-GRN), and PBKR03 for Krabbe disease. Passage Bio plans to initiate clinical trials in GM1 in the first quarter of 2021 and in FTD-GRN and Krabbe disease in the first half of 2021.

https://www.streetinsider.com/Corporate+News/Passage+Bio+%28PASG%29+Granted+FDA+Fast+Track+Designation+for+Three+Gene+Therapy+Candidates+Targeting+Rare+CNS+Disorders/18092519.html

Popular Fort Lauderdale venue bans spring breakers under 23

 A popular party spot in Fort Lauderdale, Florida, is restricting who will be allowed in during the spring break season.

On Friday, The Wharf Fort Lauderdale posted an announcement on social media, saying it won’t admit any out-of-state spring breakers under the age of 23. 

"During Spring Break season #WharfFTL will be 23+ for all guests with out-of-state ID," the announcement said. 

According to the South Florida Sun Sentinel, the venue had also posted a sign near the entrance on Friday night that says: "Must be 23+ to enter with out of state ID."

The newspaper reported that The Wharf’s new policy is designed to avoid huge crowds and slow the spread of coronavirus. 

According to the venue’s Facebook post, "walk-ups are welcome," but reservations are recommended in order to get guaranteed admission. 

"Masks must be worn at all times while walking through common areas and when not eating or drinking," the post said.

Emi Guerra, a co-owner of The Wharf, told the Sun-Sentinel that the bar would operate at 50-60% capacity. 

According to the newspaper, The Wharf closed "for months" in 2020 because of the pandemic and when it opened for just two days in November, it was cited by health officials a few times after pictures of the venue were posted online showing unmasked patrons who weren’t following social distancing rules.

When it reopened in January, the venue had more coronavirus safety measures in place, including a single entrance and exit, and more distancing between seating areas, the Sun-Sentinel reported.

https://www.foxnews.com/travel/wharf-fort-lauderdale-bans-spring-breakers

U.S. crowd-safety firm Evolv to go public in $1.7 billion SPAC deal

 U.S. crowd-safety company Evolv Technology said on Sunday it is combining with blank-check firm NewHold Investment Corp to go public in a deal that will value it at about $1.7 billion.

Evolv is backed by investors including Microsoft co-founder Bill Gates and venture capital firm General Catalyst.

The deal is expected to close in the second quarter, and the company expects to trade on the Nasdaq under the ticker “EVLV”, according to the Wall Street Journal, which first reported the news.

Special-purpose acquisition companies, or SPACs, are shell companies that raise funds to acquire a private company with the purpose of taking it public, allowing such targets to sidestep a traditional initial public offering to enter public markets.

An increasing number of companies are merging with an SPAC, as it involves less regulatory scrutiny and more certainty over the market valuation and funds raised.

Evolv uses AI technology and sensors to screen people in public spaces such as stadiums, hospitals, schools and entertainment venues among others, eliminating gaps presented by metal detectors, according to its website.

The company lists customers including Six Flags Entertainment Corp, New York City’s Metropolitan Museum of Art, and the Lincoln Center.

https://www.reuters.com/article/evolv-ma-spac/u-s-crowd-safety-firm-evolv-to-go-public-in-1-7-bln-spac-deal-idUSL4N2L60AV